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FOR TOPICAL DERMATOLOGICAL USE ONLY

Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Description OTC Product:
Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.

Sinclair Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over- the-counter (OTC) use.

The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets such criteria. Instead, it is a 510(k) premarket notification document for the "SINCLAIR SKIN EMULSION™."

Here's what can be extracted from the document regarding the device and its regulatory submission:

Device Description and Intended Use:

• Device Name: SINCLAIR SKIN EMULSION™
• Common Name: Dressing, Wound & Burn, Hydrogel w/Drug or Biologic
• Classification: Unclassified, Product Code: FRO, MGQ
• Description: A non-sterile viscous emulsion/gel formulation for topical application.
• Intended Use (Prescription): Under healthcare professional supervision, indicated to manage and relieve signs and symptoms of seborrhea and seborrheic dermatitis (itching, erythema, scaling, pain). Helps relieve dry waxy skin by maintaining a moist wound & skin environment beneficial to healing.
• Intended Use (OTC): Helps nourish skin and relieve burning and itching associated with many common types of skin irritation and wounds.

Predicate Device:

• Sinclair Wound and Skin Emulsion 510(k) K024367

Tests and Conclusions (as stated in the document):

• "Functional and performance testing has been conducted to assess the safety and effectiveness of SINCLAIR SKIN EMULSION™ and all results are satisfactory."
• The FDA determined the device is substantially equivalent to legally marketed predicate devices.

What is NOT Present in the Document (and therefore cannot be provided in the requested table/study details):

• Specific Acceptance Criteria: The document does not define measurable performance thresholds the device needed to meet. It broadly states "satisfactory" results.
• Detailed Study Design: There is no description of a clinical or analytical study, its methodology, endpoints, or results.
• Reported Device Performance: While stated as "satisfactory," no quantitative or qualitative performance metrics are provided.
• Sample Size: No information on sample sizes (test set, training set) is available.
• Data Provenance: No details on country of origin or retrospective/prospective nature of data are given.
• Number/Qualifications of Experts: No mention of experts for ground truth establishment.
• Adjudication Method: Not applicable as no ground truth establishment details are provided.
• MRMC Comparative Effectiveness Study: No such study is mentioned or summarized.
• Standalone Performance: No specific standalone algorithm performance is discussed, as this is a medical device, not an AI algorithm in the typical sense.
• Type of Ground Truth: Not applicable, as no ground truth creation process is described.
• Training Set Sample Size: Not applicable, as no training set for an algorithm is mentioned.
• How Training Set Ground Truth was Established: Not applicable.

Conclusion:

The provided text is a regulatory submission document for a medical device (a topical emulsion) seeking a 510(k) clearance based on substantial equivalence to a predicate device. It confirms that functional and performance testing was conducted, and the results were deemed "satisfactory" by the applicant, leading to FDA clearance. However, it does not include the detailed acceptance criteria and a specific study report that outlines the methodology, results, and proof of meeting those criteria. The information you are requesting about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment is typically found in dedicated study reports or test protocols, which are not part of this 510(k) summary.

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ALOCLAIR™ ORAL SPRAY is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further imitation.
ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.

ALOCLAIR™ ORAL SPRAY is a viscous spray formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.

This document is a 510(k) summary for the ALOCLAIR™ ORAL SPRAY. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study that establishes acceptance criteria or reports detailed device performance against such criteria.

The document states:

• "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL SPRAY. All results are satisfactory."

This is a general statement and does not provide the specific details required to answer your request. Therefore, I cannot provide the requested information based on the input text.

The requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) is not present in the provided 510(k) summary.

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SINCLAIR ALOCLAIR™ ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.

ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-the-counter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.

The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, as one might find for a more complex medical device with quantifiable performance metrics (e.g., diagnostic accuracy, sensitivity, specificity).

The document is a 510(k) summary for Sinclair Aloclair™ Oral Gel, which is a wound and burn dressing (hydrogel with drug or biologic) for oral use. The approval for this device is based on substantial equivalence to predicate devices already on the market, rather than a novel claim requiring extensive new clinical trials with detailed performance metrics.

Based on the provided text, here's what can be extracted and inferred:

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

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

• The document does not specify a sample size for a test set in the context of a clinical performance study.
• The review is based on substantial equivalence to predicate devices, implying that the safety and effectiveness were primarily supported by the established history and regulatory status of those predicates, combined with functional and performance testing (likely bench or in-vitro, but not specified as a human clinical test set).
• The provenance of data for any "functional and performance testing" is not detailed (e.g., country of origin, retrospective/prospective).

