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Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.

Provides long lasting relief for up to 6 hours.

The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).

The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.

Here's an analysis of the acceptance criteria and study as described in the provided document:

This document is a 510(k) summary for the Oral-B® Dry Mouth Oral Rinse (K203567), which seeks to update its "Indications for Use" from providing relief for "up to 4 hours" to "up to 6 hours." The device itself is identical to a previously cleared predicate device (K201277).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents the acceptance criteria implicitly through the study's objective: to demonstrate longer-lasting relief. The performance is reported as the outcome of that demonstration, not against explicit, pre-defined quantitative thresholds in the same way one might see for, say, diagnostic accuracy.

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

• Sample Size: Not explicitly stated as a number. The document mentions "subjects with self-reported dry mouth symptoms."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "controlled, randomized, 3-treatment, parallel clinical study," indicating it was prospective.

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

• The study used "an Oral Examination" to identify subjects who experienced dry mouth symptoms. It's not specified how many experts conducted these examinations or their particular qualifications (e.g., dentist, physician, etc.).
• Ground truth was also partly established by "subject responses to the Dry Mouth Inventory (DMI) questionnaire," which is a self-reported measure.

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method for the test set or for establishing ground truth. The primary endpoints appear to be direct comparison of product efficacy against a control based on symptom relief.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This study evaluated the direct clinical effect of an oral rinse on dry mouth symptoms, not the performance of an AI algorithm assisted by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This document describes a medical device that is an oral rinse, not an AI algorithm. Therefore, there is no "algorithm only" performance to report.

7. Type of Ground Truth Used

• The ground truth for effectiveness was based on a combination of:
  • Clinical assessment: "Oral Examination" to determine dry mouth symptoms.
  • Patient-reported outcomes: "subject responses to the Dry Mouth Inventory (DMI) questionnaire" measuring dry mouth symptom relief.

8. Sample Size for the Training Set

• N/A. As this is not an AI/machine learning device, there is no "training set."

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

• N/A. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment for one.

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Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.

Provides long lasting relief for up to 4 hours.

The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).

The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.

The provided text describes the regulatory clearance for the Oral-B® Dry Mouth Oral Rinse and details its characteristics and performance. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device is based on a "substantial equivalence" determination rather than specific pre-defined acceptance criteria for performance metrics in the way a diagnostic device might have. Substantial equivalence means the device is as safe and effective as a legally marketed predicate device. The performance data presented focuses on demonstrating this equivalence.

Note: The "acceptance criteria" here are implied by the FDA's regulatory standard of substantial equivalence to a predicate device, rather than specific numerical targets for performance metrics often seen in diagnostic AI/ML device clearances.

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

• Sample Size for the test set: Not explicitly stated as a separate "test set" in the context of an algorithm evaluation. The clinical study was a controlled, randomized, 3-treatment, 3-period crossover clinical study. The number of participants in this study is not specified in the provided text.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The clinical study was described as "conducted" which implies prospective data collection. The country of origin of the data is not specified.

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

Not applicable. This device is an oral rinse, not a diagnostic imaging or AI device requiring expert ground truth for a test set. The clinical study evaluated subjective symptom relief and objective measures related to dry mouth.

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

Not applicable. This is not a diagnostic device requiring adjudication of 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

Not applicable. This is an oral rinse, not an AI-assisted diagnostic device.

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

Not applicable. This is an oral rinse, not an algorithm. The "device performance" refers to the product's physical and clinical efficacy.

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

For the clinical study, the "ground truth" or primary outcome measures were likely:

• Subjective symptom relief: Patient-reported experiences of dry mouth moisturization and relief.
• Duration of effect: Measured time until symptoms returned or relief diminished.
• The comparison to water served as a control.

8. The sample size for the training set

Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.

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

Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.

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The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.

The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).

The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.

Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:

Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:

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

   • For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
   • For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
   • For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
   • Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.

