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Indications for Use - Hydrosurgical unit:

The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures.

Indications for Use - Applicators and ERBEJET probe:

20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used free injection including lifting of mucosal lesions by injection into the submucosa.

20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.

20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.

20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instruments (applicators and ERBEJET probe), an optional suction model ESM 2 with accessories and a one- or two-pedal footswitch. Together these components form the ERBEJET® 2 System. The system provides an adjustable high-pressure water jet (pressurized normal saline solution) intended for tissue-selective hydrodissection and needle-free injection in endoscopic and/or surgical interventions. The ERBEJET® 2 unit together with its accessories is an active invasive surgical system. The sterile normal saline solution is the "medium" which is projected under pressure through a nozzle of the connected instrument to achieve the desired tissue effect.

This document is an FDA 510(k) summary for the ERBEJET® 2 System, which is a hydrosurgical unit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable or not provided in this type of submission.

The 510(k) summary outlines the device's indications for use, describes its components, compares its technological characteristics to predicate devices, and details non-clinical performance testing. The purpose of these tests is to show that the new device does not raise new questions of safety or effectiveness, not to establish new performance metrics against clinical acceptance criteria.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present clinical acceptance criteria with corresponding device performance metrics in a table format. The "performance" discussed is related to maintaining functional equivalence with the predicate device through non-clinical testing.

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

• Sample Size: Not applicable. The document describes non-clinical testing (bench testing, verification, validation) on the device components, not a clinical test set with patient data.
• Data Provenance: Not applicable. The testing is described as internal verification and validation activities. No country of origin for clinical data or retrospective/prospective study design is mentioned because it's not a clinical study.

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

• Not applicable. This is not a clinical study involving expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication process is detailed as there's no clinical diagnostic test set.

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. The ERBEJET® 2 System is a medical device (hydrosurgical unit), not an AI-powered diagnostic system or an assistive technology that would involve "human readers" or AI assistance in interpretation.

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

• Not applicable. This device does not involve an algorithm with standalone performance in a diagnostic or interpretive capacity. Its function is to deliver a pressurized water jet.

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

• Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical tests is adherence to established engineering standards, regulatory requirements (e.g., ISO, IEC, FDA guidances), and design specifications.

8. The sample size for the training set

• Not applicable. This information pertains to machine learning models, which are not relevant to the described ERBEJET® 2 System.

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

• Not applicable, as no training set for a machine learning model is mentioned or relevant to this device submission.

Summary of the FDA 510(k) Submission Perspective:

The FDA 510(k) process for the ERBEJET® 2 System is about demonstrating substantial equivalence to legally marketed predicate devices, not about proving novel clinical performance or algorithmic efficacy. The non-clinical tests mentioned (electrical safety, EMC, functional, biocompatibility, sterilization, packaging, software) are standard engineering and regulatory verification/validation activities to ensure the device is safe and effective when compared to its predicates, despite minor modifications. The document successfully argues that the subject device "does not raise new or different questions of safety and effectiveness" compared to the predicate devices.

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The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).

The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.

The provided text describes information for a 510(k) submission for the Armis VeriCyn® Wound Wash. Based on the content, this is a medical device (a wound wash solution) and not an AI/ML device, therefore, many of the requested criteria (like ground truth, experts, MRMC studies, training set, etc.) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical testing performed to establish substantial equivalence.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating substantial equivalence to a predicate device (Next Science™ Irrigation Solution) through non-clinical testing, ensuring safety and effectiveness for its intended use. The "reported device performance" refers to the results of these non-clinical tests.

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

Not applicable for this type of device (wound wash solution). The "test set" here refers to the samples of the wound wash solution and materials that underwent physical, chemical, and biological testing, not a dataset of patient images or clinical cases. The provenance of the data is from specific laboratory tests conducted on the device components and the final product, as detailed under "Non-Clinical Tests Performed."

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

Not applicable. No expert consensus "ground truth" as typically understood for AI/ML devices is relevant here. The standards for testing (e.g., ISO 10993, USP , , ) provide the "ground truth" of performance criteria, and the tests themselves are conducted by qualified laboratory personnel following these established protocols.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials involving human interpretation, often for AI/ML device validation. For this wound wash solution, performance is assessed against established physical, chemical, and biological standards through laboratory testing.

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/ML device; it is a physical wound wash solution. MRMC studies are used to evaluate diagnostic or screening AI/ML devices.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established international and national standards and test methodologies for medical device safety, biocompatibility, and functional performance. These include:

• ISO 10993 series: For biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity).
• USP : For Preservative Effectiveness.
• USP and : For Bioburden.
• Internal specifications: For physical properties like Clarity, Color, pH, and Viscosity, which are then compared to the predicate or deemed safe.
• Functional wound-wash study: To demonstrate mechanical removal of debris.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML algorithm.

