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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

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.

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The Aequalis Ascend Flex Shoulder System is intended for use as:

• A replacement of shoulder joints in primary anatomic or in primary reverse. .
• A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. .
• The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder . prosthesis in case of revision.

IN ANATOMIC: The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intect or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity .
• . Fractures of the humeral head
• Traumatic arthritis .
• Revision of other devices if sufficient bone stock remains .

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints IN REVERSE: for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled bv:

• Rheumatoid arthritis .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity .
• . Fractures of the humeral head
• . Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The reversed adapter is indicated for use as components of the Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cufftear.

The Aequalis Ascend Flex Shoulder System consists of:

• In a Anatomic configuration: A titanium humeral stem offered in Titanium Plasma . Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
• . In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants.
  The reversed adapter is comprised of two components: a titanium tray and a UHM WPE reversed insert.
  The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium: Glenoid sphere: made from of CoCr: Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.
  The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.
  The present device submission corresponds to modifications made to the version of the device cleared in 510(k) K121493 (most recent) and K112615.

This document is a 510(k) premarket notification for the Tornier Aequalis™ Ascend™ Flex Shoulder System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than describing a study to prove acceptance criteria for a new device's performance in a clinical setting.

Therefore, the information regarding acceptance criteria and a study proving device performance as it would typically be presented for a diagnostic or AI-based device is not present in this document. This document describes a medical implant where "acceptance criteria" are related to mechanical and material performance and "proof" comes from non-clinical testing and comparison to existing devices.

Here's a breakdown of what is available based on your request, adapted to the context of a medical implant submission:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of explicit acceptance criteria with numerical performance results in the way a diagnostic device would (e.g., sensitivity, specificity). Instead, "acceptance criteria" are implied by the non-clinical tests performed, demonstrating the device's mechanical integrity and material properties meet established standards, and its design is comparable to predicates.

The "reported device performance" is summarized as:

• Non-clinical testing: "stem strength evaluation in Anatomic/Reverse configurations; taper evaluation; reverse adapter evaluation; head glenoids mismatch evaluation; system range of motion evaluation; and Titanium Plasma Spray coating validation per FDA guidance."
• Conclusion: "The results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The "test set" here refers to the physical devices (prototypes or production samples) that underwent non-clinical mechanical and material testing, not a dataset of patient information. The document focuses on demonstrating physical and functional equivalence to predicate devices through engineering tests.

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 to this type of device submission. Ground truth is not established by human experts in the context of mechanical testing of an implant; rather, it's defined by engineering specifications, material standards, and biomechanical principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of patient data, not for the mechanical testing of an implant.

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

This is not applicable. This device is a shoulder implant, not a diagnostic or AI-assisted system. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device (a medical implant), the "ground truth" for proving performance would be based on:

• Engineering specifications and standards: Adherence to established mechanical, material, and biocompatibility standards (e.g., ISO standards for implants, FDA guidance for specific tests).
• Biomechanical principles: Ensuring the device functions appropriately within the human biomechanical system.
• Material properties: Verifying that the materials used meet the required strength, durability, and biocompatibility criteria.
• Predicate device performance: The "ground truth" for substantial equivalence is often the known safety and effectiveness profile of the legally marketed predicate device(s).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an implant's mechanical and material testing.

9. How the ground truth for the training set was established

This is not applicable.

Summary of the K122698 Submission:

The document describes the Tornier Aequalis™ Ascend™ Flex Shoulder System, an implant intended for shoulder joint replacement in various configurations (anatomic and reverse).

The primary method for demonstrating its "acceptance" and safety/effectiveness for market clearance is substantial equivalence to previously cleared predicate devices (Tornier Inc. Ascend Shoulder System K121493 and Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System K112615, with K120739 as a reference).

The studies referenced are non-clinical tests designed to show that the modified device performs comparably to its predicates and meets necessary engineering and material standards. These tests include:

• Stem strength evaluation (in Anatomic/Reverse configurations)
• Taper evaluation
• Reverse adapter evaluation
• Head glenoids mismatch evaluation
• System range of motion evaluation
• Titanium Plasma Spray coating validation per FDA guidance.

The document states that the "results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device." This indicates that the "acceptance criteria" were met through these engineering and material tests, demonstrating that the device functions as intended and is as safe and effective as the predicate devices.

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