Search Results

The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

Ask a specific question about this device

The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

Ask a specific question about this device

T2Candida® 1.1 Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assy for the direct detection of Candida species in K₂EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups:

• 1. Candida albicans and/or Candida tropicalis
• 2. Candida parapsilosis
• Candida glabrata and/or Candida krusei 3.

The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei.

The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.

The T2Candida positive and negative External Controls (T2Candida QCheck Positive Kit and the T2Dx QCheck Negative Kit) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.

The T2Candida 1.1 Panel and T2Dx Instrument is comprised of the T2Candida 1.1 Panel performed on the T2Dx Instrument. The T2Candida 1.1 Panel is a qualitative molecular diagnostic assay that employs a whole blood compatible PCR amplification followed by T2 magnetic resonance (T2MR) detection. The T2Candida 1.1 Panel is performed on the T2Dx Instrument which executes all steps after specimen loading. A K₂EDTA whole blood specimen is loaded onto the T2Candida 1.1 Sample Inlet, which is then placed on the T2Candida 1.1 Cartridge along with the T2Candida 1.1 Reagent Tray. The Reagent Tray contains the internal control, amplification reagent, enzyme and the probe-coupled superparamagnetic particles for each Candida target. Two milliliters of the blood specimen is transferred to the T2Dx Instrument where lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA takes place. Amplification products are detected by T2MR detection using species-specific probes which are attached to the superparamagnetic particles. The assay identifies Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei. The test does not distinguish between C. albicans and C. tropicalis. The test does not distinguish between C. glabrata and C. krusei

The provided text describes a 510(k) premarket notification for the T2Candida 1.1 Panel, aimed at amending labeling to include pediatric patients. The information focuses on analytical and clinical performance to demonstrate substantial equivalence to a previously cleared device.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence by relying on previously obtained performance data and additional tests for pediatric populations and cross-reactivity. Explicit acceptance criteria for clinical performance are not directly stated in percentages (e.g., minimum sensitivity/specificity), but the summary indicates "acceptable performance" was demonstrated. The analytical acceptance criteria for cross-reactivity are defined for the new tests.

Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and the data provenance:

• Clinical Performance (Pediatric):
  • Sample Size: A total of 246 pediatric samples were evaluated across two peer-reviewed publications.
  • Data Provenance: The data came from existing studies (peer-reviewed publications) where the T2Candida 1.1 Panel was utilized. The document does not specify the country of origin, but generally, such studies supporting FDA submissions would often include data from the US or other regions with comparable clinical practices. The studies were retrospective in the sense that they were "existing studies" identified and utilized for this submission, although the original data collection within those studies might have been prospective.
• Analytical Cross-Reactivity:
  • Sample Size:
    • Initial testing: 3 replicates per organism at 10^6 CFU/mL.
    • For organisms showing initial cross-reactivity: Additional 6 replicates (from two additional sample preparations) at 10^6 CFU/mL, and 3 replicates at lower concentrations (1000 CFU/mL, 100 CFU/mL, 33 CFU/mL).
  • Data Provenance: This appears to be prospective laboratory testing conducted specifically for this submission, as it's described as "Additional cross-reactivity testing was performed in this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Clinical Performance (Pediatric): The ground truth for this segment of the study was primarily established by blood culture results. The document does not mention the use of experts (e.g., radiologists) for establishing this ground truth, as it's a molecular diagnostic device measuring specific microbial presence. Blood culture is a laboratory-based gold standard for candidemia diagnosis.
• Analytical Cross-Reactivity: Ground truth for this was based on known spiked concentrations of the organisms and the inherent characteristics of the T2Candida 1.1 Panel's detection mechanism (T2 signal cutoff). No external human experts are mentioned for ground truth establishment here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Clinical Performance (Pediatric): Not applicable. The ground truth was based on blood cultures.
• Analytical Cross-Reactivity: A form of adjudication was applied for cross-reactivity. If an organism demonstrated cross-reactivity at 10^6 CFU/mL, it was "further evaluated with additional replicates from two additional sample preparations." Furthermore, the rule for confirming cross-reactivity was: "Results were not considered cross-reactive if only one replicate demonstrated cross-reactivity." This implies a majority rule or consistency requirement rather than a specific expert consensus adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a molecular diagnostic test for detecting Candida species directly from blood, not an imaging-based AI diagnostic. Therefore, a multi-reader multi-case study involving human readers and AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, this is effectively a standalone device. The T2Candida 1.1 Panel (and T2Dx Instrument) runs the assay and provides results (positive/negative for specific Candida groups, or invalid). Its performance is evaluated intrinsically through its ability to detect the target organisms (clinical sensitivity/specificity) and avoid false positives/negatives (analytical cross-reactivity). While a clinician interprets the results, the device's diagnostic output itself (e.g., "Candida albicans/tropicalis detected") is generated by the algorithm/system without human intervention in the diagnostic process of reading the T2MR signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Clinical Performance (Pediatric): Primarily blood culture results.
• Analytical Cross-Reactivity: Known concentrations of spiked organisms in blood, with the "ground truth" for cross-reactivity being the absence or presence of specific amplification and detection events as defined by the assay's cutoffs.

