(121 days)
The OptiFix AT Absorbable Fixation System with Articulating Technology 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™ AT Absorbable Fixation System with Articulating Technology, hereinafter referred to as "OptiFix ""AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. Two different product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the number of preloaded fasteners; either 15 or 30. The deployment shaft of the OptiFix™ AT device is 37cm in length and designed for use with 5mm trocars. The tip of the shaft can be articulated and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide-co-glycolide) and are dyed with D & C Violet No. 2 (
The provided text describes the OptiFix™ AT Absorbable Fixation System with Articulating Technology. The document is a 510(k) premarket notification for a medical device seeking substantial equivalence to already marketed predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a consolidated table of acceptance criteria with corresponding performance data in a dedicated section. However, it states that "All samples tested met the acceptance criteria" for various performance tests. The performance data is scattered throughout Section VII. PERFORMANCE DATA.
Below is a summary of the performance testing and an inferred "met acceptance criteria" outcome:
| Test Category | Specific Tests / Endpoints Evaluated | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing | Cytotoxicity, Sensitization, Intracutaneous (Irritation), Systemic Acute Toxicity, Sub-Chronic Toxicity (13 weeks), Chronic Toxicity (26 weeks), Genotoxicity (Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation, Mouse Lymphoma Assay), Implantation (4, 8, 12, 26, 39, 52, 77 weeks), Pyrogenicity | Met established criteria | All samples met criteria |
| Product Testing | Actuation (trigger) Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Mesh Compatibility Testing | Not specified, but listed as a test conducted. | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Fastener Resorption Profile | In-Vitro Degradation, In-Vitro to In-Vivo Correlation | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Animal Study (Safety & Feasibility Endpoints) | Mesh contracture, Fastener seating properties, Tissue in-growth (T-peel analysis), Host inflammatory/fibrotic response | Safety and feasibility demonstrated (by comparison to secondary predicate) | The study demonstrated that the OptiFix AT device can safely approximate soft tissue and fixate surgical mesh to tissues during open or laparoscopic surgical procedures. |
2. Sample Sizes Used for the Test Set and Data Provenance
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Biocompatibility Testing: The document does not specify the sample sizes (number of devices or biological samples) used for each biocompatibility test.
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Product Testing: The document does not specify the sample sizes for the product tests (Actuation Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing, Mesh Compatibility, Resorption Profile).
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Animal Study: The document does not specify the number of animals used in the study.
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Data Provenance: The studies are described as "preclinical testing" and were conducted to support the 510(k) submission, implying they were prospective studies. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in Warwick, Rhode Island, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Biocompatibility Testing: Ground truth is established by standardized biological evaluation methods (ISO 10993-1). No specific "experts" for ground truth are mentioned beyond the execution of these standardized tests.
- Product Testing: Ground truth is based on engineering specifications and benchmark performance against the predicate device. No specific "experts" (e.g., engineers with a certain number of years of experience) for ground truth establishment are detailed within the narrative.
- Animal Study: The evaluation included "histological evaluation of the tissue". This would typically involve pathologists, but the number and qualifications of these experts are not provided.
4. Adjudication Method for the Test Set
Not applicable. The tests described are primarily objective, quantitative measurements (e.g., torque, force, gap height, material degradation, histological analysis in the animal study). There is no mention of a human-centric "test set" requiring adjudication or consensus for classification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical studies were not performed for the submission of this proposed device nor were clinical studies performed for the primary predicate device (OptiFix-K142873)." Therefore, no MRMC study, or any clinical study involving human readers, was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a mechanical surgical fixation system, not a software-based diagnostic algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable here. The device itself is the standalone system.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is based on the results of standardized biological tests as per ISO 10993-1, indicating biological safety (e.g., non-cytotoxic, non-sensitizing).
- Product Testing: Ground truth is derived from engineering specifications and the established performance characteristics of the primary predicate device, used for equivalence comparison.
- Animal Study: Ground truth involved histological evaluation of tissue (pathology/histology) and objective measurements of mesh contracture, fastener seating, and tissue in-growth in an animal model.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.