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The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The device may be used with supplemental fixation.

Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.

The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.

The CoreLink® M3™ Stand-Alone Anterior Lumbar System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The CoreLink® M3TM Stand-Alone Anterior Lumbar System consists of an interbody cage, locking plate, and three (3) bone screws. System components are manufactured from either titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3 or additively manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F3001. The 8°, 15°, and 20° lordotic cages may be used as a standalone system. The M3 Stand-Alone Anterior Lumbar System M3 Stand-Alone Anterior Lumbar System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document is a 510(k) Premarket Notification from the FDA regarding the CoreLink® M3™ Stand-Alone Anterior Lumbar System. It does not describe an AI/ML medical device and therefore does not contain information typically associated with acceptance criteria and study designs for such devices (e.g., performance metrics like sensitivity/specificity, ground truth establishment by experts, or MRMC studies).

The "performance data" section refers to non-clinical mechanical testing of the interbody fusion device, not performance related to algorithms or human reader improvement.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about AI/ML device performance, acceptance criteria, or related study details.

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The Synthes Radial Head Prosthesis System is intended for:

1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

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: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
• Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

• This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties 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 question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

• This question is not applicable. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
  • Mechanical properties: The ability to withstand clinical loads.
  • Material properties: Chemical composition and physical and macro/micro surface characteristics.
  • Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

• This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

• This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

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