(175 days)
When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).
When used as a vertebral body replacement device, Choice Spine lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5 , for the replacement of a collapsed or unstable vertebral body resulting from a turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.
The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.
The provided text describes the Choice Spine Lumbar Spacer System, which is a medical device. The information details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.
Therefore, many of the requested categories are not applicable to the provided document. The document describes a traditional medical device (spinal spacer), not an AI or algorithm-based device.
Here's a breakdown based on the information provided, highlighting what is and isn't available:
Acceptance Criteria and Study for Choice Spine Lumbar Spacer System
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Testing Standards) | Device Performance (Results) |
|---|---|
| Static Axial Compression Bending (ASTM F2077-11) | Substantially equivalent to predicate devices |
| Static Torsion (ASTM F2077-11) | Substantially equivalent to predicate devices |
| Dynamic Axial Compression Bending (ASTM F2267-04) | Substantially equivalent to predicate devices |
| Dynamic Torsion (ASTM F2267-04) | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes mechanical performance testing of the physical device (spinal spacer) rather than a test set for an AI/algorithm. The "test set" in this context would refer to the physical spacers subjected to the performance tests. The specific number of devices tested is not provided, but the testing was conducted by an "independent laboratory."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and "ground truth" for mechanical performance is established by standardized testing methods, not expert consensus interpretation of data.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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 device is a physical implant; it does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the performance testing, the ground truth is established by physical measurement against the requirements of the ASTM standards (ASTM F2077-11 and ASTM F2267-04) and comparison to the performance of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of the Study:
The "study" described in the provided text is a series of mechanical performance tests conducted on the Choice Spine Lumbar Spacer System. These tests were performed by an independent laboratory according to established ASTM standards (ASTM F2077-11 and ASTM F2267-04). The tests covered static axial compression bending, static torsion, dynamic axial compression bending, and dynamic torsion.
The overall conclusion of these tests was that the device's performance was "substantially equivalent to those of the predicate devices." This "substantial equivalence" is the basis for the FDA 510(k) clearance, indicating that the device is as safe and effective as legally marketed predicate devices. The document does not provide raw data, specific pass/fail values, or detailed performance metrics beyond stating substantial equivalence.
§ 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.