Search Results

For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.

OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.

The provided text is a 510(k) summary for the OraMagic™ Plus Oral Wound Rinse, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a new, novel technology. Therefore, much of the requested information regarding acceptance criteria and performance studies is not typically present in a 510(k) summary for a device like this.

Here’s an analysis of the provided text in relation to your questions:

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

Explanation: The acceptance criteria for this 510(k) revolve around establishing substantial equivalence to a predicate device (OraMagicRx™ Oral Wound Rinse) in terms of safety and effectiveness. The reported performance is an assertion that the new device is "similar" and "performs at least as well as" the predicate, based on its composition, function, intended use, and the known safety profile of its ingredients. No specific numerical thresholds or performance metrics are provided in the document for these criteria, beyond the general statement of equivalence.

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

This information is not provided in the 510(k) summary. The submission relies on a comparison to a predicate device and the known safety of its ingredients, rather than a new clinical study with a test set of patients.

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 information is not provided as there was no explicit clinical study with a test set requiring expert ground truth establishment mentioned in the document.

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

This information is not provided as there was no explicit clinical study with a test set mentioned in the document.

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 conducted. This device is a topical rinse, not an AI or imaging device that would typically involve human readers.

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 topical rinse and does not involve an algorithm.

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

This information is not explicitly stated as a ground truth for a new study. The "ground truth" for the device's efficacy is implicitly derived from the established safety and efficacy of its predicate device and the long history of safe use of its active ingredient (benzocaine).

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this device is not an AI or machine learning product.

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

This information is not applicable/not provided for the same reason as point 8.

Ask a specific question about this device

For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.

OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.

The provided 510(k) summary for K024180 (OraMagicRx™ Oral Wound Rinse) does not contain the detailed information typically associated with acceptance criteria and studies for device performance as an AI/ML-driven device or diagnostic. This submission is for a medical device (oral wound rinse) and relies on substantial equivalence to a predicate device, rather than a performance study with specific acceptance criteria in the way a diagnostic or AI algorithm would.

Therefore, many of the requested sections about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable or not present in this document.

However, I can extract the relevant information from the provided text, primarily around the basis for acceptance which is substantial equivalence.

Here's a breakdown based on the information available:

Acceptance Criteria and Study for OraMagicRx™ Oral Wound Rinse (K024180)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Radiacare™ Oral Wound Rinse, K964852) and biocompatibility testing. The submission does not describe a clinical performance study in the way a diagnostic product would.

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

• Not applicable / Not provided for clinical performance. The submission relies on substantial equivalence rather than a clinical performance study with a test set of patient data.
• Biocompatibility Testing: The sample sizes used for the biocompatibility tests (primary dermal irritation, sensitization, in vitro cytotoxicity) are not specified in the 510(k) summary (e.g., number of rabbits, guinea pigs, or specific cell lines). The data provenance for these specific tests is not stated regarding country of origin or whether they were retrospective/prospective, but these are typically prospective laboratory studies.

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

• Not applicable. No clinical test set requiring expert ground truth establishment for diagnostic performance is described. The relevant "experts" would be those who conducted and interpreted the biocompatibility tests according to standard protocols.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication for diagnostic performance is described.

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

• No. An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, to assess the impact of the AI on human reader performance.

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

• Not applicable. This device is an oral wound rinse, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

• For biocompatibility: The ground truth would be established by the observed biological responses according to standardized testing protocols (e.g., absence of irritation, sensitization, cytotoxicity).
• For substantial equivalence: The "ground truth" is the established safety and effectiveness profile of the predicate device (Radiacare™ Oral Wound Rinse) as determined by its prior regulatory clearance.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical product (oral rinse), not an AI/ML algorithm requiring a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

Ask a specific question about this device

Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.

Due to the nature of the device (a medicated wound gel), the provided documents (K020540) do not contain information about acceptance criteria and studies in the context of device performance as one would expect for an AI/software device. Instead, the "study" described is related to biocompatibility and a comparison to a predicate device for substantial equivalence.

Therefore, I cannot directly provide the requested table and detailed information as it pertains to AI/software performance criteria. However, I can extract the relevant information regarding the safety and equivalence arguments made for this specific product.

Here's a breakdown of what the document does provide, structured to address your points as much as possible within the context of a physical medical device submission for substantial equivalence:

Device: Regenecare™ Wound Gel (Medicated Hydrogel Wound and Burn Dressing)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are related to safety and substantial equivalence to a predicate device, rather than quantitative performance metrics like sensitivity/specificity for AI.