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

• Not applicable. The document does not describe a clinical study that required expert consensus for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable. There is no described clinical test set requiring adjudication.

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 topical oral gel, not an AI-powered diagnostic or treatment device, so MRMC studies are not relevant.

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

• Not applicable. This device is a topical oral gel, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the substantial equivalence claim is largely established by the regulatory history and accepted safety and effectiveness of the predicate devices for their indications. For the functional and performance testing mentioned, the "ground truth" would be objective measures of the gel's properties (e.g., pH, viscosity, stability, barrier formation ability), but these are not detailed in the summary.

8. The sample size for the training set:

• Not applicable. This device is a medical product, not an AI model, so there is no "training set."

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

• Not applicable.

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Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.

Over the counter Labeling stipulates that ORACLAIR has been 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.

SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the format requested.

The document is a 510(k) summary for a medical device called SALINUM® / ORACLAIR, an artificial saliva intended for the relief of dry mouth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria Table and Reported Device Performance: This information is not present. The submission states, "Functional and performance testing has been conducted to assess the safety and effectiveness of SALINUM® and all results are satisfactory." However, it does not specify what those criteria were or detail the performance metrics.
2. Sample Size for Test Set and Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
3. Number of Experts and Qualifications for Ground Truth: Since no performance study against a ground truth is described, there is no mention of experts or their qualifications.
4. Adjudication Method: Not applicable as no adjudication process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study, or any comparison to human reader performance, is mentioned.
6. Standalone Performance Study: While "functional and performance testing" is mentioned, no specific standalone algorithm performance study with detailed results, metrics, or methodology is provided. The submission primarily focuses on equivalence.
7. Type of Ground Truth Used: No ground truth is described for a performance study.
8. Sample Size for Training Set: This is not applicable as SALINUM® / ORACLAIR is a pharmaceutical product (saliva substitute), not an AI/algorithm-based device that would require training data.
9. How Ground Truth for Training Set Was Established: Not applicable for the reasons stated above.

The document is a regulatory submission for a physical medical device (oral solution), not an AI/software device that would typically involve the type of performance evaluation outlined in your request. The "Tests and Conclusions" section simply states that "functional and performance testing has been conducted... and all results are satisfactory," without providing details of these tests, criteria, or results.

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FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.

Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (OTC) use.

Here's a breakdown of the acceptance criteria and the study information for the SINCLAIR WOUND AND SKIN EMULSION™ based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a sample size for a test set. It mentions "Functional and performance testing," but does not detail the methodology, sample sizes, or provenance of the data (e.g., country of origin, retrospective or prospective) for these tests.

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

The provided document does not mention or describe the use of experts to establish ground truth for any test set.

4. Adjudication Method for the Test Set

The provided document does not mention or describe any adjudication method for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, not direct comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not performed or reported in the provided document. This device is a wound and skin emulsion, not an AI algorithm. The functional and performance testing mentioned refers to the physical and chemical properties and likely biocompability of the emulsion itself.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable or discussed in this submission. The "ground truth" for this device's performance would likely be established through standardized methods for assessing biocompatibility, stability, physical properties (e.g., viscosity, pH), and potentially in-vitro or in-vivo wound healing models, though these specifics are not detailed in the document. The substantial equivalence relies on comparison to predicate devices.

8. Sample Size for the Training Set

A "training set" is relevant for machine learning algorithms. Since this device is a topical emulsion and not an AI/ML algorithm, the concept of a training set does not apply to this submission.

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

As the concept of a training set does not apply, how its ground truth was established is not applicable to this submission.

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Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.

The provided 510(k) summary for Sinclair SST™ focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving quantitative measurements like those typically associated with AI/ML device evaluations.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. The device is a "Saliva Supporting Tablet" for dry mouth relief, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present specific quantitative acceptance criteria or detailed performance metrics from a clinical study for the Sinclair SST™ in the way that would be expected for an AI/ML device. Instead, the "acceptance criteria" for a 510(k) submission like this are primarily based on demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate devices.

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

• Not Applicable. This 510(k) summary does not describe a clinical "test set" in the context of an AI/ML device evaluation. The "functional and performance testing" mentioned is general and not detailed with specific sample sizes or data provenance for a clinical trial. The basis of equivalence is largely on the comparison of technological characteristics and intended use.

