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To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.

Oral-B® Sonic Complete™ is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power handle. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® Sonic Complete™ electric toothbrush has a vibrating brush head that moves with a side-to-side movement. The brush head is designed to facilitate deeper penetration of interdental areas. The brush head moves side along the axis of the brush head at 260 Hz at an unloaded angle of ± 5 degrees. The brush head has no moving parts and is similar to a manual brush. The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12. The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.

The provided text describes the Oral-B® Sonic Complete™ rechargeable electric toothbrush. While it states that the device has been tested in numerous controlled clinical studies and that these trials evaluated oral soft and hard tissue for safety, plaque, gingivitis, and bleeding, it does not explicitly detail specific quantitative acceptance criteria or the full study methodology in the typical format for medical device performance studies. The document focuses on demonstrating substantial equivalence for an expanded indication for use (treating and preventing gingivitis) rather than presenting a detailed performance study with predefined acceptance criteria for the device itself.

However, based on the information provided, we can infer some aspects related to the testing and "acceptance" of the device in the context of its 510(k) submission.

Here's an attempt to structure the information based on the typical requirements, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance

The document does not provide a table with quantitative acceptance criteria for device performance. Instead, the acceptance is based on demonstrating the device's safety and effectiveness for its intended use, particularly the expanded indication of "treating and preventing gingivitis," and its substantial equivalence to predicate devices. The "reported device performance" is descriptive rather than quantitative in the provided text excerpts.

Study Details

The document states that "Oral-B® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis." However, it does not provide all the granular details requested for a single, comprehensive study. It references two clinical studies in the bibliography.

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

   • Test set sample size: Not explicitly stated in the summary.
   • Data provenance:
     • Study 1 reference (Cronin et al., 2004): Conducted by "New Institutional Service Co., Inc., Dental Research and Product Testing, Northfield, New Jersey, USA." This suggests the data is prospective and from the USA.
     • Study 2 reference (Rosema et al., 2004): Department of Periodontology, Academic Centre for Dentistry Amsterdam. This suggests the data is prospective and from Amsterdam (Netherlands).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in the provided text. Clinical studies of this nature would typically involve trained dental professionals (e.g., periodontists, dental hygienists) for assessments.

3. Adjudication method for the test set: Not explicitly stated. For clinical studies evaluating gingivitis and plaque, assessments are typically performed by trained examiners following standardized protocols, and reliability checks (e.g., inter-rater agreement) are common, but specific adjudication methods like "2+1" are not mentioned.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • The provided text refers to "controlled clinical studies" demonstrating effectiveness, but it does not describe an MRMC study comparing human readers with and without AI assistance. This type of study (MRMC for AI) is typically for diagnostic imaging devices, not direct-to-consumer toothbrushes.
   • The studies mentioned compare the device itself (with its cleaning mechanism) against either a control or another toothbrush, not human readers and AI.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a physical toothbrush, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The device's performance is inherently "human-in-the-loop" as a user operates it.

6. The type of ground truth used:

   • Clinical Endpoints: Based on the description ("evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding"), the ground truth would be based on clinical assessments/measurements (e.g., Gingival Index, Plaque Index, Bleeding on Probing) performed by trained dental professionals.
   • Bibliography references studies that focus on "efficacy of two toothbrushes" (Study 1) and "Healing Effect of Experimental Gingivitis Using 2 Sonic Toothbrushes" (Study 2), further indicating clinical measures as ground truth.

7. The sample size for the training set: Not applicable in the context of this device and the provided documentation. This information is relevant for AI/machine learning models which are not described here. The "training set" for a physical device would refer to data used during its development and optimization, which is not detailed in a 510(k) summary for a toothbrush.

8. How the ground truth for the training set was established: Not applicable, as explained above.

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To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.

Oral-B® ProfessionalCare/Oral-B® AdvancePower is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power unit. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® ProfessionalCare/Oral-B® AdvancePower electric toothbrush has an oscillating/rotating technology, a small round brush head that aids tooth-to-tooth cleaning. The brush head is designed to facilitate deeper penetration of interdental areas. The action of the brush head has an oscillation range frequency between 63 to 73 Hz with a vibration frequency of 340 Hz (3800 strokes per minute) and an oscillating range angle of 42° to 60° depending on the toothbrush model.

The brush head design is a small circular brush head and features an arrangement of flagged bristles and power tips. The power tips have tufts of longer bristles on either side of the brush head in the outer ring. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2.

