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The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.

These devices are not intended to be used for primary diagnosis in mammography applications.

The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.

The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white or blue LED illuminator, a lens, mirrors, and a CCD linear array detector.

This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.

This document describes a 510(k) submission for the TeleradPRO Edge and TeleradPRO Edge HD-CCD film digitizers. The submission asserts substantial equivalence to a predicate device, the VIDAR TeleradPRO film digitizer (K102476).

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical image digitizer, and its performance is primarily characterized by technical specifications rather than diagnostic performance metrics like sensitivity or specificity. The "acceptance criteria" can be inferred from the stated technological characteristics and the claim of substantial equivalence to the predicate device.

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

The provided document does not specify a separate "test set" in the context of a clinical study with patient data. The performance testing mentioned refers to technical evaluations of the digitizer's hardware and software capabilities. No patient data or clinical images are described as being used for a "test set" in the sense of evaluating diagnostic accuracy. The device "has no patient contact and does not supply a diagnostic result."

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

Not applicable. As described in point 2, there is no mention of a test set requiring expert-established ground truth for diagnostic accuracy, as the device doesn't provide a diagnostic result.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication for diagnostic accuracy.

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 X-ray film digitizer, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a film digitizer, not an algorithm providing diagnostic output. Its function is to convert physical film to digital data.

7. The type of ground truth used

For the technical performance characteristics (spatial resolution, OD range, etc.), the ground truth would be established through calibrated measurement instruments and industry standards for film digitizer performance. For instance, DMAX and OD range would be measured using calibrated optical density strips.

8. The sample size for the training set

Not applicable. This device is a film digitizer; it does not utilize a "training set" in the context of machine learning.

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

Not applicable. This device is a film digitizer; it does not utilize a "training set" in the context of machine learning.

Study Proving Device Meets Acceptance Criteria:

The document states: "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use."

However, the specific details of this "extensive performance testing" are not provided in this 510(k) summary. The submission relies on claiming substantial equivalence to the predicate device (VIDAR TeleradPRO film digitizer, K102476) rather than providing a detailed report of a new clinical or technical performance study for the TeleradPRO Edge and HD-CCD. The conclusion states: "In terms of intended use, function, safety, operating environmental conditions and effectiveness of the TeleradPRO Edge and TeleradPRO Edge HD-CCD it is determined to be substantially equivalent to the predicate device used for this application." This implies that the 'study' demonstrating acceptance criteria is primarily a comparison against the predicate device's established performance and specifications, along with internal technical verification tests.

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The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, .including .printed and .radiographic .film. The .target users of these devices are .medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

The device consists of a film digitizer with multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.

The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.

This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.

The provided document is a 510(k) summary for the VIDAR DiagnosticPRO Edge X-Ray Film Digitizer. It states that "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use" and refers to "Section 19 Bench Testing." However, Section 19 Bench Testing and the specific details of the performance testing results and acceptance criteria are not included in the provided text.

Therefore, I cannot provide a table of acceptance criteria or the specific details of the study that proves the device meets the acceptance criteria based only on the provided input. The document mentions "Bench Testing" in Section 19, which implies performance evaluation, but the content of that section is missing.

Based on the available information, I can only provide general information about the device and point out the missing details.

Here's an outline of the information that would be provided if the "Section 19 Bench Testing" were available:

Missing Information from Provided Document:

The provided 510(k) summary states that performance testing was conducted and refers to "Section 19 Bench Testing" for details. However, the content of Section 19 is not included in the provided text. Therefore, I cannot extract specific acceptance criteria, reported device performance data, study design, or ground truth establishment.

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The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.
The TeleradPRO film digitizer is intended for making digital copies of medical xray films.

The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The Digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.

The provided text describes the TeleradPRO X-Ray Film Digitizer and its substantial equivalence to a predicate device (TeleRADPro Film Digitizers, K993597). However, it does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies.

The document primarily focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and intended use, rather than presenting a novel clinical study with detailed performance metrics against predefined acceptance criteria.

