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Collagen Tendon Sheet-DDI is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Collagen Tendon Sheet-DDI is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-DDI is designed to provide a layer between the tendon and the surrounding tissue during healing. When hydrated, Collagen Tendon Sheet-DDI is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-DDI is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and is packaged preloaded in a cartridge, for use with the Rotation Medical Delivery Instrument, in a dual sterile seal tray-in-tray configuration.

This document describes a 510(k) premarket notification for a medical device called "Collagen Tendon Sheet-DDI." This device is a resorbable type I collagen matrix used for the management and protection of tendon injuries. The key aspect of this submission is that the Collagen Tendon Sheet-DDI is substantially equivalent to a previously cleared predicate device, "Collagen Tendon Sheet-D" (K122048). The only difference between the two is the packaging, which has been modified to facilitate arthroscopic delivery.

Therefore, the "study" proving the device meets acceptance criteria is not a clinical trial in the traditional sense, but rather a series of non-clinical performance tests designed to demonstrate that the change in packaging does not adversely affect the device's safety and effectiveness.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Since this submission is based on substantial equivalence due to packaging changes, the acceptance criteria are linked to ensuring the new packaging and delivery system maintain the integrity and functionality of the core collagen sheet. The document highlights specific tests performed.

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 does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of collagen sheets tested for suture pull-out). These tests are typically performed in a laboratory setting, and the data provenance would be internal to the manufacturer (Rotation Medical, Inc. in Plymouth, MN, USA), and would be considered prospective in the sense that the tests were carried out specifically for this 510(k) submission.

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 applicable for this submission. The "ground truth" for non-clinical performance tests like suture pull-out or biocompatibility is established by adherence to recognized standards (e.g., ISO, ASTM) and established industry protocols, not by expert consensus in a clinical context. The performance is measured against quantifiable physical or chemical properties, or established biological response endpoints.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting subjective outcomes or imaging results where agreement among multiple evaluators is needed to establish a "ground truth." For the non-clinical tests described, the outcomes are objectively measured.

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 is not applicable. MRMC studies are related to evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology scans) often in the context of AI assistance. This submission pertains to a surgical mesh and its delivery system, not a diagnostic device.

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

This is not applicable. This device is a physical implant, not an algorithm or AI system.

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

The "ground truth" for the non-clinical performance tests is based on:

• Established engineering principles and material science standards: For tests like suture pull-out strength, hydrothermal transition temperature, and mechanical integrity.
• Recognized biocompatibility standards (e.g., ISO 10993): For evaluating the biological safety of the materials.
• Sterility and endotoxin limits: For ensuring the safety of the product related to manufacturing processes.

8. The sample size for the training set

This is not applicable. The Collagen Tendon Sheet-DDI is a physical medical device. There is no "training set" in the context of machine learning or AI, as the device's function is mechanical and biological, not based on learned patterns from data.

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

This is not applicable as there is no training set.

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The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.

The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is composed of PEEK material. The RMB Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical.

This document describes the Rotation Medical Bone Staple (RMB Staple) and its approval through the 510(k) pathway. The goal of the 510(k) process is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Pre-Market Approval) study would.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" needs to be interpreted within the context of a 510(k) submission, where the "acceptance criteria" are the demonstration of similarity in intended use, technological characteristics, and safety and performance testing to predicate devices. The "study" is the battery of tests performed to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, there isn't a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding study results in the traditional sense, as there would be for a device seeking novel claims or a PMA. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating the device is as safe and effective as a legally marketed predicate through a comparison of technological characteristics and performance in pre-clinical studies (in vitro and in vivo bench and animal testing).

The document states:

• "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices."
• "The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices."

Therefore, the "acceptance criteria" are the successful completion and positive results from these specific tests, showing comparability to the predicate devices.

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

The document does not specify exact sample sizes for the individual in vitro or in vivo tests performed. It generically mentions "number of in vitro and in vivo tests."

