KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

Device Description

The device is a cassette for holding a storage phosphor screen. It is a standard x-ray diagnostic cassette used for film screen radiography that has been modified as follows. In place of the two intensifying screens two pieces of black polycarbonate sheet are mounted on the foam presently used in the X-Omat Cassette. The storage phosphor screens is constrained by the film pocket of the cassette and held in place by the two plastic sheets when the cassette is closed.

AI/ML Overview

The provided document does not contain information regarding acceptance criteria, device performance metrics, or a study design to prove the device meets specific criteria in the way typically expected for AI/software-based medical devices.

Instead, this 510(k) summary focuses on establishing substantial equivalence for a physical medical device: the KODAK DirectView Tabletop CR Cassette.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, and AI performance metrics cannot be extracted from this document as they are not relevant to this type of device submission.

Here's an analysis of what can be extracted and why other parts are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this document. The device is a radiographic cassette, and its "performance" is primarily defined by its ability to hold a storage phosphor screen securely and allow for exposure, which is then read by a separate digitizer. The submission focuses on its physical characteristics and equivalence to existing cassettes, not quantifiable performance metrics typically associated with diagnostic accuracy or AI.

The applicable standards listed are:

CEI IEC 60406 Ed. 3.0:1997 Cassettes for medical X-ray diagnosis – Radiographic cassettes and mammographic cassettes
ISO 4090 Photography – Film dimensions – Medical radiography

These standards define physical and dimensional requirements, but specific acceptance criteria or reported performance against these are not detailed in this summary.

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

Not applicable. There is no "test set" of patient data in the context of a study for a physical cassette to evaluate diagnostic performance. The substantial equivalence is based on the device's design and function compared to previously marketed devices.

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

Not applicable. No ground truth or expert review is mentioned for this physical device.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is not an AI or software device.

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

Not applicable. This is not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable. This device does not involve a training set.

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

Not applicable.

Summary based on the provided document:

The KODAK DirectView Tabletop CR Cassette is a physical device designed to hold a storage phosphor screen for radiographic exposure. The company established substantial equivalence to existing legally marketed devices, specifically "cassettes associated with computed radiography systems marketed by Eastman Kodak Company, Fuji Medical Systems USA and Agfa Medical Imaging."

The basis for this substantial equivalence is described as:

The device is "basically a standard, screen-film diagnostic cassette that has been adapted to hold a storage phosphor screen."
It is "identical in function" to the predicate devices.
Modifications include: replacing two intensifying screens with two pieces of black polycarbonate sheet mounted on foam, and constraining the storage phosphor screen within the film pocket.

The submission points to compliance with international standards for radiographic cassettes (CEI IEC 60406 and ISO 4090). The FDA's review confirms substantial equivalence, allowing the device to proceed to market under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

Summary

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DEC 0 7 2001

Attachment 7 - 510(k) Summary

KO13686

1. Company Identification

Eastman Kodak Company Health Imaging Division 1669 Lake Avenue Rochester, NY 14652 Establishment Registration: 1317267

2. Official Correspondent

Judith A Wallace Regulatory Affairs 716 724-6111

3. Device Name

KODAK DirectView Tabletop CR Cassette Trade Name:

Common Name: Storage Phosphor Cassette

4. Device Classification

Class II

5. Applicable Standards

CEI IEC 60406 Ed. 3.0:1997 Cassettes for medical X-ray diagnosis – Radiographic cassettes and mammographic cassettes

ISO 4090 Photography – Film dimensions – Medical radiography

6. Intended Medical Use:

7. Description of Device:

The device is a cassette for holding a storage phosphor screen. It is a standard x-ray diagnostic cassette used for film screen radiography that has been modified as follows. In

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place of the two intensifying screens two pieces of black polycarbonate sheet are mounted on the foam presently used in the X-Omat Cassette. The storage phosphor screens is constrained by the film pocket of the cassette and held in place by the two plastic sheets when the cassette is closed.

8. Substantial Equivalence

The Kodak DirectView Tabletop CR cassette is basically a standard, screen-film diagnostic cassette that has been adapted to hold a storage phosphor screen. This device is identical in function and thus substantially equivalent to the cassettes associated with computed radiography systems marketed by Eastman Kodak Company, Fuji Medical Systems USA and Agfa Medical Imaging.

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle's head and neck. The eagle is facing to the right, and its feathers are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Ms. Judith A. Wallace Regulatory Affairs Manager Health Imaging Division Eastman Kodak Co. 1669 Lake Ave. ROCHESTER NY 14652

Re: K013686

Trade/Device Name: Kodak DirectView Tabletop Cassetto Storage Phosphor Cassette Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: 90 IXA Dated: November 2, 2001 Received: November 7, 2001

Dear Ms. Wallace:

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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothloadon. The PDF 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 11 you done of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Other or Cottpremarket notification" (21 CFR Part 807.97). 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. Snigdon

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

Enclosure

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Attachment 5 – Indications for Use

510(K) Number (if known):

Device Name: KODAK DirectView Tabletop CR Cassette

Indication of use: KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen Indication of use: KODAK Difect Vicw Tableop of other recording of a patient radiation
so the screen can be exposed by radiographic equipment read in a see phosphor so the screen can oc exposed by factograpme organism
pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)	✓
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Over-The-Counter	_____
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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K013686
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Regulation Number and Section

§ 892.1850 Radiographic film cassette.

(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.