(172 days)
The OSTEOTRANS™-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.
The OSTEOTRANS™ OT Screw is a sterile, single-use bone screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). There are solid screws, cannulated screws and corresponding washers. Screws and washers are provided with various shapes and sizes typical of other marketed fixation devices.
Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Screws maintain accurate alignment of bone fractures and osteotomies.
The provided text describes a 510(k) premarket notification for a medical device, the OSTEOTRANS™-OT Screw. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove device performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.
However, based on the provided text, we can extract some relevant information:
Acceptance Criteria and Reported Device Performance
The document states: "Performance data demonstrate that the OSTEOTRANS™ OT Screw has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses." This implies that the acceptance criteria for this device are related to its mechanical strength and degradation characteristics, ensuring it can adequately fix bones for its intended use and degrade favorably over time.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Strength (Mechanical) | "Requisite strength" |
| Degradation Profile | "Favorable degradation profile" |
| Bone Fixation | "Sufficient and sustained bone fixation for intended uses" |
Study Details (Based on available information)
The document does not describe a clinical study with human patients, a test set, experts, or ground truth in the way one might for an AI/diagnostic device. Instead, it relies on performance data to demonstrate equivalence to predicate devices, which typically refers to non-clinical testing.
- Sample size used for the test set and the data provenance: Not applicable. The document refers to "performance data," which in this context likely means mechanical and material testing, not human patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic or AI studies (e.g., expert consensus on images) is not relevant here. The "ground truth" for mechanical properties would be established by standardized testing methods.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device's submission.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. The device is a physical bone screw, not an algorithm.
- The type of ground truth used: For a medical device like a bone screw, "ground truth" for demonstrating performance would likely be established through:
- Mechanical testing standards: Adherence to established ISO or ASTM standards for implant strength, fatigue, torsional properties, etc.
- Material characterization: Testing of the HA/PLLA composite for its chemical composition, degradation rate in simulated physiological environments, biocompatibility, etc.
- Preclinical (animal) studies: Although not explicitly mentioned, these are sometimes used to assess biological response and degradation in vivo.
- The sample size for the training set: Not applicable. There is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the OSTEOTRANS™-OT Screw to existing predicate devices based on design, materials, intended use, and performance data (likely non-clinical mechanical and material properties testing). It does not involve a clinical study with human subjects, expert review, or AI performance metrics as typically seen in submissions for diagnostic algorithms.
§ 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.