PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.
PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States.
The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.
PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.
PSDV-SG is provided sterile and intended for single use. Sterilization occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.
This document is a 510(k) summary for a medical device called PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG). It describes the device, its intended use, comparison to predicate devices, and performance data.
Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document lists various assessments for design verification. It doesn't present these as formal "acceptance criteria" with specific pass/fail values in a table, but rather as "assessments" with the general outcome mentioned as "Testing passed the acceptance criteria" for biocompatibility and "demonstrate the performance of the PSDV-SG device is substantially equivalent to the predicate devices" for bench testing.
Based on the text, here's a conceptual table:
| Assessment/Criteria Category | Specific Assessment | Reported Device Performance/Outcome |
|---|---|---|
| Design Verification (Pre-Clinical Bench Studies) | ||
| General Performance | Visual Inspection | Results demonstrate substantial equivalence to predicate devices. |
| General Performance | Thickness | Results demonstrate substantial equivalence to predicate devices. |
| General Performance | Functional Testing | Results demonstrate substantial equivalence to predicate devices. |
| General Performance | Manipulation Testing | Results demonstrate substantial equivalence to predicate devices. |
| Material Safety | Chemical residuals | Results demonstrate substantial equivalence to predicate devices. |
| Physical Property | Drape | Results demonstrate substantial equivalence to predicate devices. |
| Material Safety | Heavy Metals | Results demonstrate substantial equivalence to predicate devices. |
| Material Safety | Endotoxin | Results demonstrate substantial equivalence to predicate devices. |
| Material Safety | Bioburden | Results demonstrate substantial equivalence to predicate devices. |
| Sterilization | Sterilant residuals | Results demonstrate substantial equivalence to predicate devices. |
| Packaging Integrity | Seal strength of packaging seals | Results demonstrate substantial equivalence to predicate devices. |
| User Interface/Workflow | Preparation time | Results demonstrate substantial equivalence to predicate devices. |
| User Interface/Workflow | Stackability | Results demonstrate substantial equivalence to predicate devices. |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009 L929 elution method) | Passed the acceptance criteria. (Specific criteria are implied by the standard but not detailed in the text). |
| Shelf Life | Aging Testing | Supports a 6-month shelf life claim. (Ongoing testing to extend). |
| Sterilization Assurance | Sterilization Cycle Adoption | Per AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization. |
| Usability/Human Factors | Human Factors Study | Successfully completed demonstrating usability and user comprehension of labeling. |
| Clinical Feedback | Surgeon Validation | Completed and supports customer satisfaction of PSDV-SG functionality. |
2. Sample sizes used for the test set and the data provenance:
- Sample Sizes: The document does not specify sample sizes for any of the tests (bench studies, biocompatibility, human factors, or surgeon validation). It broadly mentions "testing" or "studies" without numerical details.
- Data Provenance: The document implies that the data was generated by Synovis Life Technologies, Inc. (now Baxter International Inc.) as part of their 510(k) submission. There is no information about the country of origin of the data explicitly stated. The studies are pre-clinical bench studies and validation studies, which are typically conducted in a controlled environment as part of product development, not necessarily from a "retrospective" or "prospective" clinical data sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For the "Human Factors Study," "user comprehension" was assessed, implying user participants, but not "experts" in the sense of ground truth establishment.
- For the "Surgeon Validation," "surgeons" were involved, but their number and specific qualifications (e.g., years of experience, specialty) are not provided. They were involved in assessing functionality and satisfaction, not necessarily establishing a "ground truth" that would be typical for, say, an AI model's diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. The studies described (bench, biocompatibility, human factors, surgeon validation) do not involve subjective interpretation of medical images or data requiring an adjudication method common in diagnostic accuracy studies. They are focused on physical and functional performance, safety, and usability.
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 MRMC study was done. This device is a surgical mesh for staple line reinforcement, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense of diagnostic "ground truth." For this device, "ground truth" relates to the functional performance of the device against engineering specifications, biocompatibility standards, and usability criteria.
- For bench testing, the "ground truth" is likely defined by engineering specifications and comparative performance to predicate devices.
- For biocompatibility, the "ground truth" is defined by the passing criteria of the ISO 10993-5 standard.
- For human factors, "ground truth" is user comprehension and ability to use the device as intended.
- For surgeon validation, "ground truth" is customer satisfaction and functionality assessment by the surgeons.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm.
§ 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.