(91 days)
The Bio-INTRAFIX Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
The Mitek Bio-INTRAFIX Tibial Screw and Sheath is an absorbable fixation implant for the repair of soft tissue grafts during ligament reconstruction. Bio-INTRAFIX is a two-part system designed to fixate soft tissue to bone for ligament reconstruction.
This 510(k) summary (K032167) for the Bio-INTRAFIX Tibial Tapered Screws and Sheaths does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it relies on substantial equivalence to predicate devices and general compliance with standards. Therefore, most of the requested information cannot be extracted from this document.
Here's what can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document. The 510(k) summary states that "The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards." It does not list specific performance criteria (e.g., tensile strength, degradation rate, pull-out strength) and corresponding results from a study. | Not specified in document. There are no quantitative performance results presented. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described.
- Data Provenance: Not applicable. No specific study data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. No test set requiring ground truth establishment by experts is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set is described.
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
- MRMC Study: No. This device is a physical surgical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No specific study with ground truth is described. The approval is based on substantial equivalence to predicate devices.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment (Training Set): Not applicable. As there is no training set, there's no ground truth to establish for it.
Summary from the Document:
The document asserts substantial equivalence based on:
- A detailed device description.
- Conformance to consensus standards and voluntary standards.
- Comparison to predicate devices (IntraFIX (K983560) and Biocryl Interference Screws (K013572)).
This 510(k) submission is a "traditional" submission for a physical medical device, where equivalence is primarily argued through similar design, materials, intended use, and existing regulatory clearance of comparable predicate devices, rather than through complex performance studies with specific acceptance criteria as might be seen for novel diagnostic tools or AI/ML-driven devices.
§ 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.