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The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain 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.

The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.

This document pertains to the 510(k) premarket notification for the COSINE™ Spacer, an intervertebral body fusion device. Regulatory information for the device is provided in the document. However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document states that:

• Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.
• The subject implants have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• The subject interbody devices have been found substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

To answer your request, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions mechanical testing was performed in accordance with standards, but it does not list specific acceptance criteria (e.g., minimum compression strength, subsidence limits) or the actual performance values achieved by the COSINE™ Spacer.
2. Sample size used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the "ground truth" for mechanical testing is typically defined by engineering standards, not expert interpretation.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is not applicable as the device is a physical implant, not an AI or imaging system requiring human reader interaction.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ASTM standards and FDA guidance. Specific quantitative values are not given.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA communication confirms the clearance of the COSINE™ Spacer based on its substantial equivalence to predicate devices through mechanical testing. However, it does not detail the specific acceptance criteria, test results, or methodology (beyond mentioning adherence to standards) that would allow for a complete answer to your request.

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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.

Ask a specific question about this device