8. The sample size for the training set:

• The document does not explicitly mention a "training set" in the context of machine learning, as this is a molecular diagnostic device with a defined mechanism (T2MR technology, PCR amplification) rather than a machine learning algorithm that learns from data. Its "training" is inherent in its design and optimization during development, validated by analytical and clinical studies. No specific sample size for "training" is provided in the submission summary.

9. How the ground truth for the training set was established:

• As above, "training set" and its associated ground truth establishment methods (e.g., expert labels for images) are not applicable in the typical AI/ML sense for this device. The development process for such molecular diagnostics involves extensive analytical characterization (e.g., limit of detection, inclusivity, exclusivity, precision studies) to define performance parameters and establish expected results, which serves a similar function to providing "ground truth" for the device's operational parameters.

Ask a specific question about this device

T2 PLUS is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (PANO), Cephalometric (CEPH), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the Xray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

The provided document describes the T2 Plus digital X-ray imaging equipment, focusing on its substantial equivalence to a previously cleared predicate device rather than presenting a detailed study with acceptance criteria for a novel AI or diagnostic algorithm. Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly stated or applicable in this 510(k) summary.

However, I can extract the information pertinent to the device's performance evaluation and a "study" conducted to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" for diagnostic performance in terms of metrics like sensitivity, specificity, or AUC, as it's a submission for substantial equivalence of imaging equipment, not a new diagnostic algorithm that interprets images. The study's aim was to show equivalent image quality to the predicate device.

Note: The acceptance criteria are inferred from the study's objective: to demonstrate equivalent image quality for diagnostic purposes. No specific quantitative thresholds (e.g., "score must be X or higher") are provided.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: A total of 31 cases were reviewed.
  • CT: 10 cases
  • Cephalometric (Ceph): 10 cases
  • Panoramic (Pano): 11 cases
  • For each case, both the proposed device (T2-CS-P) and the predicate device (T2-CS) images were reviewed, meaning 31 image sets from T2-CS-P and 31 image sets from T2-CS.
• Data Provenance: Not explicitly stated regarding country of origin. The study states images were from "patients of the same gender and similar age group, under identical conditions." It implies retrospective image collection from existing patients, as it refers to "patients" not trial participants.
  • Given the manufacturer is based in the Republic of Korea, the data may originate from there, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: "A radiologist" (singular) was used as the "evaluator."
• Qualifications of Experts: The qualification provided is "a radiologist." No further details on years of experience, sub-specialty, or board certification are given.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/None explicitly described. Since only one radiologist served as the evaluator, there was no need for adjudication among multiple readers. The radiologist's assessment served as the primary evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

• MRMC Study: No. This was not an MRMC study. It involved a single evaluator (radiologist) comparing images from the proposed device and predicate device.
• Effect Size: Not applicable, as no MRMC study was performed and no quantitative diagnostic performance metrics (e.g., sensitivity, specificity, AUC) were reported. The evaluation was qualitative ("scores... were identical").

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

• Standalone Study: Not applicable. The device is imaging equipment. The "study" evaluated the image quality of the equipment as interpreted by a human radiologist, not the performance of an independent AI algorithm. There is no AI component described that would operate in a "standalone" mode for diagnostic interpretation.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for purpose of this image quality comparison was the expert consensus/opinion of a single radiologist regarding the image quality and its adequacy for diagnosis. This is not a "true" clinical ground truth from pathology or long-term outcomes, but rather a subjective assessment of image utility.

8. The Sample Size for the Training Set:

• This information is not provided. The document focuses on performance testing for substantial equivalence, not on the development of an AI model that requires a training set. The device is X-ray imaging equipment, not an AI diagnostic algorithm, so the concept of a "training set" for the device itself is not applicable in the typical sense of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no description of a "training set" for an AI model within the context of this device's performance evaluation.

