(42 days)
The Tibial Fastener is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.
Innovasive's proposed Tibial Fastener utilizes a central pin placed inside an outer sleeve. The central pin is threaded its entire length, resembling a "screw". The pin is cannulated in a hex shape to fit a Hex Driver for insertion into the outer sleeve. The pin is designed to lock into the central ID of the outer sleeve. The outer sleeve has a threaded central ID to accept the pin component, and an angled plate designed to lay flush against the tibia and prevent the device from pulling through the tibial tunnel. The angled plate will be offered in three angles: 40°, 45°, and 50° to accommodate varying tibial tunnel angles. The outer sleeve is manually placed in the tibial tunnel, and the graft passed through the sleeve's central ID. A Sizer is used to determine the appropriate pin diameter and length by insertion into the sleeve between the graft strands. The pin is than inserted into the central ID, and locks into the sleeve. Any excess graft ends may be removed. The proposed Tibial Fastener outer sleeve and central pin will be offered in various sizes to accommodate varying graft and tibial tunnel sizes.
The provided text is a 510(k) summary for the Innovasive Tibial Fastener, a medical device. It describes the device, its intended use, and a performance study. Here's an analysis of the acceptance criteria and the study, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in ultimate holding strength to predicate devices (LinX Tibial Ligament Fastener, Soft Tissue Screw & Washer System). | "the proposed Tibial Fastener holding strength was found to be substantially equivalent to that of the LinX Tibial Ligament Fastener, and the Soft Tissue Screw & Washer System." |
Explanation: The document does not explicitly state numerical acceptance criteria (e.g., "The holding strength must be greater than X Newtons"). Instead, the acceptance criterion for the performance study is implicitly based on demonstrating "substantial equivalence" in ultimate holding strength to already cleared predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "human cadaver," indicating the type of test material but not the number of cadavers or individual tests performed.
- Data Provenance: The data was obtained from testing on "human cadaver." This suggests a preclinical, laboratory-based study rather than data collected from live patients. The country of origin is not specified but given the submitter's address (Marlborough, MA, USA) and the FDA submission, it's highly likely to be the USA. The study would be considered prospective in the sense that the testing was designed and executed specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of information (experts, ground truth, adjudication) is relevant for studies involving diagnostic imaging or subjective assessments. The performance study described is a mechanical-biological test measuring ultimate holding strength. The "ground truth" in this context is the physically measured holding strength, not an expert's interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. See explanation above. Adjudication is not relevant for a mechanical holding strength test.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is used to assess the effectiveness of diagnostic tools or interpretations, often comparing human readers with and without AI assistance. The study described here is a mechanical test of device strength, not a diagnostic or interpretative study.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This typically refers to AI/algorithm performance. The device is a mechanical fastener, not an algorithm. The "performance" being evaluated is the physical holding strength of the device itself.
7. The Type of Ground Truth Used
- Direct Mechanical Measurement. The "ground truth" for this study is the ultimate holding strength directly measured in the mechanical tests performed on human cadaver material. It's an objective physical property rather than an expert consensus, pathology, or outcomes data interpretation.
8. The Sample Size for the Training Set
- Not Applicable. The device is a mechanical fastener, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See explanation above.
§ 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.