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

Not applicable. This device does not have a training set.

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The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:

• wound debridement (acute and chronic wounds, burns),
• soft tissue debridement and cleansing of surgical sites.

The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.

The provided text describes a 510(k) premarket notification for the VERSAJET III Hydrosurgery System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with quantitative performance metrics for AI applications. The device described (a hydrosurgery system) is a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically relies on algorithms and data for its function.

Therefore, many of the requested categories in your prompt related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this traditional medical device submission.

However, I can extract information related to the device's "performance" in the context of a 510(k) (which means demonstrating safety and effectiveness compared to a predicate) and non-clinical testing.

Here's a summary based on the provided text, addressing the applicable points and indicating when information is not present or relevant to this type of device:

Device: VERSAJET III Hydrosurgery System

Predicate Device: VERSAJET II Hydrosurgery System (K143115)

Regulation Number: 21 CFR 880.5475 (Jet lavage)

Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the way one would for an AI diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, "performance" in this context refers to the device's functional integrity, safety, and equivalence to the predicate device through non-clinical testing.

The overall conclusion for all tests is that they were completed to prove safety and effectiveness and to demonstrate substantial equivalence in performance to the predicate device. The submission states, "Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use."

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

• Not Applicable. This is a physical device, and the testing described is non-clinical bench testing, electrical safety, EMC, and human factors. There is no "test set" of patient data in the context of an AI algorithm evaluation.

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

• Not Applicable. As above, no patient data test set requiring expert ground truth for an algorithm. Human factors testing would involve user interaction, but this is different from establishing ground truth for diagnostic imaging.

4. Adjudication method for the test set

• Not Applicable. No test set of patient data requiring adjudication.

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

• No. This is not an AI-powered diagnostic device. No MRMC study was conducted.

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

• No. This is a physical, manually operated medical device tool; it does not have an algorithm that performs a standalone function for diagnosis or intervention without human control.

7. The type of ground truth used

• Not Applicable. Ground truth, in the context of AI, refers to the verified correct output for a given input. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks (e.g., a handpiece reliably delivers X pressure, a safety cutoff activates at Y point, components withstand Z cycles). The document does not detail specific "ground truth" methods beyond adherence to standards and demonstrating equivalence to predicate performance.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model that requires a training set of data.

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

• Not Applicable. As above, no training set for an AI model.

In summary, the provided document details a 510(k) submission for a conventional medical device (hydrosurgery system). The "acceptance criteria" and "study" refer to non-clinical engineering and performance testing aimed at demonstrating the device's safety, effectiveness, and substantial equivalence to a predicate device, rather than the performance metrics and ground truth methodologies typically associated with AI/SaMD products.

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BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

The subject BD Surgiphor™ Antimicrobial Irrigation System is a terminally sterilized 450 mL aqueous solution for irrigation and debridement of wounds. The device includes one bottle of Surgiphor™ solution (0.5% Povidone Iodine) which is used to loosen and remove wound debris. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the loosening and removal of debris, and foreign materials, including microorganisms, from wounds. The povidone iodine in the Surgiphor™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text describes a 510(k) premarket notification for a medical device called the "BD Surgiphor™ Antimicrobial Irrigation System." This submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K213616).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance:

The core of this 510(k) submission is to demonstrate that a modified device is substantially equivalent to a predicate device, not to establish new performance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily tied to demonstrating that the changes made do not negatively impact the safety or effectiveness of the device compared to the predicate.

The main change in the subject device (K221504) from its predicate (K213616) is the removal of the SurgiRinse™ solution bottle. The device still includes one bottle of Surgiphor™ solution. The manufacturer asserts that the fundamental "mechanism of action" (mechanical loosening and removal of debris and foreign materials, including microorganisms, from wounds through fluid pressure) remains unchanged. The povidone iodine in the Surgiphor™ solution continues to act as a preservative.

Given this context, the acceptance criteria are implicitly met by demonstrating that the modified device performs comparably to the predicate device, specifically by showing that removing the rinse bottle does not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a modified device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or accuracy (as one might see for an AI/ML device). Instead, the acceptance criteria are met by demonstrating that the changes do not degrade performance or safety.

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

The document does not describe a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects. This 510(k) relies on design verification and validation testing and standards compliance to demonstrate substantial equivalence to a predicate device, given a minor change (removal of one component from a kit).