• Data Provenance: The tests are pre-clinical studies (in vitro and in vivo animal testing), not human clinical data. The country of origin for the data is not specified, but typically these tests would be conducted by or for the applicant (Rotation Medical, Inc. based in Plymouth, MN, USA). The studies are inherently "prospective" in the sense that they were conducted specifically for this submission.

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

This information is not applicable to this type of submission. "Ground truth" established by human experts for a test set (e.g., radiologists interpreting images) is relevant for AI/CADe device submissions or clinical trials requiring human assessment of outcomes. For a medical device like a bone staple, the "ground truth" or acceptability is determined by physical and biological performance against established scientific standards and comparison to predicate devices, not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert interpretations in clinical studies or AI validation, which is not the nature of the studies described here.

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the impact of AI on human readers for diagnostic or screening tasks (e.g., radiology interpretation). This device is a mechanical implant, and its assessment involves pre-clinical performance testing, not human reader studies.

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

Not applicable. This device is a bone staple, not an algorithm or AI system. Its performance is evaluated through material science, mechanical testing, and biocompatibility, not as a standalone algorithm.

7. The Type of Ground Truth Used

For the pre-clinical tests, the "ground truth" is based on:

• Scientific Standards: Meeting established FDA and ISO standards for biocompatibility (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1).
• Engineering Specifications/Benchmarking: Performance metrics (strength, retention) are evaluated against pre-defined engineering requirements and/or compared to the performance of the predicate devices.
• Histopathology: In animal studies, histological analysis would be used to assess tissue response and integration, with findings interpreted by veterinary pathologists or similar experts.
• Gross observation of efficacy: In animal efficacy studies, the "efficacy" (e.g., successful fixation of tissue to bone) would be observed and measured.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI model that requires a "training set" of data.

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

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

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The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

RMST Staple is an absorbable polymer strap with cleat tips. RMST Staple is composed of absorbable synthetic polyester derived from lactic acid and dyed with D&C Violet #2. The RMST Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical.

The Rotation Medical Soft Tissue Staple (RMST Staple) was evaluated through a series of in vitro and in vivo tests to establish its safety and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not explicitly state specific sample sizes for each individual test (e.g., cytotoxicity, tensile strength). The phrasing "a number of in vitro and in vivo tests" suggests a sufficient number were conducted to meet regulatory requirements.
• The data provenance is not explicitly stated in terms of country of origin.
• The studies were likely prospective in nature, as they were conducted specifically for the purpose of demonstrating safety and efficacy for regulatory submission.

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

• This information is not provided in the document. The studies described are primarily laboratory and animal-based, not involving human expert interpretation for "ground truth" in the way a diagnostic AI might.

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

• Not applicable. The studies described are pre-clinical (in vitro, in vivo animal) and bench testing, not reliant on human adjudication of a specific output like in a clinical diagnostic study.

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 surgical staple, not a diagnostic imaging device or an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical surgical staple, not an algorithm.

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

• For the biocompatibility studies, the "ground truth" would be established by standard scientific and regulatory methods for assessing biological response (e.g., cellular observation for cytotoxicity, macroscopic/microscopic tissue evaluation for implantation studies).
• For the product characterization and bench testing, the "ground truth" would be objective measurements and engineering standards (e.g., force required for tensile strength, displacement for pull-out).
• For the animal efficacy study, the "ground truth" would be pre-defined clinical and histological endpoints observed in the animal models.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI model requiring a training set.

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

• Not applicable, as no training set for an AI model was involved.

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Collagen Tendon Sheet-D is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Collagen Tendon Sheet-D is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-D is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet-D is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-D is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

This 510(k) summary (K122048) describes the Collagen Tendon Sheet-D, a resorbable type I collagen matrix. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Collagen Tendon Sheet, K112423) through a comparison of technical characteristics and non-clinical studies. There is no information provided about a clinical study involving human participants, AI, or specific performance metrics like sensitivity, specificity, or accuracy for a device that relies on such evaluation.

