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The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes.

The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.

Automatic Film processor

The provided text is a 510(k) summary for the Velopex ExtraXtender Film Processor and Sprint Film Processor. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or specific studies proving a device meets
these criteria. This document is a regulatory submission, not a scientific study report.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document does not include information on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone (algorithm only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily provides:

• Device names and regulatory information.
• Contact details for the 510(k) holder.
• Predicate devices for demonstrating substantial equivalence.
• Indications for Use for both film processors.

To answer your questions, a different type of document, such as a validation study report or a different section of a regulatory submission (e.g., performance data), would be needed.

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The PCR Eleva System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The PCR Eleva system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.

A PCR Eleva consists of one or more workspots with PCR Eleva Software and one or more image plate readers. All components are connected via standard ethernet. The system complies with the ACR/NEMA DICOM Version 3 Digital Image Communication in Medicine Standard. Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR Eleva system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the Eleva workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The Eleva Workspot is also used for the scheduling of patients and exams. The Eleva Workstation consists of a PC, a keyboard, a monitor, and an optional bar-code reader.

The provided document is a 510(k) submission for the Philips PCR Eleva 1.2, a digital film processing system. It outlines the device's identification, predicate device, indications for use, and a summary of nonclinical tests. However, it does not contain the detailed information required to answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly within the context of AI performance or clinical efficacy studies.

This submission is a Special 510(k), which focuses on modifications to an existing device (Philips PCR 5.2). The core claim is that these modifications do not change the indications for use or alter the fundamental scientific technology, and therefore, the new device is at least as safe and effective as the predicate. The "study" referenced is primarily a verification and validation process against requirement specifications and risk management results, rather than a clinical trial demonstrating performance against specific clinical metrics.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document states: "All acceptance criteria for a product release according to our product release policy are met." However, it does not explicitly list the specific acceptance criteria or provide a table of reported device performance against those criteria. It generally refers to "requirement specifications and risk management results" and "software verification, validation and DICOM conformance testing" as areas where tests were performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission mentions "verification and validation tests were performed on the complete system," but it does not detail the nature of a specific test set (e.g., patient images), its sample size, or its provenance.

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)

This information is not provided. As the submission primarily concerns system modifications and verification, and not a clinical performance study with human readers assessing images, the concept of "ground truth established by experts" for a test set in the clinical sense is not discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is 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

There is no mention of an MRMC comparative effectiveness study, nor any discussion of AI assistance or its effect size on human readers. This submission predates widespread integration and evaluation of AI in medical imaging devices in this manner (2009). The device is described as a "digital film processing system," which digitizes X-ray images for viewing, storage, post-processing, and printing. It is not presented as an AI-powered diagnostic aid.

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

This information is not applicable/provided in the context of an AI algorithm. The device itself is a system for processing and managing images, not a standalone diagnostic algorithm.

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

The document does not detail how "ground truth" (in a clinical sense related to disease presence/absence) was established for any specific image test set. The "ground truth" in this context refers to the device's functional performance against its technical specifications and regulatory requirements, not clinical diagnostic accuracy.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this device development, as it is not an AI-driven system that would typically undergo a "training" phase with a dataset of labeled clinical images.

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

This information is not provided and is not applicable for the reasons stated above.

In summary:

The Philips PCR Eleva 1.2 Special 510(k) submission describes updates to a Computed Radiography system. The "study" referred to is a series of nonclinical verification and validation tests (software, DICOM conformance, and assessment against requirement specifications and risk management results) ensuring the modified device remains as safe and effective as its predicate. It does not present clinical performance data, AI performance metrics, or details about expert-adjudicated test sets. The nature of this 510(k) (Special 510(k) for device modifications) means a full-scale clinical trial with specific performance metrics against a defined acceptance criterion and a large, expert-adjudicated test set was likely not deemed necessary by the manufacturer or required by the FDA at the time for this type of device modification.

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The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .

IntraX Film Processor
Trade Name: IntraX Film Processor
Common Name: Automatic Film processor
Classification name: Processor, Radiographic-Film, Automatic
Device Class 2
Regulation Number: 892.1900

This is a 510(k) summary for a radiographic film processor, not an AI/ML medical device. Therefore, the information typically requested in questions 1 through 9 (related to acceptance criteria, study design, ground truth, and human-in-the-loop performance for AI/ML devices) is not applicable or present in this document.

