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The Catalyft™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyf(™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyfi™ LS Expandable interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable interbody device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.

The Catalyft™ LS Expandable Interbody system consists of implants, instruments, and trays. The implants are provided sterile and are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion.

Catalyft™ LS Expandable Interbody System implants are expandable height & lordotic titanium interbody fusion implants. The subject interbody implants have double curved endcaps geometry that will allow the implants to seat inside the vertebral endplate curvature. The interbody implants are made of titanium alloy (Ti-6Al-4V Eli) and they expand for adjustable height and adjustable lordosis. The purpose of the adjustable height and lordosis is to allow the surgeons to have better control and restoration of spinal alignment and lordosis in patients and to appropriately size the interbody to match the patient anatomy.

The provided text is a 510(k) summary for the Medtronic Catalyft™ LS Expandable Interbody System. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through the evaluation of mechanical and safety performance data, rather than performance studies related to AI or clinical outcomes in the traditional sense.

Therefore, many of the requested elements for an AI/clinical study acceptance criteria and performance description (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone AI performance) are not applicable to the information contained in this FDA 510(k) summary.

The document primarily describes:

• Device Description: The Catalyft™ LS Expandable Interbody System is an implant used for intervertebral body fusion in the lumbar spine. It is made of titanium alloy and is designed for adjustable height and lordosis.
• Intended Use: For skeletally mature patients with degenerative disc disease at one or two contiguous levels of the lumbar spine (L2-S1), and as an adjunct to fusion for multilevel degenerative scoliosis and sagittal deformities.
• Substantial Equivalence: The submission claims substantial equivalence to several predicate devices based on fundamental scientific technology, indications for use, design, material, and levels of attachment.
• Performance Data: This section details the engineering/mechanical verification tests conducted on the device, not clinical performance or AI algorithm performance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not applicable:

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

The document does not explicitly state "acceptance criteria" in the format of a table with numerical thresholds for clinical outcomes or AI performance. Instead, it lists the verification tests performed, implying that the device met the requirements of these standard tests for spinal implants. The "reported device performance" in this context refers to the successful completion of these mechanical and safety tests, demonstrating that the device functions as intended and is safe.

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 for Test Set: Not specified in the provided text, as this refers to mechanical testing of the device units, not a clinical trial or AI test set with patient data. These ASTM standards typically specify the number of samples required for testing.
• Data Provenance: Not applicable in the context of mechanical device testing. The data originates from laboratory testing, not patient observations. There is no mention of clinical data (retrospective or prospective) for performance evaluation.

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. The "ground truth" for a mechanical device like this is established through engineering specifications and adherence to recognized ASTM (American Society for Testing and Materials) standards. There are no radiologists or clinical experts involved in establishing ground truth for the performance of the device in this document, as it's not an AI or diagnostic device.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image analysis where expert consensus is needed. Mechanical testing follows standardized protocols, not adjudication.

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 implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this medical device's performance, as per this 510(k) summary, is based on engineering specifications and adherence to recognized mechanical testing standards (ASTM). The device's physical properties and mechanical behavior under simulated loads are compared against the requirements of these standards. There is no clinical outcomes data, pathology, or expert consensus used for the device's immediate performance evaluation as described here.

8. The sample size for the training set

Not applicable. This is not an AI model requiring a training set.

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

Not applicable. Since there is no AI training set, there is no ground truth establishment for one.

In summary, the provided 510(k) summary for the Catalyft™ LS Expandable Interbody System focuses on demonstrating substantial equivalence through standard mechanical and safety testing for an orthopedic implant. It does not contain information related to AI performance, clinical trial outcomes, or diagnostic accuracy, which are the typical contexts for the detailed acceptance criteria and study designs you've asked about.

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