(129 days)
The Vista S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista® S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.
The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.
The Vista -- S Device is a box-shaped device for interbody fusion and vertebral body replacement fabricated from polyetheretherketone (PEEK). The Vista -S currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as a cervical interbody fusion device at one level from C2-T1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.
The provided text describes a 510(k) premarket notification for a medical device called the Vista®-S Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic performance against acceptance criteria in the way one might for an AI/ML medical device.
Based on the information provided, here's a breakdown of the requested points:
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A table of acceptance criteria and the reported device performance
Acceptance Criterion Topic Acceptance Criteria Reported Device Performance Substantial Equivalence Device is substantially equivalent to legally marketed predicate devices. The Vista®-S Device was shown to be substantially equivalent. No significant differences that would adversely affect use. No new issues of safety or efficacy. Material Identical or similar material to previously cleared predicate devices. Identical material to previously cleared predicate devices. Intended Use/Indications Similar to predicate devices. Similar to its predicate devices. Expanded indications for cervical interbody fusion (C2-T1) in addition to existing thoracolumbar vertebral body replacement (T1-L5). Design Features/Geometry Similar to cleared predicate devices. Similar to cleared predicate devices. Mechanical Performance Adequately meets predetermined requirements established for its mechanical performance as per FDA guidance. Mechanical testing results and analyses demonstrate that the proposed system adequately meets predetermined requirements. -
Sample size used for the test set and the data provenance
This document describes mechanical testing and comparison to predicate devices for a physical implant, not a study involving a "test set" of patient data or images in the way an AI/ML diagnostic device would. There is no mention of a clinical test set, patient data, or provenance (country of origin, retrospective/prospective). The "test set" here refers to the actual device units subjected to mechanical tests.
- Sample Size: Not specified for mechanical testing, but typically involves a certain number of devices per test.
- Data Provenance: Not applicable in the context of device mechanical testing.
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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. This is not a diagnostic device involving expert ground truth for interpretation. Ground truth for mechanical testing would be defined by engineering specifications and standards.
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Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations. Mechanical testing results are objective measurements against predefined engineering standards.
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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, an MRMC study was not done. This device is a physical implant (interbody fusion device/vertebral body replacement), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device.
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The type of ground truth used
For the mechanical performance testing, the ground truth would be established by engineering standards and specifications based on recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. For the substantial equivalence argument, the "ground truth" is the established safety and efficacy of the predicate devices.
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The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of medical device submission.
§ 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.