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When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are intended for use with supplemental fixation.

Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR) the Vu e•POD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture). The Vu e•POD VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR System is intended for use with supplemental internal spinal fixation.

The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD, are intervertebral fusion devices intended to promote spinal fusion by acting as a disc spacer and holding autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone. The implants have teeth on the superior and inferior surfaces and a central canal for receiving the autograft. The devices are available in a variety of shapes, lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All implants are manufactured from PEEK (per ASTM F2026) with radiographic markers manufactured from tantalum (per ASTM F560). The implants are offered either in all PEEK (ASTM F2026) or coated with commercially pure titanium (ASTM F67), NanoMetalene.

The NanoMetalene spacers are provided in gamma sterilized packaging, while the PEEK spacers are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) premarket notification decision letter from the FDA regarding spinal intervertebral body fusion devices. It outlines the regulatory classification, intended use, and a summary of technological characteristics. Crucially, it explicitly states that "Clinical Testing" is "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide a table of acceptance criteria and reported device performance using this document, nor can I describe a study proving the device meets acceptance criteria. The document indicates that no clinical performance data or studies were required or used for this 510(k) clearance. The determination of substantial equivalence was based on non-clinical testing and comparison to predicate devices.

Here's why I cannot answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies are presented in this document. The FDA's determination is based on "substantial equivalence" to existing devices, not on meeting specific, de novo clinical performance criteria. The non-clinical testing mentioned (packaging, shipping, sterilization, bacterial endotoxin) relates to manufacturing and sterility assurance, not device efficacy or clinical performance.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is provided or referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set data was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set data was used.
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 document pertains to a medical device (spinal spacer), not an AI algorithm for image reading.
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 concensus, pathology, outcomes data, etc): Not applicable, as no clinical test data was used for effectiveness.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

In summary, the provided FDA 510(k) letter explicitly states that clinical testing was "Not applicable" for the determination of substantial equivalence for these spinal spacer devices. Therefore, the information you are requesting regarding acceptance criteria and performance studies is not contained within this document, because such studies were not a prerequisite for this particular 510(k) clearance.

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The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.

The system does not contain software/firmware or electrical equipment.

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the IRIX-A™ Lumbar Integrated Fusion System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria for AI/software-based devices. Therefore, much of the requested information regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided within this 510(k) summary for non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "meets or exceeds the performance of the predicate device" for these tests, implying that the acceptance criteria are based on the performance of the predicate device as established through the same ASTM standards and FDA recommendations.

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

• Test set sample size: Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving a test set of data.
• Data provenance: Not applicable. The testing is described as "Nonclinical testing" and performed on the device itself.

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

• Not applicable. Ground truth for clinical data is not relevant to this non-clinical mechanical testing.

4. Adjudication method for the test set:

• Not applicable.

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/software-based diagnostic device, nor a comparative effectiveness study involving human readers.

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

• Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

• For the non-clinical performance data: The "ground truth" or reference for performance is the established performance characteristics of the predicate device under the specified ASTM standards and FDA recommendations for static and dynamic compression, subsidence, and expulsion.

8. The sample size for the training set:

• Not applicable. This product does not involve machine learning or a "training set."

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

• Not applicable.

Summary based on the provided document:

The IRIX-A™ Lumbar Integrated Fusion System is a physical medical device (intervertebral body fusion device), not an AI/software-based diagnostic tool. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved through non-clinical performance testing (mechanical/physical tests) rather than clinical studies involving patient data and diagnostic performance metrics like sensitivity, specificity, or reader studies.

The performance data supplied focuses on:

• ASTM F2077: Static and dynamic compression testing
• ASTM F2267: Subsidence
• Expulsion testing as recommended by FDA

The conclusion is that the subject device "meets or exceeds the performance of the predicate device" for these tests, indicating that its mechanical integrity and function are comparable or superior, and it "does not introduce any new risks." The predicate device itself acts as the benchmark for establishing acceptable performance under these tests.

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