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Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit 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, self-contained irrigation device comprised of a 450 mL 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, Wound Solution Kit (K240552). It outlines the device's characteristics and compares it to a predicate device (Irrisept Antimicrobial Wound Lavage, K210536) to demonstrate substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance targets in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implicitly defined by demonstrating that the subject device's performance is equivalent to the predicate device in terms of safety and effectiveness, despite a minor modification (inclusion of sterile accessories). The underlying "performance" refers to the functional capabilities and safety profiles as evaluated through various standards and tests.

Here's an attempt to structure this information based on the provided text:

The overall acceptance criterion is "Substantial Equivalence" to the predicate device (K210536), meaning the device does not raise new safety or effectiveness questions. The rationale states: "The indication for use, intended use, principles of operation, and performance have not been altered. The minor change to add the existing Irrisept device (450 mL) with sterile accessories for use with powered irrigation does not raise any new or different questions of safety or effectiveness."

Study Details:

The provided document describes a submission for substantial equivalence for a medical device (Irrisept Antimicrobial Wound Lavage, Wound Solution Kit, K240552), not a study proving device efficacy in a clinical setting in the way one would analyze a new drug or diagnostic algorithm. Rather, it focuses on demonstrating that a modified version of an already cleared device is as safe and effective as the original. This is a common regulatory pathway for devices.

Here's how the other points apply or don't apply to this type of submission:

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

   • This submission relies heavily on bench testing and standard conformity assessments rather than "test sets" of patient data. For example, tests like Biocompatibility (ISO 10993), Preservative Antimicrobial Effectiveness (USP ), Endotoxins (USP ), Sterility (USP ), Packaging, and Functional Testing were performed.
   • The "samples" would be units of the device and its accessories subjected to these tests. The document doesn't specify the exact number of units or lot numbers used for each specific test, but implies that adequate samples were tested per the relevant standards.
   • Data Provenance: The tests are generally conducted in a laboratory setting. There is no mention of country of origin for any "data set" as might be seen for clinical trials. Some standards (e.g., from USP or ISO) are internationally recognized.

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

   • This concept is not applicable in this context. There is no "ground truth" to be established by experts in the sense of diagnosing a disease or interpreting an image for a test set. The validation is against established scientific and regulatory standards for device performance and safety (e.g., ISO, USP, ASTM). Experts involved would be those performing or supervising the laboratory tests, and their qualifications would be in areas like microbiology, toxicology, sterilization science, and engineering, demonstrating compliance with the specified standards.

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

   • This concept is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where subjective human interpretation needs to be standardized or resolved (e.g., multiple radiologists reviewing images). For this device, performance is evaluated against objective, measurable criteria defined by the listed 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a wound lavage solution and kit, not an AI-assisted diagnostic or therapeutic tool. Therefore, concepts like "human readers" or "AI assistance" are entirely irrelevant to this submission.

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

   • No, this is not applicable. This device is a physical medical device (a wound lavage solution and kit). It does not involve any algorithms or software that would have a standalone performance.

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

   • The "ground truth" here is defined by compliance with established international and national standards (ISO, USP, AAMI, ASTM) for safety, materials, manufacturing, sterilization, and functional performance. For example:
     • Biocompatibility: Ground truth is defined by the toxicological and biological response criteria specified in ISO 10993.
     • Sterility: Ground truth is "sterile" as defined by USP and validated by ISO 11135 for EO sterilization.
     • Microbial reduction: Ground truth for preservative effectiveness is defined by USP criteria for inhibiting microbial growth.
     • Functional equivalence: "Custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device." The "ground truth" for these custom tests would be the established performance characteristics of the predicate device.

8. The sample size for the training set:

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

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

   • Not applicable. As there is no training set, there is no ground truth for a training set.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a modified physical medical device to a previously cleared one, rather than presenting a clinical study with outcome-based performance metrics usually associated with AI or novel diagnostic technologies. The "acceptance criteria" are compliance with relevant safety and performance standards.

