(20 days)
The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical-TL System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be used with the bone screw fixation provided and requires no additional fixation.
NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical-TL System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7 µm). The intervening geometric lattices have 300-700um pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with a turn lock mechanism which secures the screw to the spacer component.
The provided text describes a 510(k) premarket notification for the NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System, a Class II intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and performance metrics for an AI/ML device.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving device performance, as the document does not contain this information. The document pertains to a medical device clearance for an implant, not an AI/ML diagnostic or assistive technology.
Here's a breakdown of why the requested information is not available in the provided document:
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A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics in terms of sensitivity, specificity, accuracy, or other related metrics. It states, "The modified Stand Alone Cervical-TL device components were evaluated via dimensional analyses. The results demonstrated the performance of the modified Stand Alone Cervical-TL device is substantially equivalent to the predicate. In addition, the screw pushout properties for the modified Stand Alone Cervical-TL construct were evaluated." This refers to mechanical and physical properties of the implant, not diagnostic performance.
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Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/ML system tested on a dataset.
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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): Not applicable. "Ground truth" in the context of an AI/ML device (e.g., expert-labeled images) is not relevant for this physical device.
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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. This type of study is relevant for AI-assisted diagnostic tools, not for an intervertebral body fusion device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for a spinal implant, which confirms its substantial equivalence to a predicate device based on mechanical and material characteristics. It does not address AI/ML system performance or related study details.
§ 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.