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The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management.

The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)

The Nisus ONE Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

Cork Medical has developed a negative pressure wound therapy (NPWT) system with the same intended use as the predicate device (K140022). The subject device features a modified user interface, and an adjusted feature set intended to support ease of use, while maintaining the same fundamental therapeutic function and performance characteristics as the predicate device. The Nisus ONE Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes.

The device display is limited to presenting critical operational parameters, including therapy mode, battery status, and target pressure settings. Visual and audible alarms are consistent with the predicate device (K140022) and alert critical battery, pressure leakage, system blockage, and full canister occur. While the Nisus ONE NPWT System's interface differentiates from the predicate Cork NPWT system, the mechanical components and therapy application are identical. The new model is intended to enhance accessibility by aligning with the needs of a broad and diverse patient population across various care settings.

The components included within the Nisus ONE NPWT System are:

• Nisus ONE Negative Pressure Wound Therapy Pump (OCMPP-100)
• Nisus ONE Pump Battery Charger (NIS-CHRG-A-18)
• Nisus NPWT Canister 500-mL (CPC-500)
• Nisus NPWT Canister 250-mL (CPC-250, previously cleared in K140022)

Accessory components are required to operate the device. Injection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The Nisus NPWT Canister 250-mL design was previously cleared in the Nisus NPWT system 510k application (K140022). The Nisus NPWT Canister 500-mL is based on the same design as the Nisus NPWT Canister 250-mL. The dimensions were enlarged to provide a larger reservoir for patient convenience. Thus, the subject and predicate canisters have substantially equivalent characteristics.

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. Integrated with the pump mechanism, these components ensure the safe and efficient removal of wound exudate. NPWT Accessories were previously cleared in K132004. Our application for the Nisus ONE NPWT system includes no revisions to these previously cleared components.

The provided FDA 510(k) clearance letter for the Nisus ONE Negative Pressure Wound Therapy System does not contain information related to an AI/ML-based device performance study.

The document details the substantial equivalence of the Nisus ONE system to a predicate device, focusing on changes to the user interface, physical dimensions, and technical specifications of a powered suction pump. The "Nonclinical Tests" section describes bench performance testing of the pump's functionality (e.g., pressure, alarms, flow rate) using simulated wound exudate and a test bed fixture, as well as software verification and validation, electrical safety, EMC, and usability testing. These are standard engineering and regulatory tests for medical devices, not performance studies of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample size, data provenance, expert qualifications, and adjudication methods for a test set related to an AI/ML algorithm.
• Details on MRMC studies or standalone AI performance.
• Information on training set size or ground truth establishment for an AI/ML algorithm.

The document explicitly states: "No Clinical Testing was required to support these 510(k) submissions. No clinical testing has been performed." This further indicates that no studies involving human data or expert review for AI/ML performance were conducted or reported in this submission.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it according to your criteria.

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The MV Flow Aspiration Pump is intended for general suction use in hospitals or clinics.

The MV Flow Aspiration Pump is an electrically powered (100 VAC/50 Hz, 240 VAC/60 Hz) device designed to generate vacuum pressure and serve as the vacuum source intended for general suction use in hospitals or clinics. The MV Flow Aspiration Pump is not intended for use in transport or field settings. The pump delivers 29 inHg of maximum vacuum pressure with a maximum flow rate of 36 L/min. The power button and vacuum-relief button provide pressure control. The brushless DC, dual-diaphragm pump design includes reverse-flow protection. Compatible pump accessories, supplied separately, include the MV Flow Canister. The MV Flow Canister consists of a single-use collection canister with integrated bacteria filter, overflow protection, and a pre-installed intermediate tubing.

The provided 510(k) clearance letter is for the MV Flow Aspiration Pump, which is a medical device, not an AI/ML-driven diagnostic or therapeutic device. As such, the information you've requested regarding acceptance criteria, study methodologies, and ground truth establishment (which are typically relevant for AI/ML device clearances) is not applicable to this particular device.

The clearance for the MV Flow Aspiration Pump focuses on demonstrating substantial equivalence to a predicate device (Penumbra Pump MAX) based on non-clinical performance testing, electrical safety, EMC/EMI compliance, and device-specific pump standards. There are no mentions of AI/ML components, image analysis, human reader studies, or complex ground truth establishment processes as would be found in clearances for AI-powered diagnostic tools.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication methods, or MRMC studies, as these types of studies were not conducted or required for the clearance of this specific device.

If you have a document related to an AI/ML medical device, I would be happy to analyze it according to your requested criteria.

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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Not Found

I am sorry, but the provided FDA 510(k) Clearance Letter for the "Baby Nasal Aspirator" does not contain information about acceptance criteria and a study proving the device meets those criteria.

This document is a formal clearance letter issued by the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:

• Device Identification: Trade name, regulation number, product code, