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The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris.

The FloSure Ventilation Patch is appropriate for use on the following wounds:

• · Pressure Ulcers
• · Diabetic/Neuropathic Ulcers
• · Venous Insufficiency Ulcers
• · Traumatic Wounds
• · Post-Operative and Dehisced Surgical Wounds
• · Skin Flap and Grafts

The FloSure Ventilation Patch is used with the NPWT wound dressings to improve air-flow through the dressing when desired. The FloSure Ventilation Patch augments the transparent dressing by providing additional gas permeability to the wound dressing site through its proprietary hydrophobic and micro-porous filter membrane. The access to additional air-flow can aid in keeping the vacuum in balance resulting in a continuous flow of exudate. Stagnation in the flow of exudate can cause pooling at the wound site and result in blockage alarms.

The provided text describes a 510(k) premarket notification for the "FloSure Ventilation Patch." This device is a medical accessory intended for use with Negative Pressure Wound Therapy (NPWT) systems. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel functionality.

Therefore, the study described is a non-clinical bench testing and biocompatibility assessment for substantial equivalence, not a study to prove acceptance criteria for a new functional performance or algorithm.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not Applicable" or "Not Provided" due to the nature of the submission (510(k) for an accessory, not an AI device or a novel functional device requiring extensive performance metrics):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for each test. The non-clinical testing refers to "comparative performance bench testing" and standard biocompatibility assessments. These typically involve a sufficient number of samples to ensure statistical validity for the specific test, but the exact count is not provided in this summary.
• Data Provenance: The tests are "non-clinical testing" and "comparative performance bench testing," implying laboratory-based testing conducted by or for the manufacturer. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not patient-level data.

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

• Not Applicable. This device is an accessory to a medical device, and the evaluation is for substantial equivalence to a predicate, based on bench testing and biocompatibility, not on interpretation of complex medical data requiring expert consensus or ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not Applicable. See 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

• Not Applicable. This submission is for a physical medical device accessory (a ventilation patch), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or relevant.

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

• Not Applicable. This is not an algorithmic or AI device.

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

• Bench Test Results and Biocompatibility Standards: The "ground truth" or reference for performance was industrial standards for biocompatibility (e.g., ISO standards usually underlie cytotoxicity, sensitization tests) and functional performance metrics of the predicate device (UNI NPWT Foam Wound Dressing Kit) when assessed with SIMEX NPWT Systems EX200 and EX300.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. See point 8.

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The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.

Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.

The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities.

These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions.

There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger.

This document is a 510(k) premarket notification for the SIMEX Subglottic Aspiration System, not a study report. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them in a clinical context.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical (bench) testing and a feature comparison. It does not present a clinical study with human readers, ground truth established by experts for a test set, or multi-reader multi-case (MRMC) comparative effectiveness.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, it details performance characteristics against engineering standards and comparison to predicate device specifications.

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

• Test Set Sample Size: Not applicable in a clinical sense. The testing described is "bench testing" and "simulated use environment," meaning it was conducted on the physical device itself or in a laboratory setup, not on a set of clinical cases or patient data.
• Data Provenance: The testing was non-clinical (bench testing). No country of origin for clinical data is applicable. The data is entirely retrospective technical test data.

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

Not applicable. Ground truth, in the context of clinical evaluation, is typically established by medical experts for diagnostic or prognostic tasks. This document describes technical device performance, not a clinical diagnostic aid.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a medical pump, not an AI diagnostic tool that assists human readers in interpreting clinical cases. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

This question is designed for AI/algorithm-based devices. The SIMEX Subglottic Aspiration System is a physical medical device (a pump), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The bench testing of the pump itself can be considered its "standalone" performance, as it operates independently according to its design specifications.

7. The Type of Ground Truth Used

The ground truth for the performance metrics described (electrical safety, EMI, operational lifetime, vacuum pressure, flow rate) is based on engineering standards and design specifications. For example, the "ground truth" that the device meets IEC 60601-1-2 is based on the results of tests conducted against the requirements of that standard. This is not clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set for an AI/machine learning model.

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The SIMEX Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The SIM EX200 and SIM EX300 Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside.

The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps Series: SIM EX200 and SIM EX300 are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. SIM EX200 and SIM EX300 are suitable for use in either hospitals or long term care facilities and nursing homes.

The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps series is provided in two models, the SIM EX200 and the SIM EX300. Both pumps are powered with rechargeable lithium batteries and include ports for an external power supply and/or battery charger. The pumps can also be externally powered from a 12V automotive battery source. The SIMEX pumps vary in weight from 2.9lbs and in size from 90mm x 165mm x 220mm x 359mm x 250mm. The SIMEX pumps can be programmed to operate in either continuous or intermittent settings.

The disposable and replacement parts of the SIMEX Negative Pressure Wound Therapy series of pumps include collection canisters, canister liners, pump filters, hoses, connectors and drains (tubing), gauze dressings, and transparent film and drape dressings.

The provided text describes a 510(k) submission for the SIMEX Negative Pressure Wound Therapy (NPWT) Powered Suction Pumps Series (SIM EX200 and SIM EX300). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a de novo or PMA submission might.

Therefore, the information you've requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly present or applicable in the context of this 510(k) summary.

Here's an analysis based on the information provided and the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: No specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or wound healing rates) are defined or measured in this document. The "acceptance criteria" for a 510(k) revolve around demonstrating safety and effectiveness by showing substantial equivalence to a legally marketed predicate device. This typically involves performance benchmarking in non-clinical (bench) tests and comparison of technological characteristics.
• Reported Device Performance: The reported "performance" is primarily in terms of compliance with electrical safety and electromagnetic compatibility standards, and direct comparison of technological characteristics with predicate devices.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) summary for clinical performance. The "test set" for this submission primarily consists of the device itself undergoing bench testing for safety and electrical compatibility, and a comparison of its features to predicate devices. There is no mention of human subject test sets or clinical trial data.
• Data Provenance: The data provided pertains to bench testing (electrical safety, EMC) and design comparison with predicate devices. No human data (retrospective or prospective) is mentioned.

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

• Not applicable. There is no mention of a "ground truth" in the clinical sense (e.g., disease presence, wound healing outcome) established by experts for human test data. The "ground truth" for the non-clinical tests would be the specifications of the standards (e.g., IEC 60601-1-2) which are verified by qualified test engineers/labs.

4. Adjudication Method for the Test Set:

• Not applicable. As there is no clinical test set requiring expert interpretation or consensus, no adjudication method 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 device is a powered suction pump, not an AI-assisted diagnostic or interpretative tool. No MRMC studies were conducted or reported.

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

• Not applicable. This device is hardware with software control, not an algorithm in the sense of a diagnostic or predictive model. Its "performance" is its ability to generate negative pressure, collect exudate, and comply with safety standards, not a standalone algorithmic output that would be evaluated for accuracy.

7. The Type of Ground Truth Used:

• For the non-clinical tests (electrical safety, EMC): The "ground truth" is adherence to the specifications of the referenced international standards (e.g., IEC 60601-1-2).
• For the substantial equivalence claim: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense for an algorithm. Device design and engineering would be based on general principles and standards, not a specific data training set.

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

• Not applicable for the same reasons as point 8.

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