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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments.

In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.

VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.

The provided text is a 510(k) premarket notification decision letter and a 510(k) summary for a medical device called VersaWrap®. This document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance and validation studies typically found for AI/ML-based devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI device meets acceptance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance data, or ground truth types.
• Information on training set sample size or how ground truth was established for a training set.

The document states: "Based on the risk-based assessment no additional testing is required to support the additional determination of substantial equivalence. The prior non-clinical and animal testing for the device were used to support the extended indications. Based on the risk-based assessment no clinical testing is required to support the additional determination of substantial equivalence." This indicates that the approval is based on equivalence to a previously approved device, not on new performance studies for an AI/ML component.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

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VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue.
VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant.
VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.

This document is an FDA 510(k) clearance letter for a medical device called "VersaWrap Nerve Protector." It states that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

This document is specifically for a physical medical device (a nerve cuff), and the content focuses on regulatory clearance based on substantial equivalence to an existing physical predicate device. It addresses aspects like:

• Device Name: VersaWrap Nerve Protector
• Regulation Number/Name: 21 CFR 882.5275, Nerve Cuff
• Product Code: JXI
• Indications for Use: "management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue."
• Predicate Device: VersaWrap Nerve Protector K201631
• Device Description: "thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant."
• Functional and Safety Testing: States "No additional functional or safety testing was required," implying that the substantial equivalence argument, based on the predicate device, was sufficient.
• Comparative Technological Characteristics: Highlights material (Calcium alginate and hyaluronic acid), intended use, physical structure (sheet), and precautions, showing they are identical to the predicate.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device based on this input, as this document is not about an AI/ML device.

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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the VersaWrap device, which certifies its substantial equivalence to a predicate device.

The document discusses the device description, indications for use, and confirms that non-clinical tests were performed. However, it does not detail specific acceptance criteria (e.g., performance metrics, thresholds) or the study design, sample sizes, ground truth establishment, or expert involvement that would typically be associated with proving these criteria were met for a new AI/medical device.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided text.

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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. Versa Wrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

This document is a 510(k) summary for the VersaWrap device, which is a resubmission (K203600) based on a previously cleared device (K200311). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document.

Here's what can be extracted and inferred based on the nature of a 510(k) submission for a device that is "identical to the predicate device" with "differences in the indication for use" that "do not affect the safety and effectiveness":

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this 510(k) submission. This is because it's a re-submission of an "identical" device. The acceptance criteria for this submission would have been demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Safety and Effectiveness for Modified Indications: That the modified indications for use still fall within the demonstrated safety and effectiveness profile of the original device and its predicate.

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

• Sample Size (Test Set): Not applicable for this 510(k) submission, as it relies on previous testing of the identical predicate device. No new test set data is presented.
• Data Provenance: No new data provenance information is provided as the submission relies on "prior non-clinical testing and animal model studies" for the predicate device. The document does not specify the country of origin or whether these prior studies were retrospective or prospective.

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

• Not applicable, as no new test set requiring new ground truth establishment is detailed in this 510(k) summary. The summary refers to existing non-clinical and animal model studies, but does not provide details on how ground truth was established within those studies.

4. Adjudication method for the test set:

• Not applicable, as no new test set or clinical study requiring adjudication is detailed in this 510(k) summary.

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

• No. The VersaWrap device is a surgical mesh/implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• No. This device is a physical surgical implant, not an algorithm or software. Standalone algorithm performance is not applicable.

7. The type of ground truth used:

• For the original predicate device (K200311), the ground truth for safety and effectiveness would have been established through a combination of:
  • Non-clinical testing: (e.g., mechanical properties, biocompatibility, degradation profiles).
  • Animal model studies: (e.g., observation of healing, adhesion formation, tissue response in vivo).
  • Literature review and comparison to existing similar devices.
• This 510(k) summary (K203600) states that "The prior non-clinical testing and animal model studies were used to support the modified indications." This implies the same types of ground truth from the predicate were leveraged.

8. The sample size for the training set:

• Not applicable. This device is not an AI model, so there is no concept of a "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for this type of medical device.

In summary: This 510(k) submission (K203600) is for a physical surgical implant (VersaWrap) that is identical to an already cleared predicate device (K200311), with minor modifications to the Indications for Use that do not impact its fundamental safety or effectiveness. Therefore, the submission primarily focuses on demonstrating this equivalence and does not present new clinical study data, detailed acceptance criteria, or performance metrics in the way an innovative diagnostic or AI device might. The "study" proving the device meets the (implicit) acceptance criteria is the demonstration of substantial equivalence through comparison to the predicate and leveraging its existing non-clinical and animal model data.

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VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve

The provided text describes non-clinical tests and an animal study for the VersaWrap Nerve Protector. Here's a breakdown of the requested information based on the provided input:

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

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document states the "sample size was selected to be large enough to show consistent results and to be able to compare the test, control, and untreated groups" for the animal study. However, a specific numerical sample size is not explicitly provided for the animal study (e.g., "N=X rats"). For non-clinical tests, sample sizes are implied by "testing was completed" but not detailed (e.g., number of pouches for seal integrity, number of samples for cytotoxic evaluation).
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: The animal study appears to be prospective as it involved conducting the study on "multiple injury types for subject device, predicate control device, and untreated groups" with data collected at "an early period, a mid-term period; and a late period." The non-clinical tests are also inherently prospective as they are performed on the device.

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

• The document does not provide information on the number of experts or their qualifications used to establish ground truth for the animal study or any other test. It mentions "Histopathological evaluations were performed," which implies expert analysis, but details are lacking.

