The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.

AI/ML Overview

The provided 510(k) summary for the PoRT Cassette (K032654) contains very limited information regarding detailed acceptance criteria and the specifics of the study conducted. The summary focuses on establishing substantial equivalence to a predicate device and does not include an in-depth clinical or performance study breakdown typically found in a full submission.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states: "Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications." However, it does not explicitly define what those specifications or acceptance criteria are, nor does it provide specific numerical results for device performance against those criteria. It only makes a general statement of compliance.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Study Details

The provided text mentions "Bench testing and clinical validation," but offers almost no specifics about these studies.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not specified. The document does not mention the use of experts for ground truth establishment.
Adjudication Method for the Test Set:
- Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No mention of an MRMC study being performed.
- No data on the effect size of human readers improving with AI vs. without AI assistance. This device is an accessory to a digital imaging system, not explicitly an "AI" device as typically understood today, so such a study would likely not be relevant in this context.
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
- The document implies performance testing of the device itself ("bench testing"). However, it does not explicitly detail a "standalone" study in the context of an algorithm's performance without human interaction. The PoRT Cassette is a hardware component (reusable phosphor screen) and an associated software upgrade, not a standalone diagnostic algorithm.
Type of Ground Truth Used:
- Not specified. Given the nature of a portal imaging accessory for radiation therapy quality control, ground truth would likely involve comparison to known radiation fields, phantom measurements, or possibly expert assessment of image quality for therapy verification. However, this is speculative as the document is silent on this point.
Sample Size for the Training Set:
- Not specified. The document does not mention a "training set" in the context of machine learning, as this device is not presented as an AI/ML algorithm that would typically require such a set. Its "software upgrade" likely refers to functionality rather than an AI model.
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as no training set (in the ML sense) is mentioned or implied.

Summary of Missing Information:

The provided 510(k) summary is extremely high-level and does not contain the detailed study results, acceptance criteria, or ground truth establishment methods that would typically be expected for a comprehensive clinical study report. It primarily serves to establish substantial equivalence based on intended use, technological characteristics, and operational characteristics, stating that "Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications" without providing those specifications or results.

Summary

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K032654

OCT = 9 2003

510(k) Summary

for

PcCR Digital Imaging Devices for X-Ray Systems

DATE SUMMARY PREPARED 1.

August 26, 2003

SUBMITTER'S NAME AND ADDRESS 2.

Orex Computed Radiography Ltd. Yoqneam "Star" Bldg. NESHED 36603 NESHER 36603 : 2 ISRAEL

3. CONTACT PERSON

Moshe Shenhav Telephone: 011 972 4 959 1331 Facsimile: 011 972 4 959 1262

4. DEVICE NAME

Trade/Proprietary Name: PoRT Cassette Accessory to Electrostatic X-ray imaging system Common Name: Accessory to Electrostatic X-ray imaging system Classification Name:

PREDICATE DEVICES ડ.

The legally marketed device to which equivalence is being claimed is: Kodak EC-L Cassette/EC-V Verification System for Portal Imaging (K960834)

6. DEVICE DESCRIPTION

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image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.

7. INTENDED USE

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

8. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Orex Computed Radiography Ltd. bases the claim of equivalence to cited predicate devices upon similarities in intended use, technological characteristics, and operational characteristics. Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications.

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Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal features the symbol of the Department of Health & Human Services (HHS) in the center, which is a stylized eagle with three lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Orex Computed Radiography, Ltd. % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K032654 Trade/Device Name: PoRT Cassette

Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 IXK Dated: August 26, 2003 Received: August 28, 2003

Dear Ms. McNamara-Cullinane:

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 either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (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.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

K032654

Device Name: PoRT Cassette

Indications for Use:

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc hogdon
(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Orex Computed Radiography Ltd. 510(k) PcCR Digital Imaging Devices

August 26, 2003

Regulation Number and Section

§ 892.1630 Electrostatic x-ray imaging system.

(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.