(91 days)
The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically; Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condyle Cancellous Fragments: Talus
The Arthrex Bio-Compression Screw is manufactured using poly(L-lactide). These are offered sterile, in distinct sizes.
The provided text is a 510(k) summary for the Arthrex Bio-Compression Screw, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. This 510(k) summary does not define specific performance-based acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility metrics) or report the device's performance against such criteria. The submission aims to prove substantial equivalence, implying that the device performs similarly to already approved predicate devices, not that it meets a new set of defined performance goals with quantified results.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No specific test set or clinical study data is provided in this 510(k) summary. The submission relies on a comparison to predicate devices and the known properties of the material used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no specific clinical or performance test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or related adjudication method is mentioned.
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:
- Not Applicable. This device is a bioabsorbable screw, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Since no specific performance study is detailed, no ground truth types are mentioned. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness profile of the predicate devices and the well-characterized nature of the PLLA material.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of Device Acceptance (as per 510(k) process):
The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, as stated in the 510(k) summary:
"By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Compression Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices."
The FDA's letter explicitly confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..."
In essence, the "study" proving the device meets "acceptance criteria" is the 510(k) submission itself, which primarily relied on a comparative analysis of the device's and predicate devices' intended use, technological characteristics, and material properties, rather than new, extensive performance testing data explicitly documented in this summary.
§ 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.