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IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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The EndoWrist Cadiere Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject device is a remanufactured 420049 Cadiere Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during an endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, clinical applications, patient population, or method of operation.

This FDA 510(k) clearance letter pertains to a remanufactured medical device, the Remanufactured EndoWrist Cadiere Forceps. Unlike typical AI/software device clearance documents, this document focuses on demonstrating substantial equivalence for a physical device that has undergone a process to extend its lifespan and enable additional uses. Therefore, it does not contain the typical information related to acceptance criteria, test set, ground truth establishment, or AI model training as one would find for an AI/ML-based device.

Based on the provided text, here's what can be extracted regarding the device's acceptance criteria and the study proving it meets them:

Core Reason for Clearance: The manufacturer is demonstrating that the remanufactured device performs equivalently to the original (predicate) device, especially given that its "use counter has been reset to permit an additional controlled set of uses." The acceptance criteria are implicitly tied to ensuring the remanufactured device maintains the safety and efficacy of the original.

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is a remanufactured physical device and not an AI/ML diagnostic tool, the "acceptance criteria" are not reported in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, they relate to the continued functional and safety performance of the remanufactured forceps.

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

• Test Set Sample Size: The document does not specify a numerical sample size for "life testing," "electrical safety evaluation," "biocompatibility testing," "reprocessing validation," or "cybersecurity assessment." These types of tests typically involve a defined number of units or cycles to statistically demonstrate compliance with performance specifications. However, the specific numbers are not disclosed in this summary.
• Data Provenance: The data comes from internal testing and assessments conducted by Rebotix (the manufacturer) or their designated testing facilities. There is no mention of external data sources, clinical study sites, or patient data (retrospective or prospective). The reference to K241872 (remanufactured EndoWrist ProGrasp Forceps) as a reference for testing methods suggests a consistent internal methodology.

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

This information is not applicable for this type of device and submission. "Ground truth" in the context of AI/ML devices typically refers to the definitive determination of a condition (e.g., disease presence, lesion type) established by expert consensus or other definitive methods for labeling data. For a remanufactured physical device, "ground truth" is not established in this manner. Instead, performance is validated against established engineering and safety standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions, typically in AI/ML performance studies. This is not relevant for the engineering and safety tests conducted for a remanufactured physical device.

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 information is not applicable. An MRMC study is specific to evaluating the clinical performance of AI-assisted diagnostic tools and measuring the impact of AI on human reader performance. This submission is for a remanufactured surgical instrument, not an AI diagnostic system.

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

This information is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. This is not an AI/software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance validation is primarily based on:

• Established engineering specifications and performance benchmarks for the original (predicate) device.
• Compliance with international safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
• Validation against Original Equipment Manufacturer (OEM) instructions for reprocessing.
• Demonstrating that the remanufactured device behaves mechanically and functionally identically to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI/ML model. This is a remanufactured physical device, not an AI/ML model.

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

This information is not applicable for the same reasons as #8.

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The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of an MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD) for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures using the MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health professionals in a clinical diagnostic setting. Subculturing of positive blood cultures is necessary to recover organisms for identification of organisms not identified by the MBT-CA System, for susceptibility testing and for differentiation of mixed growth.

Positive MBT Sepsityper results do not rule out co-infection with organisms that may not be detected by the MBT-CA System. Results of the MBT Sepsityper should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Results of the MBT Sepsityper should be correlated with Gram stain results and used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast bloodstream infections.

Organisms recovered from positive blood culture bottles that are suitable for identification using the MBT Sepsityper Kit US IVD and MBT-CA Systems are listed in the MALDI Biotyper CA System Package Insert Reference Library.

The MALDI Biotyper CA System uses MALDI (matrix-assisted laser desorption/ionization) TOF (time of flight) mass spectrometry technology for the identification of organisms isolated from clinical samples. Identification can be performed from an isolated colony or from a cell extract. The sample material is transferred to a target plate, dried and overlaid with a matrix. The MBT FAST Shuttle US IVD is an optional hardware tool that may be used for drying the samples deposited on the MALDI target plate under controlled conditions.

