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Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

Silatrix Oral Gel is an amorphous hydrogel that serves as a physical, protective barrier over the oral mucosa to protect against further irritation and relieve pain associated with mouth lesions. The hydrogel is formed during manufacturing by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution.

Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water, as well as pentylene glycol and glycerin-ethyl lauroyl arginate HCl that are used as preservatives. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a 10g tube.

The formulation is identical to the predicate device except for the addition of the two preservatives used to ensure device stability over the labeled shelf life.

N/A

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Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.

Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) summary for a medical device called "Elemental Granulate," which focuses on establishing substantial equivalence to a predicate device (COE PAK).

While it mentions non-clinical testing performed (biocompatibility, antibacterial activity, dental material evaluation, usability engineering risk assessment), it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, ground truth establishment, or expert qualifications for any specific study proving acceptance criteria.
• Details on adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specific ground truth types or sample sizes for training sets (as no AI/algorithm performance is detailed).

The document explicitly states: "Clinical testing, although available, was not needed in support of this 510(k) application." This reinforces that detailed clinical performance studies, which would typically include acceptance criteria and their verification, are not present in this submission summary.

Therefore, I cannot fulfill your request based on the provided text.

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HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:

1. Denture sores
2. Oral ulcers (non-infected or viral)
3. Periodontal surgical wounds
4. Extraction sites
5. Surgical wounds.
6. Traumatic wounds

The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.

The provided text describes the regulatory clearance (510(k)) for the HealiAid® Dental Collagen Wound Dressing. This is a medical device, not an AI/ML software device, and therefore the concepts of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), sample size for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, or training sets are not applicable here.

Instead, the acceptance criteria for this medical device are related to its physical and biological properties, and its performance in pre-clinical studies to demonstrate substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the information provided, framed to address the prompt's categories where applicable for a medical device without AI/ML components:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like wound dressings, "acceptance criteria" are typically defined by demonstrating compliance with established standards (like ISO 10993 for biocompatibility) and exhibiting comparable performance to predicate devices in pre-clinical tests.

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

• Test Set (Pre-clinical Studies): The document does not specify exact sample sizes for each pre-clinical test (e.g., number of animals for toxicity or implantation studies). These studies are typically conducted according to standardized protocols outlined in documents like ISO 10993, which define appropriate sample sizes for each test type.
• Data Provenance: The studies were pre-clinical (laboratory and animal studies) rather than human clinical trials. The bovine Achilles tendons are the source material.

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

• This is not applicable as the "ground truth" for this type of device is established through standardized laboratory tests and animal models, adhering to recognized international standards (e.g., ISO 10993, USP 151, ISO 22442). These tests have defined endpoints and criteria, and their interpretation is generally performed by qualified laboratory personnel following strict protocols, rather than a consensus of human "experts" evaluating an outcome like an image.

4. Adjudication Method for the Test Set

• Not applicable. The pre-clinical tests have objective measurements and pass/fail criteria based on established standards, not subjective assessments requiring adjudication.

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

• Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based AI) where multiple human readers interpret cases, and their performance is compared with and without AI assistance. The HealiAid® Dental Collagen Wound Dressing is a therapeutic/wound management device, not a diagnostic one.

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

• Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI functionality.

7. The Type of Ground Truth Used

• For the pre-clinical studies, the "ground truth" is established by the objective results of standardized biological and chemical tests (e.g., cell viability in cytotoxicity, presence/absence of mutagenic activity in genotoxicity, tissue reactions in implantation, absorption values, degradation rates). These are verifiable scientific outcomes, not interpretations of medical images or pathology.

8. The Sample Size for the Training Set

• Not applicable. This device does not use AI/ML and therefore does not have a "training set."

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

• Not applicable for the same reason as above.

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PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.

PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.

This FDA submission describes a medical device, the PerioStom™ Dental Dressing, and seeks substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The provided document describes a dental dressing, which is a physical barrier intended for temporary protection of oral mucosal tissue and to provide pain relief. This is a traditional medical device, not an AI/ML-driven device. Therefore, the requested information pertaining to AI/ML device testing (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (HemCon® Dental Bandage K060363) through:

• Comparison of technological characteristics: Both are spray-dried chitosan-based dressings that form a bioadherent gel.
• Non-clinical performance testing: Viscosity, pH, microbial testing, and wound barrier testing. The results were found to be "substantially equivalent" for the subject and predicate devices.
• Biocompatibility testing: According to ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity). The device met these requirements.

