(202 days)
The SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The hyperlordotic lumbar implants (at angles > 15°) 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. 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 Sahara Stabilization System. The implants function as an expandable intervertebral body fusion devices to provide support and stabilization to the lumbar segments of the spine. The implants are manufactured from Titanium (ASTM F1472, F67) and Cobalt Chrome (ASTM F1537).
This is a 510(k) premarket notification for a medical device called the SAHARA Stabilization System. It primarily outlines the device's substantial equivalence to previously cleared predicate devices. The information provided is typical for regulatory submissions and does not detail a clinical study of the type that would typically generate acceptance criteria and performance data for an AI/ML powered device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) nor does it report such performance data. It focuses on mechanical testing.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML powered diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implanted medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
What can be extracted/inferred from the document:
- Device Name: SAHARA Stabilization System
- Device Type: Intervertebral body fusion device
- Regulatory Class: Class II
- Predicate Devices: K2M Chesapeake (K092211, K120031, 142487), K2M Santorini (K111294), Globus Rise (K113447), Wenzel Spine Vari-Lift-L (K100820). The primary predicate is K2M Chesapeake (K092211).
- Non-clinical Performance Evaluation: Mechanical testing (static compression, static torsion, static compression shear, dynamic compression, expulsion, and subsidence) and a cadaver implantation study were performed. The conclusion was that the proposed implants were substantially equivalent to predicate devices in design, function, intended use, materials, and size based on these tests. These tests would have acceptance criteria related to biomechanical properties, but they are not detailed in this summary.
- Ground Truth for Mechanical Testing: The "ground truth" for mechanical testing would be the engineering specifications and performance expectations established for spinal implants, often based on industry standards (e.g., ASTM standards for titanium and cobalt chrome) and comparisons to the predicate devices.
- Training Set for Mechanical Testing: Not explicitly stated as a "training set," but the design and materials used would be based on established engineering principles and data from previous successful spinal implants (including the predicate devices).
In summary, this document is for a traditional medical device (spinal implant) and does not contain the type of AI/ML-specific performance evaluation and acceptance criteria requested in the prompt.
§ 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.