Therefore, there is no mention of data provenance (country of origin, retrospective/prospective) because the studies are primarily engineering and quality control tests (sterilization, packaging, shelf-life) rather than clinical performance studies on patient data.

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

This information is not applicable to this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically relevant for diagnostic AI/ML devices where a clinical reference standard is needed. This device is a physical irrigation system, and its "ground truth" for substantial equivalence is derived from a combination of:

• The established performance and safety of its predicate device.
• Laboratory testing (sterilization, packaging) against recognized standards.
• Engineering assessment that a structural change (removing a bottle) does not alter intended use or introduce new risks.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Clinical adjudication methods are not relevant for the type of testing described.

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

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic aids, particularly AI/ML algorithms, in how they affect human reader performance. This device is an irrigation system, not a diagnostic tool, and the submission is focused on physical and chemical equivalence and safety, not on human interpretation of outputs.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

• Engineering specifications and design verification: Ensuring the physical and chemical properties of the device (solution composition, packaging, sterility) remain consistent with safe and effective operation as defined by standards.
• Predicate device's established safety and effectiveness: The fundamental "truth" is that the predicate device was already deemed safe and effective for its intended use, and the current submission argues that the modified device maintains this "truth" despite the change.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device does not involve an AI/ML component.

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

This information is not applicable. Since there is no training set, there is no ground truth established for it.

In summary:

The provided FDA letter and 510(k) summary pertain to a physical medical device (an irrigation system) undergoing a minor modification. The "acceptance criteria" and "study" described are primarily related to engineering validation, quality control testing (e.g., sterility, shelf-life), and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. It does not involve the types of studies (e.g., clinical trials, AI/ML performance evaluations) that would typically require the detailed information on test sets, expert readers, or ground truth methodologies for diagnostic or AI-powered devices. The crucial point of this submission is the statement: "The changes do not impact the safety or effectiveness of the subject device [compared to the predicate device]."

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Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.

The provided document is a 510(k) summary for the Irrisept® Antimicrobial Wound Lavage (150 mL), which is a modified version of a previously cleared device (450 mL Irrisept® Antimicrobial Wound Lavage, K210536). This submission asserts substantial equivalence to the predicate device, meaning the new device generally adheres to the same performance standards established for the predicate.

The document does not detail specific acceptance criteria values or a standalone study demonstrating the device's meeting of these criteria in the context of a new clinical or performance trial for effectiveness in all aspects. Instead, it relies on demonstrating that the modified device performs equivalently to the predicate device through various tests and that the modifications do not raise new safety or effectiveness concerns.

Here's an analysis based on the provided text, addressing your specific questions to the extent the document allows:

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

The document does not explicitly state numerical acceptance criteria with corresponding reported performance values for each functional aspect. Instead, it lists various tests performed and asserts that the device (150 mL version) demonstrated the "same level of performance as the predicate device" or was "equivalent to the predicate device" in functional testing.

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

The document does not specify sample sizes for any of the tests mentioned (e.g., number of units tested for functional performance, biocompatibility, etc.).
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given that this is a 510(k) summary for a modified device, the testing would be conducted prospectively for the new iteration to demonstrate equivalence.

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

This type of information is not applicable to this document. The document describes a medical device (wound lavage) and its physical and chemical properties and functional equivalence to a predicate device, not a diagnostic or AI-driven decision support system that requires expert ground truth establishment for a test set.

4. Adjudication method for the test set

This is not applicable for the same reasons as point 3.

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

This is not applicable. The device is a wound lavage, not an AI or imaging diagnostic tool that would be part of a MRMC study.

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

This is not applicable. The device is a physical medical device, not an algorithm.

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

For the performance testing, the "ground truth" would be established by the validated methods described (e.g., ISO standards for biocompatibility, USP methods for antimicrobial effectiveness and sterility, custom tests for functional equivalence to the predicate). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. For the functional testing, "custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device" implies a controlled experimental setup to measure the efficacy of removing debris, with the predicate device's performance serving as the benchmark.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reasons as point 8.

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IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.

IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap.

The provided text describes a 510(k) premarket notification for the IRRIGO Wound Wash Jet System. This document is a submission to the FDA seeking to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical or AI-based performance metrics.

The document discusses bench testing conducted to ensure the device meets established specifications and standards related to its composition, sterility, pressure generation (up to 15 psi), biocompatibility, and packaging integrity. However, it does not present a study with the kind of acceptance criteria, test set, ground truth establishment, or human-in-the-loop performance evaluation that would be relevant for an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and study proving device performance, as the document pertains to a medical device for wound irrigation and does not describe an AI/ML-based device or a clinical study with the specified types of performance measures.

