(87 days)
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK-OPTIMA LT1 with Titanium markers. The device and associated instruments are provided non-sterile.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device was tested in compliance with FDA's guidance document titled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". Preclinical testing according to ASTM F2077 and ASTM F2267 standards was performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | (Implied) Substantial equivalence to predicate devices under specified test conditions. | Demonstrated substantially equivalent performance characteristics to the identified predicate devices in all tests. |
| Static Compression | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Static Compression Shear | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Dynamic Axial Compression | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Subsidence | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Expulsion | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Biocompatibility/Material Integrity | (Implied) The device material (PEEK-OPTIMA LT1 with Titanium markers) is suitable for implant and its integrity is maintained. | (No specific performance values reported in the summary, but the device is cleared, implying satisfactory material performance.) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes preclinical testing of the device itself and does not involve patient data or a "test set" in the context of clinical trials or AI/algorithm performance. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable to the information provided. The tests mentioned (ASTM F2077, ASTM F2267) would involve a specified number of physical device samples for mechanical testing, as per the respective standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as this document describes the preclinical mechanical testing of a medical device, not a study involving human-in-the-loop performance or diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size:
Not applicable. This is a 510(k) summary for a physical interbody fusion device, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the mechanical tests conducted (static compression, static compression shear, dynamic axial compression, and subsidence, expulsion), the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices and the relevant ASTM standards. The goal was to demonstrate "substantially equivalent performance characteristics to the identified predicate devices."
8. The Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" in the context of preclinical mechanical testing of an interbody fusion device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
§ 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.