(55 days)
The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:
- · 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
- · Illiotibial band tenodesis
The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.
The provided document is a 510(k) premarket notification decision letter from the FDA for the PEEK RCI, Bio-Composite, and SignaLoc Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing. It does not describe a study involving an AI device or human-in-the-loop performance.
Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI training sets is not applicable to this document.
However, I can provide the acceptance criteria and study information related to the non-clinical performance of the PEEK RCI, Bio-Composite, and SignaLoc Screws as detailed in the document.
Acceptance Criteria and Device Performance for PEEK RCI, Bio-Composite, and SignaLoc Screws (Non-Clinical)
The document primarily states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use." The acceptance criteria for these tests are implied to be meeting the requirements and performance characteristics of the referenced ASTM and ISO standards, and demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance values are not explicitly stated in this FDA letter but would have been part of the manufacturer's detailed testing report.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Standard Reference | Reported Device Performance |
|---|---|---|
| Insertion Torque Testing | ASTM F543 | Performance adequate for anticipated in-vivo use (meets standard requirements) |
| Torque to Failure Testing | ASTM F543 | Performance adequate for anticipated in-vivo use (meets standard requirements) |
| Pullout Testing | ASTM F543 | Performance adequate for anticipated in-vivo use (meets standard requirements) |
| Biocompatibility Evaluation | ISO 10993-1 | Meets biocompatibility requirements |
| Pyrogenicity and Endotoxin Testing | AAMI ST72 | Meets pyrogenicity and endotoxin requirements |
| Packaging and Shelf-Life Testing | ASTM F1980 | Meets packaging and shelf-life requirements |
| Sterilization Validation | AAMI TIR 56, inclusive of EO and ECH Residual Testing per ISO 10993-7 | Meets sterilization requirements (effective and residuals within limits) |
| Substantial Equivalence to Predicates | N/A (Comparative analysis) | Found substantially equivalent in intended use, indications for use, materials, design features, and sterilization to predicate devices. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified in the provided document. Non-clinical testing typically involves a sufficient number of samples to ensure statistical validity per the relevant standards, but exact numbers are not disclosed here.
- Data Provenance: The tests are non-clinical (laboratory/bench top) and engineering evaluations performed by the manufacturer, Signature Orthopaedics Pty Ltd. The country of origin for the data generation would be Australia (where the manufacturer is based) or potentially related testing facilities. The data is prospective in the sense that it was generated specifically for this submission to support the device's performance.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. This document describes non-clinical performance testing of medical screws, not an AI device or a study requiring human expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for Test Set:
- Not applicable. As this is non-clinical bench testing, there is no "adjudication method" in the context of expert consensus or dispute resolution. The results are typically determined by calibrated equipment and adherence to standard protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done as this is for a physical medical device (screws) and not an AI-assisted diagnostic or interpretative system.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used:
- Not applicable in the context of expert consensus or pathology for clinical conditions. For non-clinical testing, the "ground truth" is established by the specifications and performance requirements defined in the referenced industry standards (ASTM, ISO, AAMI) and the properties of the predicate devices. The screws' ability to meet these specified physical and biological material properties serves as the ground truth.
8. Sample Size for Training Set:
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable. This device is not an AI algorithm.
§ 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.