(56 days)
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).
This document is a 510(k) premarket notification for the "Tiger Cannulated Screw System". It primarily discusses the substantial equivalence of this device to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria in a clinical or AI-related context.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI-specific study details, ground truth, expert involvement, and sample sizes for training/test sets are not applicable to this document as it pertains to a traditional medical device (bone screws) and not an AI/ML device.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serve as the "acceptance criteria" for this type of submission.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from Non-clinical Test Summary) | Reported Device Performance |
|---|---|
| ASTM F543-07 requirements for: | The results of these evaluations indicate that the Tiger Cannulated Screws are equivalent to predicate devices. |
| - Torque to Failure | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pullout Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pull Through Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Driving/Insertion and Removal Torque | (Implicitly met standards of predicate devices / ASTM F543-07) |
| Conclusion of Equivalence: | The Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws and Washers are equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for this type of device. The non-clinical tests (ASTM F543-07) involve mechanical testing of the screws, not data from human patients or a test set in the AI sense. The number of screws tested for each mechanical property would typically be specified in the full test report, but it's not detailed in this 510(k) 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. This submission relies on engineering and material standards for mechanical properties rather than expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert labeling of AI datasets, which is not relevant here.
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 is a mechanical device, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" or reference standard would be the defined specifications and performance characteristics of the predicate devices and the requirements of the ASTM F543-07 standard.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
§ 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.