The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.

Device Description

The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.

AI/ML Overview

The provided text describes the ORCA Cardiopulmonary Exercise Testing System and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study report with methodological details commonly found for proving such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a standalone clinical study report with detailed performance metrics. Therefore, many of the requested details are not explicitly present in the provided text.

Based on the available information, here's what can be inferred and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific, quantified acceptance criteria and a study to prove the device meets these criteria as if it were a novel device requiring de novo authorization.

The "acceptance criteria" here are implicitly related to the device having similar performance, features, and intended use as the predicate devices (MedGraphics Exercise Consult K923209 and Sensormedics Vmax 229 K942211). The "study" proving this is the 510(k) submission itself, which argues for substantial equivalence by comparing the ORCA system to these predicates.

1. A table of acceptance criteria and the reported device performance

Since the regulatory pathway is 510(k) and focuses on substantial equivalence, explicit quantitative acceptance criteria for performance metrics in a pass/fail format are not presented. Instead, the document compares the features and intended use of the ORCA system to its predicates.

Feature / Criterion (Implicitly "Acceptable if comparable to predicates")	Predicate Devices (as described)	ORCA Cardiopulmonary Exercise Testing System Performance (as described)
Intended Use	Collection and analysis of gas exchange and extraction of pulse rate from ECG during stress testing.	Collection and analysis of gas exchange and extraction of pulse rate from ECG during stress testing. Further, suggests interpretive statements based on analysis results and reasons for test termination.
Intended Users	Pulmonologists, Cardiologists and Sports Medicine physicians.	Pulmonologists, Cardiologists, and Sports Medicine physicians.
Intended Population	Not specified in labeling for predicates.	Adults and children referred for stress testing.
Site of Use	Cardiology, Pulmonary and Sports Medicine clinics and physician offices; Hospitals.	Cardiology, Pulmonary and Sports Medicine clinics and physician offices; Hospitals.
Measurements	Expired concentration of O2 and CO2, expired air flow, O2 saturation, pulse rate.	Expired concentration of O2 and CO2, expired air flow, O2 saturation, pulse rate.
Patient Interfaces	ECG electrodes, disposable pneumotach, pulse oximeter.	ECG electrodes, disposable pneumotach, pulse oximeter.
Accessories	Integrated gas calibrator.	Integrated gas calibrator.
Technology / Modalities	Hardware and software devices for cardiopulmonary exercise/stress evaluation.	Self-contained unit with components to measure flow of exhaled air, analyze O2/CO2 content, transcutaneous pulse oximeter, interfaced to Pentium-based PC. Software collects, analyzes data, summarizes results, suggests implications.

Missing Information: Quantitative performance metrics (e.g., accuracy, precision, repeatability for O2/CO2 measurement, flow measurement, pulse rate measurement, or the interpretive statements' accuracy) are not provided in this 510(k) summary. The "acceptance criteria" appear to be met by demonstrating similar functionality and intended use to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe a specific clinical "test set" and study data for the ORCA system in the way a clinical trial would. The basis for equivalence is primarily a comparison of device specifications and intended use against existing, cleared devices.

3. 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)

This information is not applicable/not provided by the document. The 510(k) summary does not describe a process of establishing ground truth with experts for a test set, as would be done for an AI diagnostic device requiring such validation. The interpretive statements feature is mentioned, but its validation methodology isn't detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided by the document. There is no mention of a test set requiring adjudication in this 510(k) summary.

5. 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 information is not applicable/not provided by the document. The ORCA system is described as generating interpretive statements, but not as an "AI assistance" device in the context of improving human reader performance via an MRMC study. It's a system to collect and analyze physiological data and provide interpretive statements based on that analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as assisting in "collection and analysis of gas exchange and extraction of pulse rate information" and will "suggest interpretive statements." This suggests a standalone analytical component. However, specific standalone performance metrics (e.g., accuracy of interpretation) are not detailed in the provided summary. The focus is on the device as a whole system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided for any validation of the interpretive statements. For the measurements (O2, CO2, flow, pulse rate), the implied "ground truth" would likely be comparison to reference measurement devices or established calibration standards, but specifics are missing from this summary.

8. The sample size for the training set

This information is not provided. The 510(k) summary does not mention a "training set," implying that if any algorithms are used for interpretation, they are based on established physiological models or rules rather than machine learning trained on a dataset.

9. How the ground truth for the training set was established

This information is not applicable/not provided. Without a mention of a training set, there's no information on how its ground truth would have been established.

