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C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).

The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammation that leads to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).

The C50 is an intraoral camera intended for use in general dentistry. Its indications for use include aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations (restricted to those leading to bleeding upon probing), and functioning as an intra-oral camera for magnified visualization of anatomical details.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes comparison testing and other verification and validation tests rather than specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for caries detection). Instead, the performance testing focuses on demonstrating substantial equivalence to the predicate device and compliance with relevant safety and technical standards.

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

The document does not explicitly state a test set in the traditional sense of a clinical diagnostic study with patient data used for accuracy evaluation. Instead, it refers to "comparison testing of image quality" and "mechanical performance testing" conducted on the device and its accessories (C50, C50TIPS, protective sheath, USB cable).

• Sample Size: Not specified in terms of number of patients or cases. The testing appears to have been performed on the devices themselves and associated accessories.
• Data Provenance: Not applicable in the context of device performance testing. The "data" generated comes from direct laboratory and safety testing of the device hardware and software. No patient or human subject data is mentioned for performance evaluation.

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

Not applicable. As described above, the testing performed was focused on device characteristics and substantial equivalence to a predicate, not on a diagnostic accuracy study requiring expert ground truth establishment for patient cases.

4. Adjudication Method for the Test Set

Not applicable, as no clinical diagnostic test set with multiple reader interpretations 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

No MRMC comparative effectiveness study is described. The C50 is an intraoral camera and not an AI-powered diagnostic algorithm that assists human readers in interpretation. It provides visual information to the dental practitioner.

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

The C50 is a hardware device (intraoral camera with different illumination modes) that provides visual information. It is not an algorithm, and therefore, a standalone algorithm performance study is not applicable. The device's "diagnosis aid" function relies on the visual information it provides to the human practitioner.

7. The Type of Ground Truth Used

The ground truth used for relevant testing was based on:

• Comparison to a predicate device (SOPROCARE): Many aspects of the C50's performance (image quality, temperature elevation, functional modes) were evaluated against the known performance of the predicate device to establish substantial equivalence.
• Compliance with established standards: Electrical safety, EMC, photobiological safety, software validation, reprocessing validation, and biocompatibility were evaluated against recognized international and FDA standards.
• Engineering specifications/functional requirements: Mechanical tests ensured specific physical functionalities like the fit of accessories and light blocking.

8. The Sample Size for the Training Set

Not applicable. The C50 is a medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.
The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.
The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.

I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter and a summary of safety and effectiveness for a medical device called the ULYSS Multi View Sinuscope. It describes the device, its intended use, and compares its technological characteristics to predicate devices.

However, it does not provide details about acceptance criteria for performance metrics or a study that specifically proves the device meets those criteria in the way you've outlined (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

The "Performance Data" section (on page 4) mentions "bench testing and a cadaver study" and that "The ULYSS Multi View Sinuscope has met all specified design and performance requirements." but it does not elaborate on the specific acceptance criteria, the methodology of these studies, or the results in a quantifiable manner that would allow me to populate the tables you've requested.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.

Not Found

The provided document does not contain any information regarding acceptance criteria or a study proving device performance related to AI/algorithm performance.

The document is a 510(k) clearance letter for a laparoscopic insufflator (S698 Symbioz Flow), indicating it has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence in terms of safety and effectiveness, often through comparison to existing devices and adherence to relevant standards, rather than conducting a detailed performance study with acceptance criteria in the way you've described for an AI/algorithm-based device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

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The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX device does not contain information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC or standalone).

This document is primarily a letter from the FDA confirming the substantial equivalence of the SOPIX device to existing legally marketed devices, along with the device's indications for use. It details regulatory information rather than a performance study.

Therefore, I cannot provide the requested table and study details based on the input text.

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The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.

The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.

The provided text is a 510(k) summary from the FDA for a dental imaging device (PSPIX2). This document does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

Specifically, the document only confirms FDA's substantial equivalence determination for the PSPIX2 device and states its intended use. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how ground truth was established for training sets.

To obtain this information, you would typically need to refer to the full 510(k) submission, accompanying technical documentation, or published studies referenced within such submissions. This particular FDA letter is a notification of clearance, not the detailed technical evaluation itself.

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The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX INSIDE and SOPIX2 INSIDE devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices. It covers regulatory information, product codes, and indications for use.

Crucially, it does NOT include details about:

• Acceptance criteria table and reported device performance: This type of information would be found in the manufacturer's performance studies, which are summarized within the 510(k) submission itself, but not typically in the FDA clearance letter.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

To find this type of information, you would typically need to refer to the full 510(k) submission (if publicly available, often through a Freedom of Information Act request or directly from the manufacturer), which contains the technical specifications and detailed study reports supporting the substantial equivalence claim. The provided document is merely the FDA's formal clearance notice.

