Search Results

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

CloSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to alleviate the symptoms of dry mouth for home use. The formulation includes water, humectants/ moisturizers, flavors, sweeteners, as well as ingredients with lubricating, soothing, and refreshing properties. The product is a ready-to-use, non-sterile, semi-viscous clear liquid, packaged in 16.0 FL OZ white High-Density Polyethylene (HDPE) bottles within a carton. Accelerated stability testing of the finished product supports a shelf life of 2 years. The rinse is formulated to have similar properties as predicate product Biotene Dry Mouth Oral Rinse Fresh Mint, which is a medical device 510(k) Number K123731 and the reference device Hydris™ Oral Rinse cleared under K163029. CloSYS® Dry Mouth Sensitive Mouth Rinse will be available in 16 fl oz (473 mL) PET bottles in a carton.

The provided FDA 510(k) clearance letter and summary for the CloSYS® Dry Mouth Sensitive Mouth Rinse focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical testing. This type of submission generally does not include extensive clinical studies or acceptance criteria tables related to device performance as you might find for novel drug or high-risk medical device approvals.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance for an AI/software device are not applicable to this particular 510(k) summary for a dry mouth rinse.

Here's an analysis based on the provided document:

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

The document does not present a formal table of acceptance criteria for specific performance metrics (like efficacy percentages, reduction in dry mouth symptoms, etc.). For this type of device, substantial equivalence is primarily evaluated based on similar indications for use, technological characteristics (ingredients, presentation, function), and safety (biocompatibility, stability).

The "performance" reported is related to safety and stability, rather than clinical efficacy against a specific quantitative target.

• Results: Assays demonstrated an acceptable biocompatibility profile consistent with the predicate. |
  | Stability | - Stability Studies: Stability of the finished product is monitored at room temperature and under accelerated conditions.
• Results: Accelerated stability testing supports a shelf life of 2 years. |
  | Technological Equivalence| - Same Intended Use: Relieves symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, lubricates oral dryness.
• Same Technology: Ready-to-use liquid, similar ingredients/solvents/moisturizers/sweeteners/thickeners. |

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

Not applicable in the context of this 510(k) for a dry mouth rinse. The non-clinical studies mentioned (biocompatibility, stability) would have their own sample sizes (e.g., number of cell cultures, animal subjects, or product batches tested), but these are not specified in this summary. There is no "test set" here in the sense of a clinical trial cohort or an AI model's validation dataset.

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

Not applicable. There is no "ground truth" derived from expert consensus for clinical performance in this submission. Safety assessments (biocompatibility) would be evaluated by toxicologists/biocompatibility specialists, and stability by analytical chemists, but these are not clinical "experts" establishing a disease-related ground truth in the manner implied by the question.

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

Not applicable. No clinical test set or adjudication method is described in this 510(k) summary.

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 a mouth rinse, not an AI or imaging device that would involve human readers or MRMC studies.

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

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

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

For the safety studies, the "ground truth" is based on established scientific methods and ISO standards for biocompatibility (e.g., cell viability, irritation scores, sensitization reactions). For stability, it's based on analytical measurements over time compared to pre-defined specifications. There is no clinical "ground truth" (like pathology results for a diagnostic device) mentioned for this type of product in this summary.

8. The sample size for the training set

Not applicable. There is no "training set" for this kind of medical device approval. This concept applies to machine learning models, not physical products like a mouth rinse.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device

Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.

Salivea Dry Mouth Moisturizing Gel are specially formulated artificial saliva which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Salivea Dry Mouth Moisturizing Gel is supplied in 1 oz tube and sample foil pack.

Please note that the provided document is a 510(k) summary for a medical device (Salivea Dry Mouth Moisturizing Gel), which is a non-AI/ML device. Therefore, many of the requested criteria related to AI/ML model development and validation (e.g., test set data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, manufacturing, and non-clinical performance (biocompatibility, stability, physical properties).

Here's an analysis based on the information provided, highlighting what is applicable and what is not:

Acceptance Criteria and Study for Salivea Dry Mouth Moisturizing Gel

1. Table of Acceptance Criteria and Reported Device Performance

For this non-AI/ML device, "acceptance criteria" are typically related to physical properties, biocompatibility, and stability, rather than machine learning performance metrics. The document confirms that these criteria were met.

