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Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.

OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.

PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.

The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.

The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).

The provided text is a 510(k) Summary for the PuriCore Wound Hydrogel Spray Dressing. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against specific clinical efficacy metrics for a novel medical device. The document explicitly states "Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially equivalent to the predicate devices".

Therefore, based solely on the provided text, I cannot extract information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for a new device's clinical performance. The document describes pre-clinical testing for biocompatibility and shelf-life related attributes, which are important for safety and product stability, but not directly about clinical efficacy or specific functional performance criteria in a wound healing context beyond what the predicate devices are already cleared for.

Here's a breakdown of the requested information based on the provided text:

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

Since this 510(k) is about demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily that the PuriCore Wound Hydrogel Spray Dressing is as safe and effective as the predicates. The reported device performance is largely a confirmation of this equivalence through various non-clinical tests.

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

• Sample Size for Test Set: Not specified. The document mentions "biocompatibility studies" and "Preservative Effectiveness testing" but does not detail the number of samples or subjects used for these specific tests.
• Data Provenance: The tests are "Pre-Clinical Testing." No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

• Not applicable as this is a pre-clinical, non-human study for substantial equivalence rather than a clinical trial requiring expert consensus on outcomes. The "ground truth" for these tests would be established by the standardized methods and criteria of the specific ISO standards (e.g., ISO-10993-1 for biocompatibility) and other test protocols.

4. Adjudication method for the test set:

• Not applicable for the reported pre-clinical testing. Adjudication methods are typically relevant for human clinical trials or image interpretation studies where multiple expert opinions need to be reconciled.

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 device, nor does the document describe an MRMC study.

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

• Not applicable. This is not an algorithm or AI-based device.

7. The type of ground truth used:

• For the pre-clinical tests (biocompatibility, chemical stability, etc.), the "ground truth" is defined by the objective results against established scientific and regulatory standards/protocols (e.g., ISO-10993-1, USP preservative effectiveness tests).

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set. The term "training set" refers to data used to train machine learning models.

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

• Not applicable. (See #8)

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Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a moist environment and loosens contaminated exudate, slough and other foreign materials within the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe Wound Solution, better allows for the natural healing process to take place. This device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:

Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.

Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.

The provided 510(k) summary for Vashe® Wound Solution (K131848) does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or quantifiable outcomes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, safety, and effectiveness, primarily through non-clinical testing.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the format requested, as the submission relies on demonstrating substantial equivalence, not on meeting specific, quantifiable performance targets for the device's intended use in treatment. The "performance" is primarily shown through a comparison to existing, legally marketed predicate devices and through non-clinical safety/stability testing.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implicit acceptance criteria is a compilation of non-clinical equivalency testing aimed at demonstrating substantial equivalence to predicate devices. This includes:

• Comparison of Technical Characteristics: A qualitative comparison highlighting similarities in chemical composition, mechanical action, intended use, and packaging/closure systems to K123072, K113820, K083355, and K111313.
• Biocompatibility Studies: In-vivo and in-vitro biocompatibility testing per ISO-10993-1 standards. These were conducted to prove the product is safe, particularly under worst-case scenarios for active ingredient concentration and pH.
• Shelf Life and Chemical Stability Testing: Non-clinical tests to evaluate the product's stability over its intended shelf life.
• Preservative Effectiveness Testing: To USP standards, demonstrating the solution's ability to inhibit microbial contamination within the product.

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

• Test Set Sample Size: Not explicitly stated as a "test set" for a clinical performance evaluation. The non-clinical studies (biocompatibility, stability, preservative effectiveness) would have their own sample sizes for the materials tested, but these are not detailed in the summary. For example, for biocompatibility, it would involve a certain number of test replicates or animal subjects, but these specifics are missing.
• Data Provenance: Not specified for the non-clinical tests. It's implied these were conducted internally or by contract labs in support of the submission. The origin (e.g., country) is not mentioned. They would be considered prospective for the purpose of demonstrating equivalence for this submission.

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

Not applicable. This device is a solution, and the testing outlined is primarily chemical, physical, and biological in nature (biocompatibility, stability). There is no "ground truth" derived from expert consensus on images or clinical outcomes in the summary provided.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as there isn't a "test set" requiring such a method for this type of 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 device is a wound care solution, not an AI-powered diagnostic or imaging tool. Therefore, 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 physical solution, not an algorithm or AI.

