(267 days)
The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.
The Integrity Implant will be made available in 2 sizes:
- 20mm X 25mm
- 25mm X 30mm
The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.
The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.
The provided document is a 510(k) summary for the Integrity™ Implant, a medical device for managing and protecting tendon injuries. It is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests. The performance data is presented as evidence that the subject device performs comparably to the predicate.
| Acceptance Criteria Category (Implied by FDA Review) | Specific Tests / Performance Metrics | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 Endpoints: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Endotoxin (LAL), Genotoxicity, Implantation/Biodegradation | All tests conducted in accordance with FDA guidance. No adverse biological responses indicated. |
| Physical/Mechanical Characteristics (Bench Testing) | Sterility, Shelf Life, Dimensions, Thickness, Mesh Basis Weight/Density, Mesh Knit Characteristics, Pore Size, Patch Stiffness, Patch Compliance, Tear Resistance, Suture Pull-out/Retention Strength, Bacterial Endotoxin Limits, Residual Solvents | All tests performed; specific quantitative results are not detailed in this summary but are implied to be acceptable for substantial equivalence. |
| In Vivo Performance (Animal Study) | Gross macroscopic appearance, Radiographic changes (AP, lateral X-ray, Micro-CT), Mechanical properties of repair (tensile testing), Histological responses | No study-related complications or premature deaths. No adverse reactions observed. Tensile testing showed subject and predicate devices performed substantially equivalent. Histology demonstrated substantial equivalence in resorption and regenerative scaffold support. |
2. Sample Size Used for the Test Set and Data Provenance:
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Animal Study (Test Set):
- Sample Size: Forty-seven (47) skeletally mature sheep were enrolled.
- Data Provenance: The study used an adult bilateral infraspinatus model in sheep, making it prospective animal data. The country of origin of the animal study is not specified in this document.
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No human clinical studies were conducted for this 510(k) submission, so there is no human test set data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For the animal study, the document mentions "gross dissections and harvest," "blood work and distant organ pathology," "radiographic endpoints," and "histology results."
- While these imply expert analysis (e.g., veterinary pathologists, radiologists, histotechnologists/pathologists), the document does not explicitly state the number of experts, their qualifications, or how ground truth was established for the animal study. It only reports the findings (e.g., "Blood work and distant organ pathology were normal," "Histology results from the current study demonstrated...").
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the animal study. It's typical for animal study results to be interpreted by a single or a small team of experts (e.g., a veterinary pathologist), but this detail is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a surgical implant, not an imaging analysis AI device that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No standalone (algorithm only) performance study was done. This device is a physical implant; there is no AI algorithm being evaluated for standalone performance.
7. The Type of Ground Truth Used:
- For the animal study, the "ground truth" was established through a combination of:
- Direct Observation: Gross macroscopic appearance during dissection.
- Imaging: Radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography, 3T MRI scanning.
- Biomechanical Testing: Tensile testing of the repaired rotator cuff.
- Histopathology: Histological responses.
- These are all objective biological and physical measurements from the animal model.
8. The Sample Size for the Training Set:
- This submission is for a physical medical device (implant), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning model development. The performance data is generated through bench and animal testing.
9. How the Ground Truth for the Training Set Was Established:
- As there is no AI/ML algorithm with a training set, this question is not applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.