Search Results

The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.

The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.

The provided text describes the Progeny Inc. Vivid Intraoral Camera System and its 510(k) submission (K090079) but does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Gendex EZ CAM and Schick USB CAM) by comparing characteristics and stating that "Performance testing and verification to meet product specifications" was performed. There's no detailed study report or specific performance metrics mentioned that would constitute "acceptance criteria."

However, I can extract the available information and present it in the requested format, highlighting what is implicitly or explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not defined with numerical targets in the provided document, I will infer the implicitly accepted performance based on the comparison to predicate devices, which serves as the basis for substantial equivalence. The "Reported Device Performance" for the Progeny Vivid Camera is its ability to match or be within the range of the predicate devices' characteristics.

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

The document does not specify any sample size for a test set used to evaluate the device. The evaluation appears to be based on "Performance testing and verification to meet product specifications" and comparison of technical characteristics, rather than a clinical or user study with a defined test set. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.

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

This information is not provided in the document. The submission focuses on technical specifications and substantial equivalence, not on expert-adjudicated ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided as no specific test set or associated adjudication process is described.

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

A MRMC comparative effectiveness study was not conducted or described in the provided text. The document does not mention any studies involving human readers or AI assistance, nor does it discuss an effect size for human improvement with AI.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not conducted or described. The device is an intraoral video camera, not an AI algorithm, and its performance is evaluated based on its functional characteristics.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/performance studies (e.g., expert consensus, pathology, outcome data) is not applicable or mentioned in this submission. The evaluation is based on verifying that the camera's technical specifications and functional features are comparable to the predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set. This device is an imaging hardware component, not an AI/machine learning algorithm that would typically require a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, there is no information on how its ground truth would have been established.

Ask a specific question about this device

The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.

The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.

Here's an analysis of the provided text regarding the Progeny Imaging Software's acceptance criteria and study information.

It's important to note that this 510(k) summary is for a software display system and not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study components for AI medical devices (like sensitivity, specificity, reader studies, ground truth establishment using expert consensus or pathology) are not present or applicable in the provided document. The focus is on demonstrating substantial equivalence to existing predicate devices for image display functionality.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a formal table of acceptance criteria with specific quantitative performance metrics like sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic algorithms or AI. Instead, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices in terms of functionality and safety, as well as meeting product specifications and undergoing software testing.

Study Details (Based on the provided 510(k) summary)

1. Sample size used for the test set and the data provenance:
   The document does not specify a test set in the context of evaluating diagnostic performance from patient data. The "performance testing and verification to meet product specifications" would have involved testing the software against a variety of inputs and scenarios, but the number of images or cases used for this is not detailed, nor is the provenance of any data used for functional testing. Given it's a display software, such "test sets" would likely refer to various image formats, sizes, and simulated user interactions rather than a clinical dataset for diagnostic accuracy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable / not provided. As it's a software display system, there is no "ground truth" in the diagnostic sense needed for clinical evaluation. The ground truth for functional verification would be whether the software correctly displays images as expected, which is determined by technical specifications, not expert clinical consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable / not provided. No clinical ground truth adjudication method is mentioned or required for this type of device.

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:
   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, which this device is not. The device is a display system, not an AI or diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable in the context of diagnostic performance. The device is a standalone software component that displays images. Its "performance" is whether it correctly displays images, which is evaluated against its technical specifications, not clinical diagnostic metrics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As previously noted, the concept of clinical "ground truth" (e.g., from pathology or expert consensus) is not applicable to this device. The "ground truth" for the software's functionality would be its defined specifications (e.g., "display image A correctly," "allow zoom function B," etc.).

7. The sample size for the training set:
   This information is not applicable / not provided. This device is not an AI algorithm that undergoes training on a dataset. It is a software program developed to perform specific display functions.

8. How the ground truth for the training set was established:
   This information is not applicable / not provided. As explained above, there is no AI training set for this device.

Ask a specific question about this device

The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.

The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The system consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components include a 12 inch cone and an 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6, or 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.

The provided 510(k) summary for the Progeny, Inc. PREVA Intraoral Dental X-Ray System describes a device for generating X-rays for dental imaging. However, it does not include acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) or detailed study results demonstrating such performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Gendex Gx-770 and Gendex 765DC) based on shared indications for use, materials, design, and operational/functional features. The safety and effectiveness are supported by:

• Performance testing and verification to meet product specifications (general statement, no specifics provided).
• Software testing to validate software design and performance (general statement, no specifics provided).
• Hazard analysis and risk level assessment (general statement, no specifics provided).
• The fact that it shares the same indications for use as predicate devices.

Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their achievement cannot be extracted from this document, as the submission relies on substantial equivalence for a device generating X-rays, rather than presenting a comparative diagnostic performance study against a ground truth.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, specific quantitative acceptance criteria for diagnostic imaging performance (e.g., image quality, diagnostic accuracy measures like sensitivity, specificity, or AUC) are not defined or reported. The "acceptance criteria" presented are implicit in the comparison to predicate devices, focusing on key physical and operational characteristics to demonstrate substantial equivalence, rather than a quantifiable measure of diagnostic utility.

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

Not applicable. The document does not describe a test set or data from a diagnostic performance study to establish clinical effectiveness or accuracy. The evaluation is based on technical specifications and substantial equivalence to existing devices.

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

Not applicable. No expert ground truth establishment for a diagnostic test set is detailed in this document.

4. Adjudication method for the test set

Not applicable. No test set or related 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

Not applicable. This document pertains to an X-ray hardware system (the generator of the X-rays), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.

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

Not applicable. This device is an X-ray generator, not an algorithm.

