The “ISOCAM II” manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. Same as ISOCAM II.

Device Description

The ISOCAM II (Dual Head Gamma Camera) is a Single Photon Emission Computed Tomography (SPECT) gamma camera. This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification. The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the ISOCAM II with MCAT™:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (ISOCAM II with MCAT™)	Reported Device Performance (ISOCAM II with MCAT™)	Baseline Performance (ISOCAM II)
System Sensitivity	≥ 1000 cpm/μCi/min	1000 cpm/μCi/min (implied by "better sensitive measurements" and meeting the "≥" criteria)	190 cpm/μCi/min (with LEHR collimator)
Image Resolution (0-20 cm)	5-8 mm FWHM	5-8 mm FWHM	3.7-12.3 mm FWHM

Note: The document explicitly states "better sensitivity and resolution measurements change the effectiveness of the ISOCAM II system." It then lists the specific values for the MCAT™ version, implying these are the performance goals and achievements.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not contain information about a specific test set in terms of patient data or clinical trials for performance evaluation. The "study" described appears to be a technical comparison and verification of the device's physical and technical characteristics against a predicate device (the ISOCAM II without MCAT™).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Given the nature of the evaluation (technical performance metrics for a gamma camera), it's unlikely that traditional "ground truth" established by clinical experts in the context of diagnostic accuracy was involved in the same way it would be for AI algorithms. The performance metrics (sensitivity and resolution) are typically measured using physical phantoms and established scientific methodologies.

4. Adjudication Method

This information is not applicable to the type of evaluation described. There's no mention of a human-in-the-loop diagnostic task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted, or at least not described in this submission. The focus is on the technical specifications of the imaging equipment itself, not on comparing diagnostic outcomes with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a gamma camera, not an AI algorithm. The performance metrics listed are inherent to the machine's imaging capabilities.

7. Type of Ground Truth Used

The ground truth used for evaluating the performance metrics (sensitivity and resolution) would be based on physical measurements using standardized phantoms and radioactive sources. This is a common practice in imaging device evaluation to objectively quantify their technical capabilities. There are no mentions of expert consensus, pathology, or outcomes data being used for this specific evaluation.

8. Sample Size for the Training Set

This information is not applicable as the device is a gamma camera and not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for PARK MEDICAL SYSTEMS INC. The logo consists of a circular graphic on the left, followed by the word "PARK" in bold, sans-serif font. To the right of "PARK" are the words "SYSTÈMES MÉDICAUX INC." above "MEDICAL SYSTEMS INC.", with a horizontal line separating the two phrases. The circular graphic appears to be a stylized representation of a spiral or vortex.

K964834

FEB 2 8 1997

510(K) SUMMARY

1. SUBMITTER IDENTIFICATION

Submitter's Name and Street Address:

Park Medical Systems Inc. 3195 Louis A. Amos Lachine, Quebec, Canada H8T 1C4

Contact Person: Peter Schultz, Manager Quality and Regulatory

Telephone and Fax Numbers of Contact Person: T- (514) 633-9988, F- (514) 633-8674

Date of Summary: November 29, 1996

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2. DEVICE NAME

Device Name: Gamma Camera

Proprietary Name: ISOCAM II (Dual Head Gamma Camera)

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Classification Name: Camera, Scintillation (Gamma)

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3. INTRODUCTION

The ISOCAM II is a legally marketed device manufactured by Park Medical Systems Inc.

This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification.

The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

The intended use of the ISOCAM II with MCAT™ is identical to the intended use of the ISOCAM II system we are claiming equivalence to.

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4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Introduction

The MCAT™ collimator is a position sensitive device that improves the overall effectiveness of the ISOCAM II system. Use of the MCAT™ collimator enables physicians to examine clearer images in which to base their diagnosis.

ISOCAM II with MCAT™ is not going to be marketed for a new or different intended use. Of the criteria referenced in 21 CFR §807.81, para. 3 (i) and 3 (ii), including safety, the only change is effectiveness. The MCAT™ collimator will be added to the list of collimators presently available for use with the system.

