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N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

The N2 dental operative unit is primarily evaluated against safety and performance standards for dental equipment and medical electrical equipment. As such, the acceptance criteria and study designs differ significantly from those for AI-powered diagnostic or prognostic devices.

Here's an analysis of the provided information, structured to address your specific points where applicable, and noting where the information is not relevant to this type of device:

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

For the N2 dental operative unit, the "acceptance criteria" are compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, cleaning/sterilization validation, and software validation. The reported device performance is that it complied with these standards.

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

For this type of device, "test set" and "data provenance" don't apply in the way they do for AI/diagnostic devices. The evaluation of N2 relies on bench testing and compliance with recognized standards.

• Bench Testing: This involves testing the physical device and its components in a controlled laboratory environment against specified parameters (e.g., electrical measurements, pressure limits, temperature control, mechanical movements). The "sample size" would typically be a representative number of units from a production batch or prototypes. The document doesn't specify the exact number of units tested for each standard, but it's understood to be sufficient for demonstrating compliance.
• Data Provenance: This is not relevant. The testing is performed in accordance with international standards, and the results are primarily engineering and performance 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)

This is not applicable to the N2 device. "Ground truth" in the context of diagnostic performance (e.g., presence/absence of a disease) is established by expert consensus, pathology, or outcomes data. For a dental operative unit, the "ground truth" is adherence to engineering specifications and safety standards, which is verified through objective measurements and test procedures, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret medical images or data and their decisions need to be reconciled to establish a consensus ground truth. For equipment like N2, compliance is determined by passing objective tests against defined standards, not by human interpretation.

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 N2 is a dental operative unit (a piece of hardware for dental procedures), not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation. Therefore, an MRMC study is completely irrelevant.

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

This is not applicable. The N2 device is not an algorithm. Its "standalone performance" is its ability to function safely and effectively as a dental operative unit, which is demonstrated through component testing, system integration testing, and compliance with the listed standards. The software components are for controlling the unit's functions, not for standalone diagnostic or analytical tasks.

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

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for this device's safety and effectiveness is its conformance to established engineering and medical device standards through objective measurements and validated processes.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. The N2 device is a hardware unit with embedded software for control; it does not utilize machine learning in its described function.

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

This is not applicable for the same reasons as point 8.

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N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronicallycontrolled chair movements with software and water unit functions.

This document describes the N2, a dental operative unit, and its substantial equivalence to a predicate device (K183347), K3. The submission focuses on non-clinical testing for safety and performance rather than AI-driven image analysis. Therefore, many of the requested fields regarding AI performance, such as sample size for test/training sets, data provenance, number and qualification of experts, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.

The document details the device's technical characteristics, intended use, and indicates that no clinical studies were deemed necessary. The acceptance criteria and "reported device performance" are primarily demonstrated through compliance with various international standards and specific bench tests, rather than metrics like sensitivity, specificity, or accuracy which would be typical for an AI-enabled diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the submission describes a physical dental operative unit, not an AI/software device that processes medical image data or other patient-specific data for diagnostic or prognostic purposes. The "testing" refers to bench testing and compliance with electrical, mechanical, and safety standards for the device itself.

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. Ground truth, in the context of expert consensus, is typically established for diagnostic tasks where human interpretation is the gold standard. For this device, "ground truth" would relate to the physical and functional parameters meeting engineered specifications and safety standards, validated through direct measurement and compliance testing (e.g., measuring current, pressure, chair movement ranges).

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

This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the testing described 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

This is not applicable. MRMC studies are conducted for systems that assist human readers in tasks like image interpretation. The N2 is a dental operative unit, 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 N2 is a physical device with some electronic controls (firmware), not a standalone algorithm.

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

The "ground truth" for this device's performance is primarily established by:

• Engineering Specifications: The pre-set criteria for bench tests, electrical safety, and mechanical performance are based on design specifications and industry standards.
• Regulatory Standards: Compliance with international standards such as IEC 60601-1, IEC 80601-2-60, ISO 10993, ISO 17665, and ISO 16954 forms the basis of "truth" for safety and essential performance.
• Manufacturer Recommendations: For cleaning/sterilization, the validation is against the manufacturer's recommended protocols.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software validation refers to standard software development, verification, and validation (V&V) processes for firmware, not AI model training.

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

This is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) submission for a dental operative unit, which is a physical device. The "study" mentioned refers to non-clinical bench testing and compliance with various international electrical, mechanical, safety, and biocompatibility standards to demonstrate substantial equivalence to a predicate device. It is not an AI-enabled diagnostic or assistive device, so many of the requested fields regarding AI performance evaluation are irrelevant.

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The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.

The device does not send any real-time alarms. The device a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

With existing legally marketed vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lunq and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.

Vital signs measurement devices integrated in the CareCompanion are FDA approved devices and are used for the same purposes for which they received 510(k) approval. The Patient Station may be configured for use with one to four devices.

The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.

This document describes the CareCompanion Tele Homecare System, which facilitates remote monitoring of patient vital signs. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics like sensitivity, specificity, accuracy, or correlation coefficients. Instead, it focuses on functional equivalence and passing relevant standards.

