(88 days)
The TIGER TRACK® screw system is intended for small bone extremity and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile.
The TIGER TRACK® screw system, diameters 3.5mm or smaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalangeal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia.
The size of the chosen screw should be adapted to the specific indication.
The TIGER TRACK® screw system is not for spinal use.
The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated
The TIGER TRACK® screw system is intended for single use only, and is available in a range of different diameters, lengths and materials depending on the indication. The TIGER TRACK® screw system has two categories of screws: self-compressive screws and non-compressive screws.
The self-compressive screws have a distal and proximal thread, separated by a cylindrical shaft where the fracture or osteotomy line should be placed. The difference of pitch between the distal and proximal thread provides compression between both segments. The TIGER TRACK® snap-off Weil screw doesn't have a proximal thread, the compression is done by its head and the distal thread. The non-compressive screws have a full thread allowing surgeons to only link both segments without any compression.
All devices of the TIGER TRACK® screws system are monobloc components. The TIGER TRACK® screw system PEEK range is manufactured dry with grades of PEEK (Zeniva ZA-500) per ASTM F-2026 from Solvay Advanced Polymers released with predicate K133036, Titanium range is made of alloyed Titanium ISO 5832-3 / ASTM F-136 and released with predicate K131722, Snap-off threaded pin HV18XX range is made of Cobalt Chrome according to the ISO 5832-7 / ASTM F-1058 and released with predicate K120739.
The feature design of the TIGER TRACK® screw system is substantially equivalent to the design features of other devices previously cleared for market.
The provided document is a 510(k) premarket notification for the Synchro-Medical TIGER TRACK® Screw System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or detailed performance studies with acceptance criteria as might be seen for novel devices or software.
Therefore, the information you've requested regarding acceptance criteria and performance against those criteria, as well as details about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes, is largely not applicable or not provided in this document as it pertains to a medical device where performance is proven through physical testing rather than AI accuracy.
However, I can extract the information that is present concerning the non-clinical tests performed:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pullout force | Not explicitly stated in the document | "met the acceptance criteria" |
| Torsional Strength | Not explicitly stated in the document | "met the acceptance criteria" |
The document states, "The results of these studies showed the TIGER TRACK® Screw System met the acceptance criteria," but it does not specify what those criteria were (e.g., minimum pullout force in Newtons, minimum torsional strength in N-m).
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 the non-clinical tests.
- Data Provenance: The document describes non-clinical laboratory testing (mechanical tests). This means the "data" is derived from physical test specimens. The manufacturer is Synchro Medical, located in France.
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)
This is not applicable. The device is a surgical screw system, and its performance is evaluated through mechanical testing, not by expert interpretation of images or other data that would require a "ground truth" established by experts in the context of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to expert review processes, which are not relevant for the mechanical testing of a surgical screw.
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 type of study is relevant for diagnostic AI or imaging systems, not for a surgical screw system. The document explicitly states: "No clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical tests would be the actual physical properties measured by scientific instruments, compared against established standards (e.g., ASTM F564-10 for pullout force, ASTM F-543 for torsional strength).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical testing for a surgical implant device.
9. How the ground truth for the training set was established
Not applicable.
In summary, the document details a 510(k) submission for a physical medical device (surgical screw system) that relies on non-clinical mechanical testing for "substantial equivalence." The concepts of AI performance, ground truth, expert adjudication, and training/test sets as you've outlined are generally not relevant to this type of device and submission.
§ 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.