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

Not applicable in the clinical sense. For the non-clinical tests:

• Biocompatibility: Ground truth is established by recognized international standards (ISO-10993-1) for evaluating biological response to medical devices.
• Chemical Stability: Ground truth is against established chemical specifications and analytical methods.
• Preservative Effectiveness: Ground truth is against microbial reduction targets defined by compendial standards (USP ).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set mentioned for this device.

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Vashe® Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution. The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.

Here's a breakdown of the acceptance criteria and study information for the Vashe® Wound Therapy Solution, based on the provided 510(k) summary:

The document does not detail a clinical study with human subjects, but rather focuses on non-clinical equivalency testing related to product specifications and stability. This is a common approach for 510(k) submissions where a device is substantially equivalent to a predicate device and the changes made do not significantly alter its fundamental scientific technology or intended use.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified device (Vashe® Wound Therapy Solution manufactured centrally) are primarily based on the chemical specifications of the solution, which were slightly expanded compared to the predicate device.

Note: The document states "Lower specification expanded pH at 3.5 to 6.75ppm", which appears to be a typo and should likely read "pH at 3.5 to 6.75". The predicate device had a pH specification of "5.3 to 6.75ppm".

Study Details

The provided 510(k) summary indicates non-clinical equivalency testing was conducted.

1. Sample size used for the test set and the data provenance: Not specified in terms of number of samples, but the testing was for Shelf Life and Chemical Stability of the modified product. The data provenance is internal to PuriCore Inc. as the manufacturing process was moved from on-site generation to central manufacturing at PuriCore in Malvern, PA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For chemical stability testing, the "ground truth" is established by standard analytical chemistry methods and adherence to the defined chemical specifications.

3. Adjudication method for the test set: Not applicable. This was chemical and stability testing against predefined specifications.

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 a wound therapy solution, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical solution, not an algorithm.

6. The type of ground truth used: For the non-clinical testing, the ground truth was chemical specifications and stability over time, assessed through analytical methods.

7. The sample size for the training set: Not applicable. This is a non-clinical submission for a chemical product, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Justification

The core of the submission for Vashe® Wound Therapy Solution relies on demonstrating substantial equivalence to its predicate device (Vashe® Wound Therapy System, K100918) through non-clinical testing. The key changes are:

• Place of Production: Moving from on-site generation at the customer's location to central manufacturing at PuriCore Inc.
• Expanded Specifications: The acceptable range for Available Free Chlorine (AFC) and pH was slightly expanded.
• Shelf Life and Stability: Non-clinical testing was performed to ensure that the modified device, with its expanded specifications and centralized production, maintains chemical stability and preservative effectiveness (due to hypochlorous acid) throughout its shelf life, including under worst-case scenarios for initial and final concentrations and pH.

The conclusion drawn by PuriCore Inc. (and accepted by the FDA for 510(k) clearance) is that these modifications have not changed the Intended Use or altered the Fundamental Scientific Technology of the device, thereby demonstrating substantial equivalence.

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Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. The product contains hypochlorous acid as a preservative. The Hydrogel will be supplied in plastic tottles as described in Section 3.2. The device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The document provided refers to a 510(k) premarket notification for a medical device called "Vashe® Skin & Wound Hydrogel". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating performance against specific numerical acceptance criteria through a clinical study.

Therefore, the information you've requested regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because the 510(k) summary focuses on biocompatibility and preservative activity, not a clinical efficacy study with numerical performance metrics against specific conditions.

However, I can extract what is mentioned about the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of numerical performance for efficacy. The implied acceptance criteria for the Vashe® Skin & Wound Hydrogel is that it is safe for use and has effective preservative activity, similar to its predicate device.
• Reported Device Performance:
  • "Vashe® Skin and Wound Hydrogel is safe for use when in contact with abraded, breached or compromised skin."
  • "Vashe® Skin & Wound Hydrogel at its minimum recommended concentration demonstrates effective preservative activity and supports a preservative claim."

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are "in-vivo and in-vitro biocompatibility testing" and "preservative activity" testing, which are not typically presented with test set sample sizes or data provenance in the context of comparative clinical efficacy as one would expect for an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned (biocompatibility and preservative activity) do not involve expert-established ground truth for interpreting clinical outcomes.

4. Adjudication method for the test set: Not applicable based on the nature of the described studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC comparative effectiveness study was not done. This device is a hydrogel, not an AI or diagnostic device that would involve human readers.

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

7. The type of ground truth used:
* For biocompatibility: Adherence to ISO-10993 standards (likely comparing against established biological response limits).
* For preservative activity: Demonstrated effective preservative activity (likely against specific microbial challenges, though not detailed).

