(34 days)
The Solitaire Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
As an intervertebral body fusion device designed for use with autograft, the Solitaire Anterior Spinal System is indicated for stand-alone 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 1 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.
The components of the Solitaire™ Anterior Spinal System are comprised of Titanium alloy and are inserted into the intervertebral body space of the lumbosacral spine with bone graft material. The system consists of a spacer with radiographic markers and three bone screws.
The provided text is a 510(k) summary for the Solitaire™ Anterior Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes the device and its intended use, but it does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe device.
Here's why and what information is available (or not available) based on your request:
- Device Type: This is a physical implantable device (intervertebral body fusion device), not an AI/CADe (Computer-Aided Detection/Diagnosis) software device. Therefore, the types of "acceptance criteria" and "studies" for this device are fundamentally different from what you would expect for an AI algorithm. Its "performance" is related to its mechanical and biological compatibility, not diagnostic accuracy or image interpretation.
- Safety and Effectiveness: For this type of device, "acceptance criteria" generally refer to demonstrating substantial equivalence to a predicate device in terms of material, design, sizing, indications for use, technological characteristics, and principles of operation, without introducing new issues of safety or effectiveness. The "study" proving this is often a comparison to the predicate device and possibly mechanical testing, but not typically a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes directly in a multi-reader, multi-case study as you described for AI devices.
Given this context, I will address each point of your request based on the limited applicability to this type of device and the information present in the document.
Here's the breakdown of the information based on your request:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit for a 510(k) for a physical device): The primary acceptance criterion for a 510(k) submission like this is to demonstrate "substantial equivalence" to a legally marketed predicate device such that the new device does not raise new questions of safety or effectiveness. This is achieved by showing similar intended use, indications, technological characteristics (materials, design, sizing), and principles of operation.
- Reported Device Performance: The document does not provide quantitative "performance" metrics in the way an AI algorithm's sensitivity/specificity would be reported. Instead, it states: "The Solitaire™ Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness."
Acceptance Criteria (for 510(k) Substantial Equivalence) Reported Device Performance (as stated in the 510(k) Summary) Intended Use is similar to predicate. Substantially equivalent to predicate in intended use. Indications for Use are similar to predicate. Substantially equivalent to predicate in indications. Technological characteristics (material, design, sizing) are similar to predicate. Technological characteristics are the same as, or similar to, the predicate devices. Principles of operation are similar to predicate. Substantially equivalent to predicate in principles of operation. Device does not raise new issues of safety or effectiveness. Does not present any new issues of safety or effectiveness. Restore biomechanical integrity for a prolonged period (for vertebral body replacement). Designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a "test set" or "data provenance" in the context of an AI algorithm study. For a physical implant, "testing" typically involves mechanical tests, biocompatibility tests, and sometimes animal studies, but clinical data for 510(k)s often isn't required if substantial equivalence can be shown otherwise. No such clinical "test set" information is provided here.
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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)
- This information is not applicable to the provided document. There is no mention of a "test set" requiring ground truth established by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable to the provided document.
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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
- No MRMC study was done, as this is a physical implant, not an AI device aimed at assisting human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI study. For this device, "ground truth" would relate to successful implantation, fusion, biomechanical stability, and clinical outcomes for the patient, which are not detailed as specific "ground truths" in this 510(k) summary.
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The sample size for the training set
- Not applicable; this is not an AI algorithm.
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How the ground truth for the training set was established
- Not applicable; this is not an AI algorithm.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (spinal implant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics based on clinical trial data or AI algorithm validation studies.
§ 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.