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The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Stable-L Standalone Lumbar Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use. The subject submission seeks to gain clearance for design changes to the previously cleared devices, as well as expand the screw offerings of the system.

The provided text is a 510(k) summary for the Stable-L Standalone Lumbar Interbody System. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies involving AI or human readers, or detailed clinical performance criteria typically found in studies for diagnostic devices. Therefore, I cannot provide all the requested information.

Based on the provided text, here is what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that would be relevant for an AI-powered diagnostic device. Instead, it refers to substantial equivalence to a predicate device based on design, indications for use, materials, and mechanical performance testing.

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

The document describes bench performance testing for a medical implant (lumbar interbody system), not a diagnostic AI device using a "test set" of clinical data. Therefore, this information is not applicable and not provided. The testing involves physical devices.

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 relevant for studies validating diagnostic devices. As this document describes testing for a spinal implant, there is no mention of "experts" establishing a "ground truth" for a test set in the context of clinical interpretation or diagnosis.

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

This information is relevant for studies validating diagnostic devices, particularly when there are discrepancies in expert interpretations. As this document describes testing for a spinal implant, there is no mention of adjudication methods.

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

No such study was conducted or is mentioned in the document. This type of study is for evaluating AI-assisted diagnostic tools, not for medical implants.

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

This refers to the performance of an AI algorithm without human involvement. As described, this device is a physical medical implant, not an AI algorithm. Therefore, this is not applicable.

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

For the mechanical performance testing conducted, the "ground truth" would be established by engineering standards and measurements. The document does not explicitly state the specific "ground truth" criteria (e.g., specific torque values, force limits) but implies adherence to established mechanical testing methodologies to ensure equivalence to the predicate device.

8. The sample size for the training set

The document does not describe the development of an AI algorithm, and therefore there is no "training set."

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

As there is no AI algorithm or training set, this information is not applicable.

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The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-L Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0 , 6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Special 510(k) submission is to gain clearance for the subject devices to be provided sterile via gamma radiation.

The provided text is a 510(k) summary for the Nexus Spine Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System. It states that the purpose of the Special 510(k) submission is to gain clearance for these devices to be provided sterile via gamma radiation, whereas the predicate devices were provided non-sterile. The document explicitly states:

"The subject components are identical in indications, sizing and geometry, technological characteristics, and materials to the predicates. The only difference between the subject device and predicate device is that the subject device is provided sterile via gamma radiation and the predicate device is provided nonsterile. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness."

And under "Performance Testing":

"There is no change to the intended use, indication for use, materials, geometry, or dimensions to the Stable-L Standalone Lumbar Interbody System or Stable-C Interbody System. There is no mechanical performance testing included in this submission. Sterilization validation, packaging validations, and shelf life validation have all been performed to support the gamma radiation sterilization change."

Based on this, the acceptance criteria and study proving the device meets the acceptance criteria are not related to the clinical performance or diagnostic accuracy of an AI/ML-driven device, but rather to the sterility and packaging integrity of a medical implant after a change in sterilization method.

Therefore, I cannot provide the information requested in points 1-9 of your prompt, as it pertains to AI/ML device validation (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.). This document describes a medical device, but its 510(k) submission focuses on a sterilization method change, not an AI/ML component.

If you are looking for an example of an AI/ML device clearance document, this specific text will not provide the details you're seeking regarding AI/ML acceptance criteria and performance studies.

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The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Stable-L™ Standalone Interbody System is made of Ti-6A1-4V. The implant is offered in various angles, widths, heights, and lengths, and with various lengths of screws, to meet patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

This document is a 510(k) premarket notification summary for the Stable-L Standalone Lumbar Interbody System. It describes the device, its intended use, and provides a statement of technological comparison and performance data. However, it does not contain any information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert involvement, ground truth establishment, or specific performance metrics related to AI/algorithm performance.

The content focuses on the regulatory clearance process for a medical device (an intervertebral body fusion device), asserting its substantial equivalence to previously cleared predicate devices through mechanical performance testing. It does not involve any AI or algorithmic components that would require the kind of data and studies requested in the prompt.

Therefore, I cannot fulfill the request using the provided text as it does not contain the necessary information regarding:

1. Table of acceptance criteria and reported device performance: Not present. The document mentions mechanical testing (Static and dynamic compression and compression shear testing per ASTM F2077, screw pushout testing, and implant expulsion testing) but doesn't provide specific acceptance criteria or results.
2. Sample sizes for test set and data provenance: No information on this.
3. Number of experts and qualifications: Not applicable, as this is a mechanical device, not one requiring expert interpretation of output.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable as there's no mention of AI or human-in-the-loop performance.
6. Standalone (algorithm only) performance: Not applicable as there's no algorithm.
7. Type of ground truth used: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth establishment for training set: Not applicable.

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