(23 days)
The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.
The provided text describes a Special 510(k) submission for a line extension of the Asnis™ III Cannulated Screw System, specifically to add additional sizes of screws. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than conducting extensive new clinical studies with established acceptance criteria as would be typical for novel devices.
Therefore, many of the standard elements you've requested regarding acceptance criteria and detailed study information are not applicable in this context. The primary "study" performed here is mechanical testing to prove the new screw sizes are as strong as the predicate devices.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strength of new screw sizes is substantially equivalent to predicate systems. | Mechanical testing demonstrated that the subject components are substantially equivalent in strength to the predicate components. |
Explanation: For a 510(k) submission, especially a line extension like this, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence. The key performance metric is the mechanical strength of the new screw sizes compared to the legally marketed predicate devices. The submission asserts that this equivalence was met through mechanical testing. Specific numerical thresholds for "strength" are not provided in this summary but would have been part of the underlying test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided summary. Mechanical testing typically involves a set number of samples for each size and material tested, but the exact count isn't given here.
- Data Provenance: Not explicitly stated, but mechanical testing is usually performed in a laboratory setting by the manufacturer or a contracted testing facility. Given the manufacturer (Howmedica Osteonics Corp.) is based in Mahwah, New Jersey, USA, the testing likely occurred in the US. The data is prospective in the sense that it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For mechanical testing of this nature, "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists, pathologists) are not involved. The ground truth is established by standardized mechanical testing protocols and measurements, typically interpreted by engineering and quality control professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for clinical reads (e.g., imaging studies) where human interpretation is involved. This submission focuses on objective mechanical testing.
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 mechanical device, not an AI or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A (for clinical ground truth). The "ground truth" in this context is the objective measurement of mechanical properties (e.g., strength, stiffness) as defined by engineering standards and specifications. The performance of the new devices is compared against the measured performance of the predicate devices.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A. There is no "training set" and thus no ground truth for it to be established.
§ 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.