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TorrentX Wound Wash is indicated for use in cleansing and removal of debris, including microorganisms from wounds.

TorrentX Wound Wash is a non-sterile, clear, colorless, aqueous solution that is used to remove debris, including microorganisms from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as debris and bacteria via hydrodynamic shear.

TorrentX Wound Wash will be provided in a 20mL low density polyethylene ampoule with a twist-off seal. Ten (10) ampoules and applicator tips will be provided together in a shelf carton.

The formulation for TorrentX Wound Wash is composed of ethanol, water, sodium citrate, citric acid and benzalkonium chloride.

The provided text is a 510(k) summary for a medical device called "TorrentX Wound Wash." It describes the device, its indications for use, and a summary of nonclinical studies performed to demonstrate its substantial equivalence to a predicate device.

Regarding your request for acceptance criteria and study details, it's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving a device meets specific, quantitative "acceptance criteria" in the way a novel therapeutic might.

For the TorrentX Wound Wash, the "acceptance criteria" are implied by demonstrating that it is "as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." The studies listed are designed to show that the new device does not raise new questions of safety or effectiveness compared to the predicate.

Given this context, I will provide the information based on the available text, understanding that it's framed within a 510(k) submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative "acceptance criteria" for performance metrics are not typically presented in a 510(k) summary for a wound wash in the same way they would be for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are demonstrating similarity or equivalence to the predicate device in terms of safety and effectiveness, across various nonclinical tests.

Performance Bench Testing:

• Application Pressure Test: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to be acceptable/comparable). |
  | Antimicrobial/Preservation Effectiveness | Performance Bench Testing:
• Antimicrobial Effectiveness Test (Preservation) (USP ): Performed. (Specific results not detailed, but implied to be acceptable/comparable for the preservation properties of the formulation). |
  | Biocompatibility / Safety (no new safety concerns) | Biocompatibility Testing:
• Sensitization: Performed.
• Material-mediated Pyrogenicity: Performed.
• Toxicological Risk Assessment: Performed.

Endotoxin Test:

• Endotoxin LAL Test: Performed.

Animal Testing:

• Porcine Wound Healing Study: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to show no adverse effects or comparable healing to expectation).

Conclusion: "The difference in ingredients do not raise different questions of safety or effectiveness." and "The conclusions drawn from the performance tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." |
| Chemical Composition Compatibility | "All the components of TorrentX Wound Wash are consistent with known ingredients for cleared wound dressings under the FRO product code."
"The proposed and predicate devices contain the same surfactant to assist in the solubilization of debris and the same vehicle to carry away any debris..." |

Detailed Information on Studies:

The text describes nonclinical studies, not clinical trials with human subjects or AI performance evaluations, therefore, many of your specific questions (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of submission or the information provided.

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

• Not Applicable. This document describes nonclinical studies (bench, animal, biocompatibility) rather than a test set for an algorithm with human data. Details are not provided.

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

• Not Applicable. Ground truth, in the context of expert consensus, is not relevant for the nonclinical studies summarized here.

4. Adjudication method for the test set:

• Not Applicable. No test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a wound wash, not an AI diagnostic or assistance tool. No MRMC study was performed.

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

• Not Applicable. This device is a physical wound wash product, not an algorithm.

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

• For Bench Testing: Likely based on established physical/chemical standards (e.g., USP for Antimicrobial Effectiveness Test, standard test methods for pressure, LAL test for endotoxin).
• For Animal Testing (Porcine Wound Healing Study): Ground truth would be based on macroscopic and/or microscopic assessment of wound healing parameters, typically by veterinary pathologists or trained researchers against controls, following established protocols.
• For Biocompatibility Testing: Ground truth is against established ISO standards for biocompatibility (e.g., for sensitization, pyrogenicity, toxicology).

8. The sample size for the training set:

• Not Applicable. This is not an AI/algorithm-based device requiring a training set.

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

• Not Applicable. (See #8)

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MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.

MIS Solution is a clear, colorless solution intended for cleansing and removal of debris, including microorganisms, from wounds.