Based on the provided text, here's the information that can be extracted, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance thresholds for DMAX, medical OD range linearity, and noise are not provided, nor are detailed test results demonstrating compliance against these thresholds. The document states "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use" but does not elaborate on the specific tests or their outcomes beyond the summary characteristics.

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

This information is not provided in the document. The document refers to "extensive performance testing" and "Bench Testing" (Section 22, which is not included in the provided text), but it does not specify any test set sample sizes or the provenance of any data (e.g., country of origin, retrospective/prospective). It suggests that the testing was primarily to demonstrate the device's technical specifications and substantial equivalence, not necessarily a clinical or reader study with a specific test set of images.

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

This information is not provided in the document. As no clinical or reader study with a "test set" and "ground truth" established by experts is described, this information is not applicable. The device is a digitizer, not an AI diagnostic tool, so "ground truth" would relate to the fidelity of the digitization process itself, not an interpretation of medical images.

4. Adjudication Method for the Test Set

This information is not provided in the document. See point 3 above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done, nor is it relevant given the device is an X-ray film digitizer, not an AI diagnostic tool designed to assist human readers. The document does not mention any AI components.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The document describes "Performance Testing" and "Bench Testing" which would likely be standalone evaluations of the digitizer's technical specifications (e.g., resolution, DMAX, linearity). However, details of these studies are not provided beyond the summary characteristics listed in Section 1.

7. The Type of Ground Truth Used

Given that the device is a digitizer, the "ground truth" for its performance would typically involve comparing the digitized image to the original film's characteristics or a known standard. The document mentions "incorporates noise and linearity measurements" for the medical OD range, implying that instrumental measurements were used to verify the fidelity of the digitization process. There is no mention of "expert consensus, pathology, or outcomes data" as ground truth, as those would be relevant for diagnostic interpretation, not for a digitizing device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a film digitizer, which typically does not involve machine learning "training sets." Its operation is based on optical and electronic principles, not learned algorithms.

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

This information is not provided and is not applicable. See point 8 above.

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The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading applications.

The Dental Film Digitizer is a medical device used to convert x-ray films into a digital format. The device uses high end imaging components and design characteristics specifically geared towards the complexity of x-ray film data; offering the user a low noise, high resolution reproduction of the medical film.

The provided 510(k) summary for the VIDAR Dental Film Digitizer does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner described in the request. The document states:

"VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use. Please see Section 19 Bench Testing."

However, Section 19 ("Bench Testing") is not included in the provided text. Therefore, the following information cannot be extracted:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting a performance study with explicit acceptance criteria.

Information that could be extracted from the provided text includes:

• Device Description: The Dental Film Digitizer converts x-ray films to digital format, offering low noise and high-resolution reproduction.
• Intended Use: For making digital copies of x-ray film common in dental practices. Images are for primary, secondary, and over-reading applications by medical professionals or trained staff.
• Technological Characteristics (Performance Specifications, not Acceptance Criteria):
  • Optical resolution: 300 dpi
  • Grayscale: 16-bit
  • Optical density sensitivity (DMAX): 4.1 OD
  • Medical OD range: 0.2 - 3.6 (incorporates noise and linearity measurements)
• Predicate Device: VIDAR Sierra (P111), TeleRADPro and VXR-12 plus Film Digitizers (K993597).

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Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.

The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative manner. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not available in the provided document.

However, based on the provided text, we can infer some details related to the evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly related to demonstrating "substantial equivalence" to the predicate device, meaning the new device is as safe and effective and has no new indications for use. The performance is reported in terms of functional equivalence and technological specifications.

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

The document states "bench, user, and standards testing" were conducted. However, no specific sample sizes or details about data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text for these tests.

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

Not applicable/Not provided. The testing appears to be primarily focused on technical specifications and functionality as compared to the predicate device, rather than diagnostic accuracy against a ground truth assessed by experts.

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

Not applicable/Not provided. As there's no mention of expert evaluation of diagnostic images for ground truth, adjudication methods are not relevant here.

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 X-ray system, not an AI-powered diagnostic tool. Thus, MRMC studies and AI-assisted improvements are not relevant.