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

Not applicable. The document describes a medical device (X-ray system), not an interpretative algorithm, thus, no "ground truth" for diagnostic performance is discussed. The ground truth for the technical performance data would be the physical measurements of the device's output (e.g., kVp, mA, exposure time).

8. The sample size for the training set

Not applicable. This is an X-ray hardware system, not a software algorithm that requires a training set in the AI/machine learning sense.

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

Not applicable. As above, this is an X-ray hardware system.

Ask a specific question about this device

The Progeny MPSe system is intended to use for acquisition of digital images of intra-oral anatomy of interest to a computer for display by Ethernet.

The X-ray MPS system is an intraoral receiver of the X-ray energy used by the dentist r ne A Tay NT & Systemler as vity. The MPSe sensor consists of 3 pieces: an X-ray to image toom an X-ray sensor driver and a power supply.

The Progeny MPSe Intraoral X-ray System consists of the following main components:
Sensor
X-Ray sensor driver
Power Supply

The provided text is a 510(k) summary for the Progeny MPSe Intraoral Dental X-ray Sensor, submitted in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can summarize what is available:

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for performance metrics like sensitivity, specificity, or image quality, nor does it present a formal table of reported device performance against such criteria. Instead, it relies on a comparison table of characteristics to demonstrate substantial equivalence to predicate devices.

The "Unlimited" for "Distance between Device & PC" refers to the IEEE802.3 Standard (Ethernet), implying no practical limit within a network.

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

Not applicable. This document is a 510(k) submission focused on substantial equivalence through comparison of design and indications, not a clinical study report with a test set of patient data.

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 for a test set of clinical data is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication 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

Not applicable. This document predates widespread AI integration in dental X-ray systems and does not describe an MRMC study.

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

Not applicable. This document describes a physical X-ray sensor system, not an algorithm.

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

Not applicable. No ground truth is established as there is no clinical data analysis in this document. The "ground truth" for the device's characteristics is based on its engineering specifications and design.

8. The sample size for the training set

Not applicable. This document describes a physical device, not a machine learning model, so there is no training set mentioned.

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

Not applicable. See point 8.

Summary from the document:

The Progeny MPSe Intraoral Dental X-ray Sensor, through its 510(k) submission, demonstrates substantial equivalence to existing predicate devices (Schick Technologies Inc. CDR, VisioDent RSV, Durr Dental Vista Ray, Trophy RVG). The argument for equivalence is based on shared indications for use, materials, design, and operational/functional features, as detailed in a comparison table. The document emphasizes that the MPSe System is determined to be safe and effective when used as labeled, similar to its predicate devices. No formal clinical study with performance acceptance criteria or a dedicated test set with human readers and ground truth is presented in this 510(k) summary.

Ask a specific question about this device

The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.

The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components: 12 inch cone, 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.

The provided text is a 510(k) summary for the Progeny JB-70 Intraoral X-Ray System. It explicitly states that the device's safety and effectiveness are demonstrated by "Performance testing and verification to meet product specifications." However, the document does not detail specific acceptance criteria or the study that proves the device meets those criteria, nor does it provide the type of outcomes data that would typically be used to assess the clinical effectiveness of a medical device against a ground truth.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Gendex Gx-770 and Gendex 765DC) based on shared indications for use, materials, design, and operational/functional features. It lists a comparison table of technical characteristics between the devices.

Therefore, most of the requested information cannot be extracted from this document. I will provide the information that is present and explicitly state what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states that performance testing and verification were done to meet product specifications, but it does not specify what those product specifications (acceptance criteria) were, nor does it report the results of such performance testing in a quantifiable manner (e.g., specific metrics for image quality, radiation dose, diagnostic accuracy, etc.). The "Comparison Table" provided focuses on design characteristics (kVp, mA, field size, etc.) rather than performance metrics against acceptance criteria.

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

Not available. There is no mention of a clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on technical comparison and a general statement of performance testing.

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

Not applicable/Not available. Since no clinical test set or ground truth establishment is mentioned, there is no information about experts or their qualifications.

4. Adjudication Method

Not applicable/Not available. No clinical study or ground truth adjudication method is described.

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

Not available. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is an X-ray system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not available. The device is an X-ray system, not an algorithm. There is no mention of an algorithm-only performance study.

7. Type of Ground Truth Used

Not available. No clinical study involving ground truth (e.g., expert consensus, pathology, or outcomes data) is described for product performance evaluation. The safety and effectiveness are established via performance testing to product specifications and substantial equivalence to predicate devices.

8. Sample Size for the Training Set

Not available. The document does not describe a training set, as it's not an AI/machine learning device.

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

Not applicable/Not available. As there is no training set mentioned, there is no information on how its ground truth would have been established.

Summary of available information related to performance:

The document states:

• "Safety and effectiveness is demonstrated by: Performance testing and verification to meet product specifications."
• "Software testing to validate software design and performance."
• "Hazard analysis and risk level assessment."
• "Same indications for use as predicate devices."

The core argument for safety and effectiveness, beyond internal performance testing (details not provided), rests on substantial equivalence to two predicate devices:

• Gendex Gx-770 (510(k) K935046)
• Gendex 765DC (510(k) K992610)

The comparison table highlights similarities in key technical characteristics between the JB-70 and its predicates:

The conclusion states that the JB-70 is "substantially equivalent to the predicate devices" because it "shares the same indications for use, materials, design, operational and functional features." This implies that the performance is expected to be similar because the device is technically comparable to already cleared devices, rather than through a direct demonstration of clinical performance against specific acceptance criteria in a clinical study.

Ask a specific question about this device