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The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

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This document is a 510(k) clearance letter from the FDA for Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, and Biotene Moisturizing Mouth Spray. It states that these devices are substantially equivalent to legally marketed predicate devices.

The information requested in the prompt regarding acceptance criteria and a study proving the device meets these criteria is typically found in the 510(k) submission itself, or in supporting documentation attached to the submission. This FDA clearance letter and its attached "Indications for Use Statement" do not contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document confirms the device names and their intended use to relieve symptoms of dry mouth. However, it does not provide any specific quantitative performance metrics, study results, or details on how substantial equivalence was demonstrated beyond the general statement of equivalence to predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text.

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Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.

Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains moisturizers, humectants, a protein, and patented salivary enzymes that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief:

First, it's critical to note that the provided documents are a 510(k) Summary and an FDA clearance letter. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through rigorous clinical trials like a PMA would. Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance metrics) is usually not extensively detailed or even present in a 510(k) summary for a device like this.

The "studies" mentioned are non-clinical assessments to demonstrate safety and stability, and a "use study" for effectiveness. These are typically not analogous to the algorithm performance studies one would see for AI/ML medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not quantitative metrics typical for an AI device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria for this device appear to be qualitative demonstrations of safety, stability, and effectiveness in relieving dry mouth symptoms, benchmarked against legally marketed predicate devices.

The FDA's clearance letter states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." implying it meets the effectiveness profile of the predicates. |
| Substantial Equivalence | Device is as safe and effective as a legally marketed predicate device. | The entire 510(k) submission and FDA clearance are based on demonstrating substantial equivalence to "Oral Balance Gel cleared in (K061331)" and "Oral Balance Liquid cleared in (K061331)". The "Substantial Equivalence Comparison Chart" (Section 6) details similar intended use, method of use, applications per day, disease state, area of use, and product type. |

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

The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. The studies mentioned ("Toxicology Assessment," "Stability Study," "Use Study") are non-clinical or general product performance evaluations. Therefore, sample sizes for these are not provided in this summary, and data provenance (country, retrospective/prospective) is also not detailed.

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

This information is not applicable to the provided document. The studies conducted (toxicology, stability, use study) for this type of device do not typically involve experts establishing "ground truth" in the way an AI algorithm for diagnostic imaging would.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no "test set" for an AI algorithm's performance is described.

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

No MRMC study is mentioned or implied. This device is an artificial saliva substitute, not an AI-assisted diagnostic tool that would typically undergo such studies.

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

Not applicable. This is not an AI algorithm; it's a topical medical device.

7. Type of Ground Truth Used

The concept of "ground truth" as applied to AI/ML algorithms is not relevant here. The "effectiveness" of the device was likely assessed through a "Use Study" where subjects used the product and reported symptomatic relief, or through objective measures relevant to dry mouth. Its safety was assessed via toxicology.

8. Sample Size for the Training Set

Not applicable, as there is no AI algorithm and therefore no "training set."

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

Not applicable, as there is no AI algorithm and no "training set."

Summary of Device and Approval Context:

This document describes the 510(k) clearance for "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief." The approval is based on demonstrating substantial equivalence to existing predicate devices (Biotene Oral Balance Gel and Liquid). The "studies" mentioned are:

• Toxicology Assessment: To demonstrate safety.
• Stability Study: To demonstrate product shelf-life and consistency over time.
• Use Study: To demonstrate effectiveness in relieving dry mouth symptoms.

These are common types of non-clinical and basic clinical/user studies for medical devices like artificial saliva substitutes, and do not involve the kind of rigorous performance metrics or AI-specific evaluation criteria found in AI/ML device clearances.

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Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.

Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.

The document is a 510(k) summary for a medical device (Biotène Dry Mouth Oral Rinse) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information Present in the Document:

• Device Description: Biotène Dry Mouth Oral Rinse is an artificial saliva substitute containing moisturizers, humectants, a protein, and salivary enzymes to relieve and treat dry mouth symptoms.
• Intended Use/Indications for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
• Predicate Devices: Laclede, Inc. Oral Balance Gel (K061331) and Oral Balance Liquid (K061331).
• Nonclinical Tests: The document states that "Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use."
• Clinical Tests: It states, "It has also been shown in clinical studies to be effective (Use Studies)." It then specifies, "No other clinical tests were performed other than a Use Study for this submission."

Information NOT Present in the Document (and therefore cannot be provided by me):

• A table of acceptance criteria and reported device performance: This is completely absent. The document only states it was shown to be "effective" in "Use Studies" but provides no quantitative results, metrics, or comparison to specific acceptance thresholds.
• Sample sized used for the test set and the data provenance: While a "Use Study" is mentioned, no details about its design, sample size, or data provenance are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not mentioned, as no specific ground truth or expert consensus method for a test set is described.
• Adjudication method for the test set: Not applicable or not mentioned.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for imaging diagnostics, not typically for oral rinse effectiveness.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical product, not an algorithm.
• The type of ground truth used: Not explicitly stated. For a "Use Study," it would likely be patient-reported outcomes or clinical assessment of dry mouth symptoms, but no specifics are given.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in that context.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text serves as a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence, not a detailed scientific report on a specific study with acceptance criteria and quantitative performance metrics. While it mentions "Use Studies" proving effectiveness, it does not elaborate on the methodology, results, or specific criteria met.

