(51 days)
The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
The SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
The provided text describes a 510(k) submission for a medical device called the "SIS Plastic Surgery Matrix." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct effectiveness through clinical trials with defined acceptance criteria for device performance as would be typical for a novel and complex AI/software device.
Therefore, many of the requested categories related to acceptance criteria and ground truth for a software study do not directly apply to this particular document. The "study" here refers to demonstrating substantial equivalence through in vitro and biocompatibility testing, not a clinical efficacy study with human readers or AI algorithms.
Here's an analysis based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device must be biocompatible. (Implicit: No adverse biological reactions) | Outcomes show the device to be biocompatible. |
| Viral Inactivation: Manufacturing processes must adequately disinfect the material. | Manufacturing processes adequately disinfect the material. |
| Tensile Strength: Sufficient tensile strength for soft tissue reinforcement. (Specific quantitative criteria are not provided in this summary.) | Tensile strength... to be sufficient. |
| Suture Retention Strength: Sufficient suture retention strength for soft tissue reinforcement. (Specific quantitative criteria are not provided in this summary.) | Suture retention strength to be sufficient. |
| Substantial Equivalence: Similar intended use, materials, and technological characteristics to predicate devices. | Evidence of suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics as shown through in vitro and biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a "test set" for an AI/software device. The testing described (biocompatibility, viral inactivation, mechanical testing) applies to the material of the device rather than a clinical dataset. No specific number of samples for these tests is mentioned.
- Data Provenance: Not applicable in the context of clinical data provenance. The "data" comes from in vitro and biocompatibility testing of the porcine small intestinal submucosa material itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no concept of "ground truth" established by experts for a test set in this 510(k) summary. The evaluation focuses on material properties and manufacturing processes.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set requiring adjudication in this summary.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study type is relevant for AI-assisted image interpretation or diagnostic tools, which this device is not.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable in the AI/software sense. The "ground truth" for this device's evaluation is derived from standard scientific and engineering methodologies for material testing (e.g., laboratory measurements for tensile strength, viral assays for inactivation, histological analysis for biocompatibility).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this 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.