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The HYBRIDknife flex is intended for:
· monopolar cutting and coagulation.
· needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.

The HYBRIDknife flex is a flexible monopolar probe that combines the technologies of hydrosurgery and electrosurgery in one instrument.
Each function can be activated without the need to change instruments. The HYBRIDknife flex is a sterile, single use device which is used with endoscopes with a minimal working channel diameter of 2.8mm. The hydrosurgical function is intended to deliver a pressurized fluid for tissue-selective hydrodissection and needle-free injection whereas the electrosurgical function is intended for cutting and coagulation of tissue. By means of needle-free injection a fluid cushion is formed in the submucosa, which provides a mechanical and thermal protection layer during cutting and coagulation of the target tissue. The elevation thus reduces the risk of perforation. All HYBRIDknife flex probes have a length of 2.3 meters and an outer diameter (OD) of 2.6mm. The only difference between the variants is the electrode type and length. The HYBRIDknife flex is available with a "T-type" electrode and an "I-type" electrode whereas both electrode types are available as a long (i.e. 2mm length) and short (i.e. 1.5mm) version. The protrusion of the T-type electrode gives the user the possibility to hook and move tissue. The instruments are designed for operation with the hydrosurgical unit ERBEJET 2 (K072404; K143306 & K231023) in combination with an Erbe Electrosurgical unit of the "VIO" series (e.g. VIO 3 K190823). HYBRIDknife flex is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done by using a footswitch.

The provided text is a 510(k) summary for a medical device called HYBRIDknife® flex. This document is a regulatory submission to the FDA, demonstrating that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is NOT a study report for an AI/ML medical device. It describes a physical electrosurgical cutting and coagulation device. Therefore, the questions about AI/ML specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document. The term "device" in the context of this document refers to the physical surgical instrument, not an AI model.

The document discusses non-clinical performance testing of the device, which aims to verify its safety and performance based on engineering principles and established standards for electrosurgical equipment. This is distinct from the type of performance study conducted for AI/ML devices, which involves evaluating the performance of an algorithm against a ground truth.

Here's how to address the request based on the provided text, while clarifying the limitations:

Acceptance Criteria and Device Performance (Based on the document for a physical medical device)

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit "acceptance criteria" in the way one might for an AI/ML model's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating that the new device does not raise new questions of safety or effectiveness and performs comparably to the predicate devices for its intended use.

The "performance" is verified through various non-clinical tests to ensure the device meets design specifications and relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, a table of acceptance criteria for algorithm performance metrics (like sensitivity, specificity, AUC) is not provided in the document. Instead, the document discusses conformity to standards and comparability to predicate devices. The "performance" here refers to the device's functional integrity and safety.

2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/ML test set. The testing referenced are non-clinical (e.g., tissue testing, electrical testing, biocompatibility testing, sterilization validation) of a physical device. There isn't a "test set" of patient data in the AI/ML sense. Data provenance would refer to the characteristics of the materials or test conditions used in the lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.

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 pertains to AI/ML model validation. The device is a physical surgical instrument, not an AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML model validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML context. For this physical device, "ground truth" would be established by physical measurements, chemical analyses, biological assays (e.g., for biocompatibility), and direct observation of electrosurgical and hydrodissection effects on tissue models, as per standard engineering and medical device testing protocols. The "truth" is adherence to specifications and standards.

8. The sample size for the training set
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.

9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Non-Clinical Performance Testing)

The "study" in this context refers to a series of non-clinical performance tests designed to demonstrate the safety and effectiveness of the HYBRIDknife® flex and its substantial equivalence to predicate devices. These tests were performed rather than a clinical trial or AI/ML validation study.

The primary goal was to show that despite some technological differences (e.g., higher dielectric strength, slightly different dimensions, fixed electrode states vs. adjustable), the device performs its intended functions comparably to existing, legally marketed devices and adheres to relevant safety and performance standards.

