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510(k) Data Aggregation
(235 days)
MEDEOR MATRIX WOUND DRESSING
Medeor Matrix Wound Dressing is indicated for the management of topical 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.
Medeor Matrix Wound Dressing is intended for one time use.
Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only.
This document describes the Medeor Matrix Wound Dressing, a resorbable porcine dermis-derived dressing for topical wounds. However, it is a 510(k) summary for a medical device that is not an AI/ML device.
The provided document does not contain information about a study proving that an AI device meets acceptance criteria. It is a regulatory submission for a physical wound dressing and primarily focuses on demonstrating substantial equivalence to a predicate device based on its material, technological, and performance characteristics, as well as biocompatibility testing.
Therefore, I cannot fulfill the request to provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the provided content.
The information primarily concerns the biocompatibility and physical performance of the wound dressing, not the performance of an AI/ML algorithm.
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(42 days)
MEDEOR MATRIX
Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
The device is intended for single use only.
The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and the study that demonstrates the Medeor™ Matrix device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Must meet requirements of ISO 10993-1:2003 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis). | The Medeor Matrix surgical mesh passed the requirements of all tests conducted according to ISO 10993-1:2003, including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis. |
| Viral Inactivation | Appropriate levels of viral inactivation. | Manufacturing methods were tested by an independent laboratory to assure appropriate levels of viral inactivation. |
| Mechanical Testing | Not explicitly stated in the provided text, but implied to be sufficient for soft tissue reinforcement. | Mechanical test reports were completed for: |
- Tensile Testing
- Suture Retention. The device passed the requirements of all tests. |
| Hydration Testing | Not explicitly stated, but implied to allow for hydration with various fluids. | Hydration testing was performed using various hydration fluids. The device passed the requirements of all tests. |
| In Vivo Performance | Not explicitly stated, but implied to demonstrate appropriate tissue repair and reaction in animal models. | The device was evaluated in two in vivo studies: - Defects were repaired and evaluated in a sheep model.
- A rabbit study was performed to evaluate tissue reactions. The device passed the requirements of all tests. |
| Substantial Equivalence | Demonstrated equivalence to predicate devices (Medeor™ Matrix (K091499) and KN ECM Surgical Patch (K094061)) in materials, intended use, and technological characteristics. | Performance Testing confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each test within the performance data section. However, it indicates the following studies were conducted:
- Biocompatibility Tests: The tests were conducted "on the finished device," implying a sufficient number of samples for each specific test mandated by ISO 10993-1:2003.
- Mechanical Tests (Tensile Testing, Suture Retention): Samples of the Medeor™ Matrix were used for these tests.
- Hydration Testing: Samples were tested with "various hydration fluids."
- In Vivo Studies:
- Sheep Model: Defects were repaired and evaluated in a sheep model. The specific number of sheep is not provided.
- Rabbit Study: A rabbit study was performed to evaluate tissue reactions. The specific number of rabbits is not provided.
Data Provenance:
The data was generated through laboratory testing and animal studies. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, implying the data would be acceptable to U.S. regulatory standards. All studies appear to be prospective in nature, as they were specifically conducted to evaluate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of human interpretation or review. The evaluation of the device relied on standardized laboratory tests (biocompatibility, mechanical, hydration) and animal models (in vivo studies). The "ground truth" for these tests would be the established scientific and engineering principles, and the interpretation of results would be by qualified laboratory personnel and researchers, rather than a panel of clinical experts adjudicating cases.
4. Adjudication Method for the Test Set
Not applicable. The reported studies (biocompatibility, mechanical, in vivo) are objective tests with predefined pass/fail criteria based on scientific standards and observations, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers evaluating medical images or data, with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The Medeor™ Matrix is a surgical mesh, not an AI-powered diagnostic device, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not conducted. The Medeor™ Matrix is a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The ground truth for the various tests was based on:
- Established Industry Standards: For biocompatibility, adherence to ISO 10993-1:2003.
- Inherent Material Properties: For mechanical testing (tensile strength, suture retention) and hydration properties, the measurements are objective.
- Biological Response: For viral inactivation and in vivo studies (sheep model for repair, rabbit study for tissue reactions), the ground truth was the observable biological outcomes and whether they met safety and performance expectations.
8. Sample Size for the Training Set
Not applicable. The Medeor™ Matrix is a physical surgical mesh and not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(154 days)
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the bone, provide biomechanical strength for the tendon repair.
Medeor Matrix is intended for one time use.
Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.
This document describes the performance data for the Medeor Matrix, a surgical mesh, in support of its 510(k) submission. However, it does not describe an AI/ML device or studies typically associated with such devices (e.g., comparative effectiveness studies with human readers, standalone algorithm performance, or ground truth establishment relevant to AI models). Therefore, I cannot extract information related to AI/ML device performance or study design for an AI/ML model from this document.
The document focuses on the traditional regulatory submission requirements for a medical device (surgical mesh), including mechanical testing and biocompatibility studies.
Let's break down what is available in the document regarding its performance criteria and studies for the Medeor Matrix surgical mesh:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a formal table of acceptance criteria with numerical targets. Instead, it states that the device "passed the requirements of all tests" for biocompatibility and "demonstrated equivalence of the device to legally cleared predicate devices" for mechanical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Demonstrated equivalence to legally cleared predicate devices for Tensile Testing and Suture Retention. |
| Biocompatibility Testing | Passed the requirements of all tests conducted per ISO 10993-1:2003, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis. |
| In Vivo Studies | Results not explicitly detailed as "acceptance criteria met," but implies successful outcomes for defect repair in a sheep model and tissue reactions in a rabbit study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical Testing: Sample sizes are not specified for Tensile Testing and Suture Retention.
- Biocompatibility Testing: Sample sizes are not specified.
- In Vivo Studies:
- Sheep model: "defects were repaired and evaluated in a sheep model." Sample size not specified.
- Rabbit study: "a rabbit study was performed to evaluate tissue reactions." Sample size not specified.
- Data Provenance: Not specified within the provided text.
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)
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device adjudicated by experts.
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 information is not applicable. No MRMC study was conducted as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/ML device; therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be the measured physical properties and their comparison to established standards or predicate devices. For biocompatibility, it's adherence to ISO 10993 standards and accepted biological response criteria. For in vivo studies, the "ground truth" would be histological analysis, gross observations, and clinical outcomes in the animal models.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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