(161 days)
SABLE™ Expandable Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is to be used with supplemental fixation.
The SABLE™ Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.
SABLE™ Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.
The provided text is a 510(k) summary for a medical device called the "SABLE™ Expandable Spacer," which is an intervertebral body fusion device.
It's crucial to understand that this document describes the regulatory clearance process for a physical medical device (an implantable spacer), not an AI/software-based medical device.
Therefore, the information requested in your prompt (acceptance criteria for an AI/software device, sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, etc.) is not applicable to this document.
The document discusses mechanical testing and bacterial endotoxin testing to demonstrate substantial equivalence to predicate devices, which are standard procedures for physical implants. It does not involve any AI algorithms, image analysis, or diagnostic performance evaluation that would necessitate the metrics you've asked for.
Here's a breakdown of why your questions cannot be answered by this document:
- No AI/Software Component: The SABLE™ Expandable Spacer is a physical implant. There's no AI or software involved in its function or regulatory clearance as described.
- Performance Data for a Physical Device: The "Performance Data" section specifically mentions mechanical testing (static and dynamic compression, compression-shear, subsidence) per ASTM standards and bacterial endotoxin testing. These are physical product tests, not software performance evaluations.
- Ground Truth: For a physical device, "ground truth" relates to material properties, strength, biocompatibility, etc., not to diagnostic accuracy against expert consensus or pathology, as would be the case for AI.
- Sample Size for Test/Training Sets (AI): These concepts are irrelevant as there is no AI model to train or test.
- Experts for Ground Truth/Adjudication (AI): No human experts are used to establish ground truth for a physical implant's performance in the way they would for medical image analysis AI.
- MRMC Study/Standalone Performance (AI): These are methodologies for evaluating AI diagnostic performance and are not applicable to an implantable device.
In summary, the provided document describes a different type of medical device and regulatory process than what your questions anticipate.
§ 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.