Here's why the specific points cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: The document lists standards and tests (e.g., USP standards for sodium chloride irrigation, sterility, endotoxins, biocompatibility tests). It states that the device "is tested against established specifications and meets Biocompatibility requirements" and "IRRIGO Wound Wash Jet System is tested against established specifications and meets Biocompatibility requirements." It also mentions "IRRIGO PSI Testing/Internal Pressure Curves" and that the device "can generate upto 15 psi of stream pressure." However, these are general statements of compliance with technical standards, not a specific table of acceptance criteria with corresponding performance values that would typically be presented for an AI/ML or a complex clinical effectiveness study. There are no performance metrics like sensitivity, specificity, accuracy, or reader improvement.

2. Sample size, data provenance: Not applicable. This is not a study involving patient data or an AI model. The "testing" refers to manufacturing and device-specific technical compliance.

3. Number of experts, qualifications: Not applicable. No ground truth established by experts is mentioned, as this is not a diagnostic device or a study requiring human adjudication of performance.

4. Adjudication method: Not applicable.

5. MRMC comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.

6. Standalone performance (algorithm only): Not applicable. This is not an algorithm.

7. Type of ground truth: Not applicable.

8. Sample size for training set: Not applicable. There is no AI model.

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

In summary, the provided text describes the regulatory filing for a physical medical device (wound wash system) and its bench testing for safety and functional specifications, not a study evaluating an AI/ML device or its clinical performance in the way implied by the request.

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BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text describes a 510(k) premarket notification for the "BD Surgiphor Antimicrobial Irrigation System." It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of "microorganisms" to the device's indications for use.

Based on the provided text, the device is a medical irrigation system, not an AI/ML device. Therefore, the questions about acceptance criteria, study design, and performance related to AI/ML (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.

The document primarily addresses the substantial equivalence of a physical medical device. The "performance testing" section refers to standard medical device testing (e.g., sterility, biocompatibility, packaging, stability, fluid pressure testing for mechanical action), not AI/ML model performance.

Here's a summary of what is provided regarding acceptance criteria and performance, as applicable to this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one would for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that "Substantial equivalence has been confirmed through performance testing." The performance testing described is primarily focused on demonstrating the physical and chemical properties and safety of the device, rather than a diagnostic or predictive performance metric.

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

• Not applicable for an AI/ML context. The tests are for the physical device, not an algorithm processing data.

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. Ground truth in the context of an AI/ML study does not apply to this physical device.

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

• Not applicable. This relates to expert review of data for AI/ML model ground truth.

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 study type is for evaluating AI assistance in diagnostic tasks.

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

• Not applicable. There is no algorithm being evaluated in this submission.

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

• Not applicable in the AI/ML sense. The "ground truth" for this device's effectiveness relies on the mechanical action of fluid physically removing debris, which is demonstrated through fluid pressure testing and comparison to predicate devices, rather than a diagnostic 'truth'. The claim for "microorganism removal" is based on its mechanical action, not a specific antimicrobial kill claim.

8. The sample size for the training set:

• Not applicable. There is no training set for an AI/ML model.

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

• Not applicable. There is no training set for an AI/ML model.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, questions 1 (in the AI/ML context), 2, 3, 4, 5, 6, 7 (in the AI/ML context), 8, and 9 are not addressed in the text as they pertain to AI/ML model development and validation. The acceptance criteria and performance discussions are framed within the context of a medical device's physical, chemical, and sterility properties, and its intended mechanical action, demonstrating substantial equivalence to legally marketed predicates.

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Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.

The provided text describes the Irrisept Antimicrobial Wound Lavage device and its 510(k) submission for clearance. The submission focuses on demonstrating substantial equivalence to a predicate device, particularly by specifying the removal of "microorganisms" through mechanical cleansing.

However, the documentation does not contain information related to an AI/ML medical device, nor does it conduct studies involving human reader performance, expert consensus on images, or training/test set data and ground truth establishment typically associated with such device evaluations.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and the study proving the device meets it, as they pertain to AI/ML device performance metrics which are not discussed in this medical device submission.