Therefore, the following information is not available in the provided document:

• A table of acceptance criteria and reported device performance related to clinical outcomes.
• Sample size used for a test set (as no clinical test set for performance evaluation is described).
• Data provenance for a clinical test set.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers with AI vs. without AI.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

Based on the provided document, the device met the acceptance criteria by demonstrating substantial equivalence to a legally marketed predicate device through non-clinical studies.

Here's the relevant information that is available:

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

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

• Not applicable / Not provided. The submission focuses on non-clinical studies (in vitro and in vivo animal studies for biocompatibility, chemical, and mechanical characterization). There is no mention of a clinical test set involving human data.

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

• Not applicable / Not provided. Ground truth determination by experts is not described as part of this non-clinical testing.

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

• Not applicable / Not provided. No clinical test set or adjudication process is mentioned.

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 such study was done or reported. This device is a medical implant (collagen matrix), not an AI diagnostic or assistive device, so MRMC studies involving AI assistance are not relevant to this submission.

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

• No such study was done or reported. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For biocompatibility: Standardized assay results (e.g., cell viability, toxicity assessments, tissue response).
• For material and mechanical characterization: Laboratory measurements and analytical techniques.
• Not applicable in the context of expert-derived clinical ground truth.

8. The sample size for the training set:

• Not applicable / Not provided. No training set, as this is not an AI/algorithmic device.

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

• Not applicable / Not provided. No training set for ground truth establishment.

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

Collagen Tendon Sheet is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

This K112423 510(k) summary describes the Collagen Tendon Sheet device and its substantial equivalence determination to a predicate device. This submission relies heavily on a comparison to the predicate, rather than an independent de novo study with acceptance criteria. Therefore, the requested information elements related to standalone performance, MRMC studies, sample sizes, and ground truth establishment for a new device's performance study are not directly available from this document.

However, I can extract and infer information relevant to the substantial equivalence determination for this device, presented to the best of what the document provides:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance study. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The "performance" is therefore measured against how closely the new device matches the predicate's characteristics and safety profile.

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

• Test Set Sample Size: Not explicitly stated for specific studies (e.g., in vitro, biocompatibility, animal efficacy). The conclusion states "The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device." This implies these studies formed the basis for the "test" of substantial equivalence.
• Data Provenance: Not specified, but given the company address (Plymouth, MN) and FDA submission, it is likely mostly US-based data, though not explicitly stated. The studies are described as pre-market (non-clinical).

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

Not applicable in the context of this 510(k) submission, as it relies on pre-clinical studies (in vitro, animal) and comparison to a predicate, not on a human-read diagnostic test requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic device requiring human adjudication of results.

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 surgical mesh/tendon sheet, not an AI-assisted diagnostic or imaging device.

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

"Standalone" in the context of an algorithm or AI is not applicable here. The device itself is a physical implant. The listed studies (in vitro, biocompatibility, animal efficacy) represent the "standalone" performance evaluation of the device's material and biological properties.

7. The Type of Ground Truth Used

• For in vitro characterization: Laboratory measurements and established material science standards.
• For biocompatibility: Standards like FDA G95-1 and ISO 10993-1, with endpoints like cytotoxicity, irritation, sensitization, systemic toxicity, etc. (often evaluated by trained toxicologists/pathologists as per standard protocols).
• For animal efficacy study: Animal model outcomes (e.g., tendon healing, tissue response) compared against the predicate device. These would be assessed by veterinary researchers and often histopathologists.
• For viral inactivation: Established viral testing protocols and assays.

8. The Sample Size for the Training Set

Not applicable. This device does not use an algorithm that requires a training set. The data used for demonstrating its properties and equivalence would be considered "test" data in a general sense, not "training" data for an AI model.

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

Not applicable, as there is no training set for an algorithm.

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