(81 days)
The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.
The Voyant System is composed of the Voyant Sheath and Voyant Imager, and Accessories which includes an Image Control Box (ICB) and connecting cables. The Voyant Sheath and Voyant Imager are supplied sterile by ethylene oxide (EtO) while the ICB and connecting cables are supplied non-sterile and are reusable. The Voyant System is used in minimally invasive spine surgery to provide access and visualization of the surgical area of the spine.
The Voyant System is a sterile, single-use access and visualization device consisting of a Sheath for access to the spine and an Imager for illumination and visualization of the surgical area. The Sheaths are available in multiple diameters and lengths to accommodate a variety of patient anatomies and spinal surgical procedures. Likewise, the Voyant Imager is available in corresponding diameters to attach to the Voyant Sheath. The Voyant Imager connects to the Image Control Box (ICB) via an HDMI cable and live video image is displayed to a connected external HD monitor in the operating room. The ICB functions to power the Voyant Imager, process video data from the Voyant Imager to display live video image to the connected third-party HD Monitor.
The provided text does not contain information about acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or any other quantifiable performance measures. The document is a 510(k) summary for the Voyant System, focusing on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and various engineering performance tests.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either the test or training sets, as these details are not present in the provided text.
The information available is as follows:
- Study type: The submission primarily relies on non-clinical verification testing to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study with human subjects.
- Performance Data: The performance data section ([Section G] on page 5) lists various types of engineering and safety tests conducted, including:
- Sterilization (ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11737-1, ANSI/AAMI/ISO 11737-2)
- Packaging and shelf-life (ISO 11607-1, ASTM F1980-16, ASTM F88/F88 M-15, BS EN 868-5, ASTM F 2096-11, ASTM D 4169-16, ISTA Procedure 2A)
- Electrical Safety (IEC 60601-1, IEC 60601-2-18)
- Electromagnetic Emissions and Immunity (IEC 60601-1-2)
- Software (IEC 62304)
- Risk Management (EN ISO 14971)
- Design Verification Testing (N/A – indicating no specific external standard cited, likely internal protocols)
The conclusion in Section H states that "The subject Voyant System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use" based on these tests. This implies that the device successfully passed these engineering and safety tests, which serve as the acceptance criteria for regulatory clearance rooted in substantial equivalence. However, specific thresholds or quantitative results for these tests are not provided in this summary.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.