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The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of carcellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

The CONCORDE LIFT Expandable Interbody Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion. They are fabricated from titanium alloy (Ti-6Al-4V) per ASTM F136. A cavity internal to each device is intended to hold autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CONCORDE LIFT device is available in both a convex configuration and a lordotic configuration.

The purpose of this submission is to seek clearance for the CONCORDE LIFT devices with lower starting heights.

The provided document is a 510(k) summary for a medical device called the CONCORDE LIFT Expandable Interbody Device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, design, performance, and indications for use, which is a standard regulatory pathway for Class II medical devices like intervertebral body fusion devices. The performance data listed (ASTM standards) relate to the physical and material properties of the implant itself, such as mechanical testing, MRI safety, and bacterial endotoxin testing, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device based on the given document. The questions about sample sizes, data provenance, ground truth, experts, adjudication, MRMC studies, and standalone AI performance are not applicable to the content provided.

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The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

The CONCORDE LIFT Inserter is temporarily attached to the CONCORDE LIFT Expandable Interbody Fusion Device for implantation. A component of the CONCORDE LIFT Inserter, the driver, is then used to increase or decrease the height of the CONCORDE LIFT Expandable Interbody Fusion Device. The CONCORDE LIFT Inserter is intended to be used in conjunction with all sizes of the CONCORDE LIFT Expandable Interbody Device. The Inserter is fabricated from 17-4 PH Stainless Steel and 465 Stainless Steel that meets the requirements of ASTM F899. The inserter is provided non-sterile and is reusable.

The purpose of this submission is to capture the modifications made to the CONCORDE LIFT Expandable Interbody System Inserter.

The provided document, K173537, describes a 510(k) premarket notification for the CONCORDE LIFT™ Expandable Interbody Fusion Device. It focuses on modifications to the device's inserter. Therefore, the information provided primarily pertains to demonstrating substantial equivalence for an intervertebral body fusion device and its inserter, not an AI-powered diagnostic device.

As a result, many of the requested elements regarding acceptance criteria and study proving performance for an AI device (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance) are not applicable to this document. The document focuses on mechanical and material properties and indicates feasibility testing rather than clinical performance studies typical for AI/diagnostic devices.

Here's an analysis of the provided information in relation to your request, with a clear indication of what is not applicable based on the document's content:

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

The document does not detail specific quantitative acceptance criteria or detailed performance results in a table format as would be typical for an AI/diagnostic device. Instead, it states:

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

• Not Applicable. The document describes "feasibility testing" for a mechanical device inserter, not a clinical study involving a test set of patient data. Therefore, concepts like data provenance (country, retrospective/prospective) are not relevant here.

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 is a mechanical device, not an AI/diagnostic device that requires expert-established ground truth from images or clinical data.

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

• Not Applicable. No ground truth establishment or adjudication for a clinical test set is described.

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-assisted diagnostic device. No MRMC study was conducted or is relevant.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable. For a mechanical device inserter, "ground truth" would relate to its engineering specifications and functionality (e.g., proper engagement, force application, height adjustment), which are evaluated through "feasibility testing" against design specifications, not clinical "ground truth" from patients.

8. The sample size for the training set

• Not Applicable. This is not an AI device trained on data.

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

• Not Applicable. This is not an AI device trained on data.

In summary, the provided FDA 510(k) document (K173537) is for a mechanical medical device and its modified component (an inserter), not an AI/diagnostic software. As such, the typical "acceptance criteria" and "study proving performance" questions relevant to AI devices, which rely on large datasets and human expert annotations, are entirely out of scope for this document. The "proof" of performance for this device rests on its "substantial equivalence" to a predicate device, supported by consistency in technological characteristics, material compliance, and successful "feasibility testing" of the minor design modifications.

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The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

The CONCORDE LIFT Expandable Interbody Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6Al-4V) as per ASTM F136. A cavity internal to each device is intended to hold autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CONCORDE LIFT is available in both a convex configuration and a lordotic configuration.

The purpose of this submission is to add MR Conditional labeling, expanded indications and to document minor design modifications.

The provided document is a 510(k) Premarket Notification for the CONCORDE LIFT™ Intervertebral Body Fusion Device. This type of submission to the FDA focuses on establishing substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials.

As such, the document does not contain the detailed information typically associated with establishing acceptance criteria and proving performance through a comprehensive study, especially for an AI/ML powered device. The "performance data" section (I) refers to various ASTM standards related to MR compatibility (magnetically induced displacement force, image artifacts, radiofrequency induced heating, magnetically induced torque) and an ANSI/AAMI standard for bacterial endotoxins. These are engineering and biocompatibility tests, not clinical performance or AI algorithm validation studies.

Therefore, I cannot provide answers to most of your specific questions as they pertain to the evaluation of an AI/ML-powered medical device through a clinical performance study. The document describes a traditional medical device submission, primarily relying on mechanical and material testing, and comparison to predicate devices, rather than an AI algorithm.

However, I can extract what is available from the document regarding the device and its assessment:

Device Name: CONCORDE LIFT™
Device Type: Intervertebral Body Fusion Device (a mechanical implant, not an AI/ML algorithm)
Regulatory Class: Class II (Product Code: MAX)
Purpose of Submission: To add MR Conditional labeling, expanded indications, and to document minor design modifications.

Here's what can be inferred or confirmed from the provided text, while acknowledging that the core request for "AI acceptance criteria and study" is not applicable to this specific document:

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

The document lists standards rather than specific quantitative acceptance criteria or reported values in a table format for each test. The implicit "acceptance criterion" for these tests is "conformance to the standard" to demonstrate safety and MR compatibility.

2. Sample sized used for the test set and the data provenance:

• This information is not provided in the document. The tests mentioned (ASTM standards) are typically performed on samples of the device itself, not on patient data.
• Data provenance for a physical device would refer to its manufacturing process and quality control, not clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical intervertebral fusion device, not an AI/ML algorithm requiring expert-established ground truth from images or clinical data.

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

• Not Applicable. No human adjudication of diagnostic or clinical performance is mentioned or relevant for this type of device submission.

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 not an AI/ML assistant for readers; it's a surgical implant.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable for clinical ground truth. The "ground truth" for the device's physical and material properties would be established by the specifications defined in the ASTM standards (e.g., maximum allowable displacement force, temperature rise, etc.) and validated through specific laboratory testing methodologies.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

In summary: The provided document is a 510(k) submission for a traditional implantable medical device, the CONCORDE LIFT™ Intervertebral Body Fusion Device. The "acceptance criteria" and "study" described are focused on engineering and material performance (primarily MR compatibility) according to established industry standards, not on the clinical performance or validation of an AI/ML algorithm. Therefore, the questions related to AI/ML device validation are not applicable to the content of this specific FDA submission.

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