MAMMOLOADER BY C.M.A. SRL by C.M.A.

The MAMMOLOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.

Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.

Device Description

The MAMMOLOADER will be used to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.

AI/ML Overview

The provided text describes a 510(k) summary for the MAMMOLOADER device and its clearance by the FDA, but it does not contain information about a study that measures device performance against acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The MAMMOLOADER is a device for loading and unloading medical imaging films from cassettes under roomlight conditions. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (KODAK X-OMAT Multiloader 300) and compliance with general safety and electrical standards, rather than presenting a performance study with specific acceptance criteria for diagnostic output.

Therefore, the following information CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This type of performance data (e.g., sensitivity, specificity, accuracy, error rates) is not provided. The "performance" mentioned in the document relates to compliance with regulatory standards and the device's intended function (loading/unloading films), not diagnostic capabilities.
Sample sized used for the test set and the data provenance: No test set is described for evaluating diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant in the context of this device's regulatory submission.
Adjudication method for the test set: Not applicable.
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: This is an film loader/unloader, not an AI or diagnostic tool. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does state regarding acceptance criteria and "studies":

The "acceptance criteria" for this device, as implied by the 510(k) summary, are primarily regulatory and safety compliance. The "study" mentioned is more accurately a demonstration of compliance and substantial equivalence rather than a clinical performance study measuring accuracy or efficacy in a diagnostic sense.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device "Performance" (as implied by regulatory submission):

Acceptance Criterion (Implied)	Reported Device Performance (as stated in submission)
Substantial Equivalence to Predicate Device	The MAMMOLOADER system is determined to be substantially equivalent to the KODAK X-OMAT Multiloader 300 (K905607) for its intended use (unloading/loading medical imaging films).
Compliance with Federal Performance Standards (21 CFR, part 1000)	The MAMMOLOADER system is subject to and in compliance with the Federal Performance Standards.
Compliance with Voluntary Standards	Manufactured in accordance with voluntary standards: UL-122 (photographic equipment), IEC 380, IEC 801-4, IEC 801-3, EN 55014 E POST, EEC 87/308 EMI regulations, and EN 60950 (electrical safety).
Safe and Effective Operation	"The MAMMOLOADER Operator Guide contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use."
Hazard Analysis Completed	The submission contains the results of a hazard analysis.
Proper Functionality (Unload/Load)	Designed to unload and/or load medical imaging films from KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.

Study Information (limited to regulatory compliance and substantial equivalence):

Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this device is a film loader/unloader, not an AI or diagnostic interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) FDA submission for a film loading/unloading device. It demonstrates compliance with safety and electrical standards and substantial equivalence to a predicate device, which is the "proof" required for its clearance. It does not involve a diagnostic performance study with clinical acceptance criteria, ground truth, or expert review.

Summary

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973125

Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section

OCT - 8 1997

Date: August 1, 1997

5 1 0(k) Summary of Safety and Effectiveness for the

MAMMOLOADER by C.M.A. srl, Via S. Andrea 23, 40064 Ozzano Emilia, Bologna Italy

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to the KODAK X-OMAT Multiloader 300 (K905607). This information and data is summarized as follows:

1. The MAMMOLOADER system is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
1. The MAMMOLOADER system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

(UL-122 photographic equipment, IEC 380, IEC 801-4, IEC 801-3, EN 55014 E POST, EEC 87/308 EMI regulations, and EN 60950 electrical safety.)

The MAMMOLOADER Operator Guide contains comprehensive and extensive information 3. on how to operate the system to ensure a safe and effective use.
1. The submission contains the results of an hazard analysis.

Onurcri

Mr. Massimo Azzaroni Director C.M.A. srl Via S. Andrea 23 40064 Ozzano Emilia Bologna Italy Tel: (39) 517-97306 Fax: (39) 517-96637

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Mr. Massimo Azzaroni Director C.M.A. srl Via S. Andrea 23 40064 Ozzano Emilia Bologna Italy

Re:

K973125 MAMMOLOADER by C.M.A. srl (Room light, cassette loader/ un-loader) Dated: August 1, 1997 Received: August 20, 1997 Regulatory class: II 21 CFR 892.1900/Procode: 90 IXW

Dear Mr. Azzaroni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or . other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of -1

510(k) Number:

Device Name: MAMMOLOADER

Indications For Use:

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division
Division and Radio.	, ENT,
510(k) Num

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

and Radio...	Abdominal, ENT,
510(k) Number	K973125

Regulation Number and Section

§ 892.1900 Automatic radiographic film processor.

(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(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.