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

Not applicable. This device is an X-ray system, not an algorithm. Standalone algorithm performance is not relevant.

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

Not applicable/Not provided. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device's technical specifications and functional capabilities are compared. This is a comparison of device characteristics, not a diagnostic accuracy study requiring a clinical ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware device (X-ray system), not an algorithm that requires a training set.

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

Not applicable/Not provided. As above, this is a hardware device.

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The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.

The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography.

Digital Radiography Image Acquisition System. The device is physically and electrically (including software) identical to the predicate.

The provided text is a 510(k) submission for the VIDAR Vision 2000, which is a Traditional 510(k) submission, not a study. This means it is comparing a new device to a legally marketed predicate device to establish substantial equivalence, rather than providing new performance study data.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical trial or performance study would for a novel device. Instead, it asserts substantial equivalence based on the device being "physically and electrically (including software) identical to the predicate" (K974863).

As such, I cannot populate the requested table and answer the study-specific questions. The document explicitly states:

"The VIDAR VISION 2000 is currently manufactured by IMIX-ADR( Tampere, Finland) under the Premarket Notification of the predicate device (K974863). VIDAR intends to market this device under its own name. The device is physically and electrically (including software) identical to the predicate."

This statement is the core of their submission – they are not conducting a new performance study but rather leveraging the equivalence to an already cleared device.

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Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semi-automatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.

The VIDAR Bone Track System is comprised of three modules: The Pre-Operative Module, the Tracking Module and the Post-Operative Module

In the Pre-Operative Module, the patient's digital x-ray is then loaded into the software, either from the hospital network, via a disk or from a digital scanner. The x-ray image is located in the system using standard digital measuring tools. The physician chooses which orthopedic device to template. The user then utilizes the software tools to overlay pre-loaded digital templates onto the x-ray image to allow for proper prosthetic selection. Once the physician has selected all of the appropriate prosthetic components, the software generates a pick list to allow for easy ordering of parts. This list can be printed out.

The VIDAR Bone Track System allows for tracking of orthopedic devices used during patient surgery. Using a PDA and a bar code reader, the devices' bar codes are scanned. Device manufacturer. device part number, lot number, and serial number are captured.

The VIDAR Bone Track System's Post-Operative Module allows the physician to track migration or other changes to the implant in the bones' structures for a specific patient over time using industry-accepted algorithms. The physician can use measurements include stem dislocation, wear circle cup and wear elliptic cup. Bone Track is not a diagnostic tool. It is to be used by the physician as an assistance tool.

The Vidar Bone Track System Software, a device designed for pre-operative digital implant templating and post-operative tracking of orthopedic implants, underwent "bench testing" to ensure it met its intended performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document broadly states "Bench testing was performed." It does not specify a distinct "test set" in terms of patient data or images. The testing appears to be focused on the software's functional capabilities rather than its performance on a dataset of patient cases. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a patient dataset is not provided.

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

As no specific test set based on patient cases or outcomes is described, there is no mention of experts establishing ground truth or their qualifications. The "bench testing" likely involved internal software validation and verification by the company's development team or independent testers against functional specifications.

4. Adjudication Method for the Test Set:

Given the nature of "bench testing" without a specific patient-based test set, an adjudication method for reconciling expert opinions is not applicable and therefore not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. The document focuses on the device's functional performance and its substantial equivalence to a predicate device, not on its comparative effectiveness with human readers or the effect size of AI-assisted improvements.

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

The description implies that the software's functionality was tested in a standalone manner as part of the "bench testing." However, the device is explicitly intended to be an "assistance tool" for physicians, meaning human-in-the-loop interaction is inherent to its intended use. The performance data provided does not differentiate between standalone algorithmic performance and human-in-the-loop performance.

7. The Type of Ground Truth Used:

For the "bench testing," the "ground truth" would have been the functional specifications and design requirements of the software. Each feature, from digital templating to pick list generation and tracking capabilities, would have been tested against its intended design and expected output. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The document does not provide information about a training set. The Vidar Bone Track System Software appears to be a rule-based or template-driven system rather than a machine learning model that would require a distinct training set for algorithm development.