The MALDI process transforms the proteins and peptides from the isolated microorganisms into positively charged ions. This is achieved by irradiating the matrix-sample composite with a UV laser. The matrix absorbs laser energy and transfers protons to the intact proteins or peptides in the gas phase. These ions are electrostatically accelerated and arrive in the flight tube at a mass-dependent speed. Because different proteins/peptides have different masses, ions arrive at the detector at different times (time of flight). The MBT-CA System measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal of the ions, and the time is converted into an exact molecular mass.

The highly abundant microbial ribosomal proteins result in a mass spectrum with a characteristic mass and intensity distribution pattern. This pattern is species-specific for many bacteria and yeasts and can be used as a 'molecular fingerprint' to identify a test organism. The spectrum of the unknown test organism, acquired through the software MBT Compass HT CA of the MBT-CA System, is electronically transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to reference peak lists of organisms in the MBT-CA Reference Library and a log(score) between 0.00 and 3.00 is calculated. The higher the log(score), the higher the degree of similarity to a given organism in the MBT-CA Reference Library. The log(score) ranges reflect the probability of organism identification.

The FDA 510(k) submission document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a traditional acceptance criteria study for a new device. Therefore, the "acceptance criteria" discussed are largely driven by proving that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain or improve the performance and safety established by the predicate device.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context isn't a single set of predefined thresholds for a novel device's performance against a clinical gold standard (e.g., sensitivity/specificity targets). Instead, it's about demonstrating that the new components do not negatively impact the established performance of the predicate device and potentially offer improvements (like accelerated drying time). The "reported device performance" is presented as evidence that these conditions are met.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Study Details

Based on the provided text:

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

   • MBT FAST Shuttle - Repeatability: 120 mass spectra (presumably from 12 bacterial/yeast strains * 10 repeats * 2 runs across DT, eDT, Ext, Sepsityper workflows as indicated in Table 3 headers, although the text says "each out of 2 runs" for "each workflow/method" - suggesting 10 per method/workflow per run).
   • MBT FAST Shuttle - Reproducibility (Site-to-Site): 2700 samples for MBT workflow (900 samples per study site * 3 sites) and 1350 samples for Sepsityper workflow (450 samples per study site * 3 sites). The document mentions "10 microorganisms" used per study site.
   • MBT FAST Shuttle - Reproducibility (Device-to-device): 1080 samples for MBT workflow (360 samples per MBT FAST Shuttle * 3 shuttles) and 540 samples for Sepsityper workflow (180 samples per MBT FAST Shuttle * 3 shuttles).
   • MBT FAST Shuttle - Reproducibility (Operator-to-operator): 900 samples for MBT workflow (450 samples per operator * 2 operators) and 450 samples for Sepsityper workflow (225 samples per operator * 2 operators).
   • MBT FAST Shuttle - Reproducibility (Day-to-day): 900 samples for MBT workflow (180 samples per day * 5 days) and 450 samples for Sepsityper workflow (90 samples per day * 5 days).
   • MBT FAST Shuttle - Method Comparison (Drying): 279 mass spectra for air-dried and 279 mass spectra for MBT FAST Shuttle dried from three study sites (93 mass spectra per site per drying method). Ten (10) microorganisms and a blood culture, each spotted in triplicates.
   • MBT Compass HT CA - Low Confidence Results: 15,270 spectra in total, with 1,670 yellow log(scores) re-analyzed.
   • MBT Compass HT CA - IDealTune: Data collected from 133 BTS-QC runs at Site 1 (over 17 months) and 76 BTS-QC runs at Site 2 (over 14 months).

   Data Provenance: The studies were performed at multiple sites (at least 3 for reproducibility studies), and one study explicitly mentions that microorganisms were shipped to both US study sites. This implies the data is, at least in part, prospectively collected in a multi-center setting for verification/validation. The "low confidence results" study was a retrospective non-interventional validation using data from previous clearances.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for most of these performance studies. The studies primarily focus on performance consistency and equivalence compared to established methods using what appears to be common laboratory standards (e.g., identity confirmed organisms, BTS quality checks).
   • For the "low confidence results" study, it states: "Isolates from clinical routine were used to compare the results of the MBT-CA System against a gold standard (16S sequencing)." This suggests the ground truth was established by 16S sequencing, a molecular method, rather than solely by human experts, and then potentially interpreted by experts.

