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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plate (Cure™ OPEL-L (S)) is available in a range of sizes to coincide with the surgical approach. The Cure™ OPEL-L (S) is similar to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole, the inclusion of a central rib at the through hole location and convexity in the sagittal plane at the screw hole locations. All Cure™ Lumbar Plates continue to be manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

This document is a 510(k) premarket notification for a medical device called the "Cure™ Lumbar Plate System." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a spinal implant (Cure™ Lumbar Plate System), not an AI-powered diagnostic or assistive tool. Therefore, the typical acceptance criteria and study designs associated with AI/ML medical devices (such as MRMC studies, standalone performance, training/test sets, expert adjudication of ground truth, etc.) are not applicable here.

The document primarily discusses mechanical testing and an engineering analysis to demonstrate equivalence to a previously cleared predicate device.

Here's how to address the request given the nature of the document:

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

The document describes non-clinical mechanical testing rather than performance in a clinical setting against specific acceptance criteria for diagnostic accuracy. The acceptance criteria relate to mechanical properties and equivalence to the predicate device.

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

• Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. The "testing" here refers to mechanical engineering tests on device prototypes/samples. The document does not specify the number of individual devices tested for mechanical properties, but it's standard engineering practice to test a representative sample.
• Data Provenance: Not applicable. This involves lab-based mechanical testing, not patient data.

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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and measurements, not expert clinical consensus.

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

• Not applicable. This is relevant for clinical interpretation or subjective assessment, not mechanical properties.

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 device is a passive spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study was performed.

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

• Not applicable. This is not an algorithm.

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

• Ground Truth: For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established engineering standards (e.g., ASTM F1717) and benchmarks from the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for the "Cure™ Lumbar Plate System." This document is a regulatory submission to the FDA, asserting substantial equivalence to an existing predicate device. It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the context of AI/ML performance.

Medical device approvals like this typically focus on demonstrating safety and effectiveness based on similarity to previously approved devices (predicates) and mechanical testing for physical properties. They do not involve the kind of performance studies with ground truth, expert readers, or AI/ML metrics that your questions refer to.

Therefore, I cannot answer most of your detailed questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

Here's what I can extract based on the document's content:

• Device Name: Cure™ Lumbar Plate System
• Predicate Device: K171538 (Cure™ Lumbar Plate System)
• Purpose of the Submission: To demonstrate substantial equivalence of the Cure™ Lumbar Plate System (specifically the Cure™ - LP IView and Cure™ - LP QMax models) to the predicate device.
• Basis for Equivalence: Identical intended use and consistency in fundamental scientific technology.

Regarding "Non-clinical Testing" (Section G):
The document mentions "An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System" which "included static compression bending, static torsion, and dynamic compression bending." It concludes that the new plates are "superior in mechanical function and properties to the predicate device."

This section describes mechanical testing of the physical implant, not performance of an AI/ML algorithm. These tests are typically defined by ASTM standards and have their own internal acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) but these are for the hardware and are not related to algorithm performance metrics like sensitivity, specificity, or reader improvement.

In summary, the provided document does not support answering the questions related to AI/ML device performance studies.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vesses in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plate System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters. Cure™ Lumbar Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes a medical device, the Cure™ Lumbar Plate System, and its 510(k) premarket notification to the FDA. The information focuses on regulatory approval and equivalence to a predicate device, rather than the performance of a software or AI-driven diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/software device performance, is not present in the provided text.

The document states that the Cure™ Lumbar Plate System is substantially equivalent to a predicate device (K022791 Synthes Anterior Tension Band System) based on technological characteristics and non-clinical testing.

Here's a breakdown of the available information based on your request, highlighting what is not applicable or not found:

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):
This information is not applicable as the document describes non-clinical mechanical and biological compatibility testing, not a clinical study on human subjects or an AI diagnostic test set.

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 information is not applicable as there is no mention of a "test set" in the context of expert ground truth for a diagnostic device. The evaluation was based on engineering and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable.

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 information is not applicable. This describes a physical implantable device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of diagnostic accuracy. For the non-clinical testing, the "ground truth" would be established engineering standards (ASTM F1717) and biological standards (ANSI/AAMI ST-72:2011).

8. The sample size for the training set:
This information is not applicable as there is no AI component or training set described.

9. How the ground truth for the training set was established:
This information is not applicable.

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