No clinical performance testing was conducted or deemed necessary for this type of device and submission.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance and testing. This document describes a non-AI physical medical device.

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Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and illfitting dentures, and lesions associated with oral surgery.

Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protection side. The oral mucosa adhesive side is composed of a water soluble polymer that when exposed to moisture in the oral cavity changes into a gel state to achieve adhesion to the wound area. The protection side consists of a waterinsoluble polymer which covers the wound to protect the applicable area from the environment in the oral cavity. Intra-oral Wound Dressing is simply a non-sterile bandage to protect oral wounds.

This FDA 510(k) summary does not contain information about a clinical study with acceptance criteria and device performance. Instead, it describes a non-clinical evaluation of the "Ora-Aid Intra-oral Wound Dressing" (subject device) for substantial equivalence to a predicate device, "PerioPatch."

The document concludes that the subject device is substantially equivalent to the predicate device based on non-clinical safety and performance tests, not a clinical study demonstrating performance against acceptance criteria in human subjects.

Here's a breakdown of the requested information based on the provided text, highlighting what is not present as well:

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

This information is not available from the provided text for device performance against specific clinical acceptance criteria. The document focuses on demonstrating substantial equivalence through non-clinical testing against standards.

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

• Sample size for test set: This information is not specified as a clinical test set was not described. The non-clinical tests would have their own sample sizes (e.g., for biological materials, microbial samples, physical property tests), but these are not detailed in the summary.
• Data provenance: The submission is from TBM Corporation in Gwangju, Korea, and the consultant KMC, Inc. is in Seoul, Republic of Korea. The standards used for non-clinical testing are international (ISO, EN, ASTM) and US Pharmacopeia (USP).

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)

This is not applicable as there was no clinical study described that required expert-established ground truth. The evaluation was based on non-clinical laboratory testing against established standards.

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

This is not applicable as there was no clinical study described that required 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

This is not applicable. The device is an "Intra-oral Wound Dressing" and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

This is not applicable as the device is a physical wound dressing and not an algorithm.

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

This is not applicable as no clinical ground truth was established for a performance study. The evaluation relied on adherence to international standards and pharmacopeia for non-clinical safety and performance.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set or ground truth for training.

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PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing.

Manages pain of, for example:

• All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa
• Canker sores and cold sores
• Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
• Soft tissue pain from orthodontics
• Aphthous ulcers
• Extraction site pain
• Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)

PuraStat-OM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process.

PuraStat-OM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

Device: PuraStat-OM (an oral hydrogel wound dressing)
Predicate Device: McMerlin Dental Company's SOCKIT!® Oral Hydrogel Wound Dressing (K063148)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the purpose of demonstrating substantial equivalence. Instead, it describes a comparison of technological characteristics and performance data between the subject device (PuraStat-OM) and the predicate device (SockIt!® Gel) to argue for their substantial equivalence. The "criteria" are implicitly defined by the properties measured and compared.

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

The study described is nonclinical performance (bench testing) and GLP biocompatibility testing.

• Sample Size for Test Set: Not explicitly stated with a specific number of units for each test. The document refers to "PuraStat-OM" and "SockIt!® Gel" being tested, implying samples of each device were used. For biocompatibility, testing is typically done on multiple samples.
• Data Provenance: The biocompatibility testing was conducted as per ISO 10993-1 and consistent with FDA Guidance, indicating standard laboratory practices. The bench testing (complex modulus, viscosity, pH, etc.) was a "side-by-side comparison" of the subject and predicate devices. This is retrospective in the sense that it compares a new device to an already marketed predicate, but the testing itself would have been conducted prospectively for the submission. The origin of the data is laboratory testing.

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

N/A. This document describes nonclinical, laboratory-based performance testing and biocompatibility assessments, not a study requiring human readers or expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

N/A. Not applicable to nonclinical performance or biocompatibility testing.