The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganism, from wounds. MIS Solution is provided in a soft polypropylene 500mL container with a spikeable port. MIS Solution is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.

This document is a 510(k) summary for the device "MIS Solution," a wound irrigation solution. It focuses on demonstrating substantial equivalence to a predicate device, Next Science® Irrigation Solution (K161165).

Based on the provided text, a conventional comparative effectiveness study (like an MRMC study for AI devices) was not conducted. The primary studies are bench tests and biocompatibility studies aimed at showing the new device functions similarly and is as safe as the predicate device, rather than improving human performance or providing standalone AI output.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria and reported device performance in a table format for the primary "efficacy" aspect of debris removal. Instead, it describes performance in qualitative terms and through comparison to a predicate.

• Material Mediated Pyrogenicity (USP ): Passed.
• Guinea Pig Maximization Sensitization Test: Passed.
• Porcine Wound Healing: Did not inhibit normal wound healing over 25 days.
• Toxicological Risk Assessment (ISO 10993-17): Performed.
• Chemical Characterization of Extractables and Leachables: Performed.
• Irritation (Human): Determined to be a non-irritant. |
  | Safety: No adverse events or complications. | Human Repeat Patch Test (Clinical Study): No adverse events or complications. |

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

• Human Repeat Patch Test (Clinical Study):
  • Sample Size: Not explicitly stated, but implies multiple human subjects ("Human Repeat Patch Test"). The number of patches applied is also not stated.
  • Data Provenance: Prospective (clinical study), country of origin not specified but likely U.S. as FDA submission.
• Porcine Wound Healing Study (Animal Testing):
  • Sample Size: 16 domestic pigs were used. Each pig had eight wounds (four on the left and four on the right side of the animal's back). Two or three wounds per animal were assigned to a treatment group (subject device, predicate device, or negative control).
  • Data Provenance: Prospective animal study, country of origin not specified.
• Bench Tests (Compatibility and Irrigation Force Comparison, Combined Dissolution Efficacy): Sample size refers to the number of tests or runs; specific numbers are not provided. Data provenance is laboratory testing.

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

• This information is not provided in the document. For biocompatibility and animal studies, "ground truth" is typically objective measurements (e.g., pyrogenicity, irritation scores, wound healing progression assessed by researchers). For the bench tests, the outcomes are based on measurable physical properties (pressure, dissolution efficacy). There is no mention of experts establishing a "ground truth" in the way it would be for an AI diagnostic device reviewing images.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1 consensus) are typically relevant for human interpretation of data, particularly subjective data, where multiple readers provide initial reads. This is not applicable to the types of studies described (biocompatibility, bench tests, animal healing, human patch test), which rely on objective measurements and predefined test protocols.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI device on human reader performance (e.g., radiologists interpreting images). The "MIS Solution" is a wound irrigation solution, not a diagnostic AI device requiring human interpretation of output.

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

• Not applicable. The device is a physical solution, not an algorithm. The "standalone" performance would be its inherent chemical and physical properties as measured in the bench tests (e.g., dissolution efficacy) or its biological impact as measured in animal/human studies (e.g., wound healing, irritation).

7. Type of Ground Truth Used

• Biocompatibility Studies: Objective laboratory measurements, standardized test results (e.g., USP for pyrogenicity, ISO 10993 for irritation/sensitization).
• Animal Study (Porcine Wound Healing): Histological and macroscopic evaluation of wound healing progression, as measured by researchers using predefined assessment criteria.
• Human Repeat Patch Test (Clinical Study): Clinical assessment of skin irritation by qualified healthcare professionals based on visual inspection and patient reports, using standardized scoring.
• Performance Bench Testing: Quantitative physical measurements (e.g., pressure, dissolution rate) against established scientific benchmarks or the predicate device.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning algorithm, so there is no training set in the context of AI model development.

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

• Not applicable (as there is no training set).

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Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.

Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.

