(254 days)
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (StO2), .
- oxyhemoglobin level (HbO2), and ●
- deoxyhemoglobin (Hb) level .
in superficial tissue. The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.
The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
The Kent Camera is based on multispectral imaging technology and performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. The Kent Camera determines the approximate values of oxygen saturation (StO₂), oxyhemoglobin levels (HbO₂), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (StO2).
The device consists of:
Imaging Head: Contains light sources, camera, and spectral filters for collecting image data.
Touchscreen Computer: User interface, display of images, and image data processing.
Cart: Support and attachment points for imaging head and touchscreen computer.
The provided document is a 510(k) summary for the Kent Camera, a tissue oximeter. It describes the device, its intended use, and its substantial equivalence to a predicate device (Hypermed Inc.'s OxyVu-1). However, it does not contain any information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment for the Kent Camera.
The document primarily focuses on establishing substantial equivalence based on similar intended uses, technology, and a general statement about "results from performance testing," but it does not detail these performance tests.
Therefore, I cannot provide the requested information from the given text.
The following information is NOT available in the provided document:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance values are listed.
- Sample sized used for the test set and the data provenance: No information on test set sample size or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment.
- Adjudication method: No information about adjudication.
- 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: This device is not described as an AI-assisted device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance metrics are provided.
- The type of ground truth used: No ground truth type is specified.
- The sample size for the training set: No information about a training set or its size.
- How the ground truth for the training set was established: No information about a training set or its ground truth.
§ 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).