The flagged bristle tufts have tetralocular filaments and are designed to increase the brushing action on tooth surfaces. The bristle material is Polyamid or PA6.12. The toothbrush features a round handle with anti-slip characteristics for better control in wet conditions and offers a variable range of speeds to best meet individual needs.

Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are rechargeable battery operated toothbrushes. The toothbrush handles are inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the product is provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.

The provided text describes a 510(k) summary for the Oral-B® ProfessionalCare™ Series/Oral-B® AdvancePower™ Series powered toothbrush. The submission focuses on the expanded indication for use: "treating and preventing gingivitis," as the device is otherwise 510(k) exempt.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state quantitative acceptance criteria (e.g., "gingivitis must be reduced by X%"). Instead, it lists the general clinical outcomes for which the device was evaluated, and then concludes broad effectiveness and safety based on those evaluations.

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

• Sample Size: Not explicitly stated. The document refers to "numerous controlled clinical studies" (page 2) and lists eight bibliography entries for these studies. To determine the exact sample sizes, one would need to consult the referenced individual studies (e.g., Cronin et al. 1998, Haffajee et al. 2001, etc.).
• Data Provenance: Not explicitly stated. The bibliography titles suggest the studies are clinical investigations, likely prospective, evaluating the toothbrush's performance in human subjects. The affiliations of the researchers would likely indicate the countries where the studies were conducted (e.g., "Am J Dent" suggests American journals).

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

This information is not provided in the summary. Clinical studies on oral hygiene typically involve dentists, periodontists, and dental hygienists as examiners to assess clinical parameters (e.g., gingival index, plaque index, bleeding on probing). The document does not specify the number or qualifications of experts involved in the reported studies.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Clinical studies often employ blinding and standardized assessment protocols to minimize bias, but specific adjudication methods (like 2+1 review for discrepancies) are not detailed 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 section is not applicable. The device is a powered toothbrush, not an AI-powered diagnostic imaging tool. Therefore, there is no concept of "human readers" or "AI assistance" in the context described. The studies cited compare the powered toothbrush to manual toothbrushes or other powered toothbrushes, assessing clinical outcomes, not diagnostic accuracy.

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

This section is not applicable. As mentioned above, this is a physical medical device (powered toothbrush), not an algorithm or AI. Its performance is directly tied to its use by an individual.

7. The Type of Ground Truth Used

For the clinical studies referenced, the "ground truth" would be the clinical assessments of oral health parameters by trained professionals. This includes:

• Measurement of plaque accumulation (e.g., using a plaque index).
• Assessment of gingivitis severity (e.g., using a gingival index).
• Measurement of bleeding on probing.
• Evaluation of oral soft and hard tissue for safety (e.g., presence of abrasions, lesions).

These are direct clinical observations and measurements, often considered the gold standard for evaluating oral hygiene devices.

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models. For a conventional physical device like a toothbrush, clinical studies are conducted to test its performance, not to "train" it.

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

This information is not applicable as there is no "training set" in the context of this device. The clinical studies establish the effectiveness and safety for the intended use.

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The Braun ThermoScan IRT 2000 infrared ear thermometer is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.

Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared energy that is emitted from the tympanic membrane and surrounding tissue.

Here's a breakdown of the acceptance criteria and study information for the Braun ThermoScan IRT 2000, based on the provided text:

Acceptance Criteria and Device Performance

The submission states that the Braun ThermoScan IRT 2000 has the same accuracy and reliability specifications as its predicate device, the Braun ThermoScan IRT 4000 Series. It also explicitly states: "The accuracy and reliability specifications are the same for the IRT 2000 and IRT 4000 series thermometers." The document does not provide specific numerical acceptance criteria (e.g., a ± tolerance for temperature readings). Instead, it relies on substantiating that the new device performs at least as well as the legally marketed predicate.

The primary performance claim is that the device "measures ear canal temperature as well as the previously 510(k) cleared IRT 4000 series thermometers in all age groups" and that "Differences were within clinical acceptability." Its clinical repeatability is also stated as "statistically and clinically acceptable."

While no explicit table is provided in the document, here's a representation of what can be inferred:

Study Details

The document describes a clinical comparison study rather than an isolated standalone performance study with predefined numerical thresholds. The study's main goal was to demonstrate equivalence to the predicate device.