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

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is general "functional performance" and "performance testing to applicable mechanical, electrical and environmental standards." It implies integration testing with existing FDA-approved vital signs devices rather than a clinical trial with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. The focus is on the device's functional performance in relaying data from already approved vital signs devices, rather than on the diagnostic accuracy of the CareCompanion itself based on expert assessment of patient data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This is consistent with the lack of details on a test set involving human interpretation or clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The device is a "Tele Homecare System," not a diagnostic imaging or interpretation aid that would typically be evaluated with MRMC studies. The primary goal was to demonstrate substantial equivalence for vital signs data transmission, not a direct comparison of human reader performance with and without AI assistance.

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

Yes, in a sense, a "standalone" evaluation was part of the testing. The "functional performance" testing confirms that the integrated vital signs measurement devices "operate equivalently when integrated with CareCompanion as when operated as independent devices." This implies testing the CareCompanion's ability to accurately transmit the data generated by the vital signs devices themselves, in a standalone capacity for data transfer, before a human at the Nurse Station interprets it.

7. The Type of Ground Truth Used

The ground truth implicitly used for the functional performance testing of the CareCompanion's data transmission capabilities would be the readings directly provided by the legally marketed and FDA-approved vital signs measurement devices themselves when operated independently. The testing aimed to confirm that the CareCompanion accurately transmits these established readings.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. Given that the device is a data transmission system for pre-existing FDA-approved vital signs monitors, it likely does not involve machine learning or AI models that would require a distinct training set in the conventional sense.

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

Since no training set is mentioned or implied for machine learning, the establishment of ground truth for a training set is not applicable here. The "ground truth" for the overall system's function comes from the validated outputs of the integrated, standalone vital signs monitors.

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The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The N2000 Base Station is intended to be used upon prescription of an authorized healthcare provider, by patients where regular monitoring of vital signs information is indicated.

The N2000 Base Station is intended to be used as a means to collect and transmit patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes: blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight, and heart, lung and bowel sounds. The information is collected upon request of the healthcare provider.

The device is not indicated for diagnostic purposes. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The HomeCare Information Network System (HINS) consists of two components: the N2000 Base Station installed typically in a patient's home; and the N2001 Nurse Station located in the provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

With existing legally marketed vital signs measurement devices integrated with the N2000 Base Station, the N2000 Base Station is designed to monitor the patient's blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight and/or heart, lung and bowel sounds, and transmit this data to the N2001 Nurse Station. The real-time data is displayed to the caregiver operating the N2001 Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds are recorded from the electronic stethoscope supplied with the system.

Vital signs measurement devices integrated in the HINS are FDA approved devices and have received 510(k) approval. The N2000 may be configured for use with one to five devices.

The N2001 Nurse Station consists of two sub-components, the N2001 Nurse Station PC, which is a standard PC with supporting peripherals, and the N2001 Nurse Station Data Client, which provides the video and audio communications and monitoring functions for the Nurse Station. The N2001 Nurse Station PC can operate as a standalone device for patient data management and record keeping functions.

The provided text contains a 510(k) Summary for the Neptec Homecare Information Network System (HINS). This document predominantly focuses on regulatory compliance, outlining the device's description, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study with specific acceptance criteria and their verification.

Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Available. The document mentions "performance testing" and "testing was performed," but does not specify any sample sizes (e.g., number of patients, number of vital sign readings, duration of testing) or the nature of the data provenance.

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

• Not Applicable / Not Available. The primary purpose of this system is to transmit vital signs data from existing FDA-approved devices. The study described focuses on functional performance and regulatory compliance, not on clinical interpretation or diagnostic accuracy where expert ground truth would be established for the HINS itself. The document states: "Clinical judgement and experience are required to check and interpret the information transmitted." This implies that the interpretation is done by healthcare professionals, but they are not establishing ground truth for the device's performance.

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

• Not Applicable / Not Available. As no expert-based ground truth establishment for diagnostic or interpretative tasks is described for the HINS device, an adjudication method is not 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. An MRMC study was not described. The HINS is a "Tele Homecare System" for transmitting vital signs and enabling communication, not an AI-assisted diagnostic tool.

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

• Partially Applicable, but not for "algorithm only" in the modern sense. The N2001 Nurse Station PC (part of the HINS) "may also operate as a standalone device for patient data management and record keeping functions." This refers to its ability to function without the N2000 Base Station for certain administrative tasks, not as an "algorithm only" performance evaluation similar to AI models. The HINS itself is designed as a system requiring human oversight and interaction.

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

• Implicitly established by integrated devices. The "ground truth" for the vital signs data transmitted by the HINS is implicitly established by the FDA-approved vital signs measurement devices that are integrated with the N2000 Base Station. The HINS system's performance is based on its ability to accurately and reliably transmit data from these already validated devices, not on generating its own diagnostic ground truth.

8. The sample size for the training set

• Not Available. The document does not describe any training set, as it is not a machine learning or AI-based device in the context of this 510(k) summary.

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

• Not Applicable. No training set is described.

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