(162 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 (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide.
The provided document is a 510(k) summary for the OptiFix™ Absorbable Fixation System. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a primary clinical study establishing acceptance criteria and device performance against those criteria. Therefore, most of the questions cannot be answered directly from the provided text.
However, I can extract information related to the performance data provided to support the substantial equivalence determination, specifically focusing on the non-clinical tests and their "acceptance criteria" which is implicitly "met the established acceptance criteria" in the context of the document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "All samples tested met the established acceptance criteria." However, the specific quantitative acceptance criteria for each test are not provided. The "reported device performance" is summarized as the device passing these tests.
| Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (as stated in document) |
|---|---|
| Established acceptance criteria for Actuation (trigger) torque | Met established acceptance criteria |
| Established acceptance criteria for Fastener deployment | Met established acceptance criteria |
| Established acceptance criteria for Fastener gap height | Met established acceptance criteria |
| Established acceptance criteria for Ball burst testing | Met established acceptance criteria |
| Established acceptance criteria for Mesh compatibility testing | Met established acceptance criteria |
| Established acceptance criteria for Resorption profile of the fastener | Met established acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the non-clinical tests (e.g., how many devices were tested for "Actuation torque"). It only states "All samples tested."
The data provenance is from non-clinical bench testing performed by Davol Inc. for the proposed OptiFix™ Absorbable Fixation System and the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as there were no clinical studies described, and thus no "ground truth" established by experts in this context. The "truth" for the non-clinical tests would be the measurement results against engineering specifications, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
Not applicable. There was no clinical study with human readers requiring adjudication.
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. No MRMC study was performed, and this device is a surgical fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical surgical fixation system, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be the engineering specifications and established test protocols that define what constitutes a passing performance for each parameter (e.g., a specific torque range, a specific deployment force, a certain gap height). The document indicates "All samples tested met the established acceptance criteria," implying such specifications were used.
For the biocompatibility evaluation, the ground truth was based on recognized standards: "FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA."
8. The sample size for the training set
Not applicable. This device is a physical surgical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.