(244 days)
The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.
This document describes the SAHARA Stabilization System, an intervertebral body fusion device. The acceptance criteria and supporting study are related to the mechanical performance of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Static Compression Shear per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Static Torsion per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Subsidence per ASTM F2267 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Expulsion | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Dynamic Compression per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Dynamic Compression Shear per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
| Dynamic Torsion per ASTM F2077 | Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards. | Mechanical tests performed (implies compliance) |
Note: The document only states that "mechanical tests were performed" and that the system "has demonstrated substantial equivalence to the identified predicate devices" based on material, design, and mechanical performance. It does not provide specific numerical values for the acceptance criteria or the reported performance for each test. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device's performance must be at least as safe and effective as the legally marketed predicate devices.
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The study described is a series of mechanical tests, not a clinical study involving human 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 as the described study involves mechanical testing, not a clinical study requiring expert assessment of ground truth.
4. Adjudication method for the test set
This information is not applicable as the described study involves mechanical 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a series of mechanical tests of an intervertebral body fusion device, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through industry standards and mechanical testing protocols (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these criteria and the performance of predicate devices to demonstrate substantial equivalence.
8. The sample size for the training set
This information is not applicable. The device is a physical implant and does not involve a training set as would be used for an AI algorithm.
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.