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document indicates that the Vashe® Skin & Wound Hydrogel underwent the following testing:

• Study Type: In-vivo and in-vitro biocompatibility testing.
• Standards: ISO-10993 standards.
• Purpose: To demonstrate the device's safety when in contact with abraded, breached, or compromised skin.
• Conclusion: The results demonstrated that Vashe® Skin & Wound Hydrogel is safe for such use.
• Additional Study: Testing for preservative activity.
• Purpose: To ascertain if the hydrogel, at its minimum recommended concentration, could effectively act as a preservative.
• Conclusion: The device demonstrated effective preservative activity, supporting a preservative claim.

These studies were conducted to support the device's safety and preservative function, which are critical aspects of its substantial equivalence to the predicate device, Epicyn™ HydroGel (K102945). The 510(k) process primarily relies on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through non-clinical testing and comparison to an existing predicate.

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Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device includes a wound cleanser solution that is intended for cleansing, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.

Vashe® Wound Therapy System consists of a Vashe® Wound Therapy Generator and Vashe® Wound Therapy+ Solution. The Vashe® Wound Therapy+ Solution is produced from a Vashe® Wound Therapy Generator. The generator is an electromechanical device containing an electromechanical cell, power supply, storage tank, pump, valve, tubing, various mechanical hardware, etc. The Vashe® Wound Therapy Solution is a clear solution with a controlled pH and containing free available chlorine at a designated concentration (ppm). Cleaning and debriding is caused by the physical action of the of the Vashe® Wound Therapy Solution moving across the wound while the hypochlorous acid acts as a preservative to ensure no growth of micro-organisms in the solution. In addition. The Vashe® Wound Therapy Solution also moistens and lubricates absorbent wound dressings.

The provided document describes the Vashe® Wound Therapy System and its 510(k) submission (K100918) for market clearance. The information focuses on demonstrating substantial equivalence to predicate devices and provides details on performance testing related to safety and biocompatibility, as well as the solution's ability to inhibit contamination.

However, the document does not contain the following information typically found in studies related to AI/algorithm-based medical devices:

• Acceptance Criteria for Device Performance (beyond safety and biological compatibility): The document establishes basic safety and inhibitory properties of the solution but does not specify performance metrics for "cleansing, irrigating, moistening, and debriding" with quantitative acceptance criteria.
• Study proving device meets acceptance criteria (in terms of clinical efficacy compared to a standard or a specific performance benchmark).
• Sample size for test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training set.
• How ground truth for the training set was established.

Summary of available information from the document related to performance/testing:

The document describes performance testing primarily focused on safety, biocompatibility, and the preservative effectiveness of the Vashe® Wound Therapy Solution. It does not present a clinical study with specific performance metrics for the "cleansing, irrigating, moistening, and debriding" functions against pre-defined acceptance criteria.

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

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

• Sample Size for Test Set: Not explicitly stated for any clinical performance or efficacy studies. For the antimicrobial efficacy, 21 test microorganisms were used.
• Data Provenance: Not explicitly stated as being from a specific country or whether it was retrospective or prospective for a clinical efficacy study. The testing for generator safety (UL, Demko A/S) and toxicology/biocompatibility does not represent patient data.

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

• This information is not provided because no clinical efficacy study with expert interpretation of the results is described. The evaluations were laboratory-based (UL, Demko A/S, toxicology labs, microbiology labs).

4. Adjudication method for the test set:

• Not applicable/Not provided, as no clinical study amenable to such a method 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 or imaging 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, as this is not an algorithm-based device.

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

• The "ground truth" for the tests performed was based on established laboratory testing standards:
  • Generator Safety: Compliance with UL and EN standards.
  • Biocompatibility: ISO 10993-5 (reactivity grade), bacterial mutation genotoxicity assay, acute oral toxicity studies, irritation/sensitization tests.
  • Antimicrobial Efficacy: USP 51 requirements, quantitative reduction against specific microorganisms (e.g., Staphyloccoccus aureus, Clostridium difficile endospores).

8. The sample size for the training set:

• Not applicable, as this is not a machine learning/AI device, and no training set was used.

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

• Not applicable, as this is not a machine learning/AI device.

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Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

The subject device is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Vashe® Wound Therapy Solution, a wound cleansing solution, and a letter from the FDA confirming its substantial equivalence to predicate devices.

