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JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into centric occlusion making an impression.

The provided document (FDA 510(k) Clearance Letter - K250969) is for dental impression materials (Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast). Unfortunately, this document does not describe a study involving an AI/software device that requires intricate ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

The "Acceptance Criteria and Study" section in the document refers to performance testing for the physical properties of the impression material based on ISO 4823 standards, not an AI model's performance.

Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study details based on the provided text. The document focuses on the substantial equivalence of a physical dental impression material to a predicate device, as opposed to the validation of a software algorithm.

If you have a document describing the validation of an AI/software device, I would be happy to analyze it against your request.

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Speedex putty/putty soft

• Primary impression in the putty-wash Impression technique
• Pick-up impression in the simultaneous mixing technique
• Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
  Speedex light body
• Correction material for the correction impression technique
• Syringe material for the two-phase impression technique
• Impression material for relining
  Speedex medium
• Complete and partial prosthetics, correction material for the correction impression technique
• Monophase impression technique, simultaneous mixing technique
• Liner impression material
  Speedex Universal Activator
• Activator for Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions

Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques.

The provided text is a 510(k) premarket notification letter and summary for a dental impression material named "Speedex." This document does not describe an AI/ML-based medical device. Therefore, a study proving an AI device meets acceptance criteria, an MRMC study, or information about training and test sets for an algorithm, as requested in the prompt, are not applicable and not present in the provided text.

The document discusses the substantial equivalence of the Speedex dental impression material to a legally marketed predicate device ("PRESIDENT The Original"). Acceptance criteria and performance are outlined in the context of non-clinical performance testing for material properties, rather than AI/ML model performance.

Here's an analysis of the provided information relevant to the material's acceptance criteria and study, as much as possible given the context:

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

The document states: "Performance testing as was conducted to verify that the device complies with the requirements of ISO 4823:2021, and the same testing was carried out on the predicate device to help establish substantial equivalence. These tests include consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery, and strain in compression."

While the specific numerical acceptance criteria and reported performance values are not explicitly provided in tables, the document implies that the Speedex device met the requirements of ISO 4823:2021 for these properties. The "Summary & Conclusions" section states: "Based on the non-clinical performance data, the proposed device Speedex is as safe, as effective and performs as well as the predicate Device PRESIDENT the Original." This statement confirms that the device did meet its performance requirements to demonstrate substantial equivalence.

As the exact table is not in the text, it cannot be constructed, but the types of criteria are listed.

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

For non-clinical performance testing of a material, "sample size" typically refers to the number of specimens tested for each property (e.g., number of impression material samples tested for linear dimensional change). This information is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of material property testing as described.

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

This concept is not applicable as the testing is for fundamental material properties against an ISO standard, not for medical image interpretation or diagnostic performance involving expert consensus.

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

This is not applicable for material property testing.

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:

This is not applicable as the device is a dental impression material, not an AI-based diagnostic tool.

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

This is not applicable as the device is a dental impression material, not an AI algorithm.

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

The "ground truth" for this device's performance is compliance with ISO 4823:2021 standards for dental impression materials, and comparison to the predicate device's performance for substantial equivalence. No patient outcomes data or expert consensus on a diagnostic task is used.

8. The sample size for the training set:

This concept is not applicable as this is a physical material, not an AI model requiring a training set.

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

This is not applicable as this is a physical material, not an AI model.

In summary, the provided document pertains to a traditional medical device (dental impression material) and its non-clinical performance testing against an international standard (ISO 4823:2021) to establish substantial equivalence. The detailed questions about AI/ML acceptance criteria, ground truth, and study designs for AI (like MRMC or standalone performance) are not relevant to this type of device and thus not present in the text.

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Ultrasonic Applications for:

• All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
• Periodontal therapy

The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.

The provided document is a 510(k) Premarket Notification for a medical device called the BioSonic US200 Ultrasonic Scaler, which is an ultrasonic scaling unit for dental procedures. It is a Class II device (Regulation Number 872.4850, Product Code ELC).

This document does not contain the specific acceptance criteria and detailed study results for a device that uses a test set for performance evaluation in the way typically expected for AI/ML-driven devices. This is because the BioSonic US200 Ultrasonic Scaler is a hardware device, not an AI/ML software device.

