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Peridot Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot Intervertebral Body Fusion System is intervertebral body fixation devices intended for use as an aid in spinal fixation. The Peridot Intervertebral fusion system is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The device is available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

The device is supplied non-sterile.

The device consists of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device and instrument are supplied separately.

The device must be used in combination with the dedicated instrument supplied.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

This document is a 510(k) premarket notification for a medical device called the "Peridot Intervertebral body fusion system." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting the performance of an AI/ML powered device against acceptance criteria.

The document does not contain any information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

Instead, it describes the device, its intended use, and compares it to existing predicate devices to show substantial equivalence for regulatory clearance. It focuses on mechanical testing of the physical implant according to ASTM standards, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

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The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA.

The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

The Kuros TLIF Cage is an implant interbody fusion surgery and is used to restore intervertebral height and facilitate intervertebral body fusion in the spine. The Kuros TLIF Cage is inserted via a posterior (transforaminal) approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and should be used in combination with supplemental posterior spinal fixation systems, intended for use in the lumbar spine and cleared by the FDA.

The Kuros TLIF cage is a rigid spacer, manufactured from PEEK Optima LT1 per ASTM F2026 to maximize biocompatibility, durability, and robustness. The design includes tantalum markers for imaging and has a hollow geometry, allowing the cage to be packed with grafting material per the indications for use. The Kuros TLIF Cages are available in various lengths, and angle variants to accommodate patient anatomy, and are supplied with their specific instrumentation. The device is intended to be used by orthopedic surgeons or neurosurgeons working in a hospital who are trained to use these devices in the patient population specified in the indications for use. The implants are provided sterile to the hospital.

The provided text describes the Kuros TLIF Cage, an intervertebral body fusion device. It details the device's indications for use, description, and comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance metrics, or a study reporting on these metrics.

The document is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the document regarding the device and its evaluation, but it explicitly states "No clinical data has been presented." and therefore cannot fulfill most of the request:

Device Name: Kuros TLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX

Indications for Use:
The Kuros TLIF Cage is intended for use in intervertebral body fusion of one or two contiguous levels of the lumbar spine (L1 to S1). It is inserted via a posterior approach and designed for use with autograft and/or allograft (cancellous and/or corticocancellous bone graft) to facilitate fusion. It must be used with supplemental posterior spinal fixation systems cleared by the FDA.

It is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Description of the Device:
The Kuros TLIF Cage is a rigid spacer made from PEEK Optima LT1 (ASTM F2026). It includes tantalum markers for imaging and has a hollow geometry to be packed with grafting material. It is available in various lengths and angle variants and is supplied with specific instrumentation. The implants are provided sterile.

Summary of Performance Data (as presented in the document):
The Kuros TLIF Cage conforms to the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007."
Worst-case devices were subjected to mechanical testing, including:

• Static axial compression
• Dynamic axial compression
• Static compression shear
• Dynamic compression shear
• Subsidence testing (according to ASTM F2267)
• Expulsion testing (according to Endolab protocol)

Results: "Results demonstrate comparable (or better) mechanical properties to the predicate devices."

Crucially, the document explicitly states: "No clinical data has been presented."

Given this information, it is impossible to complete a table of acceptance criteria and reported device performance from this document for the requested metrics as clinical performance data is absent. The acceptance criteria here are related to mechanical properties in comparison to predicate devices, not clinical outcomes.

Therefore, for your specific request:

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

   • Acceptance Criteria (Mechanical): Conformity to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007." and mechanical properties comparable to or better than predicate devices across tested parameters (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion).
   • Reported Device Performance (Mechanical): The Kuros TLIF Cage demonstrated "comparable (or better) mechanical properties to the predicate devices" for the tested parameters.
   • Clinical Performance: Not reported in this document.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data, as "No clinical data has been presented." For mechanical testing, specific sample sizes are not provided, only that "Worst case devices were subjected to mechanical testing."

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 data has been presented."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as "No clinical data has been presented."

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, as "No clinical data has been presented" and this device 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, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth would be established by the ASTM standards (ASTM F2077, ASTM F2267) and the Endolab protocol. For clinical performance, no ground truth is discussed as no clinical data was presented.

8. The sample size for the training set: Not applicable, as this is a physical medical device and no clinical "training set" of data is mentioned.

9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

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