In summary: The provided 510(k) document serves to demonstrate substantial equivalence based on device features and intended use, rather than a detailed performance study with explicit acceptance criteria and validation data as typically required for novel or high-risk devices or AI/ML-enabled devices today. The "study" for acceptance here is the comparison presented in the 510(k) application itself, aligning the ORCA system's attributes with those of the predicate devices.

Summary

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K974200

JUL 21 1998

Attachment 2

510(k) Summary ORCA Cardiopulmonary Exercise Testing System ORCA Diagnostics Corporation July 18, 1998

Product Name:	Current Trade Name: ORCA Cardiopulmonary Exercise TestingSystem.TM
Generic Name:	Cardiopulmonary exercise or stresstesting equipment
Classification Name:	Calculator, pulmonary function interpreter; 21 CFR 868.1900,classification code BZM and Calculator, predicted values,pulmonary. Function, 21 CFR 868.1890, code BTY, bothdesignated as Class II devices
Contact Person:	Sheila W. Pickering Ph.D.P.O. Box 1951Los Altos, California 94123Telephone/Fax 650 969 6114

A. Legally Marketed Predicate Device

The ORCA Cardiopulmonary Exercise Testing System is substantially equivalent to the MedGraphics Exercise Consult (K923209) manufactured by Medical Graphics, Inc, and the Vmax 229 Series, Pulmonary/metabolic System (K942211) manufactured by Sensormedics, Inc., which are both hardware and software devices. The ORCA device is substantially equivalent to the predicate devices with regard to device features and specifications, as well as intended use. All devices are cardiopulmonary exercise/stress evaluation systems with similar operating requirements. The application is based on standard clinical procedures.

B. Device Description

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C. Intended Use

C. Intented Coo of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the tesults of the analysis and the reasons for the test termination. The intended patients are results of the unalysis and the intended environment of use is indoors. The ORCA System Product Manual provides warnings and precautions regarding intended use, detailed information on system operation, and further information on interpretive features.

D. Substantial Equivalence

The following tables show the basis for substantial equivalence

	Predicate Devices		Submission Device
Product Name	Medgraphics CPX/DK923209	Sensormedics Vmax 229K942211	ORCA Diagnostics
Intended Use*	Collection and analysis ofgas exchange and extractionof pulse rate from ECGduring stress testing	Collection and analysis ofgas exchange and extractionof pulse rate from ECGduring stress testing	Collection and analysisof gas exchange andextraction of pulse ratefrom ECG during stresstesting
IntendedUsers	Pulmonologists,Cardiologists and SportsMedicine physicians	Pulmonologists,Cardiologists and SportsMedicine physicians	Pulmonologists,Cardiologists andSports Medicinephysicians
IntendedPopulation	Not specified in labeling	Not specified in labeling	Adults and childrenreferred for stresstesting
Site of Use	Cardiology, Pulmonary andSports Medicine clinics andphysician offices; Hospitals	Cardiology, Pulmonary andSports Medicine clinics andphysician offices; Hospitals	Cardiology, Pulmonaryand Sports Medicineclinics and physicianoffices; Hospitals
Measurements	Expired concentration ofO2 and CO2, expired airflow, O2 saturation, pulserate	Expired concentration ofO2 and CO2, expired airflow, O2 saturation, pulserate	Expired concentrationof O2 and CO2, expiredair flow, O2 saturation,pulse rate
PatientInterfaces	ECG electrodes, disposablepneumotach, pulseoximeter	ECG electrodes, disposablepneumotach, pulseoximeter	ECG electrodes,disposablepneumotach, pulseoximeter
Accessories	Integrated gas calibrator	Integrated gas calibrator	Integrated gascalibrator

Substantial Equivalence Comparison Table

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ORCA Diagnostics, Inc. c/o Sheila W. Pickering, Ph.D. P.O. Box 1951 Los Altos, CA 94019

Re: K974200 ORCA Cardiopulmonary Exercise Testing System Requlatory Class: II (two) Product Code: 73 BZM Dated: June 24, 1998 Received: June 26, 1998

Dear Dr. Pickering:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Sheila W. Pickering, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callshan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FDA Submission Cover Sheet

510(k) Number (if known): K974200

Device Name: ORCA Cardiopulmonary Exercise Testing System

Indications For Use:

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

Concurrence Of CDRH, Office Of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21CFR 801)

Regulation Number and Section

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).