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Found 75 results
510(k) Data Aggregation
(106 days)
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
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.
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(120 days)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A,
T22B, T25B, T25C)
The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.
The device provides hair reduction using Intense Pulsed Light technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).
The Intense Pulsed Light technology works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.
In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.
The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.
The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.
The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.
The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.
Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.
Specifically, the following information is missing from the provided document:
- A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
- Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
- Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
- Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
- MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
- Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
- Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
- Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
- How the ground truth for the training set was established: Not applicable.
The "Performance Data" section (Page 16) only lists compliance with:
- Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
- Electrical Safety and EMC Safety: IEC 60601 series standards.
- Eye Safety: IEC 62471 standard.
- Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."
These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.
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(204 days)
T2 Alpha Femur Retrograde Nailing System
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.
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(267 days)
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.
The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable
The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Supporting Performance |
|---|---|---|
| Accuracy | ±0.1℃ | Bench Testing (ISO 80601-2-56) |
| Measurement Range | 25-45℃ | Bench Testing (ISO 80601-2-56) |
| Electrical Safety | Complies with IEC 60601-1 | Bench Testing (IEC 60601-1) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 | Bench Testing (IEC 60601-1-2) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatibility testing |
| Operating Environment | +5 to +40°C, ≤80% humidity (non-condensing), 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Storage Environment | -20℃ to 55℃, ≤93% humidity, 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Compatibility with Monitors | Verifies compatibility with Mindray Model PM-8000 and other YSI 400 series compatible monitors | Bench Testing |
Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.
The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.
7. Type of Ground Truth Used
The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:
- Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
- International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
- Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.
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(266 days)
T2Candida 1.1 Panel
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:
-
- Candida albicans and/or Candida tropicalis
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- 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
| Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Clinical Performance (Pediatric) | Acceptable performance for detecting Candida albicans, Candida parapsilosis, Candida glabrata, and Candida krusei infection in pediatric patients. (Implied: performance comparable to adult studies and sufficient for clinical utility). | Sensitivity (PPA): Ranged from 50-100% in pediatric studies. |
| Specificity (NPA): Ranged from 97-99% in pediatric studies. | ||
| (Note: These ranges are from external peer-reviewed publications used to support the submission, and low prevalence of positive blood cultures (1.2%) was observed in these studies, which can impact PPA/NPA interpretations). | ||
| Analytical Cross-Reactivity | Cross-reactivity defined as an increase in T2 signal above the established cutoff for the Candida detection channel when tested at clinically relevant concentrations, requiring both amplification with Candida primers and detection with capture probes. (Acceptance: No cross-reactivity at clinically relevant concentrations). | Of 5 organisms tested at 10^6 CFU/mL, 2 (S. agalactiae, H. influenzae) showed some cross-reactivity initially. |
| Retesting at "clinically relevant concentrations" (100-1000 CFU/mL): | ||
| S. agalactiae: No cross-reactivity observed at 1000 CFU/mL, 100 CFU/mL, or 33 CFU/mL. | ||
| H. influenzae: No cross-reactivity observed at 1000 CFU/mL or 100 CFU/mL. (One instance of 1/3 positive at 100 CFU/mL was observed but not deemed cross-reactive after additional replicates). | ||
| N. meningitidis, S. mitis, L. monocytogenes: No cross-reactivity at 10^6 CFU/mL. | ||
| Internal Control | Internal Control (IC) must be valid for the test to be considered acceptable. (Implicit: Pass rate for IC under various conditions). | Valid for all cross-reactivity tests (3/3 or 6/6 depending on replicates). |
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."
- Sample Size:
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.
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(282 days)
T2 Plus
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Produce images of "same diagnostic quality" as predicate. | "Upon reviewing the evaluator’s scores, it was confirmed that the scores for each question were identical for both the proposed device and the predicate device. This demonstrates that both devices deliver the same level of performance and quality." |
"In conclusion, the imaging evaluator confirmed that both the proposed device and the predicate device produce radiological images of adequate quality for dental and orthodontic diagnosis." |
| Produce "radiological images of equivalent quality" for diagnosis. | "This confirmed that the proposed device and the predicate device produce radiological images of equivalent quality, making them suitable for diagnosis." |
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.