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

   • Test set sample size: Not explicitly stated as a single number. The study was performed on "four age groups: 0-3 years, 4-10 years, 11-65 years, and >65 years." The exact number of participants within each group or total participants is not provided.
   • Data provenance: Not explicitly stated, but clinical studies for medical devices are generally prospective when compared to a predicate like this. No mention of country of origin.

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

   • Not applicable/Not stated. The ground truth for this device (body temperature) is established through comparison with other established temperature measurement methods (ear canal, oral, and axillary sites), not through expert consensus on images or interpretations.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used when subjective interpretations (e.g., image reading) need to be reconciled. For temperature measurements, the readings are direct.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is not relevant for an infrared thermometer. The study performed was a clinical comparison of the new device to a predicate and to other established temperature measurement sites.
   • Effect size of human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device for interpretation.

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

   • Yes, implicitly. The clinical comparison and repeatability testing described is the standalone performance of the device without human interpretation of its output (beyond reading the displayed temperature). The device itself measures and displays the temperature. While a human uses the device, the performance being evaluated is the device's accuracy and repeatability in measuring temperature.

6. The type of ground truth used:

   • The "ground truth" was established by comparing the IRT 2000's ear temperature readings to:
     • Readings from the predicate device (Braun ThermoScan IRT 4000 Series).
     • Temperatures measured at "oral and axillary sites." These are considered standard clinical methods for temperature measurement.

7. The sample size for the training set:

   • Not applicable. The Braun ThermoScan IRT 2000 is a hardware device that measures infrared energy; it does not utilize machine learning or AI that would require a "training set" in the conventional sense. Its "training" is inherent in its design and calibration processes.

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

   • Not applicable, as there is no training set in the context of machine learning. The device's calibration and design would have been based on physical principles of infrared measurement and established temperature references, but not a data-driven "training set."

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PRO 4000 series: The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.
IRT 4000 series: The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.

Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared enerqy that is emitted from the tympanic membrane and surrounding tissue.

Here's an analysis of the provided text regarding the Braun ThermoScan IRT/PRO 4000 series, addressing your specific points:

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

The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges, repeatability standard deviations) for the device's performance. Instead, it refers to compliance with consensus standards and clinical acceptability.

• ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
• IEC 60601-1:1988 Cor 1 1995 Medical Electrical Equipment Part 1 General requirements for Safety
• IEC 60601-1:1998 Medical Electrical Equipment Part 1 General requirements for Safety, 1998; Amendment 1, 1991-11, Amendment 2, 1995-03
• IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4 General requirements for Safety - Collateral Standard: Programmable Electrical Medical Electrical Systems
• IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 General requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
• AAMI/ISO 14971:2000 -- Medical Devices -- Application of Risk Management to Medical Devices
• AAMI/ISO 14971-1:2000 - Medical Devices - Risk Management - Part 1: Application of Risk Analysis
• EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects
• EN 980:1997+ A1:1999 Graphical Symbols for Use in the Labeling of Medical Devices
• ISO 15223:2000 Symbols Used with Medical Device Labels, Labeling, and Information to be Supplied |
  | Clinical Equivalence/Performance | "This clinical comparison study demonstrated that the Braun ThermoScan IRT 4000 measures ear canal temperature as well as the previously approved model IRT 3000 in all age groups."
  "The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites. Differences were within clinical acceptability."
  "The clinical repeatability of the device is statistically and clinically acceptable." |
  | Consumer vs. Professional Comparability | "Consumers' measurements obtained were comparable to the professional measurements, collectively, for pooled professionals, and each individual category of professionals."
  "The repeatability of temperatures obtained from the consumers was comparable to the repeatability of the temperatures obtained from the professionals." |
  | Safety and Effectiveness | "Therefore the IRT/PRO 4000 series thermometers do not raise any significant questions of safety or effectiveness." |

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

• Sample Size: The document states that a comparison study and clinical repeatability testing were performed on "the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years." However, specific numerical sample sizes for each group or the total test set are not provided.
• Data Provenance: The document does not specify the country of origin for the data.
• Prospective/Retrospective: The language "A comparison study and clinical repeatability testing was performed" suggests a prospective study design.

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)

The document mentions "health care professionals" in the context of the consumer vs. professional comparability study, but does not specify the number or qualifications of experts (e.g., physicians, nurses) used to establish ground truth or conduct the clinical comparisons. It only states that "pooled professionals" and "each individual category of professionals" were compared.

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

The document does not describe any adjudication method used for establishing ground truth or resolving discrepancies in measurements.

