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Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography.

Air Techniques High Frequency Intra-Oral X-Ray is an X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. Air Techniques High Frequency Intra-Oral X-Ray consists of the following main components: Base Unit, Tube Housing, Beam Limiting Device-inbuilt with tube Housing, Control Console, 9.84 Ft (3 m) coiled cord, Rotating yoke for tube housing mounting, Extension arm, Scissor arm. Optional Components: Long Cone 11.8in (300mm), 9.84 Ft (3m) coiled cord with exposure switch. The Power supply is regulated to provide a selectable 50 to 70 kVp in step of 1kV at a selectable tube current of 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters kV, mA & exposure time values may be stored in, selected & operated via the operator control panel.

The provided text describes a pre-market notification (510(k)) submission for an X-ray device, not an AI/ML powered device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria for an AI/ML product.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details as these are not relevant to the provided text.

The document discusses the following:

• Device Name: Air Techniques High Frequency Intra-Oral X-Ray
• Intended Use: As an extraoral source of X-Rays in Dental radiography.
• Safety and Effectiveness: Demonstrated through compliance with various electrical, mechanical, environmental safety, and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2 EMC, FDA 21 CFR 1020.30, 21CFR1020.31).
• Predicate Devices: INTRA SKAN DC (K103579), Progeny PREVA (K043092), Dentsply Gx-770 (K935046), Gendex 765DC (K992610). The device is stated to have "Same indications for use as predicate devices."

The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to proceed to market. However, it does not detail performance acceptance criteria in the context of AI/ML metrics (like sensitivity, specificity, AUC) or the type of studies typically conducted for AI/ML devices.

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The INTRA SKAN DC Intraoral Dental X-Ray System is to be used as an extraoral source of X-Rays in Dental radiography.

INTRA SKAN DC is a high frequency Intra-oral X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for manmachine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.

INTRA SKAN DC consists of the following main components:

Base Unit

Tube Housing

Beam Limiting Device-inbuilt with tube Housing

Control Console, 9.84 Ft (3 m) coiled cord.

Rotating yoke for tube housing mounting

Extension arm

issor arm Optional Components: Long Cone 11.8in (300mm) 2015 - 13m) coiled cord with exposure switch

The Power supply is regulated to provide a selectable 50 to 70 kVp in step of The Power Supply is regulated to pf 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters ky, mA & times may be stored in, selected & operated via the operator control panel.

The provided text describes a 510(k) premarket notification for the INTRA SKAN DC, a high-frequency Intra-oral X-Ray System. However, it does not contain information about a study that assesses the device's performance against specific acceptance criteria for diagnostic accuracy or clinical effectiveness.

Instead, the document details:

• Device Description and Indications for Use: The INTRA SKAN DC is an extraoral X-Ray system for dental diagnostic radiography.
• Predicate Devices: It lists several predicate devices (Progeny PREVA K043092, Dentsply Gx-770: K935046, Gendex 765DC: K992610).
• Safety, EMC, and Performance Data (Regulatory Compliance): This section confirms that the device underwent testing according to various IEC, UL, and FDA 21 CFR standards (e.g., IEC 60601-1, IEC 60601-1-2, 21 CFR 1020.30, 21CFR1020.31). These tests are typically for electrical safety, electromagnetic compatibility, and general X-ray performance characteristics (like kVp accuracy, mA, exposure time, duty cycle) to ensure the device operates safely and within expected parameters for an X-ray generator. It explicitly states: "All test results were satisfactory."
• Substantial Equivalence: The FDA's letter confirms that the device was found substantially equivalent to legally marketed predicate devices, primarily based on its analogous indications for use and compliance with relevant safety and performance standards.

Therefore, based on the provided input, I cannot fill out the requested table or answer most of the questions related to acceptance criteria for diagnostic performance, a specific study proving device meets acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The "acceptance criteria" discussed in the document are primarily related to regulatory compliance, electrical safety, and general X-ray output specifications, not clinical diagnostic accuracy or a comparison of image quality against a predefined standard using human readers or a standalone algorithm.

Here's what can be inferred or explicitly stated from the provided text, while also noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on technical safety and performance standards, not diagnostic accuracy or clinical efficacy metrics typically found in clinical trials for AI or diagnostic devices. The acceptance criteria are "satisfactory" compliance with these standards.

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

• Not applicable / Not provided. The document does not describe a clinical test set for evaluating diagnostic performance. The "test results" refer to compliance with technical and safety standards, which would involve testing of the device hardware.

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

• Not applicable / Not provided. No clinical ground truth was established for diagnostic performance.

4. Adjudication method for the test set

• Not applicable / Not provided. No clinical test set or adjudication process for diagnostic performance is mentioned.

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. The document does not mention any MRMC study, nor does it involve AI or human reader assistance.

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

• No. This device is an X-ray generator, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

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

• Not applicable / Not provided for diagnostic performance. The "ground truth" implicitly used for the technical performance tests would be the specifications and requirements of the relevant IEC, UL, and FDA standards (e.g., a certain kVp setting should produce a specific kVp output within a defined tolerance).

8. The sample size for the training set

• Not applicable / Not provided. This device is an X-ray generator and does not involve a training set as would be used for AI/machine learning.

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

• Not applicable / Not provided. No training set is mentioned.

In summary: The provided 510(k) summary focuses on demonstrating the safety and basic technical performance compliance of an X-ray generator against established regulatory and engineering standards, and its substantial equivalence to existing predicate devices. It does not include information about clinical studies, diagnostic accuracy metrics, or evaluation against specific clinical acceptance criteria that would typically involve patient data, expert review, or AI performance.

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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.

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