(228 days)
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of.
- · oxygen saturation (O2Sat),
- · oxyhemoglobin level (Oxy), and
- deoxyhemoglobin (Deoxy) level
in superficial tissue. The HyperView™M system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
HyperMed Imaging Inc.'s HyperView handheld hyperspectral imaging system consists of the HyperView Camera and the HyperView Accessories Kit that includes a Docking Station, Calibration Verification System, Power Cord and USB Cable Set.
The HyperView system provides noninvasive measurement of approximate tissue oxygenation, sensitive to local, regional, and systemic low/no-flow ischemia. HyperView uses multi-wavelength imaging technology to analyze the signature of light as it is absorbed by the patient's tissue. The HyperView system analyzes these light absorption signatures to measure oxyhemoglobin and deoxyhemoglobin levels in the tissue, and creates a color-coded image that illustrates relative concentrations of oxygenated hemoglobin and deoxygenated hemoglobin.
Quantitative data is provided for oxyhemoglobin and deoxyhemoglobin levels as well as oxygen saturation. The technology is suitable for surface assessment, as the visible spectrum light used penetrates no more than a few millimeters deep.
The HyperView is a handheld product consisting of several subassemblies including precision optical components, electro-optics, imaging sensor, a thermal sensor, flash illumination, flex circuits, printed circuit boards, a battery, plastics as well as image processing and graphics user interface software. Users will interact with the device using a built-in, resistive, touchscreen display and an image capture button similar to a digital camera. The product does not come in contact with the patient and no injectable contrast is required. The camera uses visible light to momentarily illuminate the patient's skin for photographic imaging. Such information is useful in determining viability of vascular delivery in the superficial skin and correspondingly, such information can assist the physician in determining the ability of the patient's vascular system to support normal tissue health and wound healing.
Here's an analysis of the acceptance criteria and study as described in the provided document:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for the HyperView™ Hyperspectral Tissue Oxygenation Measurement System is its substantial equivalence to the predicate device, the OxyVu™-1. The study primarily evaluated the difference in measurements between the HyperView and the predicate device, aiming to show that these differences were within acceptable limits.
Table of Acceptance Criteria and Reported Device Performance
| Metric / Endpoint | Acceptance Criteria (Implicit) | Reported Device Performance (Mean Differences ± Standard Deviation or CIs) |
|---|---|---|
| Primary Efficacy Endpoint | ||
| O2Sat Measurement Difference | Not greater than 7% nor less than -7% between mean O2Sat values | 3.22% ± 3.38% (Lower CI: 2.58%, Upper CI: 3.87%) |
| Image sequence analysis: 3.17%, 3.0%, 3.5% | ||
| Secondary Efficacy Endpoints | (Demonstrate similar performance to predicate within reasonable clinical limits) | |
| O2Sat by Skin Tone (Light) | Similar to predicate | 2.42% (mean difference) |
| O2Sat by Skin Tone (Medium) | Similar to predicate | 4.64% (mean difference) |
| O2Sat by Skin Tone (Dark - Forearm) | Similar to predicate | ≤ 4% (mean difference) |
| O2Sat in Ulcerated vs. Non-Ulcerated | Similar to predicate | Ulcer present: 1.91% (Lower CI: 0.55%, Upper CI: 3.26%) |
| No ulcer: 3.8% | ||
| O2Sat with Peripheral Artery Disease | Similar to predicate | 2.6% (Lower CI: 1.14%, Upper CI: 4.06%) |
| Oxy (Oxyhemoglobin) Mean Difference | Similar to predicate (values on 0-255 scale) | 14.07 (5.5%) |
| Oxy by Skin Tone (Light, Plantar Foot) | Similar to predicate | 11.94 (4.7%) |
| Oxy by Skin Tone (Medium, Plantar Foot) | Similar to predicate | 17.85 (7.0%) |
| Oxy by Skin Tone (Forearm) | Similar to predicate | Light: 12.62 (4.9%) |
| Medium: 13.64 (5.3%) | ||
| Dark: 17.5 (6.8%) | ||
| Oxy with Ulcer Present | Similar to predicate | 11.3 (4.4%) |
| Oxy with Peripheral Artery Disease | Similar to predicate | 12.27 (4.8%) |
| Deoxy (Deoxyhemoglobin) Mean Difference | Similar to predicate (values on 0-255 scale) | 1.95 (0.8%) |
| Deoxy by Skin Tone (Light, Plantar Foot) | Similar to predicate | 2.9 (1.1%) |