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: This is not applicable to this device. An infrared ear thermometer is a diagnostic tool that provides a direct measurement, and its operation does not involve "readers" in the sense of interpreting complex images or data fields that would typically require multi-reader studies or AI assistance for human improvement. The closest comparison is the "Consumer vs. Healthcare Professional Comparability Study," which assessed if different users (consumers vs. professionals) achieved comparable results, not how professionals improved with AI.
• Effect Size of AI improvement: No AI component is described in the device, and therefore no effect size of AI assistance for human readers is mentioned or relevant.

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

The device is an infrared ear thermometer, which is inherently a "standalone" device in its functional output of a temperature reading. It does not involve complex algorithms or human interpretation of an algorithm's output in the way that an AI diagnostic tool would. The device provides a direct measurement.

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

The document implicitly refers to traditional "gold standard" temperature measurement methods for comparison:

• "The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites." This implies that oral and axillary temperature measurements were used as a reference or a type of "ground truth" to which the ear thermometer's readings were compared.

8. The sample size for the training set

The document does not describe a "training set" as would be relevant for a machine learning model. This device is a physical measurement instrument, not an AI/ML system requiring a dedicated training phase with labeled data in the typical sense.

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

As there is no described training set for an AI/ML model, this question is not applicable. The device's operation relies on established physics of infrared measurement and calibration, not on a data-driven training process.

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The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional environment. Use may be initiated as part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.

The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.

Here's a breakdown of the acceptance criteria and study information for the Braun PrecisionSensor™ Pro (BP2590) wrist blood pressure monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for blood pressure and pulse rate accuracy. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use. However, the implicit acceptance criterion is that the device performs at least as well as the predicate device and is suitable for its intended professional use.

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

The provided document does not include information about a specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary primarily asserts substantial equivalence based on modifications to an existing device rather than presenting new clinical study data for device accuracy.

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

This information is not provided in the document. As there's no detailed clinical study presented, there's no mention of ground truth establishment by experts for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool.

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

The document does not describe a standalone performance study for an algorithm. The device itself is a standalone blood pressure monitor; its performance is inherent to its design and oscillometric method.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any formal clinical validation study. Given the nature of a blood pressure monitor and the 510(k) summary's focus on substantial equivalence, it's highly probable that if a validation study were conducted, it would involve comparison to a gold standard like auscultatory measurements by trained professionals or a thoroughly validated sphygmomanometer. However, this is an inference and not explicitly stated.

8. The Sample Size for the Training Set

There is no mention of a training set sample size in the provided document. As a conventional medical device (blood pressure monitor) relying on established oscillometric principles, it's unlikely to have a "training set" in the context of machine learning algorithms.

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

This information is not applicable as there is no mention of a training set or machine learning components.

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The Braun ThermoScan® PRO 3000 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature, by medical professionals. It is intended for use on people of all ages.

The Braun ThermoScan® PRO 3000 Infrared Thermometer is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Braun ThermoScan® PRO 3000 Infrared Thermometer.

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

The device also states it "meets the requirements established in ASTM Standard E 1965-98, 'Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature'."

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

• Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." While a specific total number of patients is not provided, the study indicates it covered four age groups: 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs.
• Data Provenance: Not explicitly stated, but based on the submitter's address (San Diego, CA) and assuming a clinical trial setting, it is likely prospective data collected in the USA.

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

This information is not provided in the document. The study compared the PRO-3000 to a predicate device (ThermoScan® IR-2000) rather than establishing ground truth against a specific expert reference.

4. Adjudication method for the test set

This information is not provided in the document. The study was a "comparison study" and "clinical repeatability 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

A MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, not an AI-assisted diagnostic tool. The study was a comparison of the new device against a predicate device.

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

Yes, a form of standalone performance was done for the device's accuracy characteristics, as it is a medical device that provides a direct measurement. The "Accuracy characteristics" table directly reports the device's accuracy against defined temperature ranges. The "Five Environment Accuracy Test" is also a standalone test.

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

The ground truth for the accuracy assessment seems to be a comparison against the predicate device (ThermoScan® IR-2000) and adherence to ASTM laboratory accuracy requirements. The clinical study specifically states: "The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups." For laboratory accuracy, it refers to "ASTM laboratory accuracy requirements."

8. The sample size for the training set

This device does not utilize a "training set" in the context of machine learning or AI. It is a measurement device, and its performance is based on inherent design and calibration, not learned parameters.

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

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

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