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The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluid, including wound exudates, irrigation fluids, body fluids and infectious materials.

The Antlia III™ Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the ITI Dressing to remove fluid and infectious materials from the wound as it may promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.

The Antlia III™ Wound Treatment System consists of the same powered suction pump components and functions the same as the Antlia II Suction Pump device, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the ITI 300cc and 500cc collection canisters, and optional pressure settings of -50mmHg, -75mmHg, -100mmHg, - 125mmHg, and -150mmHg.

Based on the provided text, the document describes a 510(k) submission for the Antlia III™ Wound Treatment System, a medical device. The information provided heavily pertains to substantial equivalence and safety and electrical testing, rather than a clinical performance study of an AI/algorithm-based device.

Therefore, I cannot fulfill most of your request as the provided text does not contain the information related to an AI/algorithm-based device's validation study including:

• Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets (beyond general product testing)
• Data provenance for clinical images/data
• Number of experts for ground truth establishment or their qualifications
• Adjudication methods
• MRMC studies or effect sizes for AI assistance
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data) for clinical performance
• Training set details (sample size, ground truth establishment)

The document focuses on demonstrating that the Antlia III is substantially equivalent to a predicate device (Antlia II) based on:

• Similar technological characteristics and function: It's described as having the same powered suction pump components and functions, just in a smaller, lighter enclosure with optional pressure settings.
• Non-clinical tests: IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility were conducted.
• Verification and Validation activities: These were performed based on risk analyses for the device modifications, and it's stated that "predetermined acceptance criteria were met." However, the specific criteria and performance results are not detailed in the summary provided. They refer to the full V&V documentation which is not included here.

In summary, the provided text describes a submission for a physical medical device (negative pressure wound therapy system), not an AI/algorithm-based device. Hence, the requested parameters for an AI device's validation study are not applicable or present in this document.

If you were expecting information on an AI device, please provide the relevant documents for such a device.

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The Sved® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.

The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing.

This document is a 510(k) summary for the Sved® Wound Treatment System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth is not present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or any functional performance thresholds. The submission is based on demonstrating "substantial equivalence" to a predicate device.

The document states: "The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure..." and "The Sved® Wound Treatment System Unit is smaller in size and weighs less compared to the predicate powered suction pump, yet and when same technological characteristics and identical functions."

This implies the "acceptance criteria" are met if the new device functions identically to the predicate, even with physical changes like size and weight.

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

No information is provided regarding a test set sample size or data provenance. This document is a regulatory submission for premarket notification (510(k)), not a clinical trial report. Equivalence is typically established through engineering comparisons, bench testing, and comparisons of indications for use and technological features.

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

Not applicable. This type of information is pertinent to studies involving human interpretation or performance evaluation against a gold standard, which is not described here.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC study is mentioned. This document is not a clinical study report.

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

Not applicable. This is a physical wound treatment system, not an AI algorithm.

7. The Type of Ground Truth Used:

Not applicable in the context of an AI device. For this physical device, the "ground truth" for substantial equivalence would be the established safe and effective performance of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "proof":

The core "acceptance criteria" for this 510(k) submission revolve around substantial equivalence to an existing legally marketed predicate device (ANTILIA™ Wound Irrigation System, K071301).

The "study" or "proof" presented is a comparison of:

• Indications for Use: The Sved® Wound Treatment System has the same indications for use as the predicate.
• Intended Use: The intended use for both devices is the same.
• Technological Characteristics: The new device employs the "same technological characteristics and identical functions" as the predicate's powered suction pump components, despite being housed in a smaller, lighter enclosure. The Svamp™ Wound Dressing components remain the same.

The document concludes that "The substantial equivalence for the Sved® Wound Treatment System is based on the same indications, intended use, and technological features of the predicate device." This is the "proof" presented in this regulatory context.

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The ANTILIA 1™ Wound Irrigation System device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The ANTLIA 1 TM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehised wounds, diabetic with with with churches, filaps and grafts.

The ANTLIA I™ Wound Irrigation System is an AC-powered, portable suction device with battery back-up that provides vacuum assisted drainage and irrigation of a wound site by controlled delivery of topical wound treatment solutions over the wound bed.

The specifically designed Aquarius I™ dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.

Here's a summary of the acceptance criteria and study information for the ANTLIA I™ Wound Irrigation System, based on the provided 510(k) summary:

This device is cleared through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to prove device performance against specific acceptance criteria. Therefore, the information provided focuses on the technological characteristics and safety standards the device meets, rather than clinical performance metrics.

