(48 days)
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle
- post traumatic loss of joint configuration
- primary implantation failure.
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm. The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.
The provided K091069 510(k) summary describes a traditional 510(k) submission for the Medacta Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material, design, and performance testing against recognized standards, rather than a clinical study evaluating diagnostic performance using AI.
Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Guideline) | Reported Device Performance |
|---|---|
| ASTM F543-07 Standard Specification and Test Methods for Metallic Bone Screws | The bone screws were tested and found to be in conformance with ASTM F543-07. |
| ISO 5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy | The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to this standard. |
| FDA Guidance Documents | Performance testing was conducted in accordance with FDA guidance documents. (Specific documents not listed, but conformance is stated). |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Performance testing," which was conducted in accordance with ASTM F543-07 and FDA guidance documents. This testing demonstrated conformance to these standards.
Information on AI-Related Aspects (Not Applicable to this 510(k)):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was not an AI-based diagnostic device. The "test set" would refer to the physical bone screws tested per ASTM F543-07, not a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There was no "ground truth" in the clinical sense for this type of device submission. Performance was based on mechanical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for bone screws is their mechanical properties meeting established engineering standards.
- The sample size for the training set: Not applicable. This was not an AI device, so there was no training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.