This document describes K192349, a 510(k) premarket notification for the "Bactisure Wound Lavage" device. The acceptance criteria described here refer to the performance testing used to demonstrate substantial equivalence to a predicate device, rather than specific performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "test set" in the context of a clinical study with patients or data points. The performance testing appears to be primarily laboratory-based (biocompatibility, sterilization, toxicological analysis, literature review) rather than a direct evaluation of device performance on a biological test set with a specific sample size. Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the typical sense for this submission type.

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

Not applicable. This submission relies on established international standards (ISO) for biocompatibility and sterilization, and internal risk analyses and literature reviews for safety related to product composition and use. There is no mention of external experts establishing a "ground truth" for a specific test set of cases.

4. Adjudication Method for the Test Set:

Not applicable, as there is no specific test set requiring adjudication in the context of clinical or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance:

Not applicable. This device is a medical lavage solution, not an AI-assisted diagnostic or assistive technology. Therefore, an MRMC study and effects on human reader performance 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 medical solution and does not involve an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• International Standards: For biocompatibility (ISO 10993-1) and sterilization (ISO 11737-2, ISO 14937, ISO 17665-1).
• Toxicological Risk Analysis: For assessing the safety implications of changes in solution composition.
• Literature Reviews and Risk Analyses: For supporting contraindications and warnings related to specific ingredients (e.g., ethanol content).

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."

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

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

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Next Science Wound Gel (Rx) is indicated for the management of wounds such as 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.

Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing. The antimicrobial agent, benzalkonium chloride, inhibits the growth of microorganisms in the hydrogel. The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to healing by either absorbing wound exudate or donating moisture. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube.

The provided text describes a 510(k) premarket notification for a medical device called "Next Science Wound Gel (Rx)". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.

Therefore, many of the requested details, such as:

• A table of acceptance criteria and reported device performance (in the context of AI)
• Sample sizes for test sets (for AI)
• Number of experts and their qualifications (for AI ground truth)
• Adjudication method (for AI ground truth)
• MRMC comparative effectiveness study results (AI assistance)
• Standalone performance (AI algorithm only)
• Type of ground truth used (for AI)
• Sample size for training set (for AI)
• How ground truth for training set was established (for AI)

are not applicable or available in this document. The document concerns a physical medical device (wound gel) and its biological and functional performance, not an AI/software device.

However, I can extract the information relevant to the device's performance testing and the grounds for its substantial equivalence.

Here's what can be extracted:

1. Acceptance Criteria and Reported Device Performance (as related to the physical device properties):

The document doesn't present a table of quantitative acceptance criteria for biological or clinical performance in the typical sense of an AI/diagnostic study, but rather demonstrates compliance with safety and effectiveness standards through various tests and comparison to predicates.

2. Sample Sample(s) Used for the Test Set and Data Provenance:

• Test Set (for the gel's performance): The document mentions a "full thickness wound study" and "biocompatibility studies" and "USP Antimicrobial Effectiveness Testing and ".
  • Sample Size: Not specified for any of these studies.
  • Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory or preclinical studies demonstrating functional and safety aspects of the gel, not clinical trials with human patient data. These would be considered prospective data generation for the purpose of demonstrating device characteristics.

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

• Not applicable: This document describes a physical medical device (wound gel) and its chemical/biological properties and performance studies (biocompatibility, antimicrobial effectiveness, wound healing observation), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or similar.

4. Adjudication Method for the Test Set:

• Not applicable: As above, this is not an AI/diagnostic study scenario where human adjudication of interpretations is required.

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

• No: This is not relevant to the presented device approval (wound gel). There is no AI component mentioned in this document.

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

• No: This is not relevant to the presented device approval (wound gel). There is no AI component mentioned in this document.

7. The Type of Ground Truth Used:

• For the physical properties and performance of the gel:
  • Biocompatibility: Likely based on established ISO 10993 standards and assays, with "ground truth" being the measured biological reaction (e.g., cytotoxicity, irritation) against control limits.
  • Functional Performance (Wound Study): Likely observational data on wound healing, potentially compared to controls or predicate devices.
  • Preservative Efficacy: Based on quantitative microbial reduction/inhibition as defined by USP standards.

8. The Sample Size for the Training Set:

• Not applicable: This is a physical medical device, not an AI/machine learning model that requires a training set.