Acceptance Criteria and Reported Device Performance

Study Details (if applicable)

For 510(k) submissions based on substantial equivalence, robust clinical studies with human participants demonstrating performance against acceptance criteria are typically not required unless there are significant differences in technological characteristics or intended use compared to the predicate device. The provided document for K071301 does not describe a clinical study in the traditional sense, but rather a demonstration of compliance with recognized safety and performance standards and a comparison to a predicate device.

Given that this is a 510(k) summary for a Class II device, the process focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance metric against acceptance criteria through a clinical trial. Therefore, the following points address what would typically be included for a clinical performance study, but clarifies their absence or alternative assessment in this 510(k) context.

1. Sample size used for the test set and the data provenance: Not applicable. The submission refers to independent testing against safety and EMC standards, not a clinical test set for performance. The "test set" would be the device itself undergoing engineering and safety evaluations, not patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this type of submission. The "experts" would be the engineers and regulatory bodies verifying compliance with medical device safety standards.
3. Adjudication method for the test set: Not applicable. There is no clinical test set requiring adjudication in this document.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic imaging tool. It is a wound irrigation system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm" in the sense of AI or image analysis. It's an electro-mechanical system. Its standalone performance refers to its ability to operate according to its specifications (e.g., maintaining negative pressure, controlling fluid delivery). This is assessed through engineering tests and compliance with safety standards, not a clinical trial.
6. The type of ground truth used: Not applicable in the clinical sense. The "ground truth" here is compliance with recognized engineering and safety standards (e.g., IEC 60601 series) and the functional specifications of the device.
7. The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.
8. How the ground truth for the training set was established: Not applicable. As there is no training set for machine learning, this is irrelevant.

In conclusion, K071301 demonstrates substantial equivalence by:

• Sharing the same indications for use with the predicate device.
• Having the same intended use as the predicate device.
• Possessing similar technological characteristics to the predicate device.
• Successfully passing independent tests against recognized medical device safety and performance standards (IEC 60601-1, EN 60601-1-2, IEC 60601-1-4).

This approach satisfies the requirements for 510(k) clearance for this type of device, focusing on safety and equivalence rather than new clinical efficacy trials against specific performance criteria.

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The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

The ANTLIA IIm Suction Pump System, an AC-powered, portable suction device with battery back-up, provides localized negative pressure when used with the Aquarius IITM dressing to remove fluids and infectious materials from the wound to promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.

The system consists of a powered suction pump device with a built-in placement holder for a fluid collection canister, the Aquarius II TM polyurethane foam dressing, and canister tubing with clamps and connectors, and two polyurethane drapes with adhesive.

The provided text is a 510(k) summary for the ANTLIA II™ Suction Pump System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy of an AI algorithm.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission for a physical medical device like a suction pump system. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

However, I can extract the relevant information from the document based on the context of a 510(k) submission for a non-AI/diagnostic device:

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

For a physical medical device like a suction pump, "acceptance criteria" generally refer to engineering specifications, performance standards, and safety requirements. The document states:

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

• Not Applicable. This 510(k) summary does not describe a clinical study with a test set of data or human subjects for performance evaluation in the context of AI or diagnostics. The submission primarily relies on comparisons to predicate devices for technological characteristics, materials, and intended use. Performance testing, if conducted, would typically be bench testing to technical specifications, not human 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. As there is no "ground truth" establishment in the context of an AI/diagnostic study, no experts were involved for this purpose in this submission.

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

• Not Applicable. No test set requiring adjudication in this context.

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

• Not Applicable. This device is a physical medical device (suction pump system), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

• Not Applicable. This device is not an algorithm.

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

• Not Applicable. The concept of "ground truth" in the context of AI/diagnostic evaluation does not apply to this device. The regulatory approval is based on demonstrating equivalence to predicate devices, which means meeting similar performance specifications and safety profiles as established, legally marketed devices.

8. The sample size for the training set

• Not Applicable. This device is not an AI model, 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 to establish for one.

In summary, the provided document is a 510(k) submission for a non-AI physical medical device. The "study" proving the device meets acceptance criteria is the overall 510(k) submission itself, which primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics, indications for use, and material composition, rather than conducting a separate clinical performance study with human data or AI-specific evaluations.

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