The PS 3000 Digital PhotoSpot System " is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed.

The PS 3000 Digital PhotoSpot System " is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains.

The PS 3000 Digital PhotoSpot System " is a prescription device. The labeling, instructions and user operations are designed for trained professionals.

Device Description

This device can be described as a Class II diagnostic system that receives an image from an image intensifier tube and acquire, record, display and publish diagnostic images using proprietary techniques. This device is composed of:

software {that runs in a qualified, ancillary computer}, .
proprietary hardware and software, and a ●
CCD Camera that receives the image. .

All ancillary equipment, which works with this device, is identified as a configured item and tested to formal procedures. This device will only be used with specific ancillary equipment, which is tested and qualified to work with PS 3000 Digital PhotoSpot System ***.

The scientific concept on which this device is based that by monitoring images from the image intensified tube a valid diagnostic image can be derived and reproduced.

This device functions by converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis.

The intended use of this device is for a trained health care professional to produce a diagnostic inage. The PS 3000 Digital PhotoSpot System " uses sophisticated digital signal processing and data collection/display techniques to offer the physician or trained health care provider, a reliable, simple tool.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving device performance in the format requested. The document is a 510(k) summary for a medical device (PS 3000 Digital PhotoSpot System) and primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted and what is not available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "A series of factory adjustments/calibration tests are conducted to verify the device is accurate can maintain calibration over its useful life" and "This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported performance metrics are not provided. The comparison is made at a high level of technological characteristics and intended use with a predicate device.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and data provenance:

Not specified. The document mentions "testing" but does not detail any specific test set, its size, or the provenance of the data (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable/Not specified. Since specific performance studies with human-established ground truth are not detailed, this information is not present. The device is intended for use by a "trained health care professional (for example an Radiologist)," implying human interpretation, but this is about the intended use of the output, not the ground truth for a performance study of the device itself.

4. Adjudication method for the test set:

Not applicable/Not specified. Without a specific test set and ground truth establishment process detailed, adjudication methods are not mentioned.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

Not mentioned. There is no indication of an MRMC study comparing human readers with and without AI assistance. The document focuses on the device's ability to produce diagnostic images to assist the physician, not on improving human reader performance.

6. Standalone (algorithm only without human-in-the-loop performance) study:

Not explicitly detailed in terms of specific performance metrics. The device itself is "a class II diagnostic system that receives an image from an image intensifier tube and acquire, record, display and publish diagnostic images using proprietary techniques." While it functions independently to process and display images, the document doesn't provide standalone performance metrics typical of an AI algorithm (e.g., sensitivity, specificity for detecting specific conditions). Its "performance" is primarily described as being able to produce "sufficient diagnostic properties as to assist the physician in establishing a diagnosis," and a general statement that "This device is safe and effective for the application for which it is intended."

7. Type of ground truth used:

Not specified. No specific ground truth type (e.g., pathology, expert consensus, outcomes data) is mentioned as part of any performance study. The core claim is that it converts images to digital images with "sufficient diagnostic properties," which implies comparison against existing diagnostic standards, but the exact method for this comparison or "ground truth" is not detailed.

8. Sample size for the training set:

Not applicable/Not specified. The document does not describe the use of machine learning or AI models that would require a "training set" in the modern sense. It refers to "proprietary hardware and software" and "sophisticated digital signal processing and data collection/display techniques," which implies traditional image processing and system design, not a learned model from a data training set.

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

Not applicable/Not specified. As there's no mention of a training set, this information is not relevant to the provided text.

In summary, the provided Exhibit 19 510(k) Summary focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use. It does not contain the detailed performance study information with specific acceptance criteria, ground truth establishment, or study designs (like MRMC or standalone AI performance) as requested.

Summary

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Exhibit 19 Summary of Safety & Effectiveness

KO30061

APR 0 7 2003

19 December 2002

The PS 3000 Digital PhotoSpot System " , Picture archiving and communications system is designed for clinical applications to allow health care providers to acquire, record, display and publish diagnostic images. As such, this device is a Class II device, having Regulation Number: 21 CFR part 892-2050, Classification Number: LLZ. JAA, OWB 892.1650

This summary is submitted in behalf of: Precise Optics/PME, Inc. 239 South Fehr Way, Bay Shore NY 11706 Voice phone number-631 242 6600 Fax phone number- 631 242 4421

This summary is submitted by: Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 voice phone number (203) 329 2700) fax phone number (203) 329 2345.

software {that runs in a qualified, ancillary computer}, .
proprietary hardware and software, and a ●
CCD Camera that receives the image. .

The scientific concept on which this device is based that by monitoring images from the image intensified tube a valid diagnostic image can be derived and reproduced.

This device functions by converting an optical (analog) image to a digital image having sufficient diagnostic properties as to assist the physician in establishing a diagnosis.

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Exhibit 19 Summary of Safety & Effectiveness

The PS 3000 Digital PhotoSpot System "" is a prescription device. The labeling, instructions and user operations are designed for trained professionals.

Precise Optics/PME, Inc. has determined that the PS 3000 Digital PhotoSpot System™ is substantially equivalent to the performance of a an existing medical device:

Patriot, now Gold One, manufactured by Infimed, Inc. of Liverpool, NY 13088 (K963037). The differences between these systems are incidental and not significant. Both devices use a similar technology and principles.

Precise Optics/PME, Inc. has determined that this device is substantially equivalent to the predicate device and has these similar technological characteristics:

both devices use computers and software having analog/digital processing, both devices produce diagnostic images, and both use computer processing to acquire, store, display and publish diagnose images.

A series of factory adjustments/calibration tests are conducted to verify the device is accurate can maintain calibration over its useful life. The PS 3000 Digital PhotoSpot System ™ has benefited from design, development, testing and production procedures that conform to Quality Systems.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. Precise Optics/PME, Inc. continues to research all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

CERTIFICATION:

I hereby certify this Summary of Safety and Effectiveness applies for the above indicated device.

Llena Corr

Mr. Glen Corso President Precise Optics/PME, Inc. 239 South Fehr Way, Bay Shore NY 11706 Voice 631 242 6600 631 242 4421 Fax

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY - 7 2012

Precise Optics/PME, Inc. % Mr. Richard Keen Compliance Consultants 1151 Hope St. STAMFORD CT 06907

Re: K030061

Trade/Device Name: PS 3000 Digital Photospot System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: December 19, 2002 Received: January 7, 2003

Dear Mr. Keen:

This letter corrects our substantially equivalent letter of April 7, 2003.

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 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,

Janine M. Morris

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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Exhibit 2 510(K) Number (If known):K63x6 no 510(K) number assigned Device Name: PS 3000 Digital PhotoSpot System "

Indications for Use

The PS 3000 Digital PhotoSpot System " is a prescription device. The labeling, instructions and user operations are designed for trained professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030041

or Over - The Counter Use XXX

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

Sheet 1 of 1

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.