(116 days)
The SpeedLock Knotless Fixation Device 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 Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedLock Knotless Fixation System. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting.
Therefore, many of the requested details, such as acceptance criteria in terms of accuracy, sensitivity, or specificity, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable to this type of regulatory submission. This document is primarily about demonstrating that a modified medical device is as safe and effective as a previously cleared device through an engineering and materials comparison.
Here's a breakdown of the available information with respect to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (from bench testing) |
|---|---|
| Substantial equivalence to predicate device (K090615) in intended use and technical characteristics. | Side-by-side comparison bench testing performed per the US FDA Guidance Document for Testing Bone Anchors demonstrated substantial equivalence. Differences between the proposed and predicate device do not raise questions regarding safety and effectiveness. Materials are well-characterized and used in predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of distinct "cases" or "samples" as would be relevant for a diagnostic or AI device study. The comparison was described as "side-by-side bench testing," which implies physical testing of the device itself and its predicate.
- Data Provenance: Not explicitly stated, however, "bench testing" typically occurs in a laboratory setting, not derived from patient data. It is a prospective test conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for this type of device comparison is established through engineering specifications, material properties, and mechanical performance tests, not expert clinical assessment of diagnostic output.
4. Adjudication Method for the Test Set:
- Not applicable. This was a direct comparison of physical device characteristics and performance, not a review of clinical or diagnostic outcomes 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:
- Not applicable. This is not a diagnostic device involving human readers or AI assistance. It is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device is based on engineering specifications, material compatibility, and mechanical performance standards outlined in the FDA Guidance Document for Testing Bone Anchors.
8. The Sample Size for the Training Set:
- Not applicable. This device does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.