(98 days)
The Peridot-EX Expandable 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 radios. 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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems and anterior screw and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.
The Peridot-EX Expandable Intervertebral body fusion system is various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. It is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and 3D Printing manufactured from titanium power (Ti-6AI-4V ELI) as described by ASTM F3001.
The Peridot-EX Expandable Intervertebral body fusion system expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
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.
All implants are intended for SINGLE USE ONLY and should not be reused under any circumstances.
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 document is a 510(k) summary for a medical device called the Peridot-EX Expandable Intervertebral body fusion system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information about clinical study design, sample sizes, expert involvement, and ground truth establishment is not available in this regulatory submission.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria. Instead, it lists various "Performance Testing" conducted according to ASTM standards for mechanical integrity. The conclusion states that the device is "substantially equivalent to predicate device," implying that its mechanical performance met the expected standards for such devices, likely by demonstrating similar or superior results to the predicate devices in these tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Implied: Meet or exceed mechanical performance of predicate devices as per ASTM standards. | - Static Compression (ASTM F2077): Tested |
- Static Compression-shear (ASTM F2077): Tested
- Static Torsion (ASTM F2077): Tested
- Fatigue Compression (ASTM F2077): Tested
- Fatigue Compression-shear (ASTM F2077): Tested
- Subsidence (ASTM F2267): Tested
- Expulsion (ASTM F-04.25.02.02): Tested |
2. Sample size used for the test set and the data provenance
The document only mentions "The worst-case devices were tested" for mechanical performance. It does not provide specific sample sizes (e.g., number of devices) for any of these tests.
The data provenance is from mechanical testing in a laboratory setting, not from human subjects or clinical data. There is no mention of country of origin of this specific test data, but the submitter is GBS Commonwealth Co., Ltd. from South Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is mechanical performance testing, not a study involving human interpretation or clinical diagnosis.
4. Adjudication method for the test set
This information is not applicable for mechanical performance testing.
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
No such study was conducted or mentioned. The device is a physical intervertebral body fusion system, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
For the mechanical performance tests, the "ground truth" would be the physical properties and failure limits defined by the ASTM standards applied and potentially the performance data of the predicate devices for comparison.
8. The sample size for the training set
This information is not applicable. This document describes mechanical testing of a medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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.