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Actiprotect™ UC N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of Influenza A viruses (tested against Influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer laver of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Actiprotect™ UC N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic straps are stapled or welded to the edge of the respirator and are used to secure the respirator to the user's face.

The provided text describes the Actiprotect™ UC N95 Respirator, a filtering facepiece respirator. The information focuses on its substantial equivalence to predicate devices and its performance in various nonclinical tests, rather than a typical AI-driven diagnostic device study. Therefore, many of the requested categories for AI device studies are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for each criterion. Instead, it describes various tests performed and implies that the device passed these tests, leading to a determination of substantial equivalence. The key performance claims relate to filtration efficiency and virus inactivation.

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

• Nonclinical Tests (Fluid Penetration, Filtration Efficiency, Flammability, Breathing Resistance): The document does not specify the sample sizes used for these tests. It simply states that the tests were conducted and passed according to the referenced standards (e.g., ASTM F1862, NIOSH 42 CFR 84.181). The data provenance is implied to be laboratory testing as part of the device development and regulatory submission process.
• Virus Inactivation: This was an "In vitro (laboratory)" test. The document does not specify the sample size (e.g., number of respirators tested) but lists a variety of Influenza A and B subtypes/strains that were tested. Data provenance is laboratory testing.
• Biocompatibility (Human Repeated Insult Patch Tests): The document states "samples of the respirator materials" were used. No specific number of human subjects is provided, but it indicates "There were no adverse reactions reported during the studies." The data provenance is from clinical (human) testing, likely conducted by the manufacturer or a contracted lab.

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

This section is not applicable as the device is a medical respirator, not an AI diagnostic device that requires expert interpretation for ground truth. Performance is determined by objective physical and chemical tests (e.g., filtration, virus inactivation, material biocompatibility).

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

This section is not applicable as the device is not an AI diagnostic device requiring human adjudication of results. Test results are based on standardized laboratory protocols.

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 personal protective equipment (respirator), not an AI system designed to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant. The submission explicitly states: "No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection."

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

This section is not applicable. The device is a physical product (respirator), not an algorithm or AI system.

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

The "ground truth" for this device is based on objective measurements and standardized test methods dictated by regulatory requirements and established scientific principles for respirators and material safety.

• For Filtration and Physical Performance: Compliance with standards (e.g., NIOSH 42 CFR 84.181 for particulate filtration efficiency, ASTM F1862 for fluid penetration). The "ground truth" is the quantitative measurement obtained per the standard.
• For Virus Inactivation: Laboratory in vitro tests demonstrating a 99.99% reduction in live virus on the surface under controlled conditions. The "ground truth" is the measured reduction in viral infectivity.
• For Biocompatibility: Results from established in vitro (cytotoxicity) and in vivo (human repeated insult patch tests) methods, indicating safety for human contact. The "ground truth" is the absence of adverse reactions or toxic effects according to these tests.

8. The sample size for the training set

This section is not applicable as this is not an AI or machine learning device that requires a training set.

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

This section is not applicable as there is no training set for this type of device.

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Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

Here's an analysis of the acceptance criteria and study information for the Actiprotect™ UF N95 Respirator, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Fluid Penetration Resistance (ASTM F1862): Not specified.
   • Particulate Filtration Efficiency (NIOSH 42 CFR 84.181): Not specified.
   • Bacterial Filtration Efficiency (MIL M36954C, ASTM F2101): Not specified.
   • Flammability (16 CFR 1610): Not specified.
   • Breathing Resistance (NIOSH 42 CFR 84.180): Not specified.
   • Influenza Virus Inactivation (In vitro): Not specified.
   • Human Repeated Insult Patch Tests: Not specified.
   • Data Provenance: The document indicates that the tests (Fluid Penetration, Particulate Filtration, Bacterial Filtration, Flammability, Breathing Resistance) are standardized tests (e.g., ASTM, NIOSH, MIL). The Human Repeated Insult Patch Tests are clinical tests conducted, but the location or specific institution is not mentioned, so the country of origin is unknown. The influenza inactivation tests were performed "in vitro (laboratory) tests."

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

   • This question is not directly applicable to the types of tests reported. The studies described are primarily bench/laboratory tests (e.g., filtration efficiency, fluid penetration, flammability, virus inactivation) adhering to standardized protocols, and biocompatibility tests (human repeated insult patch tests). These types of tests do not typically involve human experts establishing a "ground truth" in the way an imaging study or diagnostic accuracy study would. The pass/fail criteria are defined by the standards themselves.

3. Adjudication method for the test set:

   • Not applicable as the tests are objective, standardized measurements with predefined pass/fail criteria. There isn't a subjective "assessment" by experts that would require adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection."
   • Effect size of human readers improvement: Not applicable, as no MRMC study was conducted.

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

   • This device is a physical N95 respirator, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance tests described (filtration, resistance, flammability, virus inactivation, biocompatibility) are inherent to the physical device itself.