The document primarily focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices based on:

• Intended Use: Minor modification to explicitly include "microorganisms" in the removal of wound debris.
• Technological Characteristics: The proposed device remains largely unchanged from its primary predicate (Irrisept Wound Debridement and Cleansing System, K202222) in terms of solution composition, mechanism of action, how supplied, applicator, sterilization, and biocompatibility.
• Performance Testing: Extensive list of standard medical device performance tests (e.g., sterilization, biocompatibility, packaging integrity, shelf-life, endotoxin, pyrogen testing) confirming it performs as safely and effectively as the predicate. The only new specific performance claim for this 510(k) is "mechanical action equivalent to the predicate devices, demonstrating that the fluid dispensed during the use of the device is sufficient to mechanically remove debris, including microorganisms, from wounds." This implies a physical/mechanical study, not an AI/ML performance study.

Given the context, here's what can and cannot be answered:

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

This document does not present acceptance criteria and performance in the format of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by meeting various medical device standards and demonstrating equivalence to a predicate device.

Acceptance Criteria (Implied by Substantial Equivalence Basis) & Reported Performance:

Regarding the other points, they are not applicable to this submission:

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

• Not applicable. This is a medical device clearance based on substantial equivalence and standard performance testing, not an AI/ML performance study with a test set of data. The "mechanical action" testing would involve physical samples/models, not digital data sets.

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. No "ground truth" derived from expert consensus on images is mentioned or required for this type of device (wound lavage).

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

• Not applicable. No AI/ML test set or expert adjudication process 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/ML device assisting human readers. It's a wound lavage device.

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

• Not applicable. This is not an algorithm.

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

• Not applicable in the context of AI/ML. The "ground truth" for this device would be its physical/chemical properties and its ability to mechanically remove debris, established through validated laboratory tests and engineering studies, not clinical outcomes or expert image interpretation.

8. The sample size for the training set

• Not applicable. There is no AI/ML model or training set.

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

• Not applicable. There is no AI/ML model or training set.

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The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

Irrisept® Wound Debridement and Cleansing System is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.

The provided text describes a 510(k) submission for the Irrisept Wound Debridement and Cleansing System (K202222), claiming substantial equivalence to its predicate device (K080779). This is a "catch-up 510(k)" primarily addressing updates responsive to user feedback, longer-term shelf-life data, and supplier/contractor changes.

The document does not provide acceptance criteria or a study that specifically proves the device meets distinct acceptance criteria in the context of comparative effectiveness or standalone performance of an AI/algorithm-based device as requested in the prompt. The testing described is focused on demonstrating that the changes made to the device do not raise new questions of safety and effectiveness compared to the predicate device, rather than establishing performance against new, explicit acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a different type of device evaluation (e.g., AI/algorithm performance).

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" in the traditional sense for a new AI/algorithm device (e.g., minimum sensitivity, specificity, or AUC). Instead, the performance testing focuses on demonstrating that the modified device is as safe and effective as the predicate.

The table below outlines the performance testing conducted, which implicitly serves to "meet acceptance criteria" by confirming the safety and effectiveness of the updated device is maintained compared to the cleared predicate. The reported "performance" is that the tests were successfully passed, indicating equivalence to the predicate.

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

The document does not specify sample sizes for any of the performance tests, nor does it mention data provenance (country of origin, retrospective/prospective). The tests listed are primarily bench/laboratory tests on the device itself or its components (e.g., solution, packaging). This is not a clinical study involving patient data.

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 is not an AI/algorithm or diagnostic device that requires expert-established ground truth from clinical cases. The tests are laboratory and engineering-based.

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

Not applicable. No clinical test set or adjudication is mentioned.

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 medical device for wound cleansing (Jet Lavage), not an AI-assisted diagnostic or imaging system.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable in the context of clinical "ground truth." The "truth" for the performance tests is based on adherence to established international and USP standards (e.g., sterility, endotoxin limits, packaging integrity, biocompatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set.

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

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

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The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.

SURGIPHOR™ Wound Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of SURGIPHOR™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. The povidone iodine in the SURGIPHOR™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text is a 510(k) Summary for the SURGIPHOR™ Wound Irrigation System. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It describes non-clinical testing (bench studies, animal studies, biocompatibility) and some clinical testing (Human Repeat Insult Patch Test) to support its claims.

However, the document does not describe an acceptance criteria table related to an AI/ML-based device, nor does it detail a study proving such a device meets specific performance criteria in terms of metrics like sensitivity, specificity, or AUC, established through ground truths and expert consensus for a clinical decision support AI/ML system.

The "device" in this document is a physical wound irrigation system, not a software or AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML device performance (sample size for test/training set, expert involvement, ground truth establishment, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.

In summary, the provided document does not contain the information requested regarding acceptance criteria and performance study details for an AI/ML device. It describes the regulatory submission for a physical medical device (wound irrigation system) based on substantial equivalence to existing products.

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