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

No. An MRMC study is not mentioned as this submission focuses on nonclinical and bench testing to demonstrate substantial equivalence based on technological characteristics and biocompatibility, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device (hydrogel), not an imaging/AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation), the "ground truth" is defined by established biological safety standards and methodologies (ISO 10993-1). For the bench tests (e.g., Complex Modulus, Viscosity, pH), the "ground truth" is the measured values obtained using validated laboratory methods and instruments. These are objective physical and chemical properties.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A. Not applicable.

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MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz. bottles. This product, when washed around the mouth, forms a protective layer over the oral mucosa.

The provided document is a 510(k) premarket notification for a medical device called MucoLock Oral Gel. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive human studies. Therefore, many of the requested elements for a study proving device performance against acceptance criteria, especially those related to AI/MRMC studies or human clinical outcomes, will not be present in this document.

Here's an analysis of the document based on your request:

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance testing conducted is primarily non-clinical.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) and not a clinical efficacy trial, the "acceptance criteria" are not framed as clinical endpoints or specific performance metrics like sensitivity/specificity for an AI device. Instead, they are related to equivalence.

Study Details from the Document:

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

• Test Set: No human clinical test set (i.e., patient data for clinical efficacy/performance) was used for the primary evaluation of this device as part of the 510(k). The document explicitly states: "Clinical performance testing is not included."
• Provenance: N/A for clinical data. The biocompatibility and bioadhesiveness tests were laboratory-based. The bioadhesiveness test used "human oral buccal tissue constructs," which implies ex vivo or in vitro testing, not human subjects.

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

• Not applicable. No human clinical data or expert-adjudicated ground truth for a test set was part of this 510(k) submission.

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

• Not applicable. No human clinical data or adjudication process was involved.

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 device, and no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm. Its performance is assessed through non-clinical laboratory tests (biocompatibility, bioadhesiveness) demonstrating its physical and chemical properties and safety.

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

• For the non-clinical tests:
  • Biocompatibility: Ground truth is established by adherence to ISO standards (e.g., cell viability for cytotoxicity, skin reaction for sensitization, tissue reaction for irritation).
  • Bioadhesiveness: Ground truth is established by in vitro or ex vivo measurements of adherence and retention time on tissue constructs, compared to the predicate.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable.

In summary: This 510(k) submission for MucoLock Oral Gel relies on demonstrating substantial equivalence to a predicate device through:

• Identical intended use.
• Similar technological characteristics, with justified differences based on ingredient safety and common usage.
• Non-clinical laboratory testing (biocompatibility and bioadhesiveness) to show the new device is safe and performs functionally similarly to the predicate.

No clinical efficacy studies or AI-related performance evaluations were performed or submitted for this specific 510(k) clearance.

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Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

The proposed Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. The intended use of this device is achieved by physical action. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by the reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7 .0, the subject device achieves its primary mode of action through serving as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. There is no chemical action or metabolic effect associated with the mechanism of action of this device.

Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a small tube.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silatrix Oral Gel, structured to answer your specific questions.

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of your questions related to AI-specific elements (like AI-assisted MRMC studies, training set details, ground truth for AI, etc.) are not applicable to this type of submission. This summary primarily details non-clinical performance and comparisons to existing devices.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical device (oral gel) and not a software/AI device, the "acceptance criteria" are viewed through the lens of demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria would be that the device has the same intended use, similar technological characteristics, and similar principles of operation, and that any differences do not raise new questions of safety or effectiveness.

Study Details

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

   • This document describes non-clinical performance data (biocompatibility, shelf-life, and chemical verification of sucralfate). It does not rely on a clinical "test set" of patient data in the way an AI/software device would.
   • The "study" here is primarily a comparison against a predicate device and laboratory testing. Specific sample sizes for biocompatibility or shelf-life testing are not provided in this summary. Data provenance (country, retrospective/prospective) is not detailed for these non-clinical tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. There is no clinical "test set" or ground truth requiring expert consensus for a diagnostic or AI algorithm in this submission. The determination is based on non-clinical data and comparison to a predicate device.

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

   • Not applicable, as there is no clinical "test set" or ground truth requiring adjudication.

4. 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/software device. There were no human readers or AI assistance involved in the evaluation presented here.

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

   • Not applicable. This is not an AI/software device.

