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Peridot Spinal Interbody System - Cervical

The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.

The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion with supplemental fixation indicated for cervical fusion procedures.

Peridot Spinal Interbody System - Lumbar

The Peridot Lumbar Spinal Interbody system are 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 Lumbar Spinal Interbody system are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

This product is intervertebral body fixation devices intended for use as an aid in spinal fusion. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.

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

The devices are 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 devices are supplied non-sterile.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instrument supplied.

This product is intervertebral body fixation devices intended for use as an aid in spinal fixation. This product 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 devices are 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 devices are supplied non-sterile.

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

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

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

This document is a 510(k) premarket notification for a medical device called the "Peridot Spinal Interbody System." It is a submission to the FDA seeking clearance to market this device based on its substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance (Not Applicable - This is a Spinal Interbody System, Not an AI/Software Device)

The provided document describes a Peridot Spinal Interbody System, which is a physical device used for spinal fusion. It is not an AI/software device.

Therefore, the concepts of acceptance criteria related to software performance (sensitivity, specificity, AUROC, etc.), test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this type of medical device as described in this document.

The "Performance Testing" section (Page 6, Section 7) explicitly states:
"The Peridot Spinal Interbody System is the same as the legally marketed devices 'K192026' and 'K202872'. So, the performance test was proved by the previous legally marketed devices performance test."

This indicates that the performance of the device is assessed through equivalence to predicate devices, likely based on mechanical, biocompatibility, and sterilization testing, as is typical for intervertebral body fusion devices, rather than a clinical study evaluating an AI algorithm's diagnostic or predictive performance.

Summary of Relevant Information from the Document:

• Device Name: Peridot Spinal Interbody System
• Device Type: Intervertebral Body Fusion Device (physical implant)
• Product Code: ODP, MAX
• Regulatory Class: Class II
• Basis for Clearance: Substantial Equivalence to previously cleared predicate devices (K192026 Peridot Intervertebral body fusion system and K202872 Prase PEEK Anterior Cervical Interbody Spacer).
• Materials: Made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.
• Intended Use: For intervertebral body fusion in skeletally mature patients for cervical disc degeneration/instability (C2-T1) or degenerative disc disease (DDD) at L2-S1, to be used with bone graft and supplemental fixation.
• Performance Testing Strategy: Relies on the performance testing of the predicate devices due to the subject device being "the same" in design, material, scientific technologies, and indications for use. This typically involves bench testing (e.g., mechanical strength, fatigue, subsidence), biocompatibility testing, and sterilization validation, not clinical performance studies with human readers or AI algorithms.

In conclusion, the requested information regarding acceptance criteria for an AI/software device and its validation study cannot be provided from this document, as it pertains to a physical spinal implant device.

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