Substantial equivalence of ISOCAM II with MCAT™ is being claimed relative to our present ISOCAM II system. A comparison table is given in the following pages.

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4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE (Continued)

Toble (Technological Characteristics)

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Comparison Table (Technological Characteristics)
Comparison	ISOCAM II	ISOCAM II with MCAT™
FDA Status	Class I post amendment device	n/a
Intended Use	The “ISOCAM II” manufactured by Park MedicalSystems Inc. is a Single Photon EmissionComputed Tomography (SPECT) gamma camerawhich is intended to image the distribution ofradionuclides in the body by means of a singlephoton radiation detector. This system includessignal analysis and display equipment, patient andequipment supports, radionuclide anatomicalmarkers, component parts, and accessories.	Same as ISOCAM II.
EnergyUsed/Delivered	There is no new energy source requirement. Noenergy is delivered or given off. The energyrequirement is 220 V, 60 Hz (or 240 V, 50 Hz).	Same as ISOCAM II.
User Instructions	---	No additional instructions are required in theOperator's Manual. Use of the MCAT™collimator is transparent to the user in allrespects, including acquisition set-up andimage processing. The MCAT™ collimatorwill be added to the list of collimators with anISOCAM II system.
Material Changes	---	There is no addition of materials to theISOCAM II in order to secure and support thecollimator. The weight of the collimator is 200lbs., which is substantially lower than somecollimators presently available for an ISOCAMII system.
Warnings	A warning label is applied to all collimatorshighlighting instructions.	The same label will be applied to MCAT™collimator. No changes have been made to thelabel.
Comparison Table (Technological Characteristics)
Comparison	ISOCAM II	ISOCAM II with MCAT™
MechanicalChanges	---	There is no mechanical changes to theISOCAM II to secure and support theMCAT™ collimator. All connection points:collimator to frame, and frame to detector, areidentical to the ISOCAM II system. Thecollimator has been designed to be totallyinterchangeable with the collimators alreadyavailable with an ISOCAM II system.
ElectricalChanges	---	There is no electrical changes. The electronicsthat read and identify collimators inserted inthe detectors is totally unchanged, in otherwords, the electronics that presently read thecollimators available with an ISOCAM IIsystem is able to read the MCAT™ collimatorin the same manner.
Software Changes	---	No software has been added except for somedecoding software necessary to decode theinitial image data as it appears at the crystalafter the photons have passed through thecollimator. The decoding software wasdeveloped under the same development andchange procedures as previously submitted inthe ISOCAM II 510(k).
Performance(change ineffectiveness)	---System Sensitivity = 190 cpm/μCi/min(with LEHR collimator)Image Resolution = 3.7-12.3 mm FWHM(0 to 20 cm)	All performance specifications contained in theSystem Specification are identical to ISOCAMII system with the exception of SystemSensitivity and Image Resolution. Bettersensitivity and resolution measurements changethe effectiveness of the ISOCAM II system.* System Sensitivity ≥ 1000 cpm/μCi/minImage Resolution = 5-8 mm FWHM(0 to 20 cm)

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4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE (Continued)

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5. DETERMINATION OF SUBSTANTIAL EQUIVALENCE - SAFETY

The ISOCAM II with MCAT™ has been deemed by Park Medical Systems Inc. to be safe and effective. With regard to safety, the ISOCAM II has been designed (as a minimum) using the following safety standards:

CAN/CSA-C22.2 No 114-M90

Canadian Standards Association Diagnostic Imaging and Radiation Therapy Imaging

IEC 601-1

International Electrotechnical Commission Medical Electrical Equipment - General Requirements for Safety

NEMA XR13

National Electrical Manufactures Association Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment

NEMA NU 1-1994 National Electrical Manufactures Association Performance Measurements of Scintillation Cameras

UL544

Underwriters Laboratories Inc. Standard for Medical and Dental Equipment

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.