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.

Device Description

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.

AI/ML Overview

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

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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NOV - 8 2006

510(k) Summary OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System (June 28, 2006)

Submittal information:

Post-approval contact: Jenny Freeman, MD, President, Hypermed, Inc. Hypermed, Inc. 305 Second Avenue Suite B Waltham, MA 02451

Phone: 781-647-0009

510(k) prepared by Chas Burr, President, Chas Burr Q/R Systems, Inc. Phone: 781-789-1646 Fax: 781-723-2422

Device name and classification

Proprietary Name: OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System Hyperspectral Tissue Oxygenation Measurement System Common Name: Classification Name: Tissue Saturation Oximeter Classification Panel: Cardiovascular CFR Section: 21 CFR 870.2700 Class: II Product Code: MUD

Substantial Equivalence

The Oxy Vu-1 system is substantially equivalent to the Inspectra Tissue Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023933, and K012759.

Device Description

The OxyVu-1 system is based on hyperspectral imaging technology. The

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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 (HToxy), 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.

Intended Use

. 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.

Comparison with the Predicate Device

	OxyVu-1	Inspectra Model 325
Measures	Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin level	Oxygen saturation
Method ofMeasurement	Spectral analysis at specific wavelengths of light returned from target tissue.
Output Display	NumericTwo-dimensional color map ofapproximate tissue oxygenation	Numeric

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Similarities and Differences

Oth devices use spectral analysis to determine oxygenation levels in near-surface tissues. The Clyckly, I systems Both devices use spectral analysis to decomment on the hemoglobin. The OxyVu-l system a display numeric values of the approximate oxygen and deoxyhemoglobin levels necessary for the oxygen saturation calculation.

The hyperspectral scanning method used by the OxyVu-1 system provides two-dimensional mapping of color-coded oxygenation levels.

Basis of Substantial Equivalence

Based on equivalent intended uses and technologies and on comparable results in clinical testing, the Oxy Vu-1 Hyperspectral Tissue Oxygenation Measurement System is substantially equivalent to the Inspectra Model 325 Tissue Spectrometer System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2006

HyperMed, Inc. c/o Mr. Chas Burr Chas Burr Q/R Services, Inc. 11 Mystic Avenue Winchester, MA 01890-2920

Re: K061848

Trade Name: Oxy Vu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue saturation oximeter Regulatory Class: Class II Product Code: MUD Dated: October 11, 2006 Received: October 13, 2006

Dear Mr. Burr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chas Burr

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ 対応 Kole1048

Device Name: OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System

Indications for Use:

oxygen saturation (HT-Sat), �
oxyhemoglobin level (HT-Oxy), and .
deoxyhemoglobin (HT-Deoxy) level

The OxyVu-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K061848

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Regulation Number and Section

§ 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).