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

• Sample Size: Not explicitly stated in the context of a "test set" for performance evaluation in the way an AI/ML model would have one. For physical and biocompatibility testing, standard sample sizes according to relevant test methods would have been used but are not detailed here.
• Data Provenance: Not applicable in the context of a "test set" as understood for AI/ML. The data comes from the manufacturer's internal testing. The document does not specify the country of origin of the raw materials or testing facilities, nor does it refer to retrospective or prospective data collection from patients, as no clinical studies were performed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a non-AI/ML device. "Ground truth" in the AI/ML sense (e.g., expert annotations on images) is not relevant to its evaluation. The performance is assessed through biochemical and physical testing, and safety (biocompatibility) and stability studies, which rely on established laboratory standards and qualified technicians/scientists performing the tests.

4. Adjudication Method for the Test Set

• Not Applicable. No human "adjudication" of results in the AI/ML sense (e.g., resolving discrepancies in expert labels) was required. Test results are objective measurements from laboratory equipment or standardized biological assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of AI on human interpretation (e.g., radiologists reading images). Since this is a moisturizing gel and its evaluation did not involve human readers interpreting data, an MRMC study was not performed.

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

• Not Applicable. This is not an algorithm. Therefore, "standalone performance" of an AI algorithm is not relevant.

7. The Type of Ground Truth Used

• Not Applicable in the AI/ML sense. For this device, "ground truth" equates to:
  • Validated laboratory test methods: For pH, viscosity, specific gravity, and stability.
  • Standardized biocompatibility assays: Following ISO 10993 for irritation, sensitization, and toxicity.
  • Predicate device characteristics: The existing, legally marketed predicate devices serve as a benchmark for comparison regarding intended use, technological characteristics, and physiological purpose.

8. The Sample Size for the Training Set

• Not Applicable. This is a non-AI/ML device. There is no AI model, and therefore no "training set."

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

• Not Applicable. As there is no AI model or training set, "ground truth" establishment for a training set is not part of this submission.

Ask a specific question about this device

Caphosol® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol® is also indicated as an adjunct to standard oral care in treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

Caphosol® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjogren's syndrome; and Bell's Palsy.

Caphosol® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.

It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol® provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.

Caphosol® is an electrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. Caphosol® maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the: oral mucosa, as well as painful tongue conditions due to hyposalivation. Patients having this condition are also prone to dental caries and candidal infections.

Caphosol® is a partial substitute for natural saliva. Caphosol® facilitates chewing and speaking; loosens tough mucus; prevent mucous membranes from sticking together, helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. Caphosol® is an adjunct to standard oral care for treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration · of pain.

Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.

This document is a 510(k) Premarket Notification from the FDA regarding Caphosol® Artificial Saliva. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a performance study for new acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically in the context of an AI/human comparative effectiveness study, standalone algorithm performance, or training set details, is not present in this document.

The document states: "No performance testing was conducted." This explicitly indicates that a study demonstrating device performance against acceptance criteria, as typically understood for medical device efficacy or AI performance, was not performed or submitted for this specific 510(k).

The "Substantial Equivalence" section details how the new device (Caphosol® in sachets) is compared to the predicate device (Caphosol® in vials). The core of the submission is that the new device has not changed its composition or indications for use, and the only difference is the packaging (sachets versus vials).

Here's the information that is available in the document, largely pertaining to the comparison with the predicate:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present a table of new acceptance criteria and corresponding device performance data from a new study. Instead, it compares the characteristics of the subject device (Caphosol® in sachets) to the predicate device (Caphosol® in vials) to establish substantial equivalence.