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. This is a physical powered toothbrush, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:

   • Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
   • Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
   • Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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The TAMPAX® M Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

This document is a 510(k) summary for a menstrual tampon, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study to prove a device meets specific performance criteria.

Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the information that can be extracted, and where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. This document refers to nonclinical tests and extractions, which typically involve a smaller number of physical units for engineering-style testing rather than a large clinical test set.
• Data Provenance: Not specified, but given the nature of the tests (engineering/material characterization), it would be internal lab data, likely from the US, created for this submission. It is retrospective in the sense that the testing was performed to support this submission.

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

• Not applicable. This submission focuses on nonclinical performance testing and substantial equivalence, not the establishment of ground truth by human experts for a diagnostic or prognostic device.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Testing involves objective measurements of physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a menstrual tampon, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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

• Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the nonclinical tests, the "ground truth" is based on pre-defined engineering specifications, material standards, and performance characteristics of the legally marketed predicate device (K081555). For material safety, previous biocompatibility testing results for similar devices serve as a basis.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. See point 8.

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The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.

The provided text describes a 510(k) premarket notification for a medical device (TAMPAX® V Plastic Applicator Tampons, unscented) and not a study assessing an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance based on the information provided regarding the nonclinical tests and consumer preference testing.

Here's the 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)

• Sample Size: Not explicitly stated for any of the nonclinical tests. For "Consumer Preference In-use Testing," the sample size is not provided, only the outcome.
• Data Provenance: Not explicitly stated. The studies were conducted by The Procter & Gamble Company. Given the typical regulatory context for US FDA submissions, these tests would likely have been conducted in a controlled laboratory setting (for nonclinical) and with a consumer panel (for in-use testing), presumably within the US or compliant with international standards, but no country of origin is specified. The studies appear to be prospective for the current device's evaluation.

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

This is not applicable as the device is a physical medical device, not an AI model requiring expert-established ground truth. The "ground truth" for the nonclinical tests is based on established scientific measurement standards for features like strength, fluid absorption, and microbial growth, and for in-use testing, it's based on user feedback.

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

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI model ground truth.

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. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for this device's performance evaluation includes:

• Established scientific/engineering measurements: For nonclinical tests like Syngyna, expulsion force, and withdrawal cord strength, the "ground truth" is derived from standardized physical and chemical testing methods.
• Microbiological assays: For S. aureus growth and TSST-1 production, the "ground truth" comes from controlled laboratory experiments measuring bacterial growth and toxin levels.
• Consumer self-reporting/feedback: For consumer preference in-use testing, the "ground truth" is based on the subjective experiences and reports of the participants regarding comfort and adverse events.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

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The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Unscented menstrual tampons for absorption of menstrual fluid

The provided document is a 510(k) summary for a medical device (TAMPAX® C Plastic™ Tampons, unscented). This type of document is submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the study design and acceptance criteria differ significantly from what would be expected for a novel AI/software device. The document primarily focuses on non-clinical testing to establish equivalence based on material safety and specific design characteristics, rather than diagnostic performance metrics typical for AI studies.

Here's an analysis of the "acceptance criteria" and "study" described, interpreted within the context of a 510(k) submission for a tampon:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each test in the way an AI study would. Instead, it mentions "Extractions of the 510(k) device plastic applicators were performed," "Tests of the 510(k) tampon applicator expulsion force showed," "Tests of the seal strength... and peel strength... of the 510(k) modified wrapper showed."

• Test Set Sample Size: Not specified quantitatively. The implication is that sufficient units were tested to demonstrate compliance with the criteria and similarity to the predicate.
• Data Provenance: This is not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data is generated from laboratory testing of the physical device and its components.