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

   • No adjudication method involving multiple human readers for conflict resolution is mentioned or appears to be applicable given the nature of the device (mass spectrometry-based organism identification). The performance is assessed on the agreement with an expected identification or log(score) thresholds.

4. 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 MRMC or human-in-the-loop comparative effectiveness study with human readers assisting or being assisted by AI is described in this document. The device is a "clinical mass spectrometry microorganism identification and differentiation system," not an AI-assisted diagnostic imaging tool.

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

   • Yes, the performance validation studies of the MBT FAST Shuttle US IVD and MBT Compass HT CA software are essentially standalone performance evaluations of these components within the overall MALDI Biotyper CA System. The "outputs" (identification results, log(scores)) are generated by the system (including the hardware, software, and reference library) without direct human interpretation of the raw mass spectra. Human involvement is in sample preparation and operating the system, but the core identification is algorithmic.

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

   • For the analytical performance of organism identification, the ground truth appears to be based on:
     • Reference strains/known microorganisms: Used in repeatability and reproducibility studies.
     • 16S sequencing: Explicitly stated as the "gold standard" for comparing results in the "low confidence results" study.
     • Internal quality control standards: Like the Bacterial Test Standard (BTS) for IDealTune validation.
   • This is primarily laboratory-based "gold standard" ground truth (molecular methods, established reference cultures), rather than expert consensus on clinical cases.

7. The sample size for the training set:

   • This document describes the validation of new components for an existing system. It does not provide details about the training set size for the underlying MALDI Biotyper CA System's reference library or analytical algorithms. The "reference library" (which acts as a form of "training data" for identifying unknown spectra) is mentioned as being continually updated, but its size is not specified.

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

   • Similar to the above, the document does not detail how the ground truth was established for the training data (the reference library) of the overall MALDI Biotyper CA System. However, standard practice for building such libraries involves:
     • Well-characterized bacterial and yeast strains: Often from culture collections, with identity confirmed by a variety of methods including 16S rRNA gene sequencing, traditional biochemical tests, and possibly whole-genome sequencing.
     • Internal validation and verification: Ensuring the spectral patterns are consistent and representative for each species.

In summary, this 510(k) submission successfully demonstrates substantial equivalence by showing that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain the safety and effectiveness of the predicate device, and in some cases, enhance usability (faster drying time, improved instrument maintenance) without introducing new risks or compromising diagnostic accuracy. The studies presented are analytical validations focusing on performance characteristics relevant to microorganism identification in a laboratory setting.

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• HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter and Swan-Ganz Jr catheter indications for use statements for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >=18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

• HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

  • When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >=40 kg.
  • When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >=3 kg.
  • When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

The HemoSphere Advanced Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."

This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.

Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The text primarily focuses on:

• Substantial equivalence to predicate devices.
• Indications for Use for various HemoSphere configurations and modules.
• Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
• General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."

Based on the provided document, here's what can and cannot be stated:

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

Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error

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The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

RAP Femoral venous cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The device is composed of a cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the femoral vein till the vena cava. The cannula and the obturator are packaged within the same pouch and sold together.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" to ½" barbed connector for standard cardiopulmonary bypass tubing.

The RAP femoral arterial cannulae are the modified version of the disposables currently marketed as the RAP Femoral Venous cannula (K052081).

This document, an FDA 510(k) Clearance Letter, is for a medical device (a cannula) and not for a software or AI-based medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria for an AI/software device.

The questions in your prompt are highly specific to AI/Machine Learning device validation, such as:

1. Acceptance criteria for AI performance: (e.g., sensitivity, specificity, AUC)
2. Sample size, provenance, expert ground truth, adjudication: These are standard for evaluating AI model performance.
3. MRMC study and effect size: How AI assists human readers.
4. Standalone performance: Algorithm without human input.
5. Type of ground truth: Pathology, outcomes, expert consensus.
6. Training set details: Sample size and ground truth establishment.

None of this information is relevant or present in the provided 510(k) clearance letter for the RAP Femoral Arterial Cannulae, which is a physical device subject to mechanical, material, and biocompatibility testing.

