(97 days)
The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The SBi TwistoFIX System consists of a set of titanium bone screws for internal fixation. The screws are machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The devices are supplied non-sterile and are available in various sizes diameters and lengths.
Based on the provided text, the SBi TwistoFIX is a medical device, specifically a bone fixation fastener. The 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through a formal study with a test set.
Therefore, many of the requested details, such as specific performance metrics, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, are not applicable or not explicitly detailed in this type of regulatory submission for substantial equivalence.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require PMA.
- Reported Device Performance: Instead of performance against specific acceptance criteria, the submission likely focused on comparing the SBi TwistoFIX's design, materials, and intended use as being similar to predicate devices. The document directly states: "Documentation is provided which demonstrated the SBi TwistoFIX to be substantially equivalent to other legally marketed devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: In a substantial equivalence filing for a physical implant like this, there isn't typically a "test set" in the sense of a clinical trial or a dataset for an AI algorithm. The evaluation is based on engineering principles, material properties, and comparison to existing devices. Biomedical testing (e.g., mechanical strength, fatigue) would have been performed, but the sample sizes and specific provenance for such engineering tests are not detailed in this summary.
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 / Not Provided: As there is no "test set" in the context of an AI or diagnostic device, there are no experts establishing ground truth for such a set. The "experts" involved would be regulatory reviewers at the FDA and engineers/scientists at Small Bone Innovations who would evaluate the technical aspects and equivalence claims.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This concept is relevant for clinical studies or AI model evaluation. It does not apply to a 510(k) submission demonstrating substantial equivalence for a bone screw.
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 bone screw, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For substantial equivalence, the "ground truth" isn't outcomes data or expert consensus on diagnosis. Instead, it refers to established engineering standards (e.g., ISO 5832-3 for material properties), biomechanical testing acceptance criteria (which are not detailed here but would be part of the full submission), and the safe and effective history of the predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is a physical bone screw, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: See 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.