   Feature	Caphosol® Artificial Saliva in sachets (Subject Device)	Caphosol® Artificial Saliva in vials (Predicate Device K030802)
   Product Code	LFD	LFD
   Indications for Use	Same as Predicate	Same as Subject
   Device Description	Same as Predicate (electrolyte solution resembling human saliva)	Same as Subject
   Composition (% w/w)	Dibasic Sodium Phosphate 0.032	Dibasic Sodium Phosphate 0.032
   	Monobasic Sodium Phosphate 0.009	Monobasic Sodium Phosphate 0.009
   	Calcium Chloride 0.052	Calcium Chloride 0.052
   	Sodium Chloride 0.569	Sodium Chloride 0.569
   	Purified Water 99.338	Purified Water 99.338
   Package	sachets	vials
   Shelf Life	3 years	3 years
   Shelf Life Testing	Yes (includes liquid and package testing)	Yes (includes liquid and package testing)

2. Sample size used for the test set and the data provenance: Not applicable. The document states "No performance testing was conducted." The "testing" mentioned refers to accelerated shelf-life testing, not clinical or performance efficacy trials with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.

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 an artificial saliva solution, not an AI-powered diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as "No performance testing was conducted."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device; therefore, no training set was used.

9. How the ground truth for the training set was established: Not applicable. (See answer to #8).

In essence, this 510(k) submission leverages the substantial equivalence pathway, asserting that because the active ingredients, concentration, and intended use of the Caphosol® product remain identical to the previously cleared predicate, and only the packaging format has changed (from vials to sachets), no new performance data is required to establish safety and effectiveness. Shelf-life testing was conducted to ensure the integrity of the new packaging and the stability of the liquid over time, which is considered "similar" to the predicate's testing, with minor adjustments for the flexible package type.

Ask a specific question about this device

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).

The provided document, a 510(k) Pre-market Notification for GuruNanda Dry Mouth Oral Rinse and Spray, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-based medical devices.

This document is a Substantial Equivalence (SE) Determination letter for a non-AI/ML device (dry mouth rinse and spray). In such cases, the primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a predicate device that is already legally marketed. This typically involves comparing intended use, technological characteristics, materials, and performance to the predicate device.

Therefore, many of the specific questions you've asked, which are highly relevant to the evaluation of AI/ML-based medical devices (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance, ground truth establishment), are not applicable to this submission.

Here's a breakdown of what can be extracted from the document in relation to your questions, and what cannot:

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

• Not Applicable in the traditional sense for this type of device. The 'acceptance criteria' for this submission are rooted in demonstrating substantial equivalence to the predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731).
• The "reported device performance" is essentially the comparison table on pages 5-6, which shows an identical intended use, similar design, materials, chemical composition (with minor, stated differences in preservatives), and performance characteristics (e.g., appearance, color, odor, method of use, target population).
• Performance is demonstrated through:
  • Biocompatibility testing: "Cytotoxicity, sensitization, irritation tested and passed in conformity with ISO 10993-5, ISO 10993-10, 10993-23." This is a key safety performance aspect for a device that contacts mucosal membranes.
  • Chemical composition comparison: The document states that differences are minor and do not affect safety and effectiveness, and variations are "designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications."

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

• Not Applicable. This is not an AI/ML device that underwent a clinical performance study with a test set of patient data. Performance is primarily demonstrated through bench testing (like biocompatibility and chemical analysis) and comparison to a predicate.

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

• Not Applicable. Ground truth, in the context of diagnostic or AI performance, is not a concept that applies to this type of device submission.

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

• Not Applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an imaging or diagnostic device that would use human readers or AI assistance.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device, and the demonstration that the new device shares fundamentally similar characteristics.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable.

Summary of Device Acceptance/Proof based on this Document:

The acceptance of the GuruNanda Dry Mouth Oral Rinse and Spray is based on its demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731). The "study" proving this meets criteria is primarily a comparison and analysis of attributes rather than a clinical trial or AI performance study:

• Intended Use: Identical ("Relieve the symptoms of dry mouth: refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.")
• Technological Characteristics: Very similar design, materials, and chemical composition. Minor differences in chemical composition (e.g., preservatives) are justified as not impacting safety or effectiveness, citing GRAS status or history of safe use.
• Performance: Demonstrated through:
  • Biocompatibility testing: Confirmed to meet ISO standards (ISO 10993-5, 10993-10, 10993-23) for cytotoxicity, sensitization, and irritation.
  • Chemical analysis: The variations in formula/composition are stated not to alter function or safety.
  • Physical characteristics: Similar appearance, color, odor.
  • Shelf-life: While the predicate had a 3-year shelf life and the new device a 2-year shelf life, this difference was presumably accepted as not raising new questions of safety or effectiveness.