The "studies" referenced are non-clinical performance tests conducted to ensure safety and effectiveness in comparison to a predicate device, focusing on electrical and mechanical aspects, and material compatibility. There are no mentions of "test sets", "ground truth", "experts", "adjudication methods", "MRMC studies", or "standalone performance" in the context of assessing an algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as those categories are not applicable to the type of device and submission described.

However, I can extract information about the type of tests performed and the general conclusion regarding acceptance criteria (though not specific numerical criteria for performance metrics).

Here's what I can extract regarding the device's testing and intended performance from the document:

General Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Frequency testing (e.g., verifying 25kHz or 30kHz operation).
• Power testing.
• Tip displacement testing.
• Insert extraction testing. |
  | Material Compatibility | Materials compatibility testing with cleaning and disinfecting agents was performed. |
  | Substantial Equivalence to Predicate | The device's indications for use are identical to the predicate. Technological characteristics are substantially equivalent with minor differences (mechanism to change modes, automatic frequency detection, removable autoclavable sheath) that "do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate." This is the overarching acceptance criterion for 510(k) clearance. |

Why the other requested information cannot be provided from this document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device's non-clinical testing. "Test sets" in this context refer to electrical/mechanical measurements, not patient data.
• 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. "Ground truth" usually refers to diagnostic accuracy in AI/ML, not the physical properties of an ultrasonic scaler.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for this hardware device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

This document solely concerns the FDA's 510(k) clearance of a traditional, non-AI medical device based on its physical and electrical performance and comparison to a predicate device.

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The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.

The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.

The provided text describes the 510(k) summary for the Coltolux Comfort LED Curing Light (K223142). Here's an analysis of the acceptance criteria and study information provided:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific quantitative metrics. Instead, it states that "Performance testing was conducted to verify that the proposed Coltolux Comfort Curing Light meets the requirements as defined in FDA Guidance Document 'Dental Curing Lights - Premarket Notification [510(k)' and in accordance with IEC 60601-1-2."

It lists the types of non-clinical tests performed:

• Light output uniformity and dropoff testing
• Peak wavelength testing (ISO 10650:2018)
• Irradiance output (ISO 10650:2018)
• Depth of cure
• Endurance testing
• Light attenuation through barrier sleeve
• Light shield filtration
• Life testing
• Duty cycle (IEC 60601-1:2012)
• EMC (IEC 60601-1-2:2014)
• Electromagnetic disturbances (IEC 60601-1-2:2014)
• Photobiological safety (IEC 62471:2006)

The conclusion states: "Based on the non-clinical performance data the proposed Coltolux Comfort Curing Light is as safe, as effective, and performs as well as or better than the predicate device Coltolux LED Curing Light (K040551, 21 CRF 872.6070, product code EBZ)." This implies that the device met the acceptance criteria defined by the listed standards and guidance documents, but the specific numerical targets and measured results are not detailed in this summary.

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

The document focuses on non-clinical performance testing (bench testing). Therefore, the concept of "test set" in terms of subject data (like in a clinical trial) is not directly applicable. For bench testing, test articles (the devices themselves) are used. The sample size for these component-level tests (e.g., number of devices tested for endurance, light output) is not specified in this summary. The provenance of this bench testing data would typically be the manufacturer's lab, often in the country of origin of the manufacturer (Switzerland) or a contracted testing facility. The nature of these tests is inherently prospective as they are performed specifically to evaluate the new device.

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 is not applicable as the summary describes non-clinical, bench testing of a dental curing light, not an AI or diagnostic device that requires expert ground truth for interpretation of clinical data.

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

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus ground truth from expert readings.

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

This is not applicable. The device is a dental curing light, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The device is a physical medical device (a curing light), not an algorithm.

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

For the non-clinical tests, the "ground truth" or reference standards are derived from established international standards (e.g., ISO 10650:2018, IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 62471:2006) and FDA guidance documents. For instance, irradiance output is measured against defined limits or performance of a predicate device according to the ISO standard. Depth of cure would be assessed against a material's known curing characteristics.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning product and therefore does not have a "training set" in that context.

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

This is not applicable for the same reason as #8.

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