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MicroMatrix® Flex 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 (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), and draining wounds. The device is intended for one-time use.

The MicroMatrix® Flex device is a dual-syringe system for the mixing and delivery of a paste for the management of wounds. The particulate component of the device is composed of porcine-derived extracellular matrix known as urinary bladder matrix. The particulate component is identical to that particulate in the predicate device, MicroMatrix® UBM Particulate (K172399), with the standard particle size of

The provided FDA 510(k) summary for the MicroMatrix® Flex device does not describe specific acceptance criteria in the typical sense of a diagnostic device (e.g., sensitivity, specificity, AUC). Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MicroMatrix® UBM Particulate) by showing that the new device has identical intended use, similar technological characteristics, and similar principles of operation, with minor differences not raising new safety or effectiveness issues.

The "acceptance criteria" here are therefore related to demonstrating that the new device performs equivalently to the predicate in various aspects.

Acceptance Criteria and Reported Device Performance

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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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The Flowable Wound Matrix 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, 2nd degree burns, skin tears) and draining wounds.

The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.

However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
2. Sample sizes used for a test set, data provenance, or details about ground truth establishment.
3. Information on the number of experts or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Sample size for a training set or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.

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Coreleader Colla-Pad Wound Dressing 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-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Coreleader Colla-Pad is comprised of a porous matrix of cross-linked bovine collagen. Colla-Pad is made of highly absorbent material that converts to a soft, gel sheet that stays in intimate contact with the wound bed as it absorbs exudate t. The moisture held around the wound by Colla-Pad could provide a favorable wound healing environment. Coreleader Colla-Pad is easy to cut and apply. Cut to fit any size of acute or chronic wounds with light to heavy exudate. Coreleader Colla-Pad is a sterile topical wound dressing, packed in a foil pouch and a foil package and sterilized by r-ray radiation to a 10to SAL.

The provided text is a 510(k) summary for the Coreleader Colla-Pad, a collagen wound dressing. This document confirms the device's substantial equivalence to predicate devices for its intended use. However, it does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically requested for AI/software devices.

The document discusses the device description, intended use, technological characteristics, and biocompatibility testing. The biocompatibility section mentions ISO 10993-11 for systemic toxicity, blood analysis, and histological analysis showing no inflammation reaction in test animals, but this is a safety assessment, not a performance study comparing the device against specific acceptance criteria for efficacy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
7. The type of ground truth used: Not applicable, as performance efficacy is not detailed.
8. The sample size for the training set: Not applicable, as this is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/software device.

The 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety (biocompatibility) compared to existing legally marketed devices, rather than presenting a detailed clinical performance study with specific acceptance criteria.

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