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

• Not Applicable. As there is no described clinical test set with a ground truth assessment by experts in the context of an AI/ML evaluation.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set with 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 is not an AI-assisted diagnostic or prognostic device, so an MRMC study is irrelevant.

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

• Not Applicable. This is a physical product (a tablet), not an algorithm.

7. The type of ground truth used:

• Not Applicable. There is no "ground truth" used in the context of an AI/ML evaluation, as this is a physical device submission focused on substantial equivalence. The "safety and effectiveness" assessment would have involved standard medical device testing, likely chemical and physical property evaluations for the tablet, and possibly small-scale human user perception studies (though not detailed here) rather than a diagnostic 'ground truth.'

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. This is not an AI/ML device, so there is no ground truth for a training set.

Summary based on the provided document:

The 510(k) submission for Sinclair SST™ is for a medical device (saliva supporting tablets) and is based on demonstrating substantial equivalence to existing legally marketed predicate devices (Gebauer Company Salivart and Inpharma AB Caphosol). The determination of substantial equivalence means the device is considered as safe and effective as the predicate devices. The "tests and conclusions" section states that "Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory," but does not provide specific details about these tests, methodologies, or quantitative results that would be expected in a performance study for an AI/ML algorithm.

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SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.

ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.

The provided text describes the submission for a medical device (ALOCLAIR™ ORAL RINSE) for 510(k) clearance. The document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in the provided text. The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the reported device performance was.

Based on the provided information, I can only provide the following:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any information regarding a "test set" in the context of a clinical study or the sample size used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any expert involvement in establishing ground truth for a test set. This type of information is typically part of a clinical trial, which is not detailed here.

4. Adjudication Method for the Test Set:
No information is provided regarding an adjudication method, as no test set requiring ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission is focused on demonstrating substantial equivalence to predicate devices, not on comparing performance with human readers, or the effect of AI assistance.

6. Standalone (Algorithm Only) Performance:
This product is an oral rinse, not an algorithm or AI-based device. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. Type of Ground Truth Used:
No specific type of ground truth is mentioned, as the document states that functional and performance testing was conducted, but does not specify the nature of these tests or how results were validated against a "ground truth."

8. Sample Size for the Training Set:
This is an oral rinse, not an AI or machine learning device that requires a training set.

9. How Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/machine learning device.

Summary of Device and Basis for Clearance:

The ALOCLAIR™ ORAL RINSE is a viscous gel formulation intended for over-the-counter use to provide rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions.

The basis for the 510(k) clearance is substantial equivalence to two predicate devices:

• Sinclair Gelclair Concentrated Oral Gel (K013056)
• AloeCeuticals (Carrington Lab) OraRinse (K983182)

The submission highlights that ALOCLAIR™ ORAL RINSE has the "same intended/indications for use" as these predicate devices. A comparison table (Section 6) details the technological characteristics, showing similarities in claims, area of use, disease state, and presentation (non-sterile), with minor differences in method of use (pre-mixed vs. mix with water) and product type (oral rinse/mouthwash vs. concentrate for dilution).

The document states that "Functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL RINSE. All results are satisfactory." However, it does not provide specific details about these tests, the acceptance criteria, or the actual performance results in a quantifiable manner. The FDA's letter (Section 2, 3) confirms the determination of substantial equivalence, allowing the device to be marketed.

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Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated also for diffuse aphthous ulcers.

Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.

The provided document is a 510(k) summary for a medical device (Gelclair® CONCENTRATED ORAL GEL), focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not available in the provided text.

Based on the available text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or improvement effect sizes. The submission focuses on demonstrating "substantial equivalence" to a predicate device, which inherently implies that if the new device has similar technological characteristics and intended use, its performance is considered acceptable.

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

The document does not mention a specific "test set" in the context of an algorithm or AI. It refers to "Extensive functional and performance testing," but does not provide details on sample sizes or data provenance for these tests. There is no indication of retrospective or prospective data.

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

Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set, as it relates to an oral gel, not an AI or diagnostic device that requires expert interpretation.

4. Adjudication Method

Not applicable. There's no mention of adjudication for a test set.

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

No, an MRMC comparative effectiveness study was not done. The device is a "CONCENTRATED ORAL GEL" for pain management, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. This device is an oral gel, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of an AI device. For the oral gel, "ground truth" would relate to the clinical effectiveness of pain relief and mucosal adherence, likely assessed through clinical trials or user experience, which are not detailed in this 510(k) summary beyond the general statement of "satisfactory" results.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as the device is not an AI algorithm.

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

Not applicable. There is no training set for this device.

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