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Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film.

Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film. The Cassettes are available in two sizes and two models. The LifeRay™ KW Mammo Cassettes contain a window that is compatible with Kodak ID Printers for marking film with patient identification data. The LifeRay™ FW Mammo Cassettes contain a window that is compatible with Ferrania ID Printers for the same purpose as before.

Both Ferrania LifeRay™ Mammo Cassettes and the predicate device are composed of:

• a light tight chamber for preventing radiographic film exposure,
• a compressible backplate material to assure intimate film-screen contact,
• a latching mechanism for removal and replacement of radiographic film.

The provided text describes a 510(k) premarket notification for Ferrania S.p.A. LifeRay™ Mammo Cassettes. However, it does not contain information about acceptance criteria, device performance metrics, or a formal study proving the device meets specific criteria.

The submission states that the device is "substantially equivalent" to a predicate device (Kodak MIN-R 2 CASSETTE) based on technological characteristics and adherence to voluntary standards. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific quantitative acceptance criteria through a dedicated performance study with human readers or standalone algorithm performance.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not define specific quantitative acceptance criteria such as sensitivity, specificity, or image quality metrics. Instead, the "acceptance" is based on substantial equivalence to a predicate device and conformity to relevant industry standards. The reported performance is a qualitative statement of equivalence.

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

• Sample Size: Not applicable. No test set of radiographic images or patient data is mentioned. The assessment relies on a comparison of device characteristics and adherence to standards, not a clinical performance study.
• Data Provenance: Not applicable. No clinical data or test data is mentioned.

Explanation: This 510(k) summary is for a radiographic film cassette, not an imaging algorithm or a device that produces diagnosable images itself. Therefore, a "test set" of images or patient data with an established ground truth is not relevant to this submission. The device's performance is intrinsically linked to its physical characteristics and ability to hold film and screens properly, as assessed against standards and a predicate device.

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

• Number of Experts: Not applicable. No "ground truth" was established for a test set as there was no study comparing diagnostic outcomes.
• Qualifications of Experts: Not applicable.

Explanation: As no clinical performance study involving diagnostic interpretation was conducted for the cassette itself, there were no experts used to establish a ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was used.

Explanation: Without a clinical or image-based test set, adjudication methods are irrelevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable.

Explanation: An MRMC study is typically performed for AI or imaging devices where human interpretation is involved. This device is a passive film cassette, and its effectiveness is not measured by its ability to assist human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone performance study was not done as this is not an algorithm or an AI device.

Explanation: This device is a physical component (a cassette) for mammography, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No "ground truth" (such as expert consensus, pathology, or outcomes data) was used in the context of a clinical performance study for this device. The "ground truth" for the submission is based on engineering specifications, material characteristics, and conformity to voluntary standards for film cassettes.

Explanation: The "safety and effectiveness" conclusion for this device is based on its engineering design, materials, and its ability to meet published industry standards for film cassettes (e.g., maintaining light-tightness and intimate film-screen contact), as well as its substantial equivalence to an existing predicate device. This does not involve clinical diagnostic ground truth.

8. Sample Size for the Training Set

• Sample Size: Not applicable. There is no mention of a training set as this is not an AI/ML device.

Explanation: As this is not an AI/ML device, the concept of a "training set" for an algorithm is not relevant.

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

• Ground Truth Establishment: Not applicable.

Explanation: Since there was no training set, there was no ground truth established for one.

Summary of this 510(k) Submission:

This 510(k) submission for the Ferrania LifeRay™ Mammo Cassettes is a "substantial equivalence" filing. It demonstrates safety and effectiveness by:

1. Technological Comparison: Highlighting that its components and function are similar to the predicate device (Kodak MIN-R 2 CASSETTE).
2. Standards Conformance: Stating that the device conforms to relevant voluntary industry standards (ANSI PH1.49 1995 and ISO/FDIS 4090: 2000) for radiographic film cassettes.

Crucially, this type of submission does not involve clinical performance studies with patient data, human readers, or AI algorithms that would require the establishment of ground truth or the measurement of diagnostic performance metrics like sensitivity and specificity. The "acceptance criteria" are implied by the standards and the features of the predicate device, with the "study" being the engineering assessment and comparison presented in the submission.

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