In essence, the "proof" is that the device is so similar to an already cleared device that it does not raise new questions of safety or effectiveness.

Ask a specific question about this device

Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Dentilube dry mouth spray is a viscous pink electrolyte-containing solution that is designed to mimic the compositions and actions of saliva to moisturize, and refresh the mouth. It provides a lubricating and moisturizing coating inside the mouth, thereby relieving symptoms of dry mouth. The product is supplied in 50mL or 100 mL PET bottles.

The provided text describes the acceptance criteria and performance data for the Dentilube dry mouth spray (K202689). The study is a non-clinical performance test to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.

Here's the breakdown of the requested information:

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

The acceptance criteria are implicitly defined by demonstrating "similarity" or "sameness" to the predicate device, BioXtra® Moisturizing Gel (K072306), across various attributes and physical properties. The performance is reported against these comparative attributes.

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

The document does not detail a specific "test set" in the context of a clinical study with human subjects. The performance testing described is primarily non-clinical performance testing (e.g., pH, viscosity, specific gravity, shelf-life, biocompatibility). It aims to demonstrate that the physical and chemical properties of the device are substantially equivalent to the predicate device. Therefore, a sample size for a clinical test set is not applicable here.

The data provenance is not specified beyond being generated by Oxy2plus, LLC for the purpose of this 510(k) submission.

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. This is not a study involving expert assessment of images or clinical outcomes. The "ground truth" for the non-clinical tests are standard physical and chemical measurements (e.g., pH meter readings, viscometer readings).

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

Not applicable. No expert adjudication process is described as this is a non-clinical, comparative assessment of product characteristics.

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. This document describes a medical device (dry mouth spray), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

No. This is a physical product, not an algorithm.

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

For the non-clinical performance tests:

• Physical Property Measurements: The ground truth for properties like pH, viscosity, specific gravity, and solubility are the direct measurements obtained through standard laboratory instruments and methods.
• Shelf-Life/Stability: Determined by degradation studies over time.
• Biocompatibility: Determined by adherence to ISO 10993 standards (e.g., cytotoxicity assays, sensitization studies, irritation tests).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.

OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump. The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.

This document describes the premarket notification for OraLabs Dry Mouth Pocket Spray, and outlines its substantial equivalence to the predicate device, Biotene Moisturizing Mouth Spray. It is important to note that this document pertains to a device that delivers a substance (dry mouth spray) and not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth establishment for training sets, MRMC studies, AI assistance effect size) are not applicable to this submission.

Here's a breakdown of the information provided, addressing the applicable questions:

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

The document does not explicitly present "acceptance criteria" in a typical tabular format with pass/fail metrics. Instead, it describes performance testing conducted to demonstrate "substantial equivalence" to the predicate device. The performance data presented below indicates comparative results used to support this claim, rather than pre-defined acceptance thresholds.

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

The document does not specify sample sizes for most of the performance tests (e.g., pH, viscosity, moisture deabsorption, appearance, sensory properties, elemental impurity).

For biocompatibility testing, it's implied that individual samples of both OraLabs and Biotene products were tested. The specific number of replicates/samples for cytotoxicity, sensitization, and irritation is not stated.

For stability testing, the product was filled into "individual spray bottles," and tested at Baseline, 3 months, and 6 months intervals. The exact number of bottles/samples tested at each interval is not specified.

The data provenance is from OraLabs, Inc. (Parker, Colorado, USA) and is prospective as it involves the testing of their new device.

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

This question is not applicable. This is a medical device (a spray product), not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for this type of device is established through physical and chemical property testing, and comparison to a legally marketed predicate device.

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

This question is not applicable. There were no human expert adjudications for the test results of this product. The evaluation relies on laboratory test results.

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 question is not applicable. This is not an AI/ML powered device, and therefore no MRMC study involving human readers or AI assistance was conducted.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no standalone algorithm performance was assessed.

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

The "ground truth" for mechanical/chemical performance was established through laboratory testing (e.g., pH meters, viscometers, chemical analysis, microbiological assays, biocompatibility assays). For the purpose of regulatory clearance, the implicit ground truth is that the device should demonstrate substantially equivalent performance characteristics to the legally marketed predicate device (Biotene Moisturizing Mouth Spray) in terms of safety and basic functionality.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML powered device, and therefore no training set was used.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no training set or its ground truth were established.

