(125 days)
The Solitaire -C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.
The provided text describes a medical device, the Solitaire®-C Cervical Spacer System, and its clearance process. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance.
The document K113796 is a 510(k) summary for a traditional medical device (cervical interbody fusion device), cleared in 2012. The "Performance Data" section details mechanical testing performed on the physical device to ensure its strength and suitability for its intended use, according to ASTM standards. This is standard for orthopedic implants, demonstrating the physical integrity and biocompatibility of the device itself.
There is no mention of an AI/ML component in this device, nor any discussion of diagnostic or prognostic performance metrics that would typically be associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Therefore, the specific information requested about acceptance criteria, reported device performance (in terms of AI metrics), sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the provided document.
To directly answer your request based on the absence of such information in the provided text:
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A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing to established ASTM standards but does not present acceptance criteria or performance in a table format relevant to AI/ML. Mechanical testing "shows that the mechanical strength of the subject device is sufficient for its intended use," implying it met internal or regulatory mechanical performance criteria, but these are not specified quantitatively.
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Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples for mechanical testing, not a digital test set for AI/ML.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on physical measurements and compliance with engineering standards, not expert medical interpretation of images or patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. No AI component is described.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" is compliance with specified ASTM standards for static and dynamic compression, shear, torsion, subsidence, and expulsion, along with evaluation of screw back out, push through, and interconnection, and wear debris analysis.
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The sample size for the training set: Not applicable. No AI component is described.
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How the ground truth for the training set was established: Not applicable. No AI component is described.
In summary, the provided document describes the mechanical performance of a physical orthopedic implant and does not contain the type of information requested about AI/ML device performance and validation.
§ 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.