The document confirms the device meets acceptance criteria through:

• Non-Clinical Performance Data: Extensive verification and validation testing of the physical device components and function (e.g., visual inspection, connector testing, flow rate, kink test, pull strength, blood trauma characterization, biocompatibility tests).
• No Clinical Performance Data: The submission explicitly states "No clinical testing was conducted in support of the RAP Femoral venous cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

Therefore, I cannot extract the information asked in your prompt from this particular document.

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PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.

This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
• Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.

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

• Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.

4. Adjudication Method for the Test Set:

• Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.

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

• No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done:

• Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.

7. The Type of Ground Truth Used:

• Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.

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The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with auto graft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or corticocancellous bone and is to be used with supplemental fixation cleared for use in the lumbar spine. The device may be implanted via an open or minimally invasive approach.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis, kyphosis, or sagittal), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended to be used with the screws that accompany the implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with the screws that accompany the implant and with supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine. These patients should be skeletally mature and have had at least six months of non-operative treatment. The device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® TLIF-C Articulating System is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® Cervical ACDF lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF lnterbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20° lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X lnterbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (≥20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Lumbar Intervertebral Body Fusion Devices include ALIF, LLIF, TLIF, ALIF-X and TLIF-CA interbodies. The aprevo® lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws that accompany ALIF-X are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instruments are provided as single use, sterile-packed product to the end user.

The aprevo® Cervical Intervertebral Body Fusion Devices include ACDF, ACDF-X and ACDF-X no cams. The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (NO CAM) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per F3001, while the screws are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instruments are provided to the end-user as single use, sterile-packed products.

The purpose of this 510(k) is to extend the expiration of imaging used to create 3D surgical plans. There have been no changes made to the software used in the surgical planning process.

The provided FDA 510(k) clearance letter (K250827) for Carlsmed, Inc.'s "aprevo®" interbody fusion devices primarily concerns the renewal of previously cleared devices and the extension of the imaging expiration dating used for 3D surgical planning. Therefore, the document does not contain details of a clinical study assessing the performance of an AI-based device meeting acceptance criteria in the way one might expect for a novel AI/ML medical device submission.

Instead, the performance testing summary indicates that "Clinical data was used to evaluate imaging expiration. Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts." This suggests that the "device" being evaluated for performance in this context is likely related to the software's ability to accurately segment or generate 3D models from imaging data over time, rather than the interbody fusion implants themselves. The clearance is for the physical implants, which are considered substantially equivalent to previously cleared predicates. The "performance testing" here seems to be an update or validation related to the software component of the surgical planning.

Given this context, I will extract information relevant to the software's performance, as that is the only "acceptance criteria" and "study" mentioned, even if it's not a typical AI model performance study against clinical outcomes.

Here's an interpretation based on the limited information provided, assuming the "device performance" refers to the imaging processing capabilities of the aprevo® system's software, specifically regarding the "expiration" of imaging data for 3D surgical plans:

Acceptance Criteria and Device Performance Study for Imaging Expiration

The context of this FDA 510(k) submission (K250827) indicates that the performance study was specifically undertaken to extend the expiration of imaging used to create 3D surgical plans. This suggests the "device performance" being assessed relates to the consistency and accuracy of the software's ability to process imaging data for surgical planning over time, implying that "aging" of the input imaging data does not degrade the software's output beyond an acceptable threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies the acceptance criterion. The specific numerical performance result (e.g., the exact DICE score achieved) is not provided in this public clearance letter. However, the clearance implies that the criterion was met.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: "Clinical data was used." No details on the country of origin or whether the data was retrospective or prospective are provided.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none).

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

• MRMC Study Done?: No, an MRMC study comparing human readers with and without AI assistance is not mentioned or implied by the description of this performance evaluation, which focuses on "imaging expiration" and DICE score.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the use of a "DICE score" for "imaging expiration" strongly suggests an algorithm-only performance evaluation, likely comparing the software's segmentation or 3D reconstruction output against a form of ground truth derived from the clinical data. The phrase "There have been no changes made to the software used in the surgical planning process" further indicates an assessment of the software's intrinsic capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The use of "DICE score" typically implies that the ground truth involves expert-annotated segmentations or regions of interest within the medical images. The DICE score measures the spatial overlap between the algorithm's output and the ground truth. While not explicitly stated, it's highly probable that this ground truth was derived from expert consensus or manual annotation of anatomical structures on the clinical imaging data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. This submission is for an extension/validation of existing software, not the initial clearance of a newly developed AI model, so details on original training are not typically included here.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not mentioned. As above, this document focuses on a validation study for imaging expiration, not the initial development or training of the AI algorithm.

