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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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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 <1000 um. The device is packaged in a nested tray system with peel-open lids. The device is terminally sterilized using electron beam irradiation.

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

Study Information for Device Performance

This 510(k) submission does not describe a clinical study comparing device effectiveness in patients, as is common for many AI/diagnostic devices. Instead, it relies on bench (design verification) testing and biocompatibility studies to demonstrate equivalence to a previously cleared device. Therefore, many of the typical questions for AI/diagnostic device studies are not applicable.

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

   • Test Set Sample Size: Not applicable in the context of clinical cases. The "test set" here refers to samples of the device and its components used for biocompatibility and bench testing. Specific sample sizes for each bench test (e.g., number of devices tested for tip bending, number of samples for particle size analysis) are not disclosed in this summary.
   • Data Provenance: Not applicable for a clinical study. The data provenance would be from laboratory testing conducted by or for ACell, Inc.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. Ground truth, in the sense of expert consensus on patient cases, is not relevant for this type of submission focused on material and functional equivalence. The "ground truth" for bench tests would be established by validated measurement methods and equipment.

3. Adjudication Method for the Test Set: Not applicable. There is no expert adjudication process described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This device is a wound care product, not an imaging or diagnostic AI device that would typically involve human readers.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance): Not applicable. This is not an algorithm-based device. Performance tests involve bench testing of the physical properties and functional aspects of the device itself.

6. Type of Ground Truth Used:

   • Biocompatibility: Established by reference to and compliance with ISO 10993-1 standards and associated test methods, which define acceptable thresholds for biological responses.
   • Bench Testing (Design Verification): Established by engineering specifications and validated measurement techniques (e.g., particle size analysis, temperature measurements, force measurements for tip bending).

7. Sample Size for the Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the Ground Truth for the Training Set Was Established: Not applicable.

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