Ask a specific question about this device

The T2Bacteria Panel run on the T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) test for the direct detection of bacterial species in K2EDTA human whole blood specimens with suspected bacteremia. The T2Bacteria Panel identifies six species of bacter baumannii, Enterococus faccium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus.

The T2Bacteria Panel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory data. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification and for organisms not detected by the T2Bacteria Panel.

Results from the T2Bacteria Panel are not intended to be used as for diagnosis, treatment, or other patient management decisions in patients with suspected bacteremia.

The T2Bacteria Panel detects and identifies six bacterial target species directly from whole blood specimens and independent of blood culture using nucleic acid amplification and proprietary T2MR detection technology. The assay is performed on the proprietary T2Dx platform. The whole blood specimen, drawn into a blood collection tube containing K₂EDTA is used for the test. The blood collection tube containing a minimum of 3 mL of blood is loaded directly onto the T2Dx instrument as part of the assembled Cartridge, a single use self-contained unit that contains all of the reagents and disposables required to run a single test. Fully automated on the T2Dx, the blood specimen is mixed with the Lysis Reagent to lyse the red blood cells and the bacterial cells are concentrated by centrifygation. The Internal Control is added to the concentrated bacterial cells, which then undergo a bead beating step to lyse the bacteria cells. The supernatant containing the DNA from the lysed bacterial cells and the Internal Control are amplified with the target and Internal Control specific primers. The generated amplicon is then aliquoted into individual tubes containing target specific conjugated particles for Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and the Internal Control. These individual tubes are read in the MR reader and a signal is generated.

Up to seven specimens can be loaded onto the T2Dx Instrument in parallel. When running a single specimen, the first result is reported in 3.5 hours from the specimen is loaded onto the instrument. The results are interpreted using the T2Dx applications software as valid or invalid, and if valid, target specific results are reported as Positive or Target not Detected. For one target, the Escherichia coli channel, results are reported as Positive, Indeterminate, or Target not Detected. An Indeterminate result is a valid result, but the presence or absence of Escherichia coli cannot be definitively assessed, and the indeterminate status applies only to the Escherichia coli channel. Results are displayed on the T2Dx touchscreen and can be printed. Raw T2MR data are not available to the end user.

Here's a summary of the acceptance criteria and study details for the T2Bacteria Panel, specifically concerning the addition of Acinetobacter baumannii detection:

Acceptance Criteria and Device Performance for Acinetobacter baumannii

Study Details for Acinetobacter baumannii Performance

1. Test Set Sample Size and Data Provenance:

   • Clinical Performance Study (Prospective Arm): 1,427 subjects were enrolled prospectively.
     • Provenance: US (indicated by "evaluated at eleven sites within the US").
     • Type: Prospective.
   • Clinical Performance Study (Contrived Arm):
     • 50 contrived specimens directly for A. baumannii.
     • 300 blood samples not spiked with A. baumannii members (250 of these spiked with other T2Bacteria Panel organisms).
     • Provenance: Healthy donor whole blood, prepared at internal/external lab.
     • Type: Contrived (spiked samples).
   • Reproducibility Study: Total of 108 replicates (36 replicates per sample per site) for each test concentration and negative control, conducted across three sites.
   • Analytical Reactivity (Inclusivity) Study: 14 strains tested, 3 replicates each (20 replicates if initial false negative).
   • Analytical Specificity (Exclusivity) Study: 128 different organisms tested.
   • Interfering Substances Study: 3 replicates for each substance tested.
   • Evaluation of False Positive Results (Retrospective): 980 valid samples (98 replicates for each of 10 reagent lots).
   • Additional A. baumannii Contrived Samples: 33 unique strains tested.

2. Number of Experts and Qualifications for Ground Truth (Clinical Study):

   • The document implies that species identification for positive blood cultures was performed by standard laboratory methods (Gram stain, bioMerieux Vitek® 2, bioMerieux or Bruker MALDI TOF, and PCR). It does not specify the number of individual experts or their years of experience for establishing the ground truth from blood cultures. The ground truth relies on conventional microbiology techniques as the reference method.