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The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).

The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image.

Here's a detailed breakdown of the acceptance criteria and study information for the SOPROCARE device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document states the "aims of this study were to determine if: New Device has a comparable effectiveness as Predicate Device SOPROLIFE." It then presents the performance metrics of the new device and the practitioner's eyes. The acceptance criteria are implicitly defined by requiring "high accuracy," "high sensitivity," and "high specificity" and comparing them against the "gold standard."

Study Information

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

   • Test Set Sample Size:
     • Dental plaque and inflammation analysis: 120 teeth
     • Pit and fissure caries detection: 128 teeth
     • Number of participants: 20 people (9 women, 11 men)
   • Data Provenance:
     • Country of Origin: Marseille, France (study conducted from January 6 to February 7, 2012)
     • Retrospective or Prospective: Prospective (clinical data was "collected during the following study").

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

   • The document states that the predicate devices (SOPROLIFE for caries, GC Tri Plaque ID Gel for dental plaque, and bleeding upon probing technique for gingival inflammations) were used as "gold standards." It defines a gold standard as "the best available under reasonable conditions... supposed to never be wrong and so have sensitivity and specificity of 100%."
   • It does not specify a number of human experts used to establish the ground truth for the test set, nor does it provide qualifications for any such experts. The "gold standard" here refers to the performance of the predicate device or technique itself.

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

   • The document does not describe an adjudication method for the test set; the ground truth was established by the "gold standard" predicate devices/techniques.

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:

   • A comparative effectiveness study was done comparing the device's performance to "practitioner eyes" (human readers without the device).
   • This was not an MRMC study in the typical sense of evaluating human readers with vs. without AI assistance. Instead, it evaluated the standalone performance of the device against a "gold standard" and also documented the performance of "practitioner eyes" against the same "gold standard."
   • The document implies that the device improves diagnosis capability compared to practitioner using only visual inspection. However, it doesn't quantify "human readers improve with AI vs without AI assistance" as a direct effect size, but rather presents the device's performance separately from the "practitioner eyes."
     • SOPROCARE (Device) Performance: Accuracy 87%, Sensitivity 91%, Specificity 90%
     • Practitioner Eyes Performance (without device): Accuracy 66%, Sensitivity 25%, Specificity 97%

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

   • Yes, the performance metrics for "New Device" (SOPROCARE) described as "High accuracy (87% in average)", "High Sensitivity (91% in average)", and "High specificity (90% in average)" represent the standalone, algorithm-only performance, as it is compared directly to the "gold standard."

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

   • The ground truth was established by using predicate devices/techniques as "gold standards":
     • For pit and fissure caries detection: SOPROLIFE (K092583)
     • For dental plaque highlight: GC Tri Plaque ID Gel (Predicate Device)
     • For gingival inflammations: Bleeding upon probing technique (Predicate Device)

7. The sample size for the training set:

   • The document does not mention a separate training set or its sample size. The clinical study described appears to be for performance evaluation.

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

   • Since no training set is explicitly mentioned, the method for establishing its ground truth is not provided.

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"Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy"

The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status

The provided text describes a 510(k) summary for the SOPRO 281 LED LIGHT SOURCE, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study that would typically establish detailed acceptance criteria and a comprehensive study to prove the device meets them.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving the device meets them, especially in the context of device performance metrics like sensitivity, specificity, and detailed study methodologies, is not present in the provided text.

However, I can extract the information that is available and explain why some parts of your request cannot be fulfilled based on this document.

Summary of Available Information from the Provided Text:

This document is a 510(k) premarket notification for the SOPRO 281 LED LIGHT SOURCE. The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to independently prove specific numerical performance criteria through a dedicated clinical study with detailed statistical outcomes.

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

• Acceptance Criteria: The acceptance criteria for a 510(k) submission for a light source like this are generally related to demonstrating substantial equivalence in terms of technical specifications, performance, and intended use compared to the predicate devices. The document implies that the device "has the same properties of safety and effectiveness as the predicates."
• Reported Device Performance: The document states: "The SOPRO 281 is similar to the LO-50 led light source (K102167) and to LLS-050 (K093792) predicate devices in terms of technical specifications, performances, and intended use." It does not provide specific numerical performance data (e.g., light output in lumens, color temperature, lifespan) for the SOPRO 281 itself or the predicates, nor does it present a comparison table of such metrics. The "performance" is generally demonstrated by meeting relevant standards for electrical safety, electromagnetic compatibility, and potentially light output, but these specific results are not detailed in this summary.

