(131 days)
The OxyVu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (HT-Sat),
- oxyhemoglobin level (HT-Oxy), and
- deoxyhemoglobin (HT-Deoxy) level
in superficial tissue. The OxyVu-1 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 OxyVu-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
The OxyVu-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the OxyVu-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HT-oxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.
The system consists of:
- System console: cart, system electronics, CPU, monitor, keyboard, pointing device and printer.
- Hyperspectral instrument head with support arm: broadband illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
- Single use OxyVu Check Pads and Targets: The OxyVu Check Pad is used to perform an instrument check prior to patient measurements. The OxyVu Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.
The provided text is a 510(k) summary for the OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics. Therefore, many of the requested specific details, such as precise acceptance criteria values, sample sizes for training/test sets, expert qualifications, and adjudication methods, are not explicitly stated in this type of regulatory submission.
However, I can extract the information that is present and indicate where the requested details are missing.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
The 510(k) summary does not provide specific quantitative acceptance criteria or detailed performance metrics from a dedicated study. Instead, it relies on demonstrating substantial equivalence to a predicate device.
The "performance" is implied by the equivalence of "intended uses and technologies and on comparable results in clinical testing" with the Inspectra Model 325.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Approximate value of oxygen saturation (HT-Sat) in superficial tissue. | The OxyVu-1 system reports an approximate value of oxygen saturation (HT-Sat). |
| Approximate value of oxyhemoglobin level (HT-Oxy) in superficial tissue. | The OxyVu-1 system reports an approximate value of oxyhemoglobin level (HT-Oxy). |
| Approximate value of deoxyhemoglobin level (HT-Deoxy) in superficial tissue. | The OxyVu-1 system reports an approximate value of deoxyhemoglobin level (HT-Deoxy). |
| Display two-dimensional, color-coded images of tissue oxygenation. | The OxyVu-1 system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface. |
| Be indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise. | The OxyVu-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise. |
| Performance comparable to the predicate device (Inspectra Model 325). | "Comparable results in clinical testing" to the Inspectra Model 325 are stated as a basis for substantial equivalence. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the 510(k) summary. The document mentions "clinical testing" but does not detail the size or nature of the test set.
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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 explicitly stated. A 510(k) summary for a tissue oximeter typically focuses on physiological measurement accuracy rather than expert image interpretation. Ground truth for such devices usually involves direct physiological measurements or established clinical standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. This type of adjudication method is usually relevant for studies involving human interpretation of medical images. For a device measuring physiological parameters, the "ground truth" is typically established by other validated measurement techniques or clinical outcomes, not by expert consensus on interpretations.
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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 is not mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that aids human readers in image interpretation. The comparison is between the device's output and a "ground truth" or predicate device, not human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is a standalone measurement system. Its performance is evaluated on its ability to measure and report approximate values of oxygen saturation, oxyhemoglobin, and deoxyhemoglobin levels. The "clinical testing" mentioned for substantial equivalence would have evaluated the device's performance in this standalone manner.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated but for a tissue oximeter, ground truth typically involves other validated physiological measurement techniques or established clinical diagnostic standards for oxygenation levels. It is highly unlikely to be expert consensus or pathology in the context of real-time oxygenation measurement.
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The sample size for the training set:
- Not applicable/Not explicitly stated. The 510(k) summary suggests the device uses hyperspectral imaging technology for spectral analysis. While such systems might involve calibration or model development, the term "training set" in the AI context is not used here, and no details about such a set are provided. The device's operation is based on physical principles of light absorption by hemoglobin.
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How the ground truth for the training set was established:
- Not applicable/Not explicitly stated. As there is no mention of a "training set" in the AI sense, there's no information on how its ground truth would have been established. Any calibration or model development would likely rely on physically characterized phantoms or in-vitro/in-vivo studies with known oxygenation states.
§ 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).