Ask a specific question about this device

MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.

MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when dissolved in water). MucoPEG™ is formulated as a powder and packaged in a single-use packet.

The provided text describes the regulatory clearance for a device called MucoPEG™. It does not contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility.

Therefore, the following information cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: The document presents a comparison table between the subject device (MucoPEG™) and a predicate device (Hydris™ Oral Rinse) in terms of regulatory information, ingredients, conditions of use, physical properties, and biocompatibility. It does not define explicit "acceptance criteria" for MucoPEG™ in the typical sense of a performance study with a target metric. Instead, it aims to show similarity or non-inferiority to the predicate.
• Sample size used for the test set and data provenance: No test set is described in the context of an AI/ML or reader study. The "test" mentioned refers to non-clinical performance testing and biocompatibility.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set with ground truth established by experts.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no mention of an MRMC study or human reader improvement with AI assistance.
• Standalone (algorithm-only without human-in-the-loop performance) study: Not applicable. The device is an artificial saliva product, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document highlights the following non-clinical performance data and criteria for demonstrating substantial equivalence:

Acceptance Criteria (Implicit from Substantial Equivalence Comparison) and Reported Device Performance

The device MucoPEG™ demonstrated substantial equivalence to the predicate device Hydris™ Oral Rinse based on the following comparisons:

Summary of Relevant Information from the Document:

• Non-Clinical Performance Data: SunBio submitted the device for testing in accordance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), and ISO 10993-10 (sensitization).
• Physical Properties Tests: Side-by-side comparative testing was performed against the predicate device for:
  • Appearance
  • pH
  • Viscosity
  • Surface Tension
  • Moisturization/Hydration of cultured epithelial layer cells

The conclusion was that the device does not raise any new questions of safety and effectiveness when compared to the predicate device, leading to a determination of substantial equivalence.

Ask a specific question about this device

Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.

SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.

The provided document is a 510(k) summary for the SmartMouth® DryMouth Oral Rinse. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies like those for novel high-risk devices.

Therefore, the sections of your request regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this document, as it describes a clearance process for a low-risk, unclassified device based on substantial equivalence.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: For this 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to the predicate devices (Biotene Dry Mouth Oral Rinse K123731 and Hydris Oral Rinse K163029) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
• Reported Device Performance:
  • Indications for Use: The device provides relief of symptoms and discomfort of dry mouth; refreshes, moisturizes, rehydrates, cleans, soothes oral irritation and lubricates oral dryness. It also freshens breath. These are largely identical to the predicate devices, with "freshens breath" being an additional claim.
  • Technological Characteristics: The device is a "formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, and colorant" for at-home oral cavity use.
  • Shelf-life: 36 months, same as the primary predicate device.
  • Physical Properties: Demonstrated substantial equivalence to predicate devices in Appearance, Color, Odor, pH, Viscosity, Specific Gravity, and Water Content through comparative physical property data.
  • Biocompatibility: Assessed in accordance with ISO 10993-1, demonstrating safety for use as directed.

The document provides a comparison table of the proposed device against the predicate devices (see page 5 and 6 of the original document). This table effectively serves as the "performance against criteria" for this type of submission.

Table of Performance Comparison (Derived from the document):

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

• Not Applicable. This submission did not involve a test set for clinical performance evaluation. Non-clinical tests were conducted on the device itself (e.g., shelf-life, physical properties, biocompatibility).

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

• Not Applicable. No clinical test set or "ground truth" establishment by experts was part of this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication was part of this submission.

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 medical device (oral rinse), not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

• Not Applicable. This is a medical device (oral rinse), not an algorithm.

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

• Not Applicable. For the non-clinical tests conducted, the "ground truth" was based on established scientific methods for measuring physical properties, stability, and biocompatibility standards (e.g., pH meters for pH, viscometers for viscosity, ISO 10993-1 for biocompatibility). There was no "ground truth" in the clinical sense with patient outcomes or expert consensus.

8. The sample size for the training set

• Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set.

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

• Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set or ground truth for it.

Ask a specific question about this device