The non-clinical performance testing included:

• Functional Testing and Design Controls: To verify overall safety and performance, ensuring the device performs as intended and meets design specifications (in compliance with 21 CFR 820.30).
• Tissue Testing: To validate the cutting and coagulation performance and the waterjet function. This was done by comparing the HYBRIDknife® flex to the predicate device, specifically looking at the creation of equivalent fluid cushions. This would involve in-vitro or ex-vivo tissue models.
• EMC and Electrical Safety Testing: To ensure compliance with international standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2). This verifies that the device operates safely electrically and doesn't interfere with other medical equipment.
• Biocompatibility Testing: To ensure the new materials used in the device are safe for contact with the body (in compliance with ISO 10993-1).
• Sterilization Validation: To confirm the device can be consistently sterilized to a specific sterility assurance level (SAL of 10-6) and that ethylene oxide residuals are within safe limits (in compliance with ISO 11135 and ISO 10993-7).
• Packaging and Shelf-life Validation: To ensure the device remains sterile and functional over its intended shelf-life, including accelerated aging tests (in compliance with ISO 11607-1 and ASTM F 1980).

Data Provenance and "Test Set" Details (for a physical device):

The data would originate from laboratory and bench testing conditions. This is typically controlled and prospective, conducted specifically to gather data for regulatory submission. There isn't a "country of origin of the data" in the sense of patient data, but rather the location where the testing labs are.

In conclusion, the provided document is a regulatory submission for a physical medical device, not an AI/ML model. Therefore, many of the specific questions about AI/ML acceptance criteria and study design are not applicable. The "acceptance criteria" for this device are demonstrated through adherence to design specifications, relevant industry standards, and demonstrated substantial equivalence to predicate devices via rigorous non-clinical testing.

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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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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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The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.

The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.

It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.

The provided text focuses on the 510(k) summary for the "Multi-Functional Electrosurgical Knife" and details why it is considered substantially equivalent to existing predicate devices. It does not describe a study that involves acceptance criteria for device performance based on AI/human reader comparison or ground truth established by experts in a diagnostic context. Instead, the performance data section outlines bench and electrical testing to ensure the device performs similarly to predicate devices and meets safety standards for an electrosurgical knife.

Therefore, many of the requested details, such as those related to AI effectiveness, human reader improvement, and expert-adjudicated ground truth, are not applicable to this submission as it doesn't describe such a study.

However, I can extract information related to the performance data and the general approach to demonstrating substantial equivalence for this medical device.

Here's a summary of the information available based on the provided text, addressing the points where information is present or clearly not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with reported numerical performance values in the format requested (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate equivalence to predicate devices and conformance to standards. The "acceptance criteria" are implicitly that the proposed device performs "without significant difference" compared to predicate devices and meets established safety standards.

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

• The document does not specify exact sample sizes for each bench test conducted.
• Data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA. The type of study is bench testing and conformance testing against standards, rather than a clinical trial or study on patient data.

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

• This question is not applicable. The device is an electrosurgical knife, and its performance evaluation involves physical and electrical bench testing against established engineering and safety standards, and comparison to predicate devices, not interpretation of diagnostic images or data by human experts for ground truth establishment.

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

• This question is not applicable. As in point 3, the evaluation of an electrosurgical knife's performance is based on measurable physical and electrical properties, not on subjective expert consensus or adjudication of diagnostic cases.

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 question is not applicable. The device is an electrosurgical knife, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was performed.

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

• This question is not applicable. The device is a surgical instrument, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on established engineering and safety standards (e.g., IEC 60601 series) and the performance characteristics of legally marketed predicate devices. For biocompatibility, it's based on ISO 10993 standards. For tissue cutting and thermal damage, it's based on measurable physical effects demonstrated during bench testing.