3. Adjudication Method for Test Set:

   • The document does not explicitly describe an adjudication method for the clinical study results in terms of conflict resolution between multiple reviewers. The primary comparison is the T2Bacteria Panel results against the blood culture reference method.
   • For potential false positive analyses, there was a hierarchy: "Other Blood Culture positive," "Sequencing positive," "Strong evidence of infection," "Other evidence of infection," and "No evidence of infection" were used to re-evaluate T2+/BC- cases. This acts as a form of retrospective adjudication or re-classification of discrepant results.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, not an AI-assisted interpretation tool for human readers. It provides a direct result (Positive/Negative for specific bacteria), so there's no "human readers improve with AI vs without AI assistance" effect size to be measured. The output is from the device itself.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance metrics (PPA, NPA, LoD, Reproducibility, Specificity, Inclusivity) reported are for the standalone device (T2Bacteria Panel on the T2Dx Instrument) without human input for result interpretation other than loading the sample and reading the final result from the instrument's display or printout. The "algorithm" here refers to the instrument's internal processing and detection logic.

6. Type of Ground Truth Used:

   • Clinical Study: Gold Standard for bacteremia was blood culture (with species identification by Gram stain, Vitek® 2, MALDI TOF, and PCR). For some discrepant cases (T2+/BC-), gene sequencing from blood samples and clinical outcomes/other culture positives were used for further analysis.
   • Analytical Studies (LoD, Reproducibility, Inclusivity, Exclusivity, Interference, Competitive Inhibition): Ground truth was established by known concentrations of spiked bacterial strains (confirmed by colony count where applicable).

7. Training Set Sample Size:

   • The document does not explicitly state the sample size for a "training set" in the context of machine learning. This device uses T2 Magnetic Resonance (T2MR) technology and nucleic acid amplification, which points towards a rule-based or signal-processing algorithm rather than a typical machine learning model that would require a distinct "training set" for model development. The development and optimization of the assay would have involved numerous experiments, but these are generally referred to as assay development or verification, rather than a "training set" for AI.

8. How Ground Truth for Training Set was Established:

   • As there isn't a traditional "training set" in the AI/ML sense, the concept of ground truth establishment for it doesn't directly apply. The assay development would have involved extensive analytical studies using well-characterized bacterial strains at known concentrations, with confirmation by standard microbiological methods (e.g., colony counting) to establish the true presence and quantity of targets. These analytical studies ensure the robust performance of the underlying molecular and T2MR detection principles.

Ask a specific question about this device

The T2Biothreat Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the T2Dx Instrument. The T2Biothreat Panel detects nucleic acids from the following organisms directly from K2EDTA whole blood samples:

1. Bacillus anthracis (plasmids pXO1 and pXO2)
2. Francisella tularensis
3. Burkholderia spp. (B. mallei/B. pseudomallei)
4. Yersinia pestis
5. Rickettsia prowazekii

The T2Biothreat Panel will not distinguish between detection of Burkholderia mallei and Burkholderia pseudomallei but will present valid detections as a positive detection of Burkholderia species.

The T2Biothreat Panel is intended to test individuals with signs and symptoms of infection from biothreat agents and/or individuals who are at risk for exposure or may have been exposed to these agents. The T2Biothreat Panel is indicated as an aid in the diagnosis of anthrax, tularemia, melioidosis, glanders, typhus fever and plague in response to suspected or confirmed bioterrorism events or outbreaks. Diagnosis of infection must be made in conjunction with clinical, epidemiologic and other laboratory data. Results are for the presumptive identification of Bacillus anthracis, Francisella tularensis, Burkholderia spp. (B. mallei), Yersinia pestis and Rickettsia prowazekii. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidel by the relevant public health authorities. The definitive identification of Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis or Rickettsia prowazekii requires additional testing and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be required. Positive results do not rule out co-infections with pathogens not included on the T2Biothreat Panel. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The T2Biothreat Panel is indicated for use in laboratories that have the appropriate biosafety equipment, personal protective equipment (PPE), containment facilities, and personnel trained in the safe handling of clinical specimens potentially containing biothreat organisms.

The T2Biothreat Panel is indicated for use in laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.

This assay is not FDA-cleared or approved for testing blood or plasma donors.

