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

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone.

The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging.

The subject device is available in following sizes:

• 3x5 cm size
• 6x9 cm size

Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

The provided text is a 510(k) clearance letter and summary for a medical device called "Tendon Protect." It details the device's characteristics, indications for use, and a summary of the non-clinical performance testing conducted to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. However, it does not contain the specific detailed information typically found in acceptance criteria tables or a comprehensive study report, particularly regarding a multi-reader multi-case (MRMC) study, standalone algorithm performance, or the detailed methodology for ground truth establishment that would be associated with AI/ML-based medical devices.

The document describes a physical medical device (surgical mesh made from fish skin) rather than an AI/ML-based diagnostic or assistive software. Therefore, many of the questions related to AI/ML specific criteria (such as sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this particular device submission.

Here's a breakdown of the applicable information found in the document:

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

The document mentions that the device "met all the pre-defined acceptance criteria" for various tests, but it does not provide a table detailing the specific numerical or quantitative acceptance criteria and the corresponding reported performance values. It only states that the tests were "conducted and passed successfully according to the test specifications."

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

• Test Set Sample Size: Not explicitly stated for most tests (e.g., biocompatibility bench tests). For the Tendon GLP Chicken Study, it is a chronic model evaluating early, mid-term, and late time points, comparing the subject device to a control and a negative control. The specific number of animals or tendons tested is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal testing), not human clinical data, and are likely prospective given they are part of a regulatory submission.

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

This is not applicable as the device is a physical surgical mesh, not a diagnostic or AI-based device requiring expert interpretation of images or signals for ground truth. Ground truth for the animal study would be based on objective scientific measurements and observations (e.g., histology, biomechanics).

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

This is not applicable for the reasons stated above.

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 as the device is a physical surgical mesh, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical surgical mesh, not an AI algorithm.

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

For the animal study:

• Histopathology evaluation
• Macroscopic evaluations
• Tendon biomechanical function assessment
• Overall animal health

For bench testing, ground truth would be established by the physical and mechanical properties of the material itself, measured against predefined specifications.

8. The sample size for the training set:

This is not applicable as the device is a physical surgical mesh, not an AI/ML system requiring a training set.

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

This is not applicable for the reasons stated above.

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Omeza® Collagen Matrix is indicated for the management of wounds including:

• · Partial and full-thickness wounds
• · Pressure ulcers
• Venous ulcers
• · Diabetic ulcers
• · Chronic vascular ulcers
• · Tunneled/undermined wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence)
• · Trauma wounds (abrasions, lacerations, superficial thickness burns, skin tears)
• · Draining wounds
  The device is intended for one-time use.

Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular wound beds to providea conducive environment for the patient's natural wound healing process.

This document is a 510(k) Premarket Notification summary for a medical device called Omeza® Collagen Matrix. It outlines the device's characteristics and how it demonstrates substantial equivalence to a predicate device, SweetBio Apis (K182725).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through performance testing designed to show substantial equivalence to the predicate device, especially in terms of safety and effectiveness. While explicit numerical acceptance criteria for each test are not listed in a table format, the document states that all tests had "favorable results" or showed "no evidence of impairment of wound healing," demonstrating the device met an acceptable standard.

Detailed Study Information:

The document primarily describes performance data used to demonstrate "substantial equivalence" to a predicate device, rather than a single, comprehensive "study" with a traditional test set/training set split as one might see for an AI/ML device. The tests are focused on characterizing the device's safety and effectiveness compared to known standards and the predicate.

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

   • Skin Prick Study: 25 subjects. Performed in the US, in accordance with Good Clinical Practice Standards (implied prospective).
   • Human Repeat Insult Patch Test (HRIPT): 58 subjects. Performed in the US, to Good Clinical Practice Standards (implied prospective).
   • Animal Studies (Swine Wound Healing):
     • Study 1: 4 animals, 10 full-thickness circular wound sites per animal.
     • Study 2: 2 animals, 10 full-thickness circular wound sites per animal.
     • Provenance: Implied prospective, conducted specifically for this evaluation.
   • Bench Testing: "Representative lots" or "representative samples" were used for various tests. Specific quantities are not provided.

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

   • For the Animal Studies, "independent expert review" was conducted for pathology and wound evaluation. The number and specific qualifications (e.g., DACVP for pathology) are not stated, but "independent expert" implies relevant veterinary or pathology expertise.
   • For the Skin Prick Study and HRIPT, clinical evaluation was performed, presumably by trained clinicians, but "experts" in the sense of adjudicators are not explicitly mentioned for establishing "ground truth" on top of the clinical observations. The "evaluator-blinded" design in HRIPT points to a clinical assessor.
   • For Biocompatibility and Bench Testing, "ground truth" is established by laboratory standards and validated methods, implicitly overseen by qualified lab personnel.

