(256 days)
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees.
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.
The provided document is a 510(k) summary for the medical device Fix2Lock (PEEK Self Punching). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. It primarily details a non-clinical bench study to verify design specifications and compliance with material and mechanical performance standards.
Therefore, many of the requested sections regarding clinical study design, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance are not applicable or not available in this type of submission.
Here's the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| Material | ASTM F2026: PEEK polymers for surgical implant applications | Complies with standard |
| ASTM F2848: Medical-Grade UHMWPE Yarns and Surgical Implants | Complies with standard | |
| Mechanical Performance | ASTM F543: Metallic medical bone screws | Complies with standard |
| Sterilization | ISO 11135: Ethylene oxide sterilization | Complies with standard |
| ISO 11138-1: Biological indicators (General) | Complies with standard | |
| ISO 11138-2: Biological indicators (EtO) | Complies with standard | |
| ISO 11140-1: Chemical indicators (General) | Complies with standard | |
| ISO 11737-1: Microbiological methods (Estimation) | Complies with standard | |
| ISO 11737-2: Microbiological methods (Sterility tests) | Complies with standard | |
| Packaging | ISO 11607-1: Packaging for terminally sterilized medical devices (materials) | Complies with standard |
| ISO 11607-2: Packaging for terminally sterilized medical devices (validation) | Complies with standard | |
| ASTM F1980: Accelerated Aging of Sterile Barrier Systems | Complies with standard | |
| ASTM F88/F88M: Seal strength of flexible barrier materials | Complies with standard | |
| ASTM F1929: Detecting Seal Leaks by Dye Penetration | Complies with standard | |
| Bacterial Endotoxin | USP : Bacterial Endotoxin Test | Complies with standard |
| USP : Medical Devices-Bacterial Endotoxin and Pyrogen Tests | Complies with standard | |
| Functional Equivalence | To be Substantially Equivalent (SE) to predicate device (K143745) in all aspects of safety and effectiveness, including intended use, product code, regulatory class, regulation number, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf-life. | Deemed Substantially Equivalent (SE) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The study described is a bench test, and the number of units tested to demonstrate compliance with the listed standards is not provided.
- Data Provenance: Not applicable, as this is a bench test for materials, mechanical properties, and sterilization, not a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood in clinical studies (e.g., disease presence/absence determined by experts) is not relevant for this type of bench testing. Compliance with engineering standards and material specifications would be assessed by engineers and quality control personnel.
4. Adjudication method for the test set
- Not applicable. There is no mention of adjudication for the bench tests. Compliance is determined against established engineering and material standards.
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 medical device for orthopedic fixation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the bench tests, the "ground truth" is defined by the specifications and requirements stipulated in the referenced international and national standards (e.g., ASTM F2026 for PEEK, ISO 11135 for sterilization). The device's performance is compared against these quantitative and qualitative standard requirements.
- For the overall submission, the "ground truth" for demonstrating marketability is the substantial equivalence to the predicate device, Arthrex Corkscrew and SwiveLock Suture Anchors (K143745).
8. The sample size for the training set
- Not applicable. This is a physical medical device and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.