(56 days)
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.
| Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|
| Mechanical integrity under various loads according to ASTM F2077 | Device tested in static compression, static compression-shear, static torsion, fatigue compression, fatigue compression-shear, fatigue torsion |
| Resistance to subsidence according to ASTM F2267 | Device tested in subsidence test |
| Material conformity to ASTM F3001 (Ti-6AI-4V ELI) | Device stated to be made from Ti-6AI-4V ELI conforming to ASTM F3001 |
| Sterilization efficacy (ISO 11137 or ISO 17665) | Devices are to be sterilized by gamma radiation per ISO 11137 or steam sterilization per ISO 17665 |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.