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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD 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.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system).

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

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

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

The provided document is a 510(k) premarket notification for a medical device called the "Peridot-TD Spacer system" and "Anterior cervical interbody fusion - ACIF". This submission is for additional models with added sterilization methods to a previously cleared 510(k) (K230708).

The document does not contain information about software performance, AI assistance, or human reader studies. It focuses on the mechanical performance and substantial equivalence of an intervertebral body fusion device. Therefore, many of the requested criteria cannot be extracted from this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted according to ASTM standards for mechanical properties. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating substantial equivalence to the predicate device. Specific numerical "reported device performance" values or explicit criteria are not provided in this summary, only that the "worst-case devices were tested".

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

This document discusses in vitro mechanical testing, not a clinical test set with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic AI device. The sample size for the mechanical tests is not explicitly stated, although it mentions "worst-case devices were tested," implying a representative selection.

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

Not applicable. This document describes mechanical testing of a physical medical device, not a diagnostic device requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable. This document describes mechanical testing of a physical medical device.

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 is for a physical intervertebral body fusion device and does not involve AI assistance or human readers.

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

Not applicable. This document is for a physical intervertebral body fusion device and does not involve an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically defined by the specified ASTM standards and the expected mechanical properties of the materials and design. Failure criteria for these tests would serve as the ground truth.

For the clinical indications for use, the document states that cervical disc degeneration and/or spinal instability are "confirmed by imaging studies (radiographs, CT, MRI)" and degenerative disc disease by "patient history and radiographic studies." This implies a combination of imaging and clinical assessment as the basis for patient selection for the device.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.

The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD 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 at the involved level(s). This device is to be used with autogenous bone graft.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67.

And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system). The implant cages are supplied sterilized.

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

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

This is a 510(k) premarket notification for a medical device (Peridot-TD Spacer system), not a study demonstrating AI performance. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not present in the provided text.

The document describes the device, its intended use, and indicates that performance testing has been conducted according to ASTM standards to demonstrate substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria values or detailed performance data from these tests. It also does not mention any AI component or associated studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or AI-related study outcomes as these are not discussed in the provided regulatory document.

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