(144 days)
The OPTIFIX™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The OPTIFIX™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners via a straight shaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cm in length. The fasteners are designed with a retention feature on the end and are manufactured from Poly (D, L)-lactide.
The provided document describes the OPTIFIX™ Absorbable Fixation System, a medical device, and its substantial equivalence to a predicate device, SorbaFix™, based on non-clinical and animal studies. However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-driven device. It is a traditional medical device submission for a physical surgical fixation system.
Therefore, many of the requested fields related to AI/algorithm performance (e.g., test set, ground truth experts, MRMC studies, standalone performance, training set) are not applicable to this document.
Here's an attempt to extract relevant information from the provided text, acknowledging that the request is geared towards AI/algorithm studies, which isn't the subject of this 510(k) summary.
1. Table of acceptance criteria and the reported device performance
The document states that the OPTIFIX™ Absorbable Fixation System passed various non-clinical and animal test requirements, and "All samples tested met the acceptance criteria." However, the specific quantitative acceptance criteria values are not explicitly stated in the provided text. The performance is reported as meeting these (unstated) criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Tests: | |
| Shear strength testing | Met acceptance criteria |
| Mass loss determination | Met acceptance criteria |
| Dimensional changes | Met acceptance criteria |
| Inherent viscosity | Met acceptance criteria |
| Glass transition temperatures | Met acceptance criteria |
| Residual monomer content | Met acceptance criteria |
| Animal (In-vivo) Studies: | |
| Contracture | Met acceptance criteria |
| Tissue Ingrowth | Met acceptance criteria |
| Histology | Met acceptance criteria |
| Ex-vivo Test: | |
| Burst Strength on Pig wall | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be "All samples tested." The specific number of samples for each non-clinical or animal study is not provided.
- Data Provenance: Not explicitly stated. The studies are described as "non-clinical tests," "animal in-vivo studies," and "Ex-vivo Burst Strength on Pig wall." Country of origin or retrospective/prospective nature is not mentioned.
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)
- Not Applicable. This document describes the testing of a physical medical device. The "ground truth" for the performance metrics (e.g., shear strength, mass loss, burst strength) would be established by direct physical measurements and observations, not by human expert consensus or interpretation in the way it's done for AI models.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See explanation above. The assessment of physical and biological properties is based on experimental protocols and quantitative analysis, not expert adjudication of interpretations.
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 device, not an AI/algorithm. No human "readers" are involved in interpreting its output, and there's no AI assistance being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the measured physical and biological properties of the device and its interaction with tissue. This includes:
- Direct measurements of shear strength, mass, dimensions, viscosity, glass transition temperatures, and residual monomer content.
- Observations from animal in-vivo studies (e.g., contracture, tissue ingrowth, histology) which are typically assessed by pathologists or researchers following established protocols.
- Measurements of burst strength on ex-vivo tissue (pig wall).
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithm-driven device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.