The Portable Supine Patient Support and Cassette Holder is a supine support device intended to lay flat on a flat surface to hold and position a radiographis cassette, also to hold and position a patient for radiographic x-ray exposure. I intended for medical use.

Indications for Usessupine support intended to lay flat on a surface to i hold and position radiographic cassette, also to hold and position patient for radiographic exposure for medical use.

The Portable Supine Patient Support and Cassette Holder is a portable, nonionizing radiation device used for scoliosis radiography of the spine. The device consists of a head support, a rectangular cassette holder (94cm×40.5cm), which will hold the cassette, a foot support, and a removable cover top on top of the cassette holder.

The provided text describes a 510(k) premarket notification for a medical device, the "Portable Supine Patient Support and Cassette Holder." The acceptance criteria and the study to prove the device meets these criteria are mainly focused on the radiotranslucency of the carbon fiber material used in the device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Two samples of carbon fiber material were tested: "Vanguard 4"X4"" and "JPI 6"X6"". The thickness for Vanguard was 2.76mm and for JPI was 2.63mm.
• Data Provenance: The tests were conducted by K & S Associates, Inc. (Nashville, Tennessee) on March 7, 2008. The data is retrospective relative to the submission date of September 2, 2008. The country of origin is not explicitly stated for the data generation, but the testing company is US-based.

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

The ground truth for this compliance study is based on a regulatory standard (21 CFR Ch. 1, J, 1020.30(n) Table 2), not expert consensus on medical images. Therefore, the concept of "experts establishing ground truth" as it would apply to diagnostic imaging accuracy studies is not directly applicable here.

The tests were measured by Brad Horn (Calibration Tech) and reviewed by Larry G. Bryson, MS-CHS / MS, CHP (Associate Director). These individuals are qualified in relevant instrumentation and radiological health, ensuring the measurements are performed correctly against the regulatory standard.

4. Adjudication method for the test set

Not applicable. This was a direct measurement against a published regulatory standard, not a subjective assessment requiring adjudication. The measurements were taken and reviewed by an independent lab.

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 patient support and cassette holder. It does not involve AI, human readers, or diagnostic image interpretation. The study is about the physical properties of the material.

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

Not applicable. This device does not have an algorithm or AI component.

7. The type of ground truth used

The ground truth used is a regulatory standard for radiotranslucency, specifically 21 CFR Ch. 1, J, 1020.30(n) Table 2 (2008 / 2006) criteria. The device performs measurements to demonstrate compliance with these objective criteria.

8. The sample size for the training set

Not applicable. This study does not involve machine learning or data-driven model training. It is a physical property test of material samples.

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

Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established for it.

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The DS Cassette is 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. It is not intended for mammography use.

The DS Cassette is 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. The cassette is in a family of film sizes. The sizes are as follows; 35 x 43cm, 35 x 35cm, 40 x 40cm, 30 x 40cm, 30 x 35cm, 24 x 30cm, 24 x 24cm, 20 x 40cm, 18 x 43 cm, 18 x 24cm, 15 x 40cm, 15 x 30cm, 14 x 17inch, 14 x 14inch, 12 x 15inch, 11 x 14inch, 10 x 12inch, 8 x 10inch, 6.5 x 8.5inch, 7 x 17inch. The exposed film is taken out from the Cassette manually or automatically for processing by X-ray film processor such as Konica DS-7 automatic X-ray film processor, 510(k) number K931316.

The provided text is a 510(k) Summary for a radiographic film cassette. This type of document is for a medical device and typically demonstrates substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or AUC as might be done for AI/ML-based diagnostic devices.

Therefore, much of the requested information (like sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes) is not applicable to this type of device and submission. The submission focuses on product specifications and conformance to an existing standard.

Here's the information that can be extracted or deduced from the provided document:

Acceptance Criteria and Device Performance for DS Cassette

Study Information (based on available text):

1. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a clinical "test set" in the context of performance metrics for an AI/ML device. It relies on design specifications and conformance to standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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 a passive device (cassette), not an AI/ML diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" here is adherence to design specifications, the physical characteristics of the device, and conformance to the ISO standard.
7. The sample size for the training set: Not applicable. This device does not involve training data as it is not an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable.

Summary of Acceptance Criteria and Evidence from Text:

The acceptance criteria for the DS Cassette are primarily based on its physical characteristics, intended use, and conformance to an international standard, rather than performance metrics derived from clinical studies with ground truth. The study that "proves the device meets the acceptance criteria" is implicitly the design and manufacturing process certified to meet ISO 4090:2001 and the demonstration of substantial equivalence to a previously cleared predicate device (Konica Mammography Cassettes; Models CM and CM DS-7, K963914) for its non-mammography intended use. The submission includes a "certification by a manufacturer of the cassette" as evidence of compliance.