| Deoxy by Skin Tone (Medium, Plantar Foot) | Similar to predicate | 0.28 (0.1%) |
| Deoxy by Skin Tone (Forearm) | Similar to predicate | Light: 2.47 (1.0%) |
| Medium: 1.1 (0.4%) | ||
| Dark: 2.38 (0.9%) | ||
| Deoxy with Ulcerated Tissue | Similar to predicate | 3.09 (1.2%) |
| Deoxy with Peripheral Artery Disease | Similar to predicate | 3.27 (1.3%) |
| Software Verification & Validation | Conformance per FDA Guidance and IEC 62304 | PASS |
| Electrical Safety (ANSI/AAMI ES60601-1) | Compliance with standard | PASS |
| EMC/EMI (IEC 60601-1-2) | Compliance with standard | PASS |
| Laser Safety (IEC 60825-1) | Compliance with standard | PASS |
| Photobiological Safety (IEC 62471) | Compliance with standard | PASS |
| Battery Safety (IEC 62133) | Compliance with standard | PASS |
| Transportation Safety (UN 38.3) | Compliance with standard | PASS |
| Transit Testing (ASTM D4169) | Compliance with standard | PASS |
Study Details
The provided document describes a clinical validation study to demonstrate that the HyperView system is substantially equivalent to its predicate device, the OxyVu™-1.
-
Sample size used for the test set and the data provenance:
- Sample Size: A minimum of 20 subjects was planned and met.
- Data Provenance: The study was conducted with subjects enrolled in an IRB approved study. This indicates a prospective collection of data for the purpose of the study. The country of origin of the data is not explicitly stated but implies a US-based study due to FDA submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not use an expert-established ground truth in the typical sense of a diagnostic interpretation study. Instead, the "ground truth" for comparison is the measurement obtained from the predicate device, OxyVu™-1. The study's objective was to compare the investigational device (HyperView) to the legally marketed predicate.
- Therefore, no specific number or qualifications of experts for establishing ground truth are mentioned as the primary comparison is device-to-device.
-
Adjudication method for the test set:
- Not applicable. As described above, the study compared measurements from the new device directly against measurements from the predicate device. There was no explicit adjudication of findings by human readers or panels in this comparison in the manner of diagnostic performance studies.
-
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 comparative effectiveness study was not done. This study focuses on the technical performance equivalence of the new device (HyperView) to a predicate device (OxyVu™-1) in measuring tissue oxygenation, oxyhemoglobin, and deoxyhemoglobin levels. It is not an AI-assisted diagnostic device where human reader performance improvement would be evaluated. Human readers (physicians/healthcare professionals) use the device, but their improvement with "AI" assistance is not the subject of this study.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance evaluation was implicitly done in the sense that the HyperView device's measurements (O2Sat, Oxy, Deoxy) were compared directly to the predicate device's measurements. The "algorithm only" performance is represented by the output of the HyperView system itself, which is then compared to the predicate's output. While a physician uses the device, the study quantifies the difference in the device's reported values, not how a physician's diagnostic accuracy changes using the device.
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The type of ground truth used:
- The "ground truth" (or reference standard) used for comparison was the measurements obtained from the legally marketed predicate device, OxyVu™-1. The study design aimed to show that the HyperView system provided clinically comparable measurements to the established predicate.
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The sample size for the training set:
- The document does not specify a separate training set sample size. The described clinical validation study is a test set for regulatory submission. The device likely underwent internal development and algorithm training, but details regarding a specific training dataset for the algorithm are not provided in this regulatory summary.
-
How the ground truth for the training set was established:
- As no specific training set or its ground truth establishment is detailed in this document, this information is not available from the provided text.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).