• Demonstrated by Sensitization Test in Guinea Pigs
• Demonstrated by In Vitro Cytotoxicity Test |
  | Safety (Lidocaine) | - Pre-established through long history of over-the-counter use of topical lidocaine (up to 4%).
• Conclusion: Addition of 2% lidocaine to the original formulation does not raise new biocompatibility issues. |
  | Substantial Equivalence | - Similar in composition to MPM Regenecare™ Wound Gel (K992074).
• Identical in function to MPM Regenecare™ Wound Gel (K992074).
• Identical in intended use to MPM Regenecare™ Wound Gel (K992074) and other legally marketed hydrogel wound dressing products.
• Conclusion: Safe and effective for intended use, performs at least as well as legally marketed predicate devices. |

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

• Biocompatibility Tests: The document mentions "rabbits" and "guinea pigs" for animal testing, and "in vitro" for cytotoxicity. Specific sample sizes (e.g., number of animals, number of replicates) are not provided in this summary.
• Safety of Lidocaine: This relies on the general historical use of lidocaine, not a specific "test set" in this submission.
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/animal study results and a comparison to existing market data.

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

This concept is not applicable here. The "ground truth" for biocompatibility is whether the biological response meets accepted safety standards, determined by standard laboratory protocols and expert interpretation of those results. The primary "experts" involved would be toxicologists and regulatory reviewers.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or clinical endpoints requiring adjudication in the context of an AI device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical wound gel, not an AI or software device.

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

Not applicable. This is a physical wound gel, not an AI or software device.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (irritation, sensitization, cytotoxicity) against established physiological endpoints and safety thresholds.
• Safety of Lidocaine: Historical clinical use and accepted pharmacological profiles.
• Substantial Equivalence: Comparison of device characteristics (composition, function, intended use) to an already cleared (predicate) device.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary of the "Study" (Biocompatibility & Comparison to Predicate):

The "study" or evidence presented for K020540 relates entirely to establishing the safety and substantial equivalence of the Regenecare™ Wound Gel, particularly with the addition of 2% lidocaine, to an already approved predicate device (MPM Regenecare™ Wound Gel; K992074).

• Biocompatibility: The original predicate device's biocompatibility was established through:
  • A primary dermal irritation test in rabbits.
  • A sensitization test in guinea pigs.
  • An in vitro cytotoxicity test.
• Lidocaine Safety: The submission leverages the well-established long history of over-the-counter use for topical lidocaine (up to 4%) to argue that the 2% concentration does not introduce new biocompatibility issues.
• Substantial Equivalence Argument: The new device (Regenecare™ Wound Gel with lidocaine) is stated to be similar in composition and identical in function and intended use to the predicate device. This comparison forms the basis for demonstrating that the new device is "safe and effective for its intended use, and performs at least as well as legally marketed predicate devices."

In essence, for this traditional medical device, the "acceptance criteria" were that the device be biocompatible and substantially equivalent in safety and efficacy to a previously cleared device, a benchmark they met by referring to prior testing and established safety profiles.

Ask a specific question about this device

Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.

Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.

This document is a 510(k) premarket notification for a medical device called "MPM Regenecare™ Wound Gel". A 510(k) is a submission made to the FDA by medical device manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison to an existing device, rather than new extensive clinical studies that would establish acceptance criteria and device performance in the way clinical trials do for new drugs.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) generally comes from performance studies, which are not typically part of a 510(k) summary focused on substantial equivalence.

Based on the provided text, the following can be extracted:

• Device Name: MPM Regenecare™ Wound Gel
• Intended Use: Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
• Predicate Device: MPM Hydrogel™ Dressing (K952276)
• Studies Mentioned (for biocompatibility, not performance of wound healing efficacy):
  • Primary dermal irritation test in rabbits
  • Sensitization test in guinea pigs
  • In vitro cytotoxicity test

The 510(k) process focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness information, often without the need for new clinical data, especially for devices like wound dressings that have well-established predicates. The biocompatibility tests listed are to ensure the material itself is safe, not to prove the clinical efficacy of wound healing according to specific performance metrics.

In summary, there are no acceptance criteria or studies providing performance metrics for the wound healing efficacy of the device within this 510(k) summary.

Ask a specific question about this device

Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.

The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.

This document is a 510(k) summary for a medical device (MPM Hydrogel Dressing) and details the "Substantial Equivalence" to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CADe device. The provided text focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices, primarily through comparison of composition and biocompatibility testing, rather than performance metrics against specific acceptance criteria.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Explanation: The primary "acceptance criterion" mentioned is non-cytotoxicity. The study performed confirms this.

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: Not specified. The "test" here refers to a cytotoxicity test of the device material itself, not a clinical study on patients.
• Data provenance: Not specified, but likely laboratory-based (in vitro) testing.

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

Not applicable. This was a laboratory test (cytotoxicity), not an expert-driven ground truth assessment.

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

Not applicable. This was a laboratory test.

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/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

Not applicable. The "ground truth" for the cytotoxicity test would be the established scientific method for determining cell toxicity.

8. The sample size for the training set

Not applicable. This device does not use a "training set."

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

Not applicable. This device does not use a "training set."

In summary: The provided text describes a 510(k) submission for a hydrogel wound dressing, focusing on its substantial equivalence to predicate devices based on composition and a single biocompatibility test (cytotoxicity). It does not involve AI, image analysis, or clinical performance studies with human readers, and therefore, most of your requested information elements are not relevant to this type of device and submission.

Ask a specific question about this device