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The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, is indicated for use as an intervertebral body fusion device in skeletally 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 Catalyft™ 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 conditions, additional 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 and/or corticocancellous 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 approaches.

The Catalyft™ LS Expandable Interbody System device 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 System 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 is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The interbody devices incorporate Titan Surface Technologies™, where exterior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic, roughened surface with nano-scale features. nanoLOCK surface technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.

The provided document is a 510(k) Premarket Notification for a medical device called the Catalyft™ LS Expandable Interbody System. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data.

However, this document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The device described, an intervertebral body fusion device, is a physical implant, not an AI/ML software device. The "Performance Data" section specifically lists mechanical tests (e.g., Static and Dynamic Compression, Subsidence, Expulsion, Wear Debris, Bone screw push out, MRI Safety Evaluation) that are relevant to the physical and biomechanical characteristics of an implantable device, not to the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them based on the provided input, as the input concerns a traditional medical implant.

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The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally 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 Catalyft™ 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 and/or corticocancellous 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 Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System 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 with Titan nanoLOCK™ Surface Technology consists of new interbody implants that 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.
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The interbody device is a line extension to add Titan nanoLOCK™ Surface Technology to recently cleared Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021). The subject interbody incorporates Titan Surface Technologies™, where superior and inferior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic roughened surface with nano-scale features. nanoLOCK Surface Technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.

This is a medical device, not an AI/ML device. The provided text describes the regulatory submission for the "Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology," which is an implantable intervertebral body fusion device.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, and ground truth establishment is not applicable in this context. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and biocompatibility testing, not AI/ML performance.

However, I can provide information based on the performance data section of the document, which outlines the verification tests conducted to demonstrate the device's performance characteristics:

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

The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide "reported device performance" in terms of numerical results for each test. Instead, it lists the types of verification tests conducted. The underlying assumption for substantial equivalence is that the device met the established acceptance criteria for each test according to the respective ASTM standards or internal protocols, demonstrating comparable safety and effectiveness to the predicate devices.

Here's a re-interpretation of the requested table, focusing on the type of performance evaluated:

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

The document does not specify the exact sample sizes (number of devices tested) for each mechanical or physical test. These tests are typically conducted in a laboratory setting on a representative number of devices and device configurations to ensure statistically sound results. Data provenance would be from internal Medtronic laboratories or accredited third-party testing facilities, likely in the US or similar regulatory environments. The data is prospective for the purpose of the 510(k) submission, meaning the tests were specifically designed and performed for this device to generate the required performance 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)

This is not applicable as the device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on medical data. Ground truth for mechanical testing would be the physical measurements and observations made during testing according to standard protocols.

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

Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies, not the mechanical and material testing of physical medical devices.

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 a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This pertains to AI/ML software performance.

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

For the mechanical and physical tests, the "ground truth" is established by:

• Physical measurements and data acquisition: Using calibrated instruments and established test methods to measure parameters like load, deformation, wear, etc.
• Adherence to recognized standards: Compliance with ASTM standards (e.g., F2077, F2267, F1877, MRI safety standards) which define precise methodologies and sometimes acceptance criteria.
• In vitro cellular response: For the nanoLOCK™ surface, in vitro studies demonstrated the biological response, with the "ground truth" being the observed cellular and biochemical reactions under controlled laboratory conditions.

8. The sample size for the training set

Not applicable. This concept pertains to AI/ML software development.

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

Not applicable. This concept pertains to AI/ML software development.

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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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