Summary of Limitations Based on Provided Text:

The provided 510(k) summary (specifically the "Performance Testing Summary") is extremely concise regarding details of the study. It states that "Clinical data was used to evaluate imaging expiration" and that "Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts."

Therefore, many typical details requested for robust AI/ML performance studies, such as specific sample sizes, expert qualifications, and adjudication methods, are not present in this public clearance letter. This is common for 510(k) summaries, which are often condensed versions of the full submission. The key takeaway is that the "performance testing" here addresses a specific aspect ("imaging expiration" for 3D surgical planning) of the software rather than a direct clinical efficacy study of the implant or a broad AI diagnostic/prognostic model.

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Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant:
Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by premature and infant (birth to 2 years) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small:
Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant
Hudson RCI® Comfort Flo Plus Cannulas Extra Small
Hudson RCI® Comfort Flo Soft Plus Cannulas Extra Small

This is a 510(k) clearance letter for a medical device (nasal cannula), not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device validation (such as expert consensus, MRMC studies, or training/test set details) is not applicable.

The document describes the device, its intended use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It clearly states that no clinical testing was performed.

Here's a breakdown of the requested information based on the provided document, highlighting why many points are not applicable for this type of device clearance:

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

   • The document lists various non-clinical performance tests but does not provide a table of specific acceptance criteria with corresponding reported device performance values. Instead, it generally states that testing was conducted "to demonstrate substantial equivalence." For example, it lists "Relevant Humidity Output testing" but doesn't state the specific humidity output range considered acceptable or the measured output. This is typical for a 510(k) submission where broad equivalence is the goal rather than meeting precise performance thresholds for novel functionality.

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

   • Not applicable. This is a physical medical device. Testing involved bench tests on manufactured units, not data sets in the AI/ML sense. Data provenance, retrospective/prospective, and sample sizes for test sets (in the context of patient data) are not relevant as no human or clinical data was used for validation.

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. No "ground truth" was established by experts in the context of diagnostic performance, image interpretation, or similar AI/ML applications, as this is a physical medical device.

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

   • Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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-assisted device, and no MRMC study was conducted. The document explicitly states "No clinical testing was performed."

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable. The concept of "ground truth" as it applies to AI/ML model validation is not relevant here. The device's performance was evaluated against engineering specifications and industry standards for physical device functionality (e.g., flow rates, material compatibility, strength).

8. The sample size for the training set

   • Not applicable. There is no AI/ML model, and thus no training set.

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

   • Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.

In summary, the provided document is a 510(k) clearance for a physical medical device, not an AI/ML-driven product. Therefore, most of the requested information related to AI/ML validation (ground truth, expert studies, training/test sets) is irrelevant to this submission.

The acceptance criteria for this device focus on:

• Biocompatibility: Meeting ISO standards (e.g., ISO 10993 series, ISO 18562 series) to ensure the materials are safe for patient contact and breathing gas pathways. The document lists the specific ISO standards used.
• Performance Bench Testing: Covering aspects like visual inspection, humidity output, thermal overshoot, connection strength, leak testing, headgear testing, shelf life, and useful life. While the specific numerical acceptance criteria for each test (e.g., "humidity output must be within X amount") are not explicitly listed in this summary, the document indicates these tests were performed and implicitly met the company's internal acceptance criteria for demonstrating substantial equivalence.
• Substantial Equivalence: The overarching acceptance criterion for a 510(k) is demonstrating that the device is "as safe and as effective" as a legally marketed predicate device, based on the non-clinical testing performed.

The "Study that proves the device meets the acceptance criteria" for this product consists of the various Non-Clinical Testing described on pages 16-17, primarily Biocompatibility Testing and Performance Testing (Bench), which were conducted to support the claim of substantial equivalence to the predicate devices.

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