(142 days)
ProPatch™ Soft Tissue Repair Matrix is indication to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floration of the reinforcement, and reconstructive procedures.
ProPatch™ Soft Tissue Repair Matiz is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendone repair surgery including reinforcement of solt used as them soft includes, biceps, quadriceps, or other tendons.
ProPatch™ Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendor to 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. ProPatch™ Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Product configurations consist of a 7 cm round and a 5 x 8 cm oval shapes, and configurations from 1 x 1 cm to 9 x 19 cm. Each surgical mesh is packaged ready to use within a clear peel-away inter pouch, and a foil laminte peelaway outer pouch. The packaged product is supplied sterile and non-pyrogenic.
The provided text describes a 510(k) premarket notification for the ProPatch™ Soft Tissue Repair Matrix. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with acceptance criteria for device performance in the way an AI/ML device would. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, sample sizes for training/test sets, and ground truth establishment for AI/ML models) is not applicable to this submission.
However, I can extract information related to the device's physical performance and biocompatibility testing which serves a similar role to "acceptance criteria" for a medical device that reinforces soft tissues.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Biomechanical | Demonstrates acceptable tensile strength, stiffness, tear resistance, suture retention strength, and burst strength. (Specific quantitative values are not provided in the summary, but the results were deemed "acceptable" in accordance with guidance document.) |
| Biocompatibility | Suitable biocompatibility. Intramuscular implants of the device were found to be non-irritating relative to the control article. (Specific quantitative values or detailed biocompatibility test results are not provided beyond the non-irritating finding.) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this is a device for physical reinforcement, not an AI/ML diagnostic. The testing involved mechanical and biocompatibility assessments, which would have their own sample sizes (e.g., number of samples for tensile testing, number of animals for biocompatibility). These are not detailed in the summary.
- Data Provenance: Not applicable in the context of country of origin for patient data. The provenance relates to laboratory testing of the material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for this device is established by physical measurement standards and established biocompatibility testing protocols, not by expert interpretation of patient data.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, which is not the nature of this submission. The tests performed are objective physical and chemical tests.
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. This is a physical medical device (surgical mesh), not an AI/ML diagnostic or assistance tool; therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For Mechanical/Biomechanical performance: The "ground truth" is based on established engineering principles and standards for material strength, stiffness, tear resistance, suture retention, and burst strength. The compliance is assessed against the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999)."
- For Biocompatibility: The "ground truth" is based on established biological safety principles and testing protocols (e.g., ISO 10993 series), specifically stating "Intramuscular implants of the device were found to be non-irritating relative to the product control article."
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device.
§ 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.