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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.

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.

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

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.

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The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.

There are three product lines of Agfa Film Cassettes covered by the present 510(k): (1) The Mamoray Mammography Cassettes, (2) the metal-bodied CAWO Cassettes, and (3) the ABS Plastic Curix and Lightweight Cassettes.

The provided text is a 510(k) summary for Agfa Film Cassettes, focusing on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of imaging performance or diagnostic accuracy. Instead, it describes manufacturing and design standards, and the intended use.

Therefore, many of the requested categories for acceptance criteria and study details cannot be answered from this document.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance: Not applicable. No test set involving patient data or images was used for this submission as it focuses on demonstrating substantial equivalence for a physical medical device (film cassettes) based on design and standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a diagnostic sense was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.

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 document is about film cassettes and does not involve AI or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about film cassettes and does not involve algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. The "ground truth" for this submission revolved around demonstrating that the physical characteristics and performance (e.g., light-tightness, film contact) of the new cassettes met the same standards and intended use as the predicate devices, likely through engineering tests and compliance with recognized standards.

8. The sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm or a diagnostic system.

9. How the ground truth for the training set was established: Not applicable.

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KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a KODAK X-OMAT Cassette Leadless for Dental Use. This device is a physical radiographic film cassette and not an AI/ML powered medical device. Therefore, the questions related to AI/ML development, such as acceptance criteria based on algorithm performance, expert ground truth establishment, training/test sets, and comparative effectiveness studies with AI, are not applicable to this document.

The document indicates that the device has been found substantially equivalent to legally marketed predicate devices. Its intended use is as a light-tight holder for an intensifying screen and film, used with dental x-ray imaging equipment and an automatic exposure control (AEC) device, to provide a good radiographic image.

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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.

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.

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.

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

Ferrania LifeRay™ Cassettes are intended for use during diagnostic x-ray 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 in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless. Radiographic cassettes 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, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.

The provided text describes a 510(k) Premarket Notification for Ferrania S.p.A. LifeRay™ Cassettes. This document focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria for a novel AI or medical device with complex performance metrics.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in the context of this type of submission for a radiographic film cassette.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This 510(k) submission relies on conformity to voluntary standards and comparison to a predicate device, not on a clinical test set with patient data for performance evaluation in the way a diagnostic algorithm would.

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

• Not Applicable / Not Provided. Ground truth in the context of expert review is not relevant for this device.

4. Adjudication method for the test set

• Not Applicable / Not Provided.

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 a physical radiographic cassette, not an AI or software device that would assist human readers.

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

• Not Applicable. This is a physical radiographic cassette, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is its compliance with established voluntary industry standards (ANSI PH1.49 - 1995 and ISO/FDIS 4090: 2000) and its functional equivalence to the predicate device (TRIMAX RADIOGRAPHIC CASSETTE, K980722). These standards inherently define the acceptable physical and performance characteristics of such a device.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not a machine learning or AI device that would have a training set.

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

• Not Applicable / Not Provided.

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1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of radiographic view.
3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure.
4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.

Radiolucent Cassette LIMB Positioner (R-Clip)

This is a 510(k) clearance letter for a device called "Radiolucent Cassette LIMB Positioner (R-Clip)". The letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the provided documents do not contain information about the device's acceptance criteria or any study that proves the device meets those criteria.

The documents are a regulatory clearance letter and a description of the device's intended use. They do not detail the technical performance or testing conducted to support the substantial equivalence claim.

Therefore, I cannot provide the requested information.

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Imation Trimax Cassettes are 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.

Imation Trimax Cassettes are intended for use during diagnostic x-ray 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 radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.

Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.

The provided text does not contain detailed information regarding specific acceptance criteria, device performance metrics, or study designs with sample sizes, expert qualifications, or ground truth establishment for the Imation Trimax™ Cassette. The submission focuses on substantial equivalence to a predicate device and conformance to voluntary design standards.

Therefore, I cannot populate the table or answer the questions with the requested level of detail regarding performance data.

However, based on the limited information provided, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information provided. The submission relies on conformance to voluntary standards and comparison to a predicate device, rather than a specific performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no specific performance study with a test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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
No MRMC study was mentioned. The device is a radiographic film cassette, not an AI-powered system for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical component, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no specific performance study with a test set requiring ground truth is described. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate device and the adherence to relevant industry standards.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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