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The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the surgeon choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use inthe lumbar spine must be used. Supplemental fixation, cleared by the FDA for use inthe lumbosacral spine, must be used with implants ≥ 20°.

The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System consists of PEEK cages, titanium screws, and a titanium cover plate. The KMTI PEEK SA ALIF System cages are intended to be used with the bone screws, the anterior cover plate assembly (cover plate), and do not require supplementary fixation systems unless less than four bone screws are utilized or cage lordosis is ≥20°. The screws protrude through the interbody portion of the cage implant and stabilize the vertebral body while preventing expulsion of the cage implant. The KMTI PEEK SA ALIF System offers hexalobe drive with both fixed and variable angle screw options. The fixed angle screw option provides a tighter fit with the cage than the variable angle screws while the variable angle screw option provides more clearance between the screw than the fixed screw, which allows for a small amount of screw angulation. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. The cover plate assembly and screw are part of the implant construct.

The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs.

The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only.

The provided text is a 510(k) summary for the Kyocera Medical Technologies, Inc. PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through clinical studies or extensive standalone device performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text, because the submission explicitly states:

"Performance testing was not required in this submission for the modifications proposed."

The primary purpose of this submission is to introduce non-sterile packaging for previously cleared cage sizes. The device's substantial equivalence is based on its technological characteristics being identical to the predicate device, not on new performance data demonstrating its effectiveness against predefined metrics.

However, I can extract what is implied regarding the "proof" of the device meeting its intended purpose for substantial equivalence based on the provided document:

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

Since this is a 510(k) submission focused on substantial equivalence and minor modifications (non-sterile packaging), the "acceptance criteria" are implied by the features demonstrated to be identical to the predicate device. "Device performance" in this context refers to the demonstration of these identical characteristics.

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 for Test Set: Not applicable in the context of performance testing for this submission as "Performance testing was not required." The comparison is based on the inherent design and materials of the device being identical to the predicate.
• Data Provenance: Not applicable for performance testing. The "data" pertains to the specifications and design files of the device itself and its predicate.

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. No "ground truth" establishment by experts for a test set was required for this substantial equivalence submission.

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

Not applicable. No clinical or performance test set requiring adjudication was performed.

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 physical intervertebral body fusion system, not an AI/software device.

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

Not applicable. This device is a physical intervertebral body fusion system, not an algorithm. The "standalone" aspect mentioned in the Indications for Use ("The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation") refers to its mechanical functionality as an implant, not standalone algorithmic performance.

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

Not applicable. No performance data requiring "ground truth" was generated for this submission. The "truth" for substantial equivalence is based on the objective technological characteristics being identical to the predicate.

8. The sample size for the training set

Not applicable. No machine learning or AI model was developed or trained for this submission.

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

Not applicable. No machine learning or AI model was developed or trained for this submission.

Summary of "Proof" in this 510(k) Submission:

The "proof" in this document is not derived from clinical trials, observational studies, or performance testing against specific acceptance criteria. Instead, the proof that the device "meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence with minor changes) is based on the following:

• Demonstration of Identical Technological Characteristics: The submission explicitly states, "The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device." This is the core "proof."
• Validation for Sterilization Changes: For the minor modification of non-sterile packaging, the submission states, "Changes in sterilization were validated according to ISO 17665-1." This ensures that the new packaging method meets international standards for sterilization processes, thereby addressing any potential safety concerns related to the change.

In essence, the device is considered to "meet acceptance criteria" because it is fundamentally the same device as one already cleared by the FDA (the predicate), with a validated change to its packaging.

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The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System is indicated for interbody fusion procedures in skeletally mature patients with disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

Tesera-k SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-k SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Tesera-k A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System implants support foraminal height and decompression between lumbar or lumbosacral vertebral bodies during spinal correction and fusion as well as reusable instruments to assist in endplate preparation and implantation. The Tesera-k ALIF System implants are available as a monolith without integrated fixation (Tesera-k A) or as a standalone with integrated fixation (Tesera-k SA) and are additively manufactured from Ti-6Al-4Vper ASTM F2924. The Tesera-k SA constructs includes screws and a coverplate manufactured from Ti-6Al-4V per ASTM F136 from the Tesera SA ALIF System (K193320, K131122, K140106, and K180502). The Tesera-k ALIF implants are sterile packaged and inserted via a direct anterior or oblique anterior surgical approach. The Tesera-k ALIF implants are offered in a variety of sizes and lordosis options to meet patient anatomical needs.

I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document is an FDA 510(k) clearance letter and summary for a spinal interbody fusion device (Tesera-k ALIF System), which is a physical implant, not an AI or software-based device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (for AI).
2. Sample size and data provenance for a test set (for AI).
3. Number and qualifications of experts for ground truth (for AI).
4. Adjudication method (for AI).
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
6. Standalone AI performance.
7. Type of ground truth used (for AI).
8. Sample size for the training set (for AI).
9. How ground truth for the training set was established (for AI).

The document focuses on the mechanical performance data (static and dynamic axial compression, compression shear, and subsidence) for the physical implant as per ASTM standards, concluding that the Tesera-k ALIF System is substantially equivalent to predicate devices based on these non-clinical tests.

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