(117 days)
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The subject CRESCENT™ Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold autogenous bone graft. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices are designed to be implanted through the transforaminal and direct lateral approaches. The devices range from 7mm to 15mm in height and from 25mm to 36mm in length. The devices are manufactured from Medical Grade PEEK (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.
The CRESCENT™ Spinal System is regulated as a Class II medical device (21 CFR 888.3080) with product code MAX. The provided text describes non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance rather than clinical efficacy related to a device performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Axial Compression (ASTM 2077-03) | Demonstrated performance within acceptable limits or comparable to predicate devices in terms of load-bearing capacity and deformation. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance). | Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided). |
| Dynamic Axial Compression (ASTM 2077-03) | Demonstrated performance within acceptable limits or comparable to predicate devices under cyclic loading conditions for fatigue resistance. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance). | Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided). |
| Static Compression Shear (ASTM 2077-03) | Demonstrated performance within acceptable limits or comparable to predicate devices in resistance to shear forces. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance). | Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided). |
| Compression Shear Fatigue (ASTM 2077-03) | Demonstrated performance within acceptable limits or comparable to predicate devices under cyclic shear loading for fatigue resistance. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance). | Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided). |
| Subsidence Testing (ASTM F2267-04) | Demonstrated performance within acceptable limits or comparable to predicate devices in resistance to subsidence into vertebral endplates. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance). | Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size for the mechanical tests. The tests refer to devices, but the number of devices tested for each condition is not stated.
- Data Provenance: The data provenance is from non-clinical mechanical testing, performed in a laboratory setting. There is no mention of human or animal data.
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. The study described is a non-clinical mechanical test, not a study involving medical image analysis or expert review for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. The study described is a non-clinical mechanical test, not a study involving expert adjudication.
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. The provided text describes non-clinical mechanical tests for a spinal implant, not an MRMC comparative effectiveness study involving human readers and AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. The provided text describes non-clinical mechanical tests for a spinal implant. There is no mention of an algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical tests was established by adherence to recognized ASTM standards (ASTM 2077-03 and ASTM F2267-04) and comparison to the mechanical performance of legally marketed predicate devices. The "ground truth" here is the established mechanical performance characteristics and safety profiles of existing, approved devices.
8. The sample size for the training set:
Not applicable. This is a non-clinical mechanical test report, not a study involving a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is a non-clinical mechanical test report, not a study involving a training set for an algorithm.
§ 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.