Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2)

The InSpectra™ Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity.

Device Description

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is the same version of the previously cleared Hutchinson Technology Inc. (HTI) InSpectra™ Tissue Spectrometer System, Model 325, and represents changes to the indications for use statement.

The InSpectra™ is composed of the following components:
InSpectra™ Tissue Spectrometer: A spectrometer that contains light detection circuitry, a microprocessor, and a display screen.
InSpectra™ Optical Cable: A fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and transmit to the tissue, and a second set of optical fibers that receives light from the tissue and returns it to a photosensitive detector. Light emitting diodes in the optical cable connector are the light source. Optical cable distal tips are available in 12, 15, 20, 25, and 35mm spacing, and are differentiated by color. The 12-25mm cable tips are gray; the 35mm cable tip is blue. The optical cable is supplied with a storage case.
InSpectra™ Calibrator: A disposable module used to normalize the tissue spectrometer and calibrate during startup of the InSpectra tissue spectrometer system. The calibrator is available in two sizes: 12-25mm (labeled in black) and 35mm (labeled in blue).
InSpectra™ Shield: A disposable interface that attaches to the distal tip of the optical cable. The shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to attach to the patient for continuous monitoring and a liner to use for intermittent measurements. The shields are available in two sizes to fit the optical cables and are differentiated by color: 12-25mm (gray) and 35mm (blue). The shield is packaged in the calibrator. To ensure accurate Sto2 measurements, use a new InSpectra shield for each patient. Do not reuse.
InSpectra™ System Check: A method to check system measurements.
InSpectra™ OptoLink™ RS232 Optical Converter: A device used to export StO2, date, and time data from the spectrometer.
InSpectra™ Software: Software, which displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the InSpectra™ Tissue Spectrometer System, Model 325. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

Crucially, the document states:

"Test Reports: Published clinical studies are presented showing that StO2 measurements provide valuable medical information in various disease states."

However, the document does NOT contain the specific details required for the acceptance criteria and study information requested in your prompt. It mentions "published clinical studies" generally but does not provide any of the following:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the regulatory submission and device description, not performance metrics against specific criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not relevant. The InSpectra™ is a tissue spectrometer, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The InSpectra™ is a standalone device in the sense that it measures StO2; it's not an "algorithm only" that then needs human interpretation in the way AI radiology tools might. However, performance metrics for its standalone accuracy are not detailed here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any studies.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device due to a reworded indication for use. It asserts that "Published clinical studies are presented showing that StO2 measurements provide valuable medical information in various disease states," but it does not include the detailed breakdown of acceptance criteria or the specifics of any studies (sample sizes, ground truth methodology, expert involvement, etc.) that would prove the device meets these criteria. The document is a regulatory submission for a minor change (reworded indications for use) to an already cleared device, not a detailed clinical study report.

Summary

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Premarket Notification 510(K) Summary

Submitter:	Hutchinson Technology Inc.BioMeasurement Division40 West Highland Park NEHutchinson, MN 55350Phone: 320.587.1926Fax: 320.587.1555
Contact:	Thomas A. DoldRegulatory Affairs ManagerHutchinson Technology Inc.Phone: 320.587.1435Fax: 320.587.1555
Date Prepared:	July 19, 2004
Proprietary Name:	InSpectraTM Tissue Spectrometer System, Model 325
Common Name:	Tissue Spectrometer
CFR Reference:	21CFR§870.2700
Class:	II
Product Code:	74 MUD
Predicate Device:	InSpectraTM Tissue Spectrometer System, Model 325 by HutchinsonTechnology Inc. (K012759) and (K023938)
Description:	This premarket notification (510(K) Notification) is submitted to obtainmarketing clearance for the Hutchinson Technology Inc. BioMeasurementDivision "InSpectraTM Tissue Spectrometer System, Model 325"(hereinafter referred to as InSpectraTM).The InSpectraTM is designed to estimate the percent oxygen saturation ofhemoglobin in a volume of tissue (StO2). This value is a reflection oflocalized perfusion of that tissue. The InSpectraTM is the same version ofthe previously cleared Hutchinson Technology Inc. (HTI) InSpectraTM

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Tissue Spectrometer System, Model 325, and represents changes to the indications for use statement.