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(133 days)
T2Bacteria® Panel
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
| Criteria Category | Acceptance Criteria (Targeted) | Reported Device Performance for Acinetobacter baumannii |
|---|---|---|
| Limit of Detection (LoD) | Lowest concentration (CFU/mL) detected at ≥ 95% | 3 CFU/mL (for both tested strains) |
| Reproducibility | High accuracy/concordance across sites, lots, days, operators. | 1-2x LoD: 100% Accurate (108/108), 95% CI 96.6-100 |
| 3-4x LoD: 100% Accurate (108/108), 95% CI 96.6-100 | ||
| Negatives: 100% Accurate (108/108), 95% CI 96.6-100 | ||
| Analytical Reactivity (Inclusivity) | Detection of multiple strains at 2-3x LoD. If false negative, must pass with 19/20 replicates. | Passed for all 14 evaluated strains. One strain (BAA-747) initially showed 2/3 detection but passed with 20/20 replicates upon retesting. |
| Analytical Specificity (Exclusivity) | No cross-reactivity with non-panel species at 1,000 units/mL. | No reactivity detected for 90 non-reactive bacteria species, 11 fungal species, and 9 viral species at 1,000 CFU/mL (or TCID50/mL, Copies/mL for viruses). |
| Interfering Substances | No interference from common endogenous/exogenous substances. | No interference observed from 13 endogenous and 22 exogenous substances at tested concentrations, with the exception of Ferumoxytol (Feraheme). Ferumoxytol at concentrations ≥ 21 µg/mL interferes with performance. |
| Competitive Inhibition | No competitive effects in co-infection scenarios. | No competitive effects observed in samples containing competing species (panel targets or non-panel organisms) at ≤1,000 CFU/mL. |
| Clinical Performance (Overall PPA) | Calculated against samples with titer ≥ LoD (contrived) and blood culture positives (prospective). | 97.5% (39/40), 95% CI 87.1% - 99.6% |
| Clinical Performance (Overall NPA) | Calculated from all samples (including |
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(152 days)
Digital Thermometer, Model T28, T28L
The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.
Digital Thermometer, Model T28, T28L
The provided document is an FDA 510(k) clearance letter for a Digital Thermometer, Model T28, T28L. This device is a standard medical instrument for measuring body temperature and does not involve AI or complex algorithms requiring extensive studies as described in the prompt's request.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML-driven medical devices, are not applicable to this specific product.
Here's a breakdown based on the characteristics of the device and the provided document:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of AI/ML performance. For a digital thermometer, acceptance criteria would typically involve accuracy, precision, response time, and environmental operating limits, as defined by international standards (e.g., ISO 80601-2-56 for clinical thermometers). These technical performance specifications are usually provided in the device's design and testing documentation submitted to the FDA, but they are not detailed in this clearance letter. The letter confirms substantial equivalence, implying these technical specifications meet regulatory requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for AI/ML performance. For a digital thermometer, testing would involve physical measurements on a range of test subjects or using calibrated thermal sources, not a "test set" of data in the AI sense. The document does not provide details on the sample sizes for these physical performance tests or their provenance.
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. "Ground truth" in the context of expert consensus is not relevant for a digital thermometer. Accuracy is typically validated against highly calibrated reference thermometers (e.g., in a metrology lab) or in clinical trials against established methods, not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among multiple experts interpreting complex data, which is not relevant for the direct measurement function of a digital thermometer.
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 not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an "algorithm only" component that operates independently for diagnosis or prediction. It's a measurement device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of expert consensus/pathology/outcomes data. For a digital thermometer, the "ground truth" for its accuracy and performance testing would be highly accurate reference measurements from certified calibration equipment or established clinical comparison methods, not subjective expert assessment.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
In summary: The FDA 510(k) clearance letter for the Digital Thermometer, Model T28, T28L, indicates a device that does not leverage AI/ML algorithms. Therefore, the detailed questions about acceptance criteria, study design, and ground truth establishment specific to AI-driven devices are not applicable to the information provided in this document. The clearance signifies that the device has demonstrated substantial equivalence to a legally marketed predicate device based on its intended use and conventional performance standards for clinical thermometers.
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(60 days)
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
IPL Hair Removal Device (Models:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
IPL Hair Removal Device, models:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.
This document is a 510(k) Summary for an IPL Hair Removal Device. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. This type of document does not contain studies on device performance in the way an academic paper or a clinical trial report would, especially regarding specific "acceptance criteria" and "reported device performance" in terms of clinical effectiveness for hair removal.
