(30 days)
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Here's an analysis of the provided text regarding the Tiger Headless Cannulated Screws, focusing on acceptance criteria and supporting studies:
It is important to note that the provided 510(k) summary is for a medical device (bone screw), not an AI/ML powered device. As such, many of the typical questions for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) do not apply to this type of device submission. The acceptance criteria and "studies" are based on non-clinical (mechanical) testing rather than clinical performance or AI/ML algorithm evaluation.
Here's a breakdown based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Static Axial Pull Out Strength | Equivalent to predicate devices |
| Static Axial Pull Through Strength | Equivalent to predicate devices |
| Driving Torque | Equivalent to predicate devices |
| Failure Torque | Equivalent to predicate devices |
| Overall substantial equivalence | Substantially equivalent to predicate devices in terms of intended use, design, materials, mechanical safety, and performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for material properties and performance claims.
- Data Provenance: Not applicable. The "data" comes from laboratory-based mechanical testing, not human clinical data or patient records.
- Retrospective/Prospective: Not applicable. This refers to the nature of clinical data collection.
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. For mechanical testing, "ground truth" is established by direct measurement against engineering standards and specifications. There are no human experts establishing a clinical ground truth for these tests. The tests themselves are the "truth." Engineers and lab technicians conduct the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used for resolving disagreements in human interpretation of data, typically in clinical studies or AI/ML evaluations. Mechanical testing results are quantitative and do not require adjudication.
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. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted systems in diagnostic or interpretative tasks involving human readers. This device is a bone screw and does not involve AI or human interpretation in its function or evaluation in this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone screw, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is established by ensuring the device's mechanical properties (pull-out strength, torque, etc.) meet or exceed recognized standards for bone fixation devices and are comparable to the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for a training set.
Summary of the Study Proving Acceptance Criteria:
The study conducted to prove the Tiger Headless Cannulated Screws meet acceptance criteria was a non-clinical mechanical testing program. This involved subjecting the screws to a series of tests:
- Static Axial Pull Out Test: Measures the force required to pull the screw out of a material designed to simulate bone.
- Static Axial Pull Through Test: Measures the force required to pull the screw head through a material.
- Driving Torque Test: Measures the torque required to drive the screw into a material.
- Failure Torque Test: Measures the torque at which the screw (or its interface) fails.
The results of these tests were then compared to the performance of legally marketed predicate devices (Tiger Cannulated screws K081510, and 2.4 and 3.0mm Headless Compression Screws K050636/K021556). The acceptance criterion was that the Tiger Headless Cannulated Screws demonstrate equivalent mechanical performance to these predicate devices, thereby establishing "substantial equivalence" in terms of mechanical safety and performance.
No human clinical studies were performed for this 510(k) submission, as stated in the document: "No clinical studies were performed." The substantial equivalence claim is based solely on the non-clinical mechanical testing and comparison to the predicate devices.
§ 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.