The document describes a traditional medical device (IntraX Film Processor) and its substantial equivalence to predicate devices, focusing on regulatory classification, indications for use, and general controls provisions of the FDA. It does not contain information about AI/ML algorithm performance, test sets, training sets, or expert adjudication that would be used to assess an AI/ML-driven device.

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OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900).

The devices mentioned above are intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.

This may be used in all general radiographic, diagnostic imaging procedures.

Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX®, OPTIMAX® 2010 and ECOMAX™ is 35 cm, the bigger COMPACT™ 2 has 45 cm feed with. The smallest film format of all processors is 10*10 cm.

The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). All are controlled by an integrated software.

This document, a 510(k) summary for PROTEC's Automatic X-Ray Film Processor, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (DOOSAN DSP 3800 Automatic X-Ray Film Processor) based on:

1. Same intended use
2. Same target user group
3. Same technological characteristics

Therefore, I cannot provide the requested table and study details. The information necessary to construct such a response is not present within the provided text.

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The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.

The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.

The provided text is a 510(k) summary for the "Quix Digital Radiography Upgrade" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device's technical specifications and intended use against existing products.

Crucially, this document does not contain a study that proves the device meets acceptance criteria in the format typically used for performance claims of AI/ML-based devices (e.g., sensitivity, specificity, AUC, human reader studies).

Instead, the acceptance criteria for this type of device (a digital X-ray system) and the "study" demonstrating its equivalence are based on a comparison of its physical and performance specifications to those of existing, legally marketed predicate devices. The "acceptance criteria" are implied by the performance metrics of the predicate devices.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a non-AI/ML device:

1. Table of acceptance criteria and the reported device performance

For a device like the Quix Digital Radiography Upgrade, the "acceptance criteria" are implicitly defined by the performance characteristics of its predicate devices. The "reported device performance" is the specifications of the Quix DR Upgrade.

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To be used for processing of radiographed films.

Developing exposed x-ray film.

Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).

The provided document is a 510(k) summary for a Radiographic Film Processor and does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it is a traditional medical device (film processor) and not an AI/ML-based device.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document. The document focuses on the physical characteristics, intended use, and non-clinical tests for electrical safety and performance of the film processor.

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The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.

Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed with of the LifeRay PRO 1000 is 35cm, the smallest film format of the processor is 10x10cm.

This 510(k) submission (K023801) is for a medical device called the "LIFERAY PRO 1000 Automatic Radiographic Film Processor." It is important to note that this document does not contain information about a study proving the device meets acceptance criteria.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria.

Here's why;

• Device Type: This is an automatic radiographic film processor. Its function is to develop, fix, wash, and dry X-ray films. It is a piece of equipment that processes analog data (film), not a device that generates or analyzes diagnostic information itself (like an AI model for image interpretation).
• 510(k) Process: The 510(k) pathway for medical devices focuses on demonstrating that a new device is substantially equivalent to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness profiles, rather than conducting new clinical trials with acceptance criteria for device performance.
• Content of the Document: The document explicitly states: "The comparison of similarities and differences shows that the new device LifeRay PRO 1000 Automatic Radiographic Film Processor... Have the same intended use. Have the same target user group. Have the same technological characteristics. There are no new questions about safety and effectiveness. The new device is a safe and effective as the predicate device." This statement is the core of its argument for substantial equivalence.

Therefore, most of the specific information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance, training set) would not be relevant or present in this type of 510(k) submission for this particular device. These types of studies are typically associated with devices that perform diagnostic interpretations, especially those incorporating AI or novel diagnostic algorithms.

Based on the provided document, here's what can be extracted related to your request, with the understanding that direct "acceptance criteria" and "study results" as you've framed them are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This submission focuses on substantial equivalence based on technological comparison, not a performance study using a test set of data.

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

• Not applicable. No test set or ground truth establishment by experts is described in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set described.

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. An MRMC study was not done. This device is a film processor, not an AI-assisted diagnostic tool for human readers.

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

• No. This device is a film processor, not a standalone diagnostic algorithm. Its performance is related to consistent and correct film processing.

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

• Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this device's type of submission.

8. The sample size for the training set:

• Not applicable. This device does not use a training set in the context of machine learning.