The InSpectra™ is composed of the following components.

InSpectra™ tissue spectrometer system shown is comprised of the following components:

InSpectra™ Tissue Spectrometer: A spectrometer that contains light detection circuitry, a microprocessor, and a display screen.

InSpectra™ Optical Cable: A fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and transmit to the tissue, and a second set of optical fibers that receives light from the tissue and returns it to a photosensitive detector. Light emitting diodes in the optical cable connector are the light source. Optical cable distal tips are available in 12, 15, 20, 25, and 35mm spacing, and are differentiated by color. The 12-25mm cable tips are gray; the 35mm cable tip is blue. The optical cable is supplied with a storage case.

InSpectra™ Calibrator: A disposable module used to normalize the tissue spectrometer and calibrate during startup of the InSpectra tissue spectrometer system. The calibrator is available in two sizes: 12-25mm (labeled in black) and 35mm (labeled in blue).

InSpectra™ Shield: A disposable interface that attaches to the distal tip of the optical cable. The shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to attach to the patient for continuous monitoring and a liner to use for intermittent measurements. The shields are available in two sizes to fit the optical cables and are differentiated by color: 12-25mm (gray) and 35mm (blue). The shield is packaged in the calibrator. To ensure accurate Sto2 measurements, use a new InSpectra shield for each patient. Do not reuse.

InSpectra™ System Check: A method to check system measurements.

InSpectra™ OptoLink™ RS232 Optical Converter: A device used to export StO2, date, and time data from the spectrometer.

InSpectra™ Software: Software, which displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file

Intended Use:

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity. shoulder, or lower extremity.

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Technological Characteristics:

The fundamental changes from the predicate device include:

. A reworded indication-for-use statement (note: the fundamental intended use is retained)

Substantial Equivalence Rationale:

Essentially, the device and its predicate are identical with the exception of a reworded indication for use statement (the fundamental intended use remains unchanged). The devices share the intended use of measuring an approximated value of percent oxygen saturation of hemoglobin in a volume of tissue. In addition, they share the same design principles that incorporate a light source, fiber optic cables (which direct the light to and from the target tissue), optical detectors, analysis of specific wavelengths, and a software algorithm that provides the estimate of hemoglobin oxygen saturation.

Changes to the device necessitating this submission include only a change to the indications for use statement. The basic operating principles and measurement algorithm remain the same.

Test Reports:

Published clinical studies are presented showing that StO2 measurements provide valuable medical information in various disease states.

Conclusion:

Hutchinson Technology Inc. concludes that the InSpectra™ with changes to the indications for use is substantially equivalent the predicate device. InSpectra™ Tissue Spectrometer System, Model 325.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Hutchinson Technologies, Inc. c/o Mr. Thomas A. Dold Regulatory Affairs Manager Biomeasurement Division 40 West Highland Park NE Hutchinson, MN 55350

Re: K042020

Trade Name: Inspectra™ Tissue Spectrometer System, Model 325 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: MUD Dated: July 22, 2004 Received: July 27, 2004

Dear Mr. Kuhn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abouted in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered proxes to 1125 2008 in accordance with the provisions of the Federal Food, Drug, do noos that have been require approval of a premarket approval application (PMA). the coomete i ros (110) that 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 either 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. Thomas A. Dold

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse of action and a determination that your device complies with other requirements of the Act that + Drederal statutes and regulations administered by other Federal agencies. You must or uny I odetar banks and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF Part 820) tures (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. product radiation on to begin marketing your device as described in your Section 510(k) I mo lotter will and h your he FDA finding of substantial equivalence of your device to a legally premated notification "caresults 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Btomimimfor

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

Enclosure

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K042020
page 1 of 1
Page 26 of 33

INDICATIONS FOR USE 9.0

Indications For Use Statement

Device Name:

InSpectra Tissue Spectrometer System, Model 325

Indications For Use:

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity.

Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use

B. Hurrison

510(k) Number K011000

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).