(114 days)
The Lateral Button™ is intended to protect the suture / bone during transosseous fixation procedures.
The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.
The provided text is a 510(k) Summary for the "Lateral Button™" device, which is a smooth or threaded metallic bone fixation fastener. The summary focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided document. The document primarily describes the device, its intended use, and comparisons to a predicate device based on technological characteristics and design verification (static and dynamic testing).
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for performance, nor does it provide specific quantitative results of the "static and dynamic testing" beyond a general statement of "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance (static and dynamic testing). | "The performance is the same as verified by design verification. This consisted of static and dynamic testing in which the results demonstrated substantial equivalence to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "static and dynamic testing" as part of design verification, but does not specify the sample size used for these tests. The data provenance (country of origin, retrospective/prospective) is also not provided.
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)
This type of information is not applicable and not provided in the document, as the study described is a device performance test (static and dynamic) rather than a clinical study requiring expert assessment of outcomes or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided for the type of device performance testing 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
This is not applicable. The device is a bone fixation fastener, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm. The "standalone" mentioned in the document refers to the implant being supplied as a standalone device or as part of a kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "static and dynamic testing," the "ground truth" would likely be engineering specifications, material properties, and established biomechanical testing standards for bone fixation devices. The document does not explicitly detail these "ground truth" sources, but it implies comparison to predicate device performance.
8. The sample size for the training set
This is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.