(25 days)
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
The provided text is an FDA 510(k) clearance letter for a medical device called "Fix2Lock" (a bone anchor). This type of document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data (bench tests). It does not contain information about clinical studies involving human patients, human readers (e.g., radiologists interpreting images), or AI algorithms for diagnostic purposes.
Therefore, I cannot provide details on:
- Acceptance criteria related to AI performance (e.g., sensitivity, specificity).
- Sample sizes for test sets or data provenance for AI.
- Number of experts or their qualifications for establishing ground truth for AI.
- Adjudication methods for AI test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone AI performance.
- Training set details for AI.
The document discusses bench testing to demonstrate the device's mechanical and material properties, and sterility, compared to existing standards and a predicate device.
Here's the information that can be extracted relevant to the performance and acceptance criteria for this specific type of medical device, which is a bone anchor, not an AI diagnostic tool:
Acceptance Criteria and Study for the Fix2Lock Device
The acceptance criteria and supporting studies for the Fix2Lock device are based on non-clinical (bench) testing, primarily to demonstrate that the device meets established material and mechanical performance standards and is substantially equivalent to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Standard | Acceptance Criteria (Implied by Compliance) | Reported Device Performance (Implied by "met all design specifications" and "complies") |
|---|---|---|
| Material Standards | Compliance with: | Confirmed compliance based on bench tests |
| ASTM F2026: 2017 | Polyetheretherketone (PEEK) polymers for surgical applications met standard requirements. | Met. |
| ASTM F2848: 2021 | Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants met standard requirements. | Met. |
| ASTM F2502: 2017 | Absorbable Plates and Screws for Internal Fixation Implants (materials aspects) met standard requirements. | Met. |
| Mechanical Performance Standards | Compliance with: | Confirmed compliance based on bench tests |
| ASTM F543: 2013 | Metallic Medical Bone Screws (mechanical aspects) met standard requirements. | Met. |
| ASTM F2502: 2017 | Absorbable Plates and Screws for Internal Fixation Implants (mechanical aspects) met standard requirements. | Met. |
| Sterilization, Shelf-life & Packaging Standards | Compliance with: | Confirmed compliance based on bench tests |
| ISO 11135:2014 | Ethylene oxide sterilization process requirements. | Met. |
| ISO 11138-1:2017, ISO 11138-2:2017 | Biological indicators for sterilization processes. | Met. |
| ISO 11140-1:2014 | Chemical indicators for sterilization. | Met. |
| ISO 11737-1:2018 (incl. AMD1:2021) | Microbiological methods for determination of microorganism population on product. | Met. |
| ISO 11737-2:2019 | Sterility tests. | Met. |
| ISO 11607-1:2019 | Requirements for materials, sterile barrier systems, and packaging systems. | Met. |
| ISO 11607-2:2019 | Validation requirements for forming, sealing, and assembly processes. | Met. |
| ASTM F1980:2016 | Accelerated Aging of Sterile Barrier Systems. | Met. |
| ASTM F88/F88M:2021 | Seal strength of flexible barrier materials. | Met. |
| ASTM F1929:2015 | Detecting Seal Leaks in Porous Medical Packaging. | Met. |
| Bacterial Endotoxin Testing | Compliance with: | Confirmed compliance based on bench tests |
| USP <85>, USP <161> | Bacterial Endotoxin Test and Pyrogen Tests. | Met. |
| ISO 11737-3:2023 | Bacterial endotoxin testing methods. | Met. |
| Product Size Comparison (vs. Predicate) | Anchor diameter: Ø 3.75 to 6.5 mm; Anchor length: 12.0 to 14.0 mm | Matches or is within the range of the predicate device (Ø 2.6 to 6.5 mm diameter, 10.0 to 20.8 mm length). Safety evaluated by performance bench tests. |
| Shelf-life | 3 Years | 3 Years (Matches predicate) |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of units) used for each bench test. However, it indicates that "Bench tests were conducted to verify that the subject device met all design specifications."
- Data Provenance: Not applicable in the human patient context. The data is from laboratory bench testing of the physical medical device. The sponsor is OSTEONIC Co., Ltd. from Korea, South. The testing would have been conducted by or for the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for this type of device is established through compliance with recognized consensus standards (e.g., ASTM, ISO) and comparison of physical/mechanical properties to a predicate device via laboratory testing, not through expert human interpretation of data like in an AI study.
4. Adjudication method for the test set:
- Not applicable. Bench tests have objective, measurable endpoints based on engineering and material science principles, not subjective interpretation 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:
- No. This is a physical medical device (bone anchor), not an AI diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI algorithms, not physical implanted devices.
7. The type of ground truth used:
- The "ground truth" for this device is compliance with established engineering, material, and sterilization standards (ASTM and ISO standards) and demonstration of equivalent performance characteristics (material, mechanical, sterilization properties) compared to a legally marketed predicate device through objective bench testing.
8. The sample size for the training set:
- Not applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.