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

As no training set is mentioned or implied for this device, information on how its ground truth was established is not provided.

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The MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for coveting analog Medical x-ray films to digital images.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

The x-ray film digitizer, an electronic device used to convert analog x-ray film to digital images.

This 510(k) summary (K993598) focuses on demonstrating substantial equivalence of the MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers to a predicate device (MedScan 12, K933632). It does not contain specific acceptance criteria, a study proving device performance against those criteria, or most of the requested detailed information about clinical studies.

The document states: "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness." This implies that the performance is considered equivalent to the predicate without needing new, extensive performance studies with acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

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

   • Not provided in the document. The document claims "Technical differences... raise no new issues of safety and effectiveness," implying performance similar to the predicate. No specific performance metrics or acceptance criteria are listed.

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

   • Not provided in the document. There is no mention of a test set or data provenance for a performance study.

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/Not provided. No test set or ground truth establishment process is described.

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

   • Not applicable/Not provided. No test set or adjudication method is 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. This device is an x-ray film digitizer, not an AI-assisted diagnostic tool. A MRMC comparative effectiveness study for human readers with and without AI assistance is not relevant to this type of device and is not mentioned.

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

   • Not applicable. This device digitizes images; it's not an algorithm performing a diagnostic task.

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

   • Not applicable/Not provided. No ground truth is mentioned as relevant for a substantial equivalence claim for a digitizer based on technical differences.

8. The sample size for the training set

   • Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.

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

   • Not applicable/Not provided. This is not an AI/machine learning device that would require a training set and ground truth.

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The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.

The x-ray film digitizer is an electronic device that converts analog x-ray films into digital data. The maximum film width is 14".

This 510(k) summary (K993599) does not appear to contain the level of detail requested for a comprehensive study description and acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device (MedScan 12) rather than providing extensive performance data from a specific study.

However, based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence, and the "study" demonstrating this equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is tied directly to the performance of the predicate device, MedScan 12. The underlying assumption is that if the new devices (Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO) perform comparably to the predicate device, they meet the necessary safety and effectiveness standards. The document states: "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness." This implies that the current devices meet the same performance standards as the MedScan 12.

Without specific quantitative performance metrics listed for the predicate or the new devices in this summary, a direct table of numerical "acceptance criteria" and "reported device performance" is not available. However, based on general expectations for X-ray film digitizers, the acceptance criteria would implicitly revolve around:

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

The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "study" presented here is a comparison to a predicate device, not an independent clinical or technical performance study with a defined test set. The claim relies on the established safety and effectiveness of the existing MedScan 12.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The summary does not describe a study involving human expert review to establish ground truth. The basis of equivalence is technical comparison to a predicate device already on the market.

4. Adjudication Method

Not applicable. There is no mention of adjudication methods as no human expert review or formal "test set" evaluation is described in this summary for the purpose of establishing a new ground truth.

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

No. The K993599 summary does not describe an MRMC comparative effectiveness study, either with or without AI assistance. The devices are film digitizers, not AI-powered diagnostic tools. There is no mention of human readers or AI in the context of improving diagnostic accuracy.

6. Standalone Performance Study

The summary does not present a standalone (algorithm only) performance study with quantitative metrics. The "study" described is the assertion of substantial equivalence to a predicate device based on technical similarities and the absence of new safety/effectiveness concerns. The emphasis is on the digitizer's ability to convert analog films to digital data, implicitly assuming the digital output is faithful to the original film.

7. Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic algorithm. For a film digitizer, the "ground truth" would implicitly be the physical X-ray film itself. The performance evaluation, if there were one detailed here, would relate to how accurately the digital representation matches the analog film. However, this 510(k) simply states that "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness," indicating an assumption of equivalent fidelity without explicitly defining or evaluating a "ground truth" for the new devices.

8. Sample Size for the Training Set

Not applicable. The devices are film digitizers, not machine learning or AI algorithms that require a "training set."

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

Not applicable. As the devices are not AI or machine learning based, there is no training set or ground truth establishment method for it.

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