The T2Biothreat Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the T2Dx Instrument. The T2Biothreat Panel detects nucleic acids from the following organisms directly from K2EDTA whole blood samples: Bacillus anthracis (plasmids pXO1 and pXO2), Francisella tularensis, Burkholderia spp. (B. mallei/B. pseudomallei), Yersinia pestis, and Rickettsia prowazekii. The T2Biothreat Panel is run on the T2Dx, a fully automated, benchtop instrument. During processing on the T2Dx, intact pathogen cells are concentrated directly in whole blood, then lysed to release the target DNA. After amplification, target amplicon is hybridized with superparamagnetic particles and then detected by T2MR. The Internal Control on the T2Biothreat Panel monitors performance for each sample. The T2Biothreat Panel is a qualitative molecular diagnostic assay that employs whole blood compatible PCR amplification followed by T2 Magnetic Resonance (T2MR) detection. The T2Biothreat Panel is performed on the T2Dx Instrument, which executes all steps after specimen loading, with the capability of loading up to seven blood specimens at the same time. Individually, a KeEDTA whole blood specimen containing a minimum of 3 mL is loaded directly onto the T2Biothreat Sample Inlet, which is then placed on the T2Biothreat Cartridge along with the T2Biothreat Reagent Tray. The Cartidge and Reagent Tray contain the lysis reagent, internal control, primers, enzyme, buffer and probe-coupled superparamagnetic particles for each detected tarqet. After loading into the T2Dx. the blood specimen is mixed with the red blood cell lysing reagent and the bacterial cells and human cellular debris are concentrated by centrifygation. The internal control is added to the concentrated pellet and a bead-beating process lyses the bacterial cells. The supernatant containing the DNA from the lysed bacterial cells and the internal control is amplified using the target and internal control-specific primers. The generated amplified product is aliquoted into individual tubes containing target-specific probe conjugated particles for each detected target and the internal control. The amplified to target-specific probes attached to superparamagnetic particles causing clustering of the particles. The hybridization occurring in individual tubes is analyzed in the T2MR reader and a signal for each target is generated, which indicates the presence of the target organism(s). This automated process is the same process followed by the FDA cleared T2Candida and T2Bacteria Panels performed on the T2Dx Instrument system. When running a single specimens simultaneously, the first specimen will be reported in approximately 4 hours from the specimen is loaded onto the instrument. The results are interpreted by the device software as valid or invalid (based on the result of the internal control or target detections), and if valid, results are reported as "Positive" or "Target not Detected" for each specific target.

Here's a breakdown of the acceptance criteria and study information for the T2Biothreat Panel, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes standalone performance studies for the T2Biothreat Panel. It does not mention any multi-reader multi-case (MRMC) comparative effectiveness study.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Performance):

  • Negative Arm: Undisclosed number of K2EDTA whole blood samples from healthy donors (no signs/symptoms of infection) and febrile donors (fever ≥ 100.4 °F).
  • Positive Arm: Sequence-verified clinical bacterial strains spiked into whole blood collected from febrile donors. The sample sizes for the positive arm are listed as:
    • B. anthracis (pXO1 & pXO2): 6 (< LoD), 32 (1-3x LoD), 12 (3-5x LoD) = 50 samples
    • Burkholderia spp.: 17 (< LoD), 77 (1-3x LoD), 6 (3-5x LoD) = 100 samples
    • F. tularensis: 7 (< LoD), 35 (1-3x LoD), 8 (3-5x LoD) = 50 samples
    • R. prowazekii: Undisclosed (< LoD), 10 (1-3x LoD), 40 (3-5x LoD) = 50 samples
    • Y. pestis: 26 (< LoD), 24 (1-3x LoD), undisclosed (3-5x LoD) = 50 samples
  • Data Provenance: Not explicitly stated regarding country of origin, but implies clinical samples from "7 geographically diverse sites" and "healthy and febrile donors." The study appears to be prospective in its design, using collected samples for testing.

• Test Set (Analytical Performance - Reproducibility): Sample types consisted of negative K2EDTA-treated whole blood and various positive K2EDTA-treated whole blood samples (single, dual, and triple species spikes) at 1-1.5x LoD or 2-3x LoD. The total number of replicates for each condition varied but was sufficient to achieve the stated agreements (e.g., 128 replicates for B. anthracis at 1-1.5x LoD, 379 for negatives).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: For this in vitro diagnostic device, ground truth for the clinical performance study was established by spiking sequence-verified clinical bacterial strains into whole blood samples at specific concentrations, meaning the "truth" was known by controlled experimental design rather than expert human interpretation of results. No external "experts" were used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• Not Applicable: As the clinical performance study involved spiking known concentrations of sequence-verified bacterial strains into samples, the ground truth was inherently known. There was no need for an adjudication method as the results are compared directly against the known composition of the spiked samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of how human readers improve with or without AI assistance. This device is an automated in vitro diagnostic panel, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance (Algorithm Only)

• Yes: The entire set of analytical and clinical performance studies presented (Limit of Detection, Analytical Reactivity, Analytical Specificity, Reproducibility, Interfering Substances, Competitive Inhibition, Clinical Performance Characteristics) represents the standalone performance of the T2Biothreat Panel without human-in-the-loop for interpretation or decision-making. The device is fully automated, and results are interpreted by the device software.

