(464 days)
InnovaMatrix PD 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 (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), draining wounds, and partial-thickness burns. The device is intended for one-time use.
InnovaMatrix® PD is a powder manufactured from the decellularized extracellular matrix (ECM) derived from porcine placental tissue harvested according to Good Manufacturing Practices. Further treatment and final sterilization yield a particulate device prepared for the management of wounds. The particulate is meant to be deployed by the user to manage wounds of the types outlined in the Indications for Use of the device. InnovaMatrix® PD is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in a particulate form as a single-use, sterile wound covering.
This document is a 510(k) Summary for the InnovaMatrix PD device, a collagen wound dressing. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence to a legally marketed device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving the device meets them:
Crucially, this document (a 510(k) Summary) focuses on demonstrating "substantial equivalence" of a new medical device to a legally marketed predicate device. This process typically relies heavily on comparing technological characteristics and non-clinical performance data to show the new device is as safe and effective as the predicate.
It does NOT describe a study with "acceptance criteria" for a device's performance in a clinical setting in the way you've outlined (e.g., diagnostic accuracy metrics like sensitivity, specificity, or human reader improvement with AI assistance). These types of detailed performance studies are commonly seen for diagnostic devices or AI/ML-driven software, not typically for wound dressings demonstrating substantial equivalence.
Therefore, I cannot provide all the requested information as it is not contained within this type of regulatory submission. However, I can extract what is present and clarify what is absent.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies acceptance criteria by performing specific non-clinical tests and concluding that the device is "substantially equivalent" to predicate devices. However, explicit numerical performance targets (e.g., "Device must achieve X sensitivity") are not stated. The "performance data" section lists the types of tests performed to mitigate risks, not specific performance metrics against pre-defined criteria.
- Reported Device Performance: Instead of explicit performance metrics, the document reports that the conducted tests support the conclusion of substantial equivalence. For example, Biocompatibility Testing was performed, and the implication is that the results were acceptable.
Table (Inferred based on non-clinical testing performed):
| Test Category | Implied Acceptance / Purpose | Reported Performance (Qualitative from text) |
|---|---|---|
| Sterilization Validation Testing | To ensure sterility and validate the E-Beam process. | Performed to mitigate risk from processing steps. (Assumed successful to support clearance) |
| Shelf-Life Testing (Packaging, Product) | To demonstrate stability and integrity over shelf life. | Performed to mitigate risk. (Assumed successful) |
| Transportation (Packaging Performance) | To ensure product integrity during transport. | Performed. (Assumed successful) |
| Endotoxin | To ensure endotoxin levels are within safe limits. | Performed. (Assumed acceptable levels) |
| Physician Usability Testing | To assess the ease and safety of use by physicians. | Performed. (Assumed positive feedback/no significant issues) |
| Particle Size Analysis | To confirm the particulate form meets specifications. | Confirmed particles ≤ 1000 µm as specified in comparison table. |
| Residual Moisture | To ensure appropriate moisture content for stability/performance. | Performed. (Assumed within acceptable range) |
| Water Absorption | To confirm expected hydration properties. | Performed. (Assumed to behave as expected, becoming hydrated and moist during use as per predicate) |
| Chemical Characterization & Toxicity Risk Assessment | To confirm composition and assess potential toxicity. | Performed. Confirmed as "chemically identical" to reference device (InnovaMatrix®). (Assumed safe) |
| Heavy Metals and Elemental Impurities | To ensure levels are below harmful thresholds. | Performed. (Assumed acceptable levels) |
| Biocompatibility Testing (Cytotoxicity, Intracutaneous, Acute Systemic Toxicity, Sensitization, Implantation, Material-Mediated Pyrogenicity) | To ensure the device is biologically safe when interacting with the body. | Performed. (Assumed to pass all relevant ISO 10993 requirements for contact duration/type) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified. The document does not mention the country of origin of data or whether it was retrospective/prospective. This is typical for non-clinical lab testing.
3. Number of Experts and Qualifications for Ground Truth
- This concept does not apply to this type of submission. "Ground truth" established by experts (e.g., radiologists for image analysis) is applicable to studies of diagnostic accuracy or AI performance where expert interpretation is the reference standard. This document focuses on material properties, manufacturing controls, and physical/chemical performance of a wound dressing. "Physician Usability Testing" involved physicians, but their role was to assess usability, not to establish a "ground truth" for a performance metric.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert interpretations, which is not relevant to the non-clinical testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study for Human Readers
- Not applicable. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader performance with/without AI assistance are not relevant or performed for this product.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a physical wound dressing, not an algorithm or software.
7. Type of Ground Truth Used
- Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical tests performed is typically defined by established laboratory standards, specifications, and regulatory requirements (e.g., ISO standards for biocompatibility, USP for endotoxins, validated test methods for particle size).
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How Ground Truth for Training Set Was Established
- Not applicable.
Summary of what the document does provide regarding "acceptance":
The document effectively describes the regulatory acceptance process for a medical device through the 510(k) pathway, which primarily involves demonstrating substantial equivalence to an existing predicate device. The "acceptance criteria" here are that the new device (InnovaMatrix PD) must be as safe and effective as the predicate device (Cook® ECM Powder), despite minor differences in technological characteristics (e.g., raw material source, sterilization method, form factor).
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing listed in Section 7. These tests were performed to address any potential risks introduced by changes from the predicate or reference devices. The successful completion of these tests, combined with the comparison of technological characteristics, forms the basis for the FDA's determination of substantial equivalence and subsequent market clearance. The "proof" is the FDA's clearance letter itself, stating they "have determined the device is substantially equivalent."
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