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

   • Not explicitly stated for any of the studies in a formal "adjudication" sense.
   • In the Animal Studies, "independent expert review" suggests a form of expert consensus or verification, but the exact method (e.g., multiple experts with a tie-breaker) is not detailed.
   • Clinical studies (Skin Prick, HRIPT) typically involve clinical assessment and data collection by trained personnel, rather than multi-reader adjudication of images or diagnoses.

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 study was performed or described. This document is for a wound dressing, not an AI-assisted diagnostic device. The evaluation focuses on the physical and biological performance of the dressing itself.

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

   • Not applicable. This device is a physical wound dressing, not a software algorithm.

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

   • Biocompatibility: Ground truth is established by standardized ISO 10993 testing endpoints and criteria.
   • Clinical Studies (Skin Prick, HRIPT): Ground truth is based on direct clinical observation of immediate allergic reactions, irritation, and sensitization markers as per established dermatological study protocols.
   • Animal Studies: Ground truth for wound healing endpoints is established through gross observation, pathology (histopathology), and "independent expert review" of the wounds.
   • Bench Testing: Ground truth is established by validated analytical methods, physical property measurements, and established quality specifications (e.g., ISO, AOAC standards).

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The data presented is for performance validation, not algorithm development.

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

   • Not applicable. Since there is no AI/ML algorithm, there is no training set mentioned in this context.

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NeoMatriX® Wound Matrix is intended for management of wounds, including:

• · Partial and full-thickness wounds,
• · Pressure ulcers,
• Venous ulcers,
• · Diabetic ulcers.
• · Chronic vascular ulcers,
• · Tunneled / undermined wounds,
• · Surgical wounds (donor sites / grafts, post Moh's surgery, post-laser surgery, podiatric, and wound dehiscence),
• · Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
• Draining wounds.

The device is intended for one-time use.

NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. This device is derived from an amphibian farm-raised hybrid axolot! source from a closed herd in a dedicated facility. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation.

NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.

The provided text describes the 510(k) summary for the NeoMatriX® Wound Matrix, a collagen wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria against predefined acceptance thresholds for an AI/CADe device.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable as this document describes a traditional medical device (wound matrix) and not an AI/CADe system.

The closest relevant information relates to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the information that is available or why certain sections are not applicable:

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

Not Applicable: This document is for a traditional medical device (wound matrix), not an AI/CADe device. Therefore, there are no specific performance metrics like sensitivity, specificity, accuracy, or AUC with corresponding acceptance criteria typically used for AI/CADe devices. The performance is assessed through various non-clinical and clinical tests to demonstrate safety and effectiveness for its intended use, mainly by showing it's comparable to existing predicate devices.

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

• Animal Test Set: Porcine testing was conducted. The specific sample size (number of pigs or wounds) is not explicitly stated.
• Human Clinical (Immunogenicity) Test Set:
  • Human Repeated Insult Patch Test (HRIPT): 68 healthy subjects.
  • Skin Prick Test (SPT): 22 healthy human subjects.
• Data Provenance: Not specified, but generally, such studies are prospective if conducted for regulatory 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)

Not Applicable: For animal and human immunogenicity testing, ground truth is established through direct observation for adverse events, histological analysis (for animal testing), and skin reactions (for human patch/prick tests). These are objective measurements, not subjective interpretations requiring external expert consensus in the way an AI/CADe system would.

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

Not Applicable: Ground truth for the described tests (biocompatibility, sterilization, bench, animal, and human immunogenicity clinical testing) does not involve adjudication by multiple human readers in the context of diagnostic interpretation. Results are typically based on laboratory analyses, pathologist's reports (for histopathology), or direct clinical observation and scoring.

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/CADe device, and therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

Not Applicable: This is not an AI/CADe device.

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

• Biocompatibility Testing: Compliance with ISO-10993-1 standards, results from standard laboratory assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, genotoxicity), and endotoxin testing.
• Sterilization Validation: Sterility assurance level of 10^-6 per ISO 11137.
• Bench Testing: Results of in vitro physio-chemical tests.
• Animal Testing: Histopathology (no necrosis, comparable epithelialization) and absence of adverse effects compared to predicate.
• Human Clinical Testing (Immunogenicity): Absence of skin reactions in HRIPT and SPT.

8. The sample size for the training set

Not Applicable: This is not an AI/CADe device; there is no training set mentioned.

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

Not Applicable: No training set for an AI/CADe algorithm was used.

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