7. Type of Ground Truth Used

• Known Spiked Concentrations / Sequence-Verified Strains: For both analytical and clinical performance, the ground truth was established by carefully spiking known concentrations of sequence-verified clinical bacterial strains into K2EDTA whole blood samples. This provides a definitive "true positive" or "true negative" status against which the device's performance is measured.
• For the negative arm of the clinical study, the ground truth was based on samples from "healthy donors" (presumed negative) and "febrile donors" (presumed negative for the target biothreat agents unless proven otherwise through the spiking).

8. Sample Size for the Training Set

• Not provided/Applicable in the sense of ML training data: The document does not explicitly mention a "training set" in the context of machine learning model training data. This is an in vitro diagnostic device that uses a pre-defined algorithm (nucleic acid amplification followed by T2 magnetic resonance detection) rather than a machine learning model that requires a distinct training phase with labeled data. The development of the assay (primers, probes, algorithm parameters) would have involved extensive R&D and optimization, but this wouldn't be referred to as a "training set" in the same way as for AI/ML.

9. How Ground Truth for the Training Set Was Established

• Not Applicable (for ML training data): As noted above, the concept of a separate "training set" for an AI/ML model with established ground truth is not explicitly addressed or relevant in the provided text for this in vitro diagnostic device. The "ground truth" during device development and optimization would come from standard microbiological and molecular biology techniques to confirm the presence, identity, and concentration of target organisms.

Ask a specific question about this device

T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.

T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

The provided document is a 510(k) summary for the T2 imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria for clinical performance, sample sizes, expert qualifications, and ground truth establishment from a clinical trial perspective are not available in this document. The document explicitly states: "No clinical studies are submitted."

Here's a breakdown of the available information based on the prompt's questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity) against a clinical ground truth. Instead, the substantial equivalence hinges on non-clinical performance tests demonstrating compliance with relevant standards and technical specifications being similar to the predicate device.

The closest to "acceptance criteria" are the performance specifications listed in the "Substantial Equivalence Matrix" (pages 4-5) which compare the proposed device (T2) to the predicate device (T1-CS, T1-C). These are primarily technical specifications rather than diagnostic performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical studies were submitted. Non-clinical performance tests were conducted, but details on the "test set" for those are not provided in terms of origin or type (e.g., phantom data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies were submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies were submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The T2 device is an X-ray imaging system, not an AI-assisted diagnostic tool. No clinical studies, let alone MRMC studies, were reported.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The T2 device is an X-ray imaging system, not an AI algorithm. Its performance is related to image acquisition and reconstruction, not autonomous diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies were submitted. For the non-clinical performance, the "ground truth" would be established by physical measurements and adherence to technical standards.

8. The sample size for the training set

Not applicable. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. This device is a hardware imaging system, not a machine learning algorithm.

Ask a specific question about this device

The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.

The T2 Femoral Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Retrograde Nailing System and update the Indications for Use for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System to include the compatibility of components with the T2 Alpha Femur Retrograde Nailing System.

This submission encompasses multiple systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System) that have similar intended use and will be used together during the surgical procedure.

The T2 Alpha Femur Retrograde Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6A14V ELI) as per ASTM F136.

Additionally, the T2 Alpha Femur Retrograde Nailing System will be used with the existing locking screws most recently cleared in K200880 (Titan Tibial Nailing System), the locking screws and advanced locking screws of IMN Screws System (K191271), the condyle screws and nuts most recently cleared in K200880 (T2 Femoral Nail System), the Compression Screw Femur most recently cleared in K191271 (T2 Alpha Antegrade GT/PF Nailing System), and the end caps most recently cleared in K200880 (T2 Supracondylar Nail System), The T2 Alpha Femur Retrograde Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The T2 Alpha Femur Antegrade GT/PF Nailing System most recently cleared in K191271 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).

The sterile implants (Femoral Nail GT, Femoral Nail PF, Compression Screw Femur, and End Cap GT/PF, Set Screws) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6A14V ELI) per ASTM F136 and PEEK. The targeting devices are manufactured from stainless steel, PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws most recently cleared in K200880 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K200880), the Lag Screw Recon of T2 Recon System (K200880), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K191271), the locking screws and advanced locking screws of IMN Screws System (K191271), the distal targeting device femur antegrade of IMN Instruments System (K191271) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).

The T2 Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and various end caps are manufactured from titanium alloy and are used with the nails. The T2 Tibial Locking Nail is available in two versions, each differing from the other only in diameter, length and number and orientation of screw holes.