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

   • For the non-clinical data:
     • Biocompatibility: In-vitro and in-vivo testing (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The "ground truth" is the established safety standard for these tests.
     • Component Verification: USP national standards (chemical analysis, e.g., spectroscopy, chromatography) to verify the presence and properties of sucralfate. The "ground truth" is adherence to these established chemical standards.
     • Equivalence: The established safety and effectiveness profile of the predicate device (ProThelial & Orafate Sucralfate Paste), which serves as a benchmark and "ground truth" for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/software device, so there is no "training set."

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

   • Not applicable, as there is no "training set" for an AI algorithm.

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Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.

Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.

The provided FDA 510(k) summary for Synvaza and Synvaza II describes non-clinical and clinical performance testing but does not explicitly state formal acceptance criteria or directly report device performance against such criteria in a table format as requested. Therefore, the information has been extracted and presented as closely as possible to the request based on the available text.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As formal acceptance criteria are not explicitly defined in the document, I will infer what the acceptance criteria were based on the reported "Results" of the non-clinical tests. For the clinical study, the acceptance criteria are not quantifiable in the provided text.

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

• Non-clinical Testing: The sample sizes for the biocompatibility and preservation tests are not specified in the document.
• Clinical Performance Testing: The sample size is described as "preselected study subjects," but the exact number is not provided. The document does not specify the country of origin of the data, but the context of an FDA submission suggests it would be relevant to U.S. regulatory standards. The study was "open label, single arm," and involved using the device for 72 hours, which indicates it was a prospective study.

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

This information is not provided in the document. The clinical study describes self-reported pain relief by subjects, not a judgment by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the clinical study did not involve multiple readers or experts evaluating outcomes requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not mentioned or discussed in the provided document. The clinical study was a single-arm study evaluating the device's performance, not a comparison to human readers with or without AI assistance.

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

• Not applicable. The device is a physical wound rinse, not an algorithm or AI.

7. Type of Ground Truth Used

• Non-clinical Testing: The ground truth for biocompatibility and preservation tests would have been established through standard laboratory assays and compliance with specified standards (e.g., USP <51>).
• Clinical Performance Testing: The ground truth for pain relief was based on subjective self-reported experience of pain relief by the study participants.

8. Sample Size for the Training Set

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.

Orapeutic™ Oral Pain Gel is a viscous hydrogel wound dressing composed entirely of food grade ingredients including a food grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissue in the mouth to manage the pain associated with injuries to the mouth.

Orapeutic Oral Pain Gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier. It also maintains a moist wound environment.

Orapeutic Oral Pain Gel is provided in 10mL syringes.

Here's a breakdown of the acceptance criteria and study information for the Orapeutic™ Oral Pain Gel device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Bench testing comparing Oral Pain Gel and Sock It! were performed," implying comparative tests, but does not provide specific numbers of samples or replicates used for pH, Hydrogel Barrier Testing, or Microbial Testing.
• Data Provenance: The studies were non-clinical performance testing (bench testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying the data would be expected to originate from, or be acceptable to, a U.S. regulatory context. These were likely prospective bench tests designed to compare the new device to the predicate.

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

• This information is not applicable as there was no clinical study involving human patients, and therefore no "ground truth" established by clinical experts or readings of patient data. The "ground truth" for the non-clinical tests was likely established by standard laboratory methods and equipment, and the comparison was to the performance of the legally marketed predicate device.

4. Adjudication Method for the Test Set

• This is not applicable as there were no human readers or subjective interpretations in the non-clinical bench testing that would require adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was conducted."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a hydrogel wound dressing, not an algorithm or AI-based product. Therefore, no standalone algorithm performance testing was performed.

7. The Type of Ground Truth Used

• For the non-clinical performance testing, the "ground truth" was established by objective laboratory measurements of physical and chemical properties (pH) and functional characteristics (hydrogel barrier, microbial presence). The primary form of "ground truth" for demonstrating equivalence was the performance of the legally marketed predicate device (Sock It! Oral Pain Gel) as measured by these objective tests.

8. The Sample Size for the Training Set

• This is not applicable as there is no AI/algorithm involved in this device that would require a training set.

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

• This is not applicable as there is no AI/algorithm involved in this device, and thus no training set or associated ground truth.

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