(30 days)
The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot
reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.
The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.
The SpeedLock System also includes associated instruments for implanting the anchor into bone.
The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.
The provided text is a 510(k) summary for the ArthroCare® Corporation SpeedLock® Knotless Fixation System. This document outlines a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for a diagnostic AI algorithm.
Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission, as it concerns a physical bone fixation device, not a diagnostic AI or software.
However, I can extract information related to product performance and testing where available.
Acceptance Criteria and Device Performance (ArthroCare® Corporation SpeedLock® Knotless Fixation System)
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Not explicitly stated as numerical criteria in this document. The overarching goal is that modifications "do not alter the device's intended use or performance." | "The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications." |
| Insertion Strength | Not explicitly stated as numerical criteria in this document. | Testing was conducted. Results are not detailed but the summary states the system "performs as intended." |
| Pull-out Strength | Not explicitly stated as numerical criteria in this document. | Testing was conducted in a simulated bone substrate. Results are not detailed but the summary states the system "performs as intended." |
| Design, Performance, Safety | Not explicitly stated as numerical criteria in this document. | "The test results demonstrate that the modified SpeedLock Knotless Fixation System meets its design, performance, and safety specifications." |
| Substantial Equivalence | Demonstrate that the modified device's intended use and technological characteristics are the same as the cleared predicate device and do not raise new questions of safety or effectiveness. | "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." |
Study Proving Device Meets Acceptance Criteria:
The study referenced is a Design Verification testing program.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified quantitatively in the document. The testing involved "Insertion strength and pull-out strength testing."
- Data Provenance: The testing was conducted in a simulated bone substrate. This indicates a bench-top, in-vitro (non-human/animal) lab setting. The country of origin for the data is not specified but implicitly refers to the testing performed by ArthroCare Corporation.
- Retrospective/Prospective: Not applicable, as this was laboratory testing of a physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This submission is for a physical medical device (bone anchor) and its performance in mechanical tests, not a diagnostic AI algorithm requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No. This is a hardware device; MRMC studies are relevant for software/AI interpretation where human readers are involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device; "standalone performance" generally refers to AI algorithm performance without human intervention. The testing described is of the physical device itself.
7. The type of ground truth used:
- For the mechanical tests (insertion strength, pull-out strength), the "ground truth" would be the measured mechanical properties against pre-defined engineering specifications or performance standards. The document refers to "design, performance, and safety specifications."
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
Summary of the Study:
The study involved Design Verification testing for the modified SpeedLock® Knotless Fixation System. This testing specifically included:
- Evaluation to demonstrate that the modifications did not alter the device's intended use or performance.
- Insertion strength testing in a simulated bone substrate.
- Pull-out strength testing in a simulated bone substrate.
The purpose of these tests was to demonstrate that the modified device continues to meet its pre-established design, performance, and safety specifications and that its mechanical properties remain substantially equivalent to its predicate device. The submission states that "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." No clinical or animal data were included in this submission, indicating reliance solely on non-clinical, bench-top testing.
§ 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.