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

Rotium® is composed of two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Rotium® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. Rotium® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. Rotium® is designed for stand-alone use. At the discretion of the surgeon, Rotium® may be hydrated with sterile isotonic solution.

The provided text is a 510(k) premarket notification for a medical device called Rotium®, a surgical mesh for tendon injuries. It does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence of the Rotium® surgical mesh to a predicate device based on its material composition, physical and mechanical properties, biocompatibility, and animal testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device (surgical mesh) and its traditional regulatory submission.

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BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extraarticular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, soring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The BioBrace® implant is a bioresorbable and bioinductive scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly- L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 micron filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm3, and median pore diameter of 19 microns. The highly porous collagen sponge comprises the majority of implant surface area (0.7 m2/gram) versus the PLA filaments alone (0.2 m2/gram), creating a large biologic matrix for cellular ingrowth, tissue regeneration, and healing. BioBrace implants are approximately 3 mm thick, provided in multiple sizes, and provide for soft tissue and tendon augment, and clinically relevant strengthening of the surgical repair. The BioBrace implant is single-use and supplied sterile with SAL of 10-6.

This document is a 510(k) Summary for the BioBrace® surgical mesh. It details the device, its intended use, and comparative studies for substantial equivalence. However, it does NOT contain the specific information required to answer your prompt about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, AI-based device and then proving them. The prompt asks about an AI/algorithm-based device and its performance metrics, such as sensitivity, specificity, or reader improvement. This document describes a surgical mesh, which is a physical implant, not an AI or software device.

Therefore, I cannot provide the requested information based on this document. The document primarily discusses:

• Device Description: Bioresorbable and bioinductive scaffold made of collagen and PLLA yarn.
• Intended Use/Indications for Use: Reinforcement of soft tissue, particularly in tendon and ligament repair, including expansion to extra-articular ligaments.
• Technological Comparison: Emphasizes that the subject device is identical to the primary predicate (K203267) in design, materials, manufacturing, and sterilization, with new sizes and expanded indications for use being the primary changes.
• Non-Clinical and/or Clinical Tests Summary & Conclusions: Mentions cadaver-based studies, an in-vivo study in sheep, and literature reviews to support the expanded indications and performance characteristics like bioinductivity, strengthening, and stiffness.

There are no details related to an AI/algorithm device, its acceptance criteria (like sensitivity, specificity, AUC), test set characteristics (sample size, data provenance), ground truth establishment by experts, or MRMC studies, as would be expected for an AI device submission.

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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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The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.

It appears you've provided a 510(k) submission document for a medical device called "SpinMedix Absorbable Fibrous Membrane." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria for an AI/CADe system.

The information provided describes:

• Device Name: SpinMedix Absorbable Fibrous Membrane
• Intended Use: Management and protection of tendon injuries where there has been no substantial loss of tendon tissue.
• Composition: Poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol).
• Testing: Mechanical performance, biocompatibility (ISO 10993-1), and an in vivo animal study (calcaneal tendon incision model and inguinal hernia model).

Crucially, this document does NOT describe an AI/CADe system or a study that would require acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" you are asking for, with details like sample size for test/training sets, expert ground truth establishment, MRMC studies, etc., are specific to the validation of diagnostic AI algorithms, not for a physical medical implant like an absorbable fibrous membrane.

Therefore, I cannot extract the requested information from this document because it is not relevant to the type of device and study you are asking about.

To reiterate, the provided document does NOT contain information about:

• A table of acceptance criteria and reported device performance for an AI algorithm.
• Sample sizes for test sets for an AI algorithm or data provenance.
• Number of experts or their qualifications for establishing AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC studies for human readers with/without AI assistance.
• Standalone AI performance.
• Type of ground truth (expert consensus, pathology, outcomes) for AI diagnostics.
• Sample size for a training set for an AI algorithm.
• How ground truth for a training set for an AI algorithm was established.

This document focuses on showing the physical implant is substantially equivalent to existing implants based on design, materials, performance (mechanical), and biological safety (biocompatibility, animal integration/resorption).

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FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

FlexBand®, FlexPatch®, and FlexBand® Plus are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

The FlexBand® / FlexPatch® / FlexBand® Plus products are knitted mesh made from ARTELON® fibers. ARTELON® fiber is made of degradable polycaprolactone-based polyurethane urea. The construction permits the mesh to be cut into any desired shape or size without unraveling. FlexBand® Plus devices have suture attached to each end of the knitted mesh strip. The pre-loaded suture is intended to aid in usability in the operating room. The devices are supplied sterile, one product per package in double layer peel pouch packaging.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

It's important to note that the provided FDA 510(k) summary for FlexBand®, FlexPatch®, and FlexBand® Plus does not detail specific quantitative acceptance criteria with numerical thresholds, nor does it describe a formal "study" in the typical sense of a clinical trial or a statistically powered performance study against such criteria.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance data" section primarily describes types of mechanical testing performed to support this equivalence, rather than a direct measurement against predefined numerical acceptance criteria for a new clinical claim.

Therefore, the following information is extracted and presented based on what is explicitly stated or directly implied in the given text. Many fields, particularly those related to clinical studies, will be marked as "Not Applicable" or "Not Provided" because the submission is for substantial equivalence based on in-vitro performance and literature review, not a new clinical efficacy study with specific PIs.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the "Study that Proves the Device Meets the Acceptance Criteria" and other requested details:

As highlighted above, the submission is focused on demonstrating substantial equivalence (SE) to predicate devices by showing that the current device has the same technological characteristics or differences that do not raise different questions of safety and effectiveness. It does not describe a singular, novel study designed to meet specific quantitative performance criteria for a new clinical claim.