The information primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Submitter and Contact Information.
• Predicate Devices: A list of previously cleared devices to which Vashe® Wound Therapy Solution is compared for substantial equivalence.
• Device Description: What the device is and its mechanical action.
• Indications for Use: What the device is intended for (management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin).
• Substantial Equivalence Argument: How it is similar in function and intended use to the predicate devices.
• Non-clinical Performance: A brief mention that pre-clinical testing demonstrated biocompatibility.
• FDA Clearance Letter: Confirmation of substantial equivalence and regulatory information.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A formal study designed to demonstrate the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type or establishment of ground truth.

The "Non-clinical Performance" section states: "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." This is the only mention of any testing, but it's limited to biocompatibility and does not involve performance metrics related to acceptance criteria for the indicated uses. The basis for clearance is substantial equivalence to already marketed predicate devices, not meeting specific performance criteria through a new clinical or benchmark study.

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Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device includes a wound cleanser solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vashe® Wound Therapy System:

Based on the provided text, the Vashe® Wound Therapy System is a wound cleanser solution. The document is a 510(k) summary, which indicates a claim of substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to establish new acceptance criteria.

The device is not an AI-powered one, and therefore the details you requested regarding AI performance (test set, training set, experts, MRMC studies, standalone performance) are not applicable.

Here's a breakdown of the information that is available:

Acceptance Criteria and Device Performance for Vashe® Wound Therapy System

The acceptance criteria for the Vashe® Wound Therapy System are not explicitly stated in terms of specific performance metrics within this 510(k) summary. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices. This means the device is considered acceptable if its performance is comparable to or safe and effective as the predicate devices for its intended indications for use.

The study that "proves the device meets the acceptance criteria" is a pre-clinical testing study that demonstrated biocompatibility. The 510(k) process relies heavily on demonstrating similarity to already approved devices rather than establishing new efficacy or performance benchmarks via clinical trials, especially for devices like wound cleansers.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a non-AI device. The "test set" here would refer to the subjects in the biocompatibility testing, but specific numbers are not provided.
• Data Provenance: The biocompatibility testing likely involved in-vitro and/or in-vivo animal studies, which are standard for such evaluations. The specific country of origin or whether it was retrospective/prospective is not mentioned.

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

• Not applicable as this is a non-AI device. Ground truth, in this context, would be the results of the biocompatibility tests themselves, assessed against established standards, not expert consensus on findings.

4. Adjudication Method for the Test Set

• Not applicable for a non-AI device. Adjudication methods are typically used in clinical studies or expert reviews of complex data (like medical images) where multiple interpretations are possible. Biocompatibility testing results are usually evaluated against pre-defined scientific 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

• Not applicable. This device is not an AI product and does not involve human readers interpreting AI output.

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

• Not applicable. This device is not an AI algorithm. Its performance is inherent to the chemical composition and mechanical action of the solution itself.

7. The Type of Ground Truth Used

• The "ground truth" for the biocompatibility testing would be scientific standards and established biological responses to the test materials. This could involve cell viability assays, irritation tests, sensitization tests, and systemic toxicity tests, where the absence of adverse reactions against predefined thresholds constitutes "truth."

8. The Sample Size for the Training Set

• Not applicable as this is a non-AI device. There is no training set mentioned or implied.

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

• Not applicable as this is a non-AI device.

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Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device is a wound cleansing and disinfecting solution that is intended for cleansing, irrigating, debriding and disinfecting dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Vashe is offered in various volumes.

The provided text is a 510(k) Summary for the Vashe™ Wound Cleanser and an FDA clearance letter for a later submission (K092232) for Vashe® Wound Cleanser. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device's performance.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and sample sizes for testing and training sets cannot be extracted from this document in the typical sense applied to a performance study for, for example, an AI medical device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Performance for wound cleansers is typically demonstrated through biocompatibility, chemical and physical properties, and a comparison of intended use to similar predicate devices. The document does not specify quantitative "acceptance criteria" in the format one might expect for a performance study (e.g., specific sensitivity/specificity thresholds). Instead, "performance" is implicitly demonstrated through substantial equivalence to existing, legally marketed devices.

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

The provided text does not describe a "test set" in the context of an algorithm or performance study involving specific data samples (e.g., patient images or cases). The "pre-clinical testing" for biocompatibility would have involved a sample size of test subjects (e.g., animals or in vitro cultures), but this specific information is not provided.

• Sample Size for Test Set: Not specified in the provided text for a "test set" for performance evaluation. The "pre-clinical testing" likely involved a sample size for biocompatibility testing, but details are not given.
• Data Provenance: Not applicable in the context of a "test set" for algorithm performance. The pre-clinical testing would have been conducted in a laboratory setting.

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

This information is not applicable/not provided. The device is a wound cleanser, not an AI diagnostic device that requires expert-established ground truth on a test set of medical cases. Biocompatibility testing is typically assessed by laboratory experts following standardized protocols, not by medical experts establishing "ground truth" on patient data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or diagnostic assessment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is a wound cleanser, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This information is not applicable. The device is a wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used for AI medical devices (e.g., pathology, outcomes data) is not directly applicable here. For a wound cleanser, the "ground truth" for demonstrating safety and effectiveness relies on:

• Biocompatibility testing standards: Meeting established standards for non-toxicity, non-irritation, etc.
• Chemical and physical properties: Verifying the composition and stability of the solution.
• Clinical experience with predicate devices: Relying on the known safety and effectiveness of similar products already on the market.

8. The Sample Size for the Training Set

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set.

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

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set with established ground truth.

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Sterilox™ is a high level disinfectant system intended for processing heat sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.

The device is intended for use by qualified health care personnel trained in its use.

The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared capability to maintain the solution temperature at 30°C used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.

Here's an analysis of the provided text regarding the Sterilox™ High Level Disinfectant System, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for each microbiological or toxicity test test set, other than:

• "Clinical In-Use": "No surviving microorganisms on any of the endoscopes tested" implies a sample size of multiple endoscopes, but the exact number isn't given.
• "Simulated Use Test": "inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C." implies multiple scopes, but quantity not specified.
• General Microbiological Tests (AOAC, EPA methods): These methods typically have defined sample sizes, but the report summarizes the results rather than detailing the experimental setup for each test performed on this specific device.

Data Provenance: The information provided generally describes laboratory testing (e.g., AOAC methods for efficacy, animal studies for toxicity). There is no explicit mention of data origin (e.g., country) for these studies. The "Clinical In-Use" implies real-world usage, making it prospective in nature for that specific part of the study. The remaining tests are laboratory studies.

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

There is no information in the provided text about the use of "experts" to establish ground truth in the way one might for diagnostic AI. The ground truth for the microbiological efficacy tests and toxicological tests is established by standardized laboratory methods (e.g., AOAC, EPA protocols) which inherently define what constitutes a positive or negative result. For instance, for sporicidal activity, the ground truth is whether spores are killed as per the method's criteria, not an expert's interpretation of an image.

4. Adjudication Method for the Test Set

Not applicable. This device is a high-level disinfectant, not an AI or diagnostic tool where expert adjudication of results would typically be employed. The tests are laboratory-based and use objective endpoints.

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

No. This is a chemical disinfectant, not a diagnostic imaging device or AI algorithm for human interpretation enhancement. Therefore, an MRMC study is not relevant or included in this submission.

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

Yes, in the sense that all efficacy and safety studies were conducted on the device itself (the Sterilox Liquid Chemical High Level Disinfectant System and its germicide solution), demonstrating its performance independently without a human interpretation component that would require "human-in-the-loop" considerations.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

• Laboratory outcomes/direct measurements: For microbiological efficacy, it's the destruction or inactivation of specific microorganisms (e.g., spores, bacteria, fungi, viruses, mycobacteria) under specified conditions, measured by standard laboratory culture techniques.
• Physiological/toxicological responses: For toxicity, the ground truth is the observable response (or lack thereof) in animal models (e.g., irritation, sensitization, LD50 values, mutagenicity) against established biological endpoints.
• Chemical analysis: For residue data, the ground truth is the quantifiable level of Sterilox components remaining after rinsing.
• Physical observation: For material compatibility, the ground truth is visible changes, damage, or corrosion.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of supervised learning. The testing described is empirical validation against pre-defined performance standards.

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

Not applicable, as there is no training set for this type of device submission.

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Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides. The mechanical action of the solution moving in the root canal facilitates easy removal of debris and necrotic pulp tissue from the root canal.

The Aquatine™ EC Endodontic Cleanser is deemed substantially equivalent based on non-clinical performance and biocompatibility data. The provided document, K061689, does not contain information about specific acceptance criteria or a study with detailed performance metrics, sample sizes, expert involvement, or comparative effectiveness studies that would be typical for an AI/ML powered device. Instead, the clearance is based on the device's similarity in function and intended use to existing legally marketed predicate devices and the fact that all components of Aquatine™ EC have been used in legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The document is a 510(k) summary and clearance letter for a non-AI/ML medical device, which explains why these details are absent.

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