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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:

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.

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The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.

This 510(k) summary for the Tiger Cannulated Screw System does not contain the information you requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is provided:

What the document does say:

• Device Description: The Tiger Cannulated Screw System is comprised of screws (2.0mm, 2.4mm, 3.0mm, and 4.0mm diameter) and instruments for bone fixation in the hand and foot following trauma or osteotomy.
• Materials: Screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
• Intended Use/Indications for Use: Fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot.
• Predicate Device: The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws.
• No Testing: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Trilliant Surgical believes that the Tiger Cannulated Screw Fixation System does not raise any new safety or effectiveness issues and does not require any nonclinical testing."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states no nonclinical testing was required or performed because of substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set was used as no testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established as no testing was performed.
4. Adjudication method for the test set: Not applicable. No test set was used.
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 medical device (screw system), not an AI-assisted diagnostic tool. No such study was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth was used as no testing was performed.
8. The sample size for the training set: Not applicable. No training set was used as no AI model was developed or tested.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

In essence, for this 510(k) submission, the manufacturer leveraged the "substantial equivalence" pathway, arguing that the device is so similar to already-approved devices that no new performance testing or clinical studies were necessary to demonstrate its safety and effectiveness. Therefore, the document does not contain any of the detailed performance study information you've requested.

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