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

• The document does not specify any adjudication method for the test set, whether for the animal study or non-clinical tests.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical nerve protector and not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical medical implant, not an algorithm or software.

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

• For the animal study, the ground truth appears to be based on pathology/histopathology ("Histopathological evaluations were performed to assess local and systemic tissue effects...There were no microscopic changes in the nerve...") and physiological/observational outcomes data ("motor and sensory neurological assessments were conducted...no significant events reported").
• For non-clinical tests, the "ground truth" is typically defined by pre-defined specifications and validated test methods (e.g., ISO standards for biocompatibility, direct measurements for dimensional analysis).

8. The sample size for the training set

• This device is not an AI/ML model, so there is no concept of a "training set" as described in the context of AI.

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

• As there is no training set for an AI/ML model, this question is not applicable.

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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a Wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.

The provided text describes a 510(k) premarket notification for the VersaWrap Tendon Protector, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as a multi-reader multi-case comparative effectiveness study or a standalone algorithm-only performance study) with detailed acceptance criteria and performance metrics typically associated with AI/software-as-a-medical-device.

Therefore, much of the requested information regarding acceptance criteria, study design for performance evaluation (test set, training set, ground truth, expert involvement), and comparative effectiveness is not typically found in a 510(k) summary for a physical implantable device.

However, based on the provided text, I can infer the following:

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

The document indicates that "Functional and Safety Testing" was performed to verify that the device design met functional and performance requirements. The specific type of testing mentioned is "dimensional/visual inspection." While explicit acceptance criteria and corresponding performance results are not detailed in a quantitative table within this document, the implication of the 510(k) clearance is that these tests passed, demonstrating equivalence to the predicate.

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

The document mentions "representative samples of the device underwent bench testing." It does not specify the exact sample size for these bench tests, the country of origin of the data, or whether it was retrospective or prospective. Given it's bench testing, it refers to product samples rather than patient data.

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

This type of information is not relevant or provided in a 510(k) for a physical implantable device like the VersaWrap Tendon Protector. "Ground truth" established by experts is typically for diagnostic devices or AI algorithms that interpret medical images or data. The "acceptance criteria" here relate to the physical and functional properties of the device itself.

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

Not applicable for the type of device and testing described. Adjudication methods are typically used in clinical studies or performance evaluations involving human interpretation of data, often with AI.

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

No. An MRMC comparative effectiveness study is not mentioned. This type of study is primarily for diagnostic devices, particularly those involving AI in image interpretation. The VersaWrap Tendon Protector is an implantable surgical mesh.

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

No. This concept is for AI/software devices. The VersaWrap Tendon Protector is an absorbable implant.

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

For this device, "ground truth" would relate to whether the device physically performs as intended (e.g., integrity, dimensions, sterility, biocompatibility) rather than a diagnostic 'truth'. The text doesn't specify the exact type of "ground truth" but implies that the device's physical and functional properties were evaluated against predefined specifications and requirements.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a "training set" or corresponding ground truth establishment process for this device.

Summary of the Study (as described in the 510(k) summary):

The regulatory submission for the VersaWrap Tendon Protector focused on demonstrating substantial equivalence to a predicate device (K160364 VersaWrap® Tendon Protector). This process primarily involves showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.

The study mentioned is bench testing to verify that the device design met functional and performance requirements. This included "dimensional/visual inspection." The conclusion of the submission is that the subject device is equivalent to the predicate device based on equivalent intended use and no technological differences that raise new safety and effectiveness questions. The document does not provide details on the methodology, specific quantitative results, or acceptance criteria for these bench tests beyond their general purpose.

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The VersaWrap Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy placement under, around. or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.

The provided text is a 510(k) summary for the VersaWrap Tendon Protector. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way typically expected for an AI/CADe device.

This document is for a medical device (a tendon protector), not an AI/CADe system. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or described in the context of this type of device submission.

Here's a breakdown of the information that can be extracted, and what is missing based on the request:

1. Table of acceptance criteria and reported device performance:

The document describes "Functional and Safety Testing" and "Non-Clinical Tests Submitted." However, it presents these as categories of tests performed rather than specific quantitative acceptance criteria with corresponding reported performance values. For instance, it mentions "Puncture strength" but does not provide a target value for puncture strength or the measured value for the VersaWrap.

Missing: Specific, quantifiable acceptance criteria (e.g., "puncture strength > X Newtons") and the direct numerical results demonstrating the device met those criteria.

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

• Test Set Sample Size: Not applicable in the context of this device. The tests mentioned are bench testing and animal studies, not a "test set" of patient data for an algorithm.
• Data Provenance: The document mentions "animal studies" (specifically, a "Chicken flexor tendon repair model"). No country of origin is specified for these studies. The studies are non-clinical, not retrospective or prospective patient data.

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

Not applicable in the context of this device. The ground truth for device performance is established via physical and chemical testing, and observations in animal models, not by expert consensus on clinical data.

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

Not applicable. This concept applies to expert review of clinical cases, not the physical testing of a medical device.

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

Not applicable. This device is a physical tendon protector, not an AI or CADe system intended to assist human readers.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the performance claims would be:

• Physical properties: Measured values from bench tests (e.g., puncture strength, dimensions).
• Biocompatibility standards: Results against defined ISO 10993 criteria.
• Animal study observations: Outcomes from the "Chicken flexor tendon repair model" (e.g., improved mobility, protective interface functionality).

8. The sample size for the training set:

Not applicable. This device does not have a "training set" in the sense of machine learning.

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

Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device. It details functional, safety, and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device. It does not contain the types of information (e.g., quantitative acceptance criteria for image analysis performance, clinical test set details, expert ground truth, AI/CADe study methodologies) typically requested for an AI/CADe device.

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