The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.

Device Description

The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography. The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.

AI/ML Overview

This 510(k) submission (K040373) for the KODAK DirectView CR Cassette / GP / 15 x 30 cm does not describe a study with acceptance criteria and device performance in the typical sense of a diagnostic algorithm or predictive model. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (an X-ray cassette) to a previously cleared predicate device. Therefore, the information provided in the input does not directly align with the requested structure for acceptance criteria and study details for an AI/algorithm-based device.

However, I can extract and present the relevant information provided in the context of substantial equivalence for a physical medical device. The "acceptance criteria" here are implicitly tied to the performance requirements for an X-ray cassette, and the "study" is the comparison made to the predicate device.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Implicit Acceptance Criteria (based on predicate)	Reported Device Performance (compared to predicate)
Functionality	Must hold a storage phosphor screen, be exposed by radiographic equipment, and be loaded into a laser scanner to read the latent image.	"identical in function" to the currently marketed Kodak DirectView CR cassette.
Radiographic Applications	Suitable for general radiology and dental panoramic radiography applications.	Can be used for general radiology and dental panoramic radiography applications.
Compatibility with Dental Units	Must be compatible with common dental panoramic x-ray units designed to accept cassettes that meet the ISO 4090 standard.	Can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard.
Panel Materials	Materials should be consistent with current CR cassette designs, ensuring structural integrity and proper X-ray interaction.	Panel materials (Corus Hylite, Toray Panel, Omnova) "consistent with the current design."
AEC Compatibility	Must accommodate Automatic Exposure Control (AEC) in dental X-ray units (a design change from previous versions).	Lead mylar removed to "accommodate Automatic Exposure Control (AEC) in dental x-ray units."
Image Processing Software	Must function with existing image processing software without requiring modification.	"image processing software algorithm will not be modified" and remains the same as previously cleared.
Overall Performance	Performance should be equivalent to the predicate device for its intended use.	"identical in...performance" to the currently marketed Kodak DirectView CR cassette.

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

This is not applicable in the context of this 510(k) submission. The "test set" here would refer to the physical cassette itself being compared. The comparison is primarily based on design specifications, materials, and functional claims relative to a predicate device, rather than a clinical trial with a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for a physical X-ray cassette's performance is established by engineering specifications, material properties, and regulatory standards, not by expert interpretation of clinical images from a "test set." The FDA reviewers evaluate the technical documentation.

4. Adjudication Method for the Test Set

Not applicable. There isn't a "test set" of cases requiring adjudication in this type of submission.

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 device is a passive X-ray cassette, not an AI or imaging interpretation algorithm. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant.

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

Not applicable. The device is a physical X-ray cassette, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for demonstrating substantial equivalence are:

Engineering Specifications: Design, materials, and manufacturing standards for X-ray cassettes.
Regulatory Standards: Adherence to standards like ISO 4090 for dental panoramic cassettes.
Predicate Device Performance: The established, cleared performance of the Kodak Ektascan SP Cassette (K925997) / Kodak DirectView CR Cassette serves as the benchmark for "truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets its (implicit) acceptance criteria is the Substantial Equivalence demonstration. The manufacturer asserts and provides documentation to support that the KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997) (currently marketed as the Kodak DirectView CR Cassette).

The key arguments for this demonstration are:

Identical Function and Performance: The new cassette size is stated to be "identical in function and performance" to the predicate.
Consistent Panel Materials: The panel materials are consistent with the current design, using Corus Hylite and Toray Panel.
AEC Accommodation: A specific design modification (removal of lead mylar) was made to accommodate Automatic Exposure Control (AEC) in dental X-ray units, which is a functional enhancement for specific applications.
Unchanged Image Processing Software: The device uses the same, previously cleared, image processing software algorithm, ensuring consistent image quality and processing characteristics.
Broad Application: It maintains suitability for general radiology and dental panoramic radiography and is compatible with ISO 4090 standard dental X-ray units.

The FDA reviewed these claims and determined that the device is substantially equivalent, allowing it to be marketed. This regulatory approval serves as the "proof" that the device meets its acceptance criteria for safety and effectiveness, based on its equivalence to a device already on the market.

Summary

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510(k) Summary

KO40373

1. Company Identification

Eastman Kodak Company 343 State Street Rochester, NY 14650

Establishment Registration: 1317267

2. Contact Person

Susan Pate Regulatory Affairs Associate (716)-724-4302

3. 510(k) Summary Preparation Date

02/12/2004

4. Device Name

Trade Name: KODAK DIRECTVIEW CR Cassette / GP / 15 x 30 cm

Common Name: CR 15 x 30 cm Cassette

5. Device Classification

Class II

6. Indications for Use

7. Description of Device

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dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography.

The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.

The image processing software algorithm will not be modified for the CR 15 x 30 cm cassette, and remains the same as the image processing software previously cleared for Kodak DirectView CR 800 and CR 900 Systems (K020635, March 21, 2002).

8. Substantial Equivalence

The KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997), previously cleared on Dcccmber 17, 1992. The Kodak Ektascan SP Cassette is currently marketed as the Kodak DirectView CR Cassette. The new cassette size is identical in function and performance to the currently marketed Kodak DirectView CR cassette.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2004

Ms. Susan M. Patc Regulatory Affairs Associate Health Imaging Division Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K040378 Trade/Device Name: KODAK DirectView CR Cassette/GP/15x30 cm Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film/cassette changer Regulatory Class: II Product Code: 90 IXA Dated: February 13, 2004 Received: March 16, 2004

Dear Ms. Pate:

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 111 (PMA), it may be subject to such 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. Brydon

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 1 - Intended Use and Indications for Use

510(k) Number(s) (if known):

Device Name: KODAK DirectVicw CR Cassette / GP / 15 x 30 cm

Indications of Use:

Concurrence of CDRH, Office of Device Evaluation

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter
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(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K040378

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.