(67 days)
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:
- 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.
- Sample sized used for the test set and the data provenance: Not applicable. No test set was used as no testing was performed.
- 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.
- Adjudication method for the test set: Not applicable. No test set was used.
- 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.
- 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.
- The type of ground truth used: Not applicable. No ground truth was used as no testing was performed.
- The sample size for the training set: Not applicable. No training set was used as no AI model was developed or tested.
- 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.
§ 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.