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The PLATEAU-A Ti Anterior Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-X Ti Lateral Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolistthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The PLATEAU-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6A1-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.

The Plateau-X Ti Lateral Lumbar Spacer is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The provided document is a 510(k) summary for the Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a new device with novel performance claims.

Therefore, the information typically requested regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance as understood in the context of AI/ML or diagnostic devices is not directly applicable or available in this document.

However, I can extract information related to the device's substantial equivalence demonstration for mechanical performance.

Here's an analysis based on the provided text, addressing the points where possible:

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

• Acceptance Criteria: The document does not specify quantified acceptance criteria (e.g., specific load values or displacement limits) for the mechanical tests. Instead, it relies on demonstrating that the new device performs acceptably compared to its predicate devices. The implicit acceptance criterion is that the new device's mechanical performance is equivalent to or better than the predicate devices, as demonstrated by meeting relevant ASTM standards.
• Reported Device Performance: The document states: "Testing according to ASTM F2077 & F2267 included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411/K111569)." It does not provide numerical results of these tests, only that the tests were performed and were sufficient to demonstrate substantial equivalency to the predicate.

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 explicitly provided. For mechanical testing, the "sample size" would refer to the number of device units tested. The document does not specify the number of units or the specific test specimens.
• Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing. The testing would be conducted in a laboratory setting.

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. This device is an implanted medical device (spinal spacer), and its evaluation for 510(k) clearance primarily involves mechanical and material testing, not subjective assessment by medical experts for ground truth establishment.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to establish ground truth or resolve discrepancies. This document describes mechanical testing.

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 is not an AI/ML device or a diagnostic device that would involve human readers or AI assistance.

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

• Not applicable. This is an implanted medical device, not an algorithm.

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

• For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., load-displacement curves, failure loads). Compliance with relevant ASTM standards (F2077 & F2267) serves as the benchmark against which performance is measured.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for an orthopedic implant through mechanical testing. It does not contain information typically found in submissions for diagnostic or AI/ML devices regarding clinical study design, expert ground truth, or performance metrics against specific acceptance thresholds in a clinical context. The "study" mentioned is the series of mechanical tests to ASTM standards, and the "acceptance criteria" are implicitly met by demonstrating equivalency to the predicate devices through these tests.

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