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

   • For the performance tests (filtration, fluid resistance, etc.), the "ground truth" is defined by the established criteria of the standardized test methods (e.g., ASTM, NIOSH, MIL standards). A device "passes" if its measured performance meets or exceeds these pre-defined thresholds.
   • For the influenza inactivation, the "ground truth" is the measured viral reduction percentage (99.99%) in controlled in vitro laboratory conditions, compared against a baseline.
   • For the biocompatibility tests, the "ground truth" for safety is the absence of adverse reactions (sensitization or irritation) in human subjects and the results of cytotoxicity tests.

7. The sample size for the training set:

   • This question is not applicable to the device described. The Actiprotect™ UF N95 Respirator is a physical medical device, not a machine learning algorithm that requires a "training set" of data.

8. 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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Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2JJP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic clastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

The document describes a series of nonclinical bench tests and clinical (biocompatibility) tests.

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

• Fluid Penetration Resistance, Particulate Filtration Efficiency, BFE, VFE, Flammability, Breathing Resistance: The document states "standardized tests" were performed and the device "passed." Specific sample sizes for these tests are not provided in the document. The data provenance is implied to be from laboratory testing as part of the device's manufacturing and regulatory submission. No specific country of origin for this testing data is explicitly stated, though the manufacturer is based in France and the applicant in the USA.
• Biocompatibility (Cytotoxicity): The document states "cytotoxicity" testing was conducted. Specific sample sizes are not provided. The provenance is laboratory testing.
• Biocompatibility (Human Repeated Insult Patch Tests): The document states "Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches." Specific subject sample sizes are not provided. The provenance is clinical testing on human subjects.
• Influenza A Virus Inactivation (In vitro testing): The document states "In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses..." The number of samples/replicates for the in-vitro testing is not provided. The provenance is laboratory testing, in vitro.

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

This information is not applicable and not provided in the document. The tests performed are primarily objective performance benchmarks (e.g., filtration efficiency, flammability, virus inactivation rates) or biocompatibility studies, which do not typically involve human experts establishing a "ground truth" in the way, for example, a diagnostic imaging study would.

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

This information is not applicable and not provided. As mentioned above, these are not studies that would typically require an adjudication method. Outcomes are generally based on pass/fail criteria against established standards.

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:

An MRMC comparative effectiveness study was not done. The device is an N95 respirator with a virucidal coating, not an AI-assisted diagnostic tool using human readers.

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

A standalone performance evaluation was done for the device itself against established physical, chemical, and biological performance criteria (e.g. filtration efficiency for particulates, bacteria, and viruses; fluid penetration; flammability; breathing resistance; virus inactivation). These tests are "algorithm only" in the sense that they measure the device's inherent performance without human interpretation as part of the primary measurement.

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

The ground truth for most of the performance tests (e.g., filtration, fluid resistance, flammability, breathing resistance) is defined by the standardized test methods and their predetermined pass/fail criteria. For the virus inactivation claims, the ground truth is established by in vitro laboratory assays rigorously measuring reduction in viral infectivity. For biocompatibility, the ground truth is established by absence of cytotoxic effects or adverse skin reactions according to established toxicology and dermatological assessment protocols.

8. The sample size for the training set:

There is no mention of a training set as this product is not a machine learning or AI-based device. The testing described is for the physical and biological performance of a medical device (respirator).

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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Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.

OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.

The provided text describes a 510(k) premarket notification for a medical device (OASIS® Dry Mouth Relief Discs OR OASIS® Mouth Moisturizing Discs). It is a submission for a substantially equivalent device, not a new device requiring extensive clinical trials with acceptance criteria and performance studies in the way a novel AI/software medical device would.

Therefore, many of the requested categories (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. This document focuses on demonstrating similarity to already cleared devices.

Here's a breakdown of what is available from the provided text, aligning with the spirit of your request where possible, and indicating N/A where information for AI/software device studies is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices with a similar intended use and technological characteristics. The criteria are thus implied by the characteristics of the predicate devices and the safety/effectiveness assessment by the FDA.

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

• Sample size: Not applicable for this type of submission. This is not a study comparing the device to a control group or assessing its performance on a dataset of clinical cases in the way an AI/software device would. The evaluation is based on functional and performance assessment and comparison to predicate devices.
• Data provenance: Not applicable.

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" establishment in the context of clinical images or data for this 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 device is not an AI/software device that assists human readers.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable in the typical sense. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate devices and the consistency of the new device's characteristics with those predicates and known medical principles regarding dry mouth relief.

8. The sample size for the training set

• Not applicable. There is no training set for this type of device.

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

• Not applicable.

Study that proves the device meets the acceptance criteria:

The provided text states: "Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory."

This statement, combined with the detailed comparison to predicate devices (Section 6, Table provided), constitutes the "study" or evidence demonstrating that the device meets the implied acceptance criteria for a 510(k) submission. The FDA, by issuing the 510(k) clearance, concurred that the device is substantially equivalent to legally marketed predicate devices and therefore is considered safe and effective for its intended use. The actual details of the "functional and performance evaluation" are not provided in this summary document, as is typical for 510(k) summaries which often highlight conclusions rather than raw data.

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