(58 days)
The Sterile bone screw (PEEK ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery.
Knee
- · ACL repairs
- · PCL repairs
- Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
- Patellar realignment and tendon repairs - Vastus medialis obliquus advancement
- Iliotibial band tenodesis
The Sterile bone screw (PEEK ACL screw) is a bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
The implanted screw is made of PEEK (poly-ether-ether-ketone, ASTM F2026).
The Sterile bone screw (PEEK ACL screw) is supplied gamma irradiation sterile state and it is packed in Tyvek Pouch.
The provided text describes the 510(k) summary for a medical device (Sterile bone screw (PEEK ACL screw)) seeking substantial equivalence to a predicate device. This document focuses on the mechanical and material performance of the medical device itself, rather than the performance of an AI algorithm or software.
Therefore, many of the requested elements for an AI/ML device approval (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the device's mechanical properties as presented in the document.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are implicitly defined by the "PASS" result for each test conducted according to the specified ASTM standards. The study proves the device meets the acceptance criteria by indicating "PASS" for all relevant tests.
| No. | Test Article | Test Method | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|---|---|
| 1 | Axial Pullout Strength | ASTM F543-A3.Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. | Meets ASTM F543-A3 standards | PASS |
| 2 | Torsional Yield Strength | ASTM F543-A1.Test Method for Determining the Torsional Properties of Metallic Bone Screws. | Meets ASTM F543-A1 standards | PASS |
| 3 | Driving Torque Insertion | ASTM F543-A2.Test Method for Driving Torque of Medical Bone Screws. | Meets ASTM F543-A2 standards | PASS |
| Driving Torque Removal | ASTM F543-A2.Test Method for Driving Torque of Medical Bone Screws. | Meets ASTM F543-A2 standards | PASS | |
| 4 | Fatigue | After fully inserting the screw with the tendon into the fixed artificial bone (20PCF), a fatigue tensile load of 70 to 220N on the tendon is repeated 1000 cycles at 1 Hz. | Withstands 1000 cycles of specified fatigue loading | PASS |
2. Sample Size and Data Provenance for Test Set
The document states: "All specimens selected (worst-case) to verify the performance of the screw met the test criteria." However, it does not specify the exact sample size (number of screws tested) for each test. The data provenance is a bench test, implying ex-vivo lab testing, not human patient data. There is no information regarding the country of origin of this specific test data, but the company is based in South Korea.
3. Number of Experts and Qualifications for Ground Truth
Not applicable as this is a mechanical device performance test, not an AI/ML algorithm requiring expert ground truth for interpretation of images or clinical data. The "ground truth" is established by the physical properties and performance of the screw itself, measured against established engineering standards.
4. Adjudication Method for Test Set
Not applicable. As this is a bench test for mechanical properties, there is no need for human adjudication of results in the traditional sense, beyond verifying that the test was conducted correctly according to the standard and the measurements fall within passing ranges.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device, so no MRMC study was performed. The "improvement" measured is an engineering performance against a standard, not an improvement in human reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for this device is based on established engineering and medical device standards (ASTM and ISO standards) for material properties, mechanical performance, sterilization, and biocompatibility. The "worst-case" specimens were tested against these pre-defined, quantitative standards.
8. Sample Size for Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable. As above, no training set for an AI/ML algorithm was used.
§ 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.