(27 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 describes the Voyant System, an arthroscope used for minimally invasive spine surgery, and its 510(k) submission (K191579) to the FDA. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K181885).
However, the document does not provide specific acceptance criteria as quantitative thresholds for performance metrics to be met by the device. Instead, it relies on demonstrating equivalence to the predicate device and compliance with relevant standards.
Therefore, many of the requested items regarding specific acceptance criteria, study details, ground truth, sample sizes, and expert qualifications cannot be directly extracted from the provided text because such information is not included. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study like a clinical trial or a standalone algorithm evaluation.
Below is a summary of the information that can be extracted, along with explanations for the information that is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in terms of quantitative thresholds for device performance. Instead, it demonstrates performance by showing that the subject device's characteristics are "Same" or comparable to the predicate device, or meet certain technical specifications.
| Feature | Predicate Device Performance | Subject Device Performance | Acceptance Criteria (Not explicitly stated in text) |
|---|---|---|---|
| I. Key Performance Specs | |||
| Camera resolution | 1080p | Same (1080p) | N/A (implied to be at least 1080p) |
| Sensor resolution | 3280 x 2464 pixels | Same (3280 x 2464 pixels) | N/A (implied to be at least 3280 x 2464 pixels) |
| Camera sensor | 1/4" CMOS | Same (1/4" CMOS) | N/A (implied to be 1/4" CMOS) |
| Compressive force (Tubular retractor) | $\geq$ 100N | Same ($\geq$ 100N) | $\geq$ 100N |
| Image resolution | $\geq$ 11 lp/mm at 63mm | $\geq$ 11 lp/mm at 80mm | $\geq$ 11 lp/mm at 80mm |
| Working length | 6-13cm | 4-13cm | N/A (implied new range is acceptable) |
| II. Compliance | |||
| Electrical Safety | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | Compliance with IEC 60601-1 |
| Electromagnetic Emissions/Immunity | Compliant with IEC 60601-1-2 | Compliant with IEC 60601-1-2 | Compliance with IEC 60601-1-2 |
| Software | Compliant with IEC 62304 | Compliant with IEC 62304 | Compliance with IEC 62304 |
| Risk Management | Compliant with EN ISO 14971 | Compliant with EN ISO 14971 | Compliance with EN ISO 14971 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "non-clinical performance verification testing" but does not detail the nature of these tests, including sample sizes for physical or image testing, nor does it mention data provenance (e.g., clinical data, country of origin). The study seems to be focused on engineering verification rather than clinical data.
3. 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 provided in the document. Given that the testing mentioned is "non-clinical performance verification testing," it's unlikely that clinical expert ground truth was established for a test set in the conventional sense of a medical diagnostic device study. The testing appears to be technical validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
There is no indication that an MRMC comparative effectiveness study was done. The Voyant System is an access and visualization device, not an AI-assisted diagnostic tool. The document describes a "Design Comparison Table for Substantial Equivalence" showing features of the subject device against the predicate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
There is no indication of a standalone algorithm performance study. The device is hardware-based for visualization, not an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "non-clinical performance verification testing," implying that the "ground truth" was likely established through engineering specifications, metrology, and physical testing to ensure the device's technical parameters (e.g., image resolution, compressive force) meet mechanical and optical design requirements and regulatory standards. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's submission.
8. The sample size for the training set
This information is not provided in the document. The device is a physical arthroscope system, not an AI/machine learning model, so the concept of a "training set" in that context does not apply.
9. How the ground truth for the training set was established
This information is not provided in the document, as the concept of a training set for an AI/ML model is not applicable here.
§ 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.