(64 days)
The tibial screws and washers are indicated for the following procedures: 1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. Iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.
The provided text is a 510(k) summary for a medical device called the "Nonresorbable CentraLoc™ Tibial Screw and Washer." It describes the device, its intended use, and claims substantial equivalence to existing legally marketed devices.
Based on the information provided, here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Premarket Equivalence (General) | Substantial Equivalence to Predicate Devices | "found the Nonresorbable CentraLoc™ Tibial Screw and Washer to be substantially equivalent to the predicate No Profile Lactosorb® L-15 Screw and Washer devices" for intended uses. |
| Mechanical Performance | Equivalent mechanical properties to predicate devices for intended uses. | "Mechanical testing found the Nonresorbable CentraLoc™ Tibial Screw and Washer to be substantially equivalent to the predicate No Profile Lactosorb® L-15 Screw and Washer devices for the uses intended." |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission states "Clinical testing was not necessary." The evaluation was based on mechanical testing and comparison to predicate devices, not on a clinical test set.
- Data Provenance: Not applicable for a clinical test set. The mechanical testing would have been conducted in a laboratory setting, likely in the US, but specific details are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set. The determination of substantial equivalence was made by the FDA based on the provided information, which included mechanical testing results and comparison to predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence for the Nonresorbable CentraLoc™ Tibial Screw and Washer."
- Effect Size: Not applicable as no such study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Was it done? Not applicable. This is a physical medical device (tibial screw and washer), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
- Not applicable for a clinical ground truth. The "ground truth" for this submission was the established safety and effectiveness of the legally marketed predicate devices, against which the new device's mechanical properties and intended use were compared.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a physical medical 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.