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Collymer Self-Assembling Scaffold is intended 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, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.

The provided FDA 510(k) Clearance Letter for the GeniPhys Collymer Self-Assembling Scaffold (K250329) does not include information about any clinical studies or the performance of a device based on acceptance criteria.

The clearance letter explicitly states:
"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Collymer Self-Assembling Scaffold to the predicate device."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such clinical study data is presented in this document.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use and Technological Characteristics to a predicate device (Integra Flowable Wound Matrix, K072113) and several reference devices.
• Non-Clinical Testing: Biocompatibility assessments, viral inactivation studies, sterility assessments, shipping studies, and stability evaluations. For these non-clinical tests, it is stated that "All results met the acceptance criteria" or "The acceptance criteria were met," but the specific numerical acceptance criteria themselves are not detailed, nor are the specific performance results beyond a qualitative statement of meeting the criteria.

To directly answer your specific points based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document for any clinical performance. For non-clinical tests, only a qualitative statement that acceptance criteria were met is given.
2. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described. For non-clinical tests, sample sizes are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
4. Adjudication method for the test set: Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document states clinical testing was not necessary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (wound scaffold), not a software algorithm.
7. The type of ground truth used: Not applicable as no clinical study or test set with a "ground truth" (in the context of AI/diagnostic device performance) is described.
8. The sample size for the training set: Not applicable, as the document refers to a physical device and not a machine learning model that would have a training set.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device and extensive non-clinical testing, rather than a clinical study demonstrating performance against specific acceptance criteria.

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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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