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

  • Mechanical Testing (Suture Retention, Tensile Strength): Not explicitly stated. These are in-vitro tests, not human data. The sample size would be for the number of device units tested.
  • Clinical Literature: The "Clinical literature" section refers to existing published studies on "the subject device involving ligament reinforcement procedures." This implies retrospective data analysis from already completed studies, not a new prospective test set for this 510(k). The provenance (e.g., country of origin) of these literature studies is not provided in this summary.

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

  • Not Applicable. For the mechanical testing, ground truth is based on physical measurements of device properties. For the clinical literature, the "ground truth" (clinical effectiveness) would have been established by the authors and expert reviewers of those original published studies, but not specifically for this 510(k) submission.

• 4. Adjudication Method for the Test Set:

  • Not Applicable. No human adjudication of a test set is described.

• 5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • Not Applicable. This device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was performed.

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

  • Not Applicable. This is a physical surgical mesh, not an algorithm.

• 7. The Type of Ground Truth Used:

  • Mechanical Testing: In-vitro physical measurement results (e.g., force in Newtons, displacement in mm) for suture retention and tensile strength.
  • Clinical Literature: Peer-reviewed clinical outcomes and effectiveness data from published studies concerning the device in relevant surgical procedures.

• 8. The Sample Size for the Training Set:

  • Not Applicable. There is no "training set" in the context of this device and submission, as it is not an AI/machine learning device.

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

  • Not Applicable. No training set exists for this device.

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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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The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

The STR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The STR GRAFT is a bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber. The STR GRAFT is available in rectangular and square sizes of 23 mm x 12 mm, 23 mm x 23 mm x 40 mm, and 23 mm x 60 mm; all STR GRAFT devices are approximately 1.0 mm thick; with the thickness comprised of three layers of 3-D braided fiber bundles. The STR GRAFT is supplied sterile (EtO) and is single-use only.

The provided text describes a 510(k) submission for a surgical mesh device, the STR GRAFT. It outlines the device's characteristics, intended use, and claims of substantial equivalence to predicate devices, supported by various performance tests. However, it does not describe or include an acceptance criterion table for overall device performance, nor does it detail a study that explicitly proves the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearances. This pathway often relies on showing that the new device has similar technological characteristics and performance to existing devices, rather than conducting new clinical trials to establish de novo safety and effectiveness with pre-defined acceptance criteria.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be extracted from this document, as such a study and acceptance criteria are not presented in the context of a clinical performance evaluation.

Here's a breakdown of what can and cannot be derived from the provided text, addressing your specific points:

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

• Cannot be provided. The document does not present an overall acceptance criteria table for the device's clinical performance. It mentions performance data derived from mechanical and biocompatibility testing against standards (ASTM, ISO), and an in-vivo animal model. These are used to support substantial equivalence, not to meet a specific, pre-defined set of clinical acceptance criteria for safety and effectiveness.

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

• Cannot be fully provided for a human clinical "test set." The document mentions "a 12 week ovine model of rotator cuff repair was performed." This is an animal study, not a human clinical test set.
  • Sample size for animal model: Not specified (e.g., how many sheep were used).
  • Provenance: An ovine model (sheep). No country of origin is mentioned for this specific animal study data within the document. It's likely considered pre-clinical or non-clinical data.
  • Retrospective or prospective: Animal studies for device evaluation are typically prospective, but this is not explicitly stated.

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. Since there's no human clinical "test set" or ground truth based on expert consensus described for overall device performance, this information is not available. The animal model likely involved veterinarians or animal researchers, but their number and qualifications are not provided.

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

• Not applicable. No human clinical test set with an adjudication method is described.

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. This document describes a surgical mesh, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant or discussed.

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

• Not applicable. This document describes a surgical mesh, not an algorithm.

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

• For the animal model: The "ground truth" would be based on surgical observations, histological examination of tissues, mechanical testing of the repaired tendons, and other animal study endpoints relevant to rotator cuff repair in the ovine model. The document broadly states "results of physical, mechanical, in-vivo, and biocompatibility testing indicate that the STR GRAFT possesses appropriate physical and mechanical characteristics." This implies outcomes data from the animal model.

8. The sample size for the training set

• Not applicable. This pertains to machine learning models. The STR GRAFT is a medical device (surgical mesh), not an AI algorithm.

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

• Not applicable. As above, this pertains to machine learning models.

Summary of available "Performance Data" from the document:

The "Performance Data" section (G) details the types of tests conducted to support substantial equivalence:

• Mechanical Testing: Performed per ASTM Standards F-2150-07, D3787-07, D2261-07a, D882-10, F2392-04, F1877-05, D4032-08, and D6767-11. The document notes these methods were "modified as appropriate regarding the length and width of the STR GRAFT."
• Biocompatibility Testing: Performed per ISO Standards 10993-3, -5, -7, -10, and -11.
• In-vivo Testing: A "12 week ovine model of rotator cuff repair was performed."

The conclusion states that these tests, along with material selection and design features, support the determination of substantial equivalence to predicate devices, implying that the device performs similarly and safely enough to existing devices on the market. It does not establish explicit clinical acceptance criteria or report performance against them in a human study.

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