The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the ProxiScan™ device, focusing on acceptance criteria and study details.

Please note: The provided document is a 510(k) summary and FDA clearance letter. These types of documents typically summarize the results of testing rather than providing the full, detailed study reports. Therefore, some specific details commonly requested about study design (like exact sample sizes for test sets, detailed ground truth establishment for training, or MRMC study specifics) are often abbreviated or not explicitly stated in this format. My answers will reflect what is discernible from the provided text.

Acceptance Criteria and Device Performance

The document states that "All specifications were met" for both non-clinical and functional testing. While the specific numerical performance targets (i.e., the acceptance criteria) are not explicitly laid out with numerical thresholds in the provided text, the reported device performance is that it successfully met all of these unstated specifications.

Here's a table based on the information provided:

Acceptance Criteria Category	Reported Device Performance
Non-Clinical Testing	All specifications for appropriate performance were met.
Electrical Safety	Complied with IEC-60601-1 requirements.
Biocompatibility	Complied with ISO-10993 standard.
Functional Testing	All specifications were met for:
System Energy Linearity	Specifications met
Intrinsic Energy Resolution	Specifications met
Spatial Resolution	Specifications met
Contrast Evaluation	Specifications met
Uniformity	Specifications met
Count Rate Characteristics	Specifications met
Sensitivity	Specifications met

Study Details

Based on the provided K093706 510(k) summary:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document refers to "appropriate performance testing" and "functional testing" without detailing the number of samples or cases used for each test.
- Data Provenance: Not explicitly stated. The tests are described as performance and functional tests, which typically involve phantom studies, bench testing, and engineering validations, rather than patient data in the context usually implied by "test set" for AI/clinical studies. Given it's a gamma camera, these tests likely involve phantoms or controlled radioactive sources.
- Retrospective or Prospective: Not applicable as the tests described are primarily engineering and performance characterization, not clinical studies with patient data.
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 applicable. The "ground truth" for the tests described (e.g., energy linearity, spatial resolution) would be established by the device's design specifications and by quantitative measurements using calibrated equipment and known standards (e.g., specific radioactive sources, phantom designs). It does not involve expert readers establishing ground truth for images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where human judgment is used to establish ground truth from patient data, particularly in complex or ambiguous cases. The described tests are objective performance measurements.
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. The ProxiScan™ is a medical imaging device (a handheld gamma camera), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the primary testing described is "standalone" performance of the device itself. The functional and non-clinical tests evaluate the device's intrinsic characteristics (e.g., resolution, uniformity, sensitivity) independent of a human operator's interpretation decisions. However, this is not an "algorithm-only" standalone performance in the context of AI, as the device's output is an image for human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the reported tests refers to established engineering standards, physical properties of radioactive sources and phantoms, and predefined performance specifications. For example, for "system energy linearity," the ground truth is the known energy of a radionuclide and the device's measured response. For "spatial resolution," it would be a known physical dimension in a phantom.
The sample size for the training set:
- Not applicable. This is a medical imaging device, not a machine learning or AI algorithm in the context typically implying a "training set." The device's software processes signals from CZT detectors to display images; this processing is based on engineering design and calibration, not machine learning training data.
How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 7.

Summary

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APR - 2 2010

Hybridyne Imaging Technologies, Inc. ProxiScan™

510(k) Premarket Notification November 30, 2009

K093706

510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

DEVICE DESCRIPTION:

Hybridyne Imaging Technologies, Inc.

Terrence Lall

October 30, 2009

ProxiScan™

Handheld Gamma Camera

Gamma Camera (21 CFR 892.1100 Product Code: IYX)

Anzai Medical Company, Ltd. Anzai eZScope AN Portable Gamma Camera (K022342) and the Siemens Medical Solutions USA, Inc EC9-4 Ultrasound Transducer (K060879)

INDICATION FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure. which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing. Signals from CZT detectors are transferred frame to the display computer. A software program in the computer reads the data and displays the images.

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NON CLINICAL TEST RESULTS:

Appropriate performance testing was performed. All specifications were met. It was also tested in accordance with the requirements of the IEC-60601-1 for electrical safety and in accordance with the ISO-10993 standard for biocompatibility.

FUNCTIONAL TEST RESULTS:

ProxiScan™ was subjected to functional testing including system energy linearity, intrinsic energy resolution, spatial resolution, contrast evaluation, uniformity, count rate characteristics and sensitivity. All specifications were met.

CONCLUSIONS:

This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes on its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR - 2 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Hybridyne Imaging Technologies, Inc. % Mr. Barry S. Sall, RAC Principal Consultant PAREXEL Consulting 195 West Street WALTHAM MA 02451

Re: K093706

Trade/Device Name: ProxiScan™ Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: II Product Code: IYX Dated: March 8, 2010 Received: March 9, 2010

Dear Mr. Sall:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Amell Joff

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K093706

Device Name: ProxiScan™

Indications for Use:

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Office of In

510K to93701

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).