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

• Not applicable. Same as above.

In summary: This 510(k) is a declaration of substantial equivalence for an automatic film processor. The "study" here is essentially the internal analysis by the manufacturer demonstrating that their new device is technologically equivalent to an already approved predicate device, and thus, does not raise new questions of safety or effectiveness. The detailed performance metrics, test sets, and ground truth methodologies typically associated with diagnostic AI or similar advanced diagnostic devices are not part of this submission.

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The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.

Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 2500 is 35cm, the smallest film format of the processor is 10x10cm.

This looks like a 510(k) premarket notification for a medical device: "LIFERAY PRO 2500 Automatic Radiographic Film Processor." The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria in the way envisioned by your request.

Based on the provided text, there is no specific study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or performance evaluation with quantifiable metrics. The submission primarily argues for substantial equivalence to an existing predicate device.

Here's an analysis based on your requested information, highlighting what is and is not present in the provided text:

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

• Not Applicable. The document does not define specific performance acceptance criteria (e.g., image quality metrics, processing speed within a certain tolerance, chemical residue levels) nor does it report quantifiable performance results against such criteria for the LIFERAY PRO 2500.
• Instead, the submission states that the device "Have the same technological characteristics" and uses the "same photographic processing (developing) technique" as the predicate device. This implies that the performance is expected to be equivalent to the predicate, but no specific data is presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no mention of a "test set" in the context of a performance study for the LIFERAY PRO 2500.
• The comparison is conceptual and based on the established equivalence of the device's design and operating principle to the predicate.

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. No ground truth establishment by experts is described, as there is no performance study with a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is mentioned, as there is no performance study with a test set.

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 an automatic radiographic film processor, not an AI-powered image analysis tool or diagnostic aid. Therefore, MRMC studies or AI-related effectiveness are not relevant to this submission.

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

• Yes, implicitly, but not as a formal study. The LIFERAY PRO 2500 is a standalone physical device. Its "performance" would be its ability to process films according to its design. The submission argues for this standalone performance based on its technological equivalence to the predicate, rather than through a dedicated performance study.

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

• Not Applicable. No ground truth of this nature is used or discussed, as the submission focuses on technological equivalence rather than diagnostic accuracy or clinical outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device is a mechanical/chemical processor, not a learning algorithm.

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

• Not Applicable. As there is no training set, there is no ground truth for one.

Summary of Device Acceptance (based on the provided text):

The acceptance of the LIFERAY PRO 2500 Automatic Radiographic Film Processor by the FDA, as indicated by the 510(k) clearance (K023825), is based on its substantial equivalence to a legally marketed predicate device (Protec Medizintecnick OPTIMAX K992818).

The rationale for equivalence includes:

• Same intended use.
• Same target user group.
• Same technological characteristics, including the photographic processing technique (mechanical transport, two chemical baths with temperature regulation, circulation, and automatic replenishment, rinsing, drying, ejection for viewing), rollers, guides, and additional functions (anti-crystallization, stand-by mode).
• Both are controlled by integrated software.

The FDA's review concluded that "There are no new questions about safety and effectiveness" and that "The new device is as safe and effective as the predicate device." This means the device met the regulatory bar for market clearance through the 510(k) pathway, but this acceptance was not based on a study demonstrating quantifiable performance against a predefined set of acceptance criteria specific to the LIFERAY PRO 2500. Instead, it relied on the argument that its design and function are sufficiently similar to an already cleared device.

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THE Ax200 is intended to develop medical x-ray film.

AX200 Automatic X-Ray Film Processor Model # 6586.03

The provided document is a 510(k) premarket notification letter from the FDA regarding an automatic x-ray film processor (AX200, Model #6586.03). This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding the performance of the device.

The letter focuses solely on the regulatory approval process and does not delve into the technical validation or clinical study results that would typically include the requested information.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the given input.

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The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.

Automatic Radiographic Film Processor. This film processor is operates like most predicate devices in that it uses a series of transport rollers to pull film through a series of open developer solution, fixer solution, and wash water tanks. Developer and fixer solution temperature is controlled automatically by a computer board. No plumbing is required.

This document is a 510(k) summary for an X-ray film processor. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a regulatory submission for premarket notification of a medical device to the FDA, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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