Instead, the "performance data" section focuses on safety and regulatory compliance rather than clinical efficacy metrics. It confirms that the device meets safety standards (biocompatibility, electrical safety, EMC, eye safety) and software validation requirements.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly answered from this regulatory summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present clinical acceptance criteria for hair removal efficacy (e.g., percentage reduction in hair regrowth) or reported device performance against such criteria. The "performance data" section focuses on safety and engineering standards.
| Acceptance Criteria Type (as inferred for regulatory compliance) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (Cytotoxicity) | Passed ISO 10993-5:2009 |
| Biocompatibility (Irritation & Skin Sensitization) | Passed ISO 10993-10:2010 |
| Electrical Safety (General) | Passed ANSI AAMI ES60601-1 |
| Electrical Safety (EMC) | Passed IEC 60601-1-2 |
| Electrical Safety (Home Healthcare) | Passed IEC 60601-1-11 |
| Electrical Safety (Home Light Therapy) | Passed IEC 60601-2-83 |
| Eye Safety | Passed IEC 62471 |
| Software Verification & Validation | All software requirement specifications met, all software hazards mitigated to acceptable risk levels. Consistent with moderate level of concern. |
| Usability | Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For Biocompatibility, Electrical Safety, Eye Safety, and Software Validation: These tests are typically performed on a limited number of device units or components in a laboratory setting. The specific "sample size" of devices or components tested is not provided, but it would not be a "test set" of patient data. The provenance for these engineering and safety tests is typically the manufacturing environment or a third-party testing lab. The document confirms these were conducted by a "reliable third-party lab" (for biocompatibility).
- For Clinical Hair Removal Efficacy: This document does not describe any clinical study for hair removal efficacy with a patient test set. The claim for "permanent reduction in hair regrowth" is listed under "Indications for Use," which implies it is an intended function, but the document does not include data from a study directly demonstrating this on a test set for this specific device. It relies on substantial equivalence to predicate devices which have likely demonstrated this.
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. The document does not describe a clinical study for which a ground truth based on expert consensus would be established for a human test set. For the engineering and safety tests, the "ground truth" is adherence to established international standards, verified by testing specialists at accredited labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human test set or clinical study requiring adjudication is detailed.
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 is not an AI/imaging device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical IPL device. "Standalone performance" in this context refers to the device operating according to its design specifications regarding light emission, safety features, etc., which is covered by the safety and engineering tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For safety and engineering tests: The "ground truth" is compliance with international standards (e.g., ISO 10993, IEC 60601, IEC 62471) as verified by laboratory measurements and procedures.
- For hair removal efficacy: While "permanent reduction in hair regrowth" is stated in the Indications for Use, which would typically require clinical outcomes data or expert assessment in a clinical trial to establish, this document does not present such data for this specific device. It relies on the substantial equivalence to predicate devices, implying those predicate devices have acceptable evidence for this claim.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning or AI model that would require a "training set." The "software" mentioned is for operational control and safety features, not for learning from data related to hair removal.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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(130 days)
T2 Biothreat Panel
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
- 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
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | 95% positivity rate at minimum bacterial concentration | Ranges from 2-17 CFU/mL or 9 CAGe/mL |
| Analytical Reactivity | 100% inclusivity for target sequences | All tested strains successfully detected, except Y. pestis strains lacking pPCP plasmid. |
| Analytical Specificity | No cross-reactivity with common bloodstream infection organisms or genetically similar pathogens | No cross-reactivity observed at 1,000 CFU/mL (or IU/mL) for 30 out of 31 tested strains. One Bacillus cereus strain (G-9241) with a pXO1-like plasmid showed cross-reactivity with the BaPXO1 channel, but the device differentiates this from fully virulent B. anthracis. No cross-reactivity at higher concentrations (1x10^5 copies/mL) for exclusivity strains. |
| Reproducibility | High agreement with expected positive and negative results across sites, operators, lots, and instruments. | Overall agreement of 98.4% for expected positive results; 100% for expected negative results. |
| Interfering Substances | No interference with detection of targets or sample validity by specified endogenous and exogenous substances. | None of the tested substances (excluding Feraheme, Magnevist, and Ablavar which are known interferents at high concentrations from previous studies) demonstrated interference. |
| Competitive Inhibition | No competitive effects impacting positive detection in co-infection scenarios. | No competitive effects observed for any combination of Panel members or non-Panel members. |
| Clinical Sensitivity (PPA) | High Positive Percent Agreement (PPA) for target analytes. | Ranged from 94.3% to 100% for analyte concentrations at 1-3x LoD. |
| Clinical Specificity (NPA) | High Negative Percent Agreement (NPA) for all analytes. | 100% for all analytes. |
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 (
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