The T2 Femoral Nail is a cylindrical, cannulated titanium allow tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

This is a 510(k) premarket notification for multiple intramedullary nailing systems, not a study describing the acceptance criteria and performance of a device, especially not one using AI or requiring human-in-the-loop performance. Therefore, most of the requested information regarding acceptance criteria for an AI/device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for various bone fixation systems. The "performance data" section refers to mechanical and material testing, not human performance or AI performance.

Here's an attempt to answer the relevant questions based only on the provided text, while acknowledging that many questions are not applicable to this type of submission.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with corresponding device performance values as would be typical for clinical or AI-based performance studies. Instead, it states that "Comparative mechanical testing to the predicate systems demonstrated substantial equivalence." and "Mechanical testing demonstrated that the T2 Alpha Femur Retrograde Nailing System is equivalent to the predicate devices (K200880, K101622)."

The specific performance tests conducted were:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a premarket notification for a medical device (intramedullary nailing system), not an AI/software device that would typically have a "test set" of patient data. The performance data provided is mechanical and material testing. Therefore, information about patient data sample size, country of origin, or retrospective/prospective nature is not applicable. The sample sizes for the mechanical tests would be specific to each test protocol but are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. Manual bone fixation devices do not typically involve experts establishing "ground truth" for patient data in the same way as an AI diagnostic device. The evaluation of these devices is primarily through engineering, mechanical, and material testing against established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. There is no "test set" of patient data or clinical observations requiring adjudication for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The document is for mechanical bone fixation devices and does not involve AI or human "readers" (e.g., radiologists, pathologists). No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This submission is for physical medical devices (intramedullary nailing systems), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM F1264, F2052, F2213, F2182, F2119) and the performance characteristics of the predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no training set.

9. How the ground truth for the training set was established

This question is not applicable. This is not an AI/machine learning device, so there is no training set or ground truth establishment method for one.

Ask a specific question about this device

The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion.

The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to hip joint, Nonunions and malunions.

The T2 Supracondylar Nail System is indicated for: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures including those with intra-articular extension, Fractures distal to total hip prosthesis, Nonunions and malunions.

The T2 Recon Nail is indicated for: Subtrochanteric fractures, Intertrochanteric fractures, Ipsilateral neck/shaft fractures, Comminuted proximal femoral shaft fractures, Femoral fixation required as a result of pathological disease, Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following: Open and closed femoral fractures, Pseudarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Nonunions and malunions.

The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis, Previously infected arthrosis (second degree), Revision of Failed Ankle Arthrodesis, Failed Total Ankle Replacement, Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot, Osteoarthritis, Nonunions or Pseudarthrosis of hindfoot and distal tibia, Malunited tibial pilon fracture, Charcot foot, Severe endstage degenerative arthritis, Severe defects after tumor resection, Pantalar arthrodesis.

The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following: Aseptic failed total knee arthroplasty, Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathological fractures, impending pathological fractures, and tumor resections, Ipsilateral femur fractures, Failed external fixation, nonunions and malunions, Periarticular fractures where repair is not possible, Knee arthrodesis.

The T2 Tibial Nailing System is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The T2 Tibial Nailing System is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.

The T2 Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

The T2 Recon Nail System is a family of nails for various types of femoral fractures. The system includes Recon Nails in various lengths and diameters (both left and right versions), Lag Screws, Locking Screws, end caps, an Antegrade Set Screw and other accessories for use with the nails.

The T2 Greater Trochanter Nail (GTN) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Ankle Arthrodesis Nail is a fluted, cannulated, titanium alloy nail and has a compression screw to provide internal compression of the upper ankle joint. The nail is inserted using an open or closed technique and can be locked in static, dynamic or compression mode. The T2 Ankle Arthrodesis Nail and accessories are intended for single use only. The T2 Ankle Arthrodesis Nail is available in left and right version in diameters 10 mm to 13 mm with the length ranging from 150 mm to 480 mm in increments of either 20mm or 50 mm. It has a 5 "lateral bend.

The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis Nail is available in lengths from 540 mm to 780 mm in 40 mm increments, and in diameters from 10 mm to 15 mm.

