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Peridot-PT Anterior Cervical Intervertebral body fusion System: The Peridot-PT 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 Perior Cervical Intervertebral 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-PT Anterior Cervical 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-PT Intervertebral body fusion system: The Peridot-PT 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-PT 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-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.

The Peridot-TD Intervertebral body fusion system: The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion 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.

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system: The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices 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), Direct Lateral (LIF), 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 screws, anterior plate system or anterior screw and rod 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 Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation should be an anterior plate system.

The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system: This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod 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) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.

The provided text describes a 510(k) premarket notification for various intervertebral body fusion systems. It outlines the device identification, indications for use, comparison to predicate devices, and performance testing. However, it does not contain specific acceptance criteria, reported device performance values, details of a study proving compliance, sample sizes for test or training sets, data provenance, information on expert ground truth establishment, adjudication methods, or MRMC study results.

The "Performance Testing" section lists the types of mechanical tests performed according to ASTM standards for static compression, shear, torsion, and fatigue, as well as subsidence and wear. It states that "The worst-case devices were tested," but does not provide any results from these tests or the acceptance criteria used to evaluate them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other numbered questions related to study details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices (K232822 and K233084) based on similar indications for use, technological characteristics (materials, design principles), and the use of established ASTM mechanical testing standards. The conclusion explicitly states: "Based on the information provided in this premarket notification... concludes that Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system are substantially equivalent to predicate devices." This implies that the device meets the same performance benchmarks as the predicate devices, but the specific numerical targets and results are not disclosed in this summary.

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Peridot-PT Anterior Cervical Intervertebral body fusion System

The Peridot-PT 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 Perior Cervical Intervertebral 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-PT 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-PT Intervertebral body fusion system

The Peridot-PT 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-PT 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-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices 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), Direct 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 screws, anterior plate system or anterior screw and rod system).

The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 decree) the form of supplemental fixation should be an anterior plate 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 provided document is a 510(k) premarket notification for "Peridot-PT Anterior Cervical Intervertebral body fusion System" and "Peridot-PT Intervertebral body fusion system." This document focuses on demonstrating substantial equivalence to previously cleared devices, primarily through technological comparison and mechanical performance testing, rather than clinical efficacy studies often associated with AI/software devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to clinical performance, human expert analysis, and multi-reader studies) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" as one might see for clinical accuracy metrics. Instead, the performance testing focuses on mechanical characteristics, and the implicit acceptance criterion is that the device performs comparably to the predicate device and meets established ASTM standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in the context of clinical data or patient studies. The testing described is mechanical (benchtop) in nature. The data provenance is implicit; the tests were conducted as part of the submission process, likely by the manufacturer or a contract testing lab. There is no information regarding country of origin for mechanical testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This submission concerns a physical implantable device, not a diagnostic or AI-powered software device requiring expert-established ground truth from medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of adjudication for clinical or image-based data.

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 device, and no MRMC study was performed.

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

Not applicable. This is not an algorithmic or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the established ASTM standards and the expected performance of the predicate devices. The device's performance is compared against these engineering standards and the known characteristics of equivalent devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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Peridot-PT Anterior Cervical Intervertebral body fusion System

The Peridot-PT 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-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The Peridot-PT 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-PT Intervertebral body fusion system

The Peridot-PT 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-PT 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-PT Cages are a comprehensive portfolio of 3D-pri interbody devices 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), Direct 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 screws, anterior plate system or anterior screw and rod system).

The implant cages are supplied sterilized.

The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.

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

The provided FDA 510(k) clearance letter and summary for the Peridot-PT Anterior Cervical Intervertebral body fusion System and Peridot-PT Intervertebral body fusion system do not contain information about the device's acceptance criteria or a study proving its performance in a clinical or AI-assisted setting.

The document outlines a typical medical device clearance process for a Class II device, specifically focusing on substantial equivalence to existing predicate devices. This typically relies on:

• Mechanical and Biocompatibility Testing: Ensuring the device's physical properties are safe and effective. The document explicitly mentions "Performance Testing" with ASTM standards (F2077 for static/fatigue and F2267 for subsidence), which are engineering tests for intervertebral body fusion devices, not clinical performance or AI performance.
• Material Equivalence: The document states the devices are made from Ti-6Al-4V ELI conforming to ASTM F3001, which is a standard for titanium alloy implants.
• Indications for Use Equivalence: The indications for use are compared to predicate devices.

Therefore, based solely on the provided text, I cannot answer questions 1 through 9 as they pertain to clinical performance, AI-assisted performance, or the establishment of ground truth for such studies.

The document describes a medical device, an intervertebral body fusion system, which is a physical implant. It does not describe a device that performs any diagnostic or AI-assisted function requiring performance criteria like sensitivity, specificity, or human reader improvement with AI assistance.

In summary, the provided text details the regulatory clearance of a physical medical implant (intervertebral body fusion system) based on substantial equivalence to predicate devices, primarily through engineering performance testing and material compliance, not clinical or AI performance studies.

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