8. The sample size for the training set:

• This question is not applicable. The device is a physical electrosurgical knife; it does not involve machine learning or a "training set" of data in the conventional sense.

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

• This question is not applicable for the same reason as point 8.

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Single Use Electrosurgical Knife:
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System.

The Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.

The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the Cutting Knife. The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.

Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm. Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.

The Fluid Pump System included in the proposed device is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

The Fluid Pump System consists of a Foot Pedal, a Fluid Pump Console (with a Power Cord and a Control Button Cord), a Disposable Pump Cartridge, a Disposable Tubing Set, and a Disposable Control Button. The Disposable Pump Cartridge adopts the structure of a reciprocating pump, and the purpose of conveying sterile fluid is achieved through the piston's reciprocating movement. The Disposable Tubing Set is used to connect the Disposable Pump Cartridge's fluid outlet and Single Use Electrosurgical Knife's fluid injection port. The Fluid Pump Console provides a drive the Disposable Pump Cartridge to achieve reciprocating motion. The user can set the Effect value via the touch button on the touch screen or the physical knob. The Effect setting value range is 10 to 40, where Effect 10 corresponds to the minimum flow rate of 25mL/min, and Effect 40 corresponds to the maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.

The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year.

The Disposable Pump Cartridge, Disposable Tubing Set and Disposable Control Button of Fluid Pump System are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year. The Foot Pedal and Fluid Pump Console of Fluid Pump System are non-sterile and reusable, the service life of the Foot Pedal and Fluid Pump Console are 8 years.

The acceptance criteria and the study proving the device meets them are not detailed in the provided text in the way the request specifies (e.g., a table with reported device performance, sample sizes for test sets, expert qualifications, etc.). The document is a 510(k) summary, which provides an overview of the device and its substantial equivalence to a predicate device, rather than a detailed report of individual study methodologies and results.

However, based on the Performance Data section (page 9-10), I can infer the types of acceptance criteria indirectly from the performed tests and provide a general overview of the supporting studies.

Here's a breakdown of what can be extracted and what information is missing:

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

The document states: "The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601)."

While the specific numerical acceptance criteria and reported device performance values are not provided, the types of tests conducted imply the categories of criteria the device had to meet.

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

• Sample Size: Not specified for any of the tests.
• Data Provenance (country of origin, retrospective/prospective): Not specified. These appear to be laboratory/bench tests, not clinical data sets.

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

• This information is not applicable as the described performance data pertains to bench testing against established standards and internal criteria for physical, mechanical, and safety aspects, not interpretation of medical images or clinical outcomes requiring clinical expert ground truth.

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

• This information is not applicable as the described performance data pertains to bench testing against established standards and internal criteria, not interpretation of medical images or clinical outcomes.

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 information is not applicable as no clinical or MRMC study using AI assistance is mentioned. The device is a physical electrosurgical knife and fluid pump system.

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

• This information is not applicable as the device is not an algorithm or AI system. Its performance evaluation is based on bench testing.

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

• The "ground truth" for the performance data appears to be established industry standards and predetermined internal specifications/criteria for device function, safety, and performance (e.g., ISO, IEC, ASTM standards, and internal material/design specifications). No clinical ground truth (like pathology or outcomes data) is mentioned as part of the performance data for this 510(k) submission.

8. The sample size for the training set

• This information is not applicable as the device is not an AI/ML system requiring a training set.

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

• This information is not applicable as the device is not an AI/ML system requiring a training set.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a physical medical device (electrosurgical knife and fluid pump system) through bench testing against recognized standards and internal specifications. It does not involve AI/ML components, clinical studies for human reader interpretation, or advanced ground truth establishment methods typically seen in AI device submissions. The "acceptance criteria" are implied by the types of tests performed (e.g., dimensional accuracy, functional performance, safety compliance), and the "study" consists of these various bench tests, shelf-life studies, sterilization validation, biocompatibility testing, and electrical/software safety assessments.

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