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

• Number of Experts: Not applicable. For this type of device, "ground truth" is established by direct physical measurements and engineering standards, not by expert interpretation of clinical data.
• Qualifications of Experts: Not specified, but implied to be technicians or engineers qualified to perform the described physical and chemical tests (e.g., performing extractions, operating Thwing-Albert and Instron machines).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no expert adjudication for physical/chemical test results as there would be for medical image interpretation or clinical outcomes. The results are objective measurements against predefined specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and AI assists that interpretation. This is a physical, non-AI medical device.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is not an algorithm. Its "performance" is its physical characteristics and safety, measured directly.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on engineering specifications, material science principles, and direct physical/chemical measurements. The primary method for establishing "equivalence" (which is the goal of a 510(k)) is by comparing these measured characteristics to those of the predicate device and established safety standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

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

Summary in the Context of a 510(k) Submission:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TAMPAX® Pearl Tampons, unscented, K081555). The "study" conducted for this device is a series of non-clinical, laboratory-based tests. The acceptance criteria essentially boil down to:

• The new device (TAMPAX® C Plastic™ Tampons) must exhibit material safety equivalent to or better than the predicate.
• Its functional physical characteristics (applicator expulsion force, wrapper integrity, pledget design, fluid handling) must be similar to or within acceptable limits compared to the predicate device.

The study "proves" the device meets these criteria by showing that the results of the specific physical and chemical tests either match the results of the predicate device (where available) or fall within established acceptable ranges for safe and effective use. The changes made (pigment addition, applicator shape, wrapper modification) were assessed to ensure they did not negatively impact the safety or fundamental performance, and the evidence provided supports this conclusion for FDA's substantial equivalence determination.

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Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.

Vicks Powershot Dry Throat and Mouth Relief Liquid – For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.

Vicks Powershot Dry Throat and Mouth Relief is available for application cither as a spray or as a bulk liquid, the latter using a dispensing cup. It is a device intended for over-the-counter (OTC) consumer use. The device delivered as a spray form will be packaged in a 1.01 Fl.Oz. (30 mL) polyethylene tercphthalate (PET) plastic bottle and will be dispensed from the bottle via a positive displacement pump. The device delivered using a dispensing cup will be packaged in a 6 Fl.Oz (177mL) PET plastic bottle and will be dispensed via a polypropylene dispensing cup. The device is a clear liquid and contains polymers, including carboxymethylcellulose (CMC) that is known to coat and lubricate, as well as components that function as humectants and solvents. The device is preserved and lightly flavored for improved taste. Upon application the device coats and lubricates the mucus membrane of the mouth and oropharynx thereby providing immediate relief of dryness. The device thus functions as an artificial saliva device.

The provided text is a 510(k) Premarket Notification for Vicks Powershot Dry Throat and Mouth Relief. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive clinical study data to prove novel safety and effectiveness. Therefore, the document does not describe a study that establishes acceptance criteria for performance metrics in the way a traditional clinical trial or performance study would.

Instead, the submission focuses on comparing the new device's technological characteristics and intended use to existing predicate devices to argue for substantial equivalence.

Based on the provided text, here’s a breakdown of the requested information:

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

The document does not specify quantitative acceptance criteria or corresponding performance metrics for the Vicks Powershot device. The basis for acceptance is substantial equivalence to predicate devices, which implies that its performance is considered comparable without requiring specific numerical targets beyond those inherent in the predicate's marketing.

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

No specific test set or sample size for performance evaluation is mentioned. The submission relies on a comparison of device characteristics and intended use.

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. There is no mention of experts establishing ground truth for a test set, as no such performance study is described.

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

Not applicable. No test set or expert 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. This device is not an AI-assisted diagnostic tool, and no MRMC study or AI component is mentioned.

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

Not applicable. This device is a physical product (artificial saliva device), not an algorithm or AI.

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

Not applicable. The submission does not describe a study involving "ground truth" establishment in the context of diagnostic accuracy. Its "ground truth" for marketing approval is its similarity to already approved devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that requires a "training set."

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

Not applicable. This device is not an AI/ML product, and thus no training set or ground truth for it was established in this context.

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