(65 days)
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets through which multiple loops of suture are threaded. There are two types of Toggle Buttons, the standard toggle button with two eyelets and the NS toggle button with one larger eyelet only. The suture loops provide a means to attach the soft tissue grafts to the toggle buttons. The loops are attached to the toggle button by putting the loops through the eyelet(s). This device is used to anchor the suture loops to bone.
The provided text describes a 510(k) premarket notification for a medical device called "Titanium Toggle Button(s)". This submission is for a physical medical device, not a software algorithm or an AI-powered diagnostic tool. Therefore, the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets in AI, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through material similarity, intended use, size comparisons, and non-clinical mechanical testing.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pull-out strength at least equivalent to predicate devices | The Titanium Toggle Button(s) has a greater pull-out strength than that of the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the mechanical testing.
- Data Provenance: Not specified (implied to be internal laboratory testing).
3. 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. Ground truth for mechanical testing is based on physical measurements and engineering standards, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing data is objective.
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:
- No. This is a physical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" would be the objective measurements of pull-out strength according to established engineering standards or test protocols.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Information from the Document:
- Clinical Testing: None provided as a basis for substantial equivalence. The submission relies solely on non-clinical (mechanical) testing and comparison to predicate devices.
- Summary of Technologies: "The titanium Toggle Buttons are similar to or identical to predicate devices in terms of material, intended use, and size."
§ 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.