This document describes the Stryker GmbH T2 Nail Systems, which are intramedullary fixation rods. The submission is a Traditional 510(k) Premarket Notification (K200880).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are not explicitly enumerated in a numerical or pass/fail table format within the provided excerpt. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

The reported device performance is demonstrated by showing that the newer components (IMN Locking Screws) perform equal to or higher than the previously cleared components (T2 Locking Screw) in various test disciplines.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "computational assessment" or "various test disciplines." It mentions "constructs of T2 nails and IMN Locking Screws" were compared to "constructs of T2 nails used with T2 Locking Screw." For the T2 Femoral Nail System, "new Student t-tests were performed with the corrected data input" and "the 09mm Synthes Solid Femoral Nail (K923580), which was tested in the same manner and statistically compared to the T2 Femoral Nails." These phrases imply testing was conducted on an unspecified number of physical or computational models.
• Data Provenance: The data appears to be from retrospective testing and analysis, as it refers to comparisons with "previously cleared" components and "reevaluation of the dynamic fatigue strength testing." There is no mention of country of origin for the data; typically, such non-clinical testing would be conducted in the manufacturer's R&D facilities or contracted labs, likely within the regions where the manufacturing or development is centered (e.g., Switzerland, as per the Sponsor's address, and/or the US).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission relies on non-clinical (benchtop) testing and computational assessment, not clinical data or expert visual assessment of medical images for ground truth. Therefore, the concept of "experts" establishing ground truth for a test set in the way it would apply to AI/imaging devices is not directly applicable here. The "ground truth" is defined by the objective, measurable mechanical properties and performance characteristics established through engineering principles and testing standards. Regulatory bodies (like the FDA) evaluate this data.

4. Adjudication Method for the Test Set

Not applicable, as this is non-clinical testing. Adjudication methods like "2+1" or "3+1" are typically used for clinical study data where multiple human readers are involved in assessing outcomes or classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "Clinical testing was not required for this submission." MRMC studies are typically performed for diagnostic or AI devices where human reader performance is a key variable. This device is a mechanical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a mechanical implant (intramedullary fixation rod), not an algorithm or AI. The performance demonstrated is intrinsic to the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by objective, measurable mechanical properties and performance characteristics derived from:

• Computational assessments (e.g., "IMN Screws DOF 25-039 Functional Interface Analysis-Locking Screws").
• Mechanical testing (e.g., "dynamic fatigue strength testing").
• Statistical comparisons against predicate devices ("Student t-tests").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The data presented is from verification and validation testing of a mechanical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:

• · Neuropathic osteoarthropathy (Charcot)
• · Fracture fixation
• · Osteotomies
• · Non-unions
• · Mal-unions
• · Fusions

The T2 ICF System is a cannulated intramedullary nail system intended for internal fixation and stabilization of various foot instabilities and reconstructions. The T2 ICF system includes sterile packed implants (intramedullary nails and endcaps) available in various diameters and lengths to better accommodate patient anatomy as well as non-sterile instrumentation (targeting devices). The intramedullary nails are assembled with a pre-loaded compression screw, which allows for the nail to compress the bony fragments. The sterile packed intramedullary nails (including the preloaded compression screw) and endcaps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.

Additionally, the T2 ICF System will be used with an existing subset of VariAx 2 bone screws (previously cleared under K191412) to achieve fixation of the nail.

Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.

This document describes the T2 ICF System, a cannulated intramedullary nail system for internal bone fixation. Since the provided text is an FDA 510(k) summary, it details the substantial equivalence of the device to existing predicate devices, rather than presenting a study proving acceptance criteria for a novel AI device or software. Therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.

Here's an analysis of the provided information within the context of your request, focusing on what is available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense for an AI/software device. Instead, it describes bench testing conducted to demonstrate "substantial equivalence" to predicate devices. The performance is reported in terms of successfully meeting the requirements of these tests to prove equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The document describes bench testing for a physical medical device, not a software or AI device that uses a "test set" of data. The "tests" refer to laboratory-based evaluations of material and mechanical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of this document, refers to established scientific and engineering standards and validated testing methodologies described in ISO and ASTM standards. The "experts" involved would be the engineers and scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for expert consensus in cases involving interpretation of medical images or outcomes, which is not relevant to the bench testing described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices; the T2 ICF System is a physical bone fixation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The T2 ICF System is a physical medical device. There is no algorithm or AI component discussed in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench testing described in this document is represented by established scientific and engineering standards (e.g., ISO 10993, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119, ANSI/AAMI ST72) and the performance characteristics of the legally marketed predicate devices. The "truth" is whether the subject device performs equivalently to these established benchmarks and predicate devices.

8. The sample size for the training set

This information is not applicable. There is no training set as the device is a physical product, not an AI or machine learning model.

9. How the ground truth for the training set was established

This information is not applicable for the same reason given in point 8.

Ask a specific question about this device