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

• Not Applicable / Not Provided: This is a light source, not a diagnostic or AI-driven device that would typically involve a "test set" of clinical cases or data. The "study" for a 510(k) for a light source usually involves engineering bench testing to ensure it meets general performance, safety, and electrical standards, and comparing its technical specifications to predicates. There is no mention of a human-interpretable dataset, sample size, or data provenance in the context of evaluation.

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

• Not Applicable / Not Provided: As this device is an LED light source, not a diagnostic imaging or AI system, the concept of "ground truth" established by experts for a test set of clinical data does not apply in this context. The "truth" here would refer to the physical properties of the light source, verified through engineering tests.

4. Adjudication method for the test set

• Not Applicable / Not Provided: 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 / Not Provided: This is a hardware device (an LED light source), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.

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

• Not Applicable / Not Provided: This is a hardware light source, not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided: For a light source, "ground truth" would relate to its physical and electrical characteristics (e.g., light intensity, color rendering, operating temperature, safety features) verified through engineering specifications and testing, not clinical outcomes or expert consensus on medical findings. This document does not detail specific engineering tests or their outcomes.

8. The sample size for the training set

• Not Applicable / Not Provided: As this is a physical device and not an AI algorithm, there is no concept of a "training set."

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

• Not Applicable / Not Provided: No training set is involved.

In summary: The provided document is a 510(k) notification for an LED light source. The "study" referenced in such a submission typically involves demonstrating that the device's technical specifications and safety profile are substantially equivalent to those of existing legally marketed predicate devices through engineering tests and comparison of specifications, rather than a clinical trial with performance metrics like accuracy, sensitivity, or specificity against established ground truth. Therefore, most of the detailed questions regarding study design, sample sizes, expert involvement, and AI performance are not applicable to the information contained in this specific document.

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The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.

The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.

This document is a 510(k) summary for the SOPRO SOPIX2 system, an intraoral digital X-ray sensor for dental applications. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The document acts more as a regulatory submission for market clearance based on equivalence rather than a detailed performance study report.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document's purpose is to argue for substantial equivalence to a predicate device, implying that its performance should be comparable to the predicate. There are no quantitative performance goals or thresholds mentioned.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) are reported for the SOPIX2 system. The document generally states that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPIX2." This is a qualitative statement of equivalence, not a quantitative performance report.

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

• Sample Size: Not mentioned. No specific test set or study size is described.
• Data Provenance: Not mentioned. There is no information about the origin of any data used for testing (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Reasoning: Since no specific performance study with a test set generating ground truth is described, information on experts is absent.

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

• Adjudication Method: Not mentioned.
• Reasoning: Similar to the above, no specific ground truth establishment or adjudication process for a test set 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

• MRMC Study: No, there is no indication that an MRMC comparative effectiveness study was done.
• AI Assistance: The device described is an X-ray sensor system, not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Standalone Performance: Not explicitly done in the context of an algorithm. The device is a hardware sensor. Its performance is inherent to its image acquisition capabilities, which are argued to be equivalent to the predicate device.

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

• Type of Ground Truth: Not mentioned. No formal ground truth establishment is described in the provided summary.

8. The sample size for the training set

• Sample Size: Not applicable. This device is a hardware sensor, not an AI algorithm that requires a training set.

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

• Ground Truth Establishment: Not applicable, as there is no training set for this hardware device.

In summary, the provided document is a regulatory submission for market clearance based on substantial equivalence to a predicate device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in reports for novel diagnostic algorithms or devices requiring extensive clinical validation beyond equivalence to an existing product.

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The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.

The SOPROLIFE is a fluorescence caries detection device . This device is a fluorescence detector housed in a dental handpiece, and a control unit that performs device calibration, as well as variable tone emitting and fluorescence measurement functions.
The handbiece can be connected with 5 different control units : Dock M VIDEO Dock M USB2. Dock MU VIDEO, Dock MU USB2, Dock USB2.
The SOPROLIFE is a device used in clinical dental applications to observe the condition of hard dentinal tissues.
As the SOPROLIFE can be adapted to the most complex of clinical situations, it quickly helps the dentist to get a complete analysis as it adjusts treatment options in Diagnosis aid mode. In Treatment aid mode, the SOPROLIFE facilitates observation of the dentinal tissue condition in progress and at the end of the treatment. In daylight mode the SOPROLIFE enables the dentist to visualize anatomical details invisible to the naked eye or with mirror like an intra oral camera SOPRO 595.

This document is a 510(k) summary for the SOPROLIFE device, a fluorescence caries detection device. It outlines the device description, intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing the results of performance studies against specific acceptance criteria.

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