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

• Not applicable: This is a physical medical device, not an AI/machine learning model that requires a training set.

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Next Science™ Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.

Next Science™ Irrigation Solution is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Next Science™ Irrigation Solution will be provided in a 1000 mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged with six (6) containers per case. The formulation for Next Science™ Irrigation Solution is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Next Science Irrigation Solution:

I. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a structured table. Instead, it relies on a qualitative comparison to the predicate device regarding safety and effectiveness, supported by various tests. The core acceptance criterion is "Substantial Equivalence" to the predicate device, Prontosan Wound Irrigation Solution (K072876).

Since no numerical performance metrics are provided in the document, I cannot create a table with specific acceptance criteria and reported device performance. The information focuses on whether the device is at least as safe and effective as the predicate.

II. Study Details

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

   • Test Set Description: The core "test set" for the critical animal study involved eight Yorkshire pigs.
   • Data Provenance: The document does not specify the country of origin for the animal study. It was a prospective study designed to evaluate the effect of the irrigation solution.

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

   • The document does not mention the use of experts to establish a "ground truth" for the animal study in the typical sense of expert annotation for AI algorithms. The assessment of wound healing was likely conducted by the study investigators based on observable physiological responses and histological analysis (though not explicitly detailed beyond "normal wound healing").
   • Therefore, information on the number and qualifications of experts for ground truth establishment is not provided.

3. Adjudication method for the test set:

   • The document describes that "The four wounds were treated with the same control or test solution, or an empty control (no treatment)." This indicates a controlled experimental design where different treatments (test solution, control article, no treatment) were applied to wounds on the same animals.
   • However, it does not describe an adjudication method for establishing ground truth, as it's not a human-reader interpretation study. The assessment of wound healing would be based on scientific observation and measurement.

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:

   • No MRMC study was done. This device is a medical solution (irrigation solution), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.

5. 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. Therefore, no standalone algorithm-only performance study was conducted.

6. The type of ground truth used:

   • For the animal study, the "ground truth" was based on biological outcomes or physiological response, specifically "normal wound healing." This would have been assessed through direct observation and potentially histological analysis of the wound sites over the 24-day study period.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device that requires a training set.

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

   • Not applicable. As there is no training set, there's no ground truth to establish for it.

In summary, the provided document describes a medical device (an irrigation solution) and its substantial equivalence determination based on biocompatibility, functional performance, and animal testing, rather than an AI/software device requiring a test set for algorithm performance evaluation, human reader studies, or training sets.

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Next Science™ Wound Gel is indicated for the management of skin abrasions, minor irritations, cuts, exit sites and intact skin.

The Next Science™ Wound Gel is a white, virtually odorless hydrogel. The Wound Gel provides management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin by maintaining a moist wound environment that is conducive to wound healing while inhibiting the growth of microorganisms in the hydrogel. The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to wound healing. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube.

The provided document is a 510(k) summary for the Next Science™ Wound Gel. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods for an AI/CAD/software device as requested in the prompt. The "performance testing" mentioned is chemical/biological for a wound gel, not algorithm performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Sample Size (Test Set): Not specified in the document. The studies mentioned are a "full thickness wound study" and "USP Antimicrobial Effectiveness Testing prototypes/samples."
• Data Provenance: Not specified.

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

• Not applicable/Not specified. This relates to diagnostic interpretation, which is not the function of this wound gel.

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

• Not applicable/Not specified. This relates to diagnostic interpretation.

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. This is a wound gel, not an AI/CAD device.

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

• No. This is a wound gel, not an AI/CAD device.

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

• For biocompatibility: Adherence to ISO standards, implying laboratory testing against specific metrics.
• For wound management: Results from a "full thickness wound study," which would likely involve direct observation of healing, possibly histological assessment, or other direct biological measurements.
• For preservative efficacy: Results against USP and standards, which are laboratory microbiological tests.

8. The sample size for the training set:

• Not applicable/Not specified. This product is a wound gel, not a machine learning model.

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

• Not applicable/Not specified. This product is a wound gel, not a machine learning model.

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