(93 days)
The restor3d Metallic Interference Screw is used to provide bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
The proposed restor3d Metallic Interference Screw is a sterile, single use implant available in either titanium alloy or cobalt chrome alloy. The device is cannulated to allow a guidewire to assist with placement of the screw into the bone tunnel. The screw is used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
This document describes the premarket notification for the restor3d Metallic Interference Screw. The information provided does not pertain to an AI/ML powered device, but rather a traditional medical device (an orthopedic implant). Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study, standalone performance) are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a physical orthopedic implant and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on physical and mechanical testing rather than diagnostic accuracy metrics.
| Acceptance Criteria / Test Performed | Reported Device Performance (Summary from text) |
|---|---|
| Pullout Strength | Passed (supports substantial equivalence) |
| Insertion Torque | Passed (supports substantial equivalence) |
| Biocompatibility [ISO 10993-1] | Passed (supports substantial equivalence) |
| Pyrogenicity [ANSI/AAMI ST72] | Passed (supports substantial equivalence) |
| Sterilization | Passed (supports substantial equivalence, according to ISO 11137-1, ISO 11137-2, and AAMI TIR33) |
| Substantial Equivalence to Predicates (Overall) | The device is considered substantially equivalent to the predicate devices (Conmed EZ-Start Interference Screw, K182955, and Smith&Nephew CANNU-FLEX SILK Interference Screw, K921481) in intended use and important physical and performance specifications. |
The document states that "No new questions of safety or effectiveness were identified during device testing" which indicates the device met the pre-defined acceptance criteria for these tests. The specific quantitative values for "passed" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. For mechanical and biocompatibility testing of physical devices, the "sample size" refers to the number of physical devices tested, which is typically determined by relevant standards and statistical considerations to ensure robust results.
- Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by restor3d or a contracted testing facility. This is not clinical data, but rather engineering and materiale testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device, and the "ground truth" for its performance is established through standardized laboratory mechanical and material tests, not through expert human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not a diagnostic device or a study involving human interpretation, adjudication methods like 2+1 or 3+1 are irrelevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study is not relevant or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device (an interference screw), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical and Mechanical Standards Compliance: For this device, the "ground truth" is adherence to established engineering principles, material specifications, and performance requirements as defined by recognized standards (e.g., ISO 10993-1 for biocompatibility, ANSI/AAMI ST72 for pyrogenicity, ISO 11137 series for sterilization) and comparative performance to legally marketed predicate devices. The "truth" is whether the device physically performs as expected and is safe/effective, as demonstrated through laboratory testing.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device that requires a training set or associated ground truth.
§ 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.