(86 days)
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed 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 implants may be implanted via a minimally invasive lateral approach.
The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft. The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).
The information provided pertains to the CLYDESDALE® Spinal System, which is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets those criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Tests Performed | Applicable Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Compression-Shear | ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety. | "The subject implants met the acceptance criteria." |
| Compression-Shear Fatigue | ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety. | "The subject implants met the acceptance criteria." |
The report states, "Based on the results, the subject implants demonstrated that they are as safe, as effective and perform as well as the predicate device(s)." This indicates that the acceptance criteria were met by showing equivalency to predicate devices in mechanical testing.
2. Sample Size Used for the Test Set and the Data Provenance
This submission did not involve clinical testing. The tests conducted were non-clinical mechanical tests on the device itself. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature. The tests were performed on the medical devices (implants).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this was a non-clinical mechanical study, no human experts were involved in establishing a "ground truth" for a test set of patient data. The ground truth was established by the specified mechanical testing standards.
4. Adjudication Method for the Test Set
Not applicable. No human readers or adjudication method were involved as this was a non-clinical mechanical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this was a non-clinical mechanical study. No human readers or AI were involved in the evaluation of the device's performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical implant, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.
7. Type of Ground Truth Used
The ground truth for this study was based on established mechanical testing standards and the performance of legally marketed predicate devices. Specifically, the device's performance was compared to the requirements outlined in the FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device," and demonstrated substantial equivalence to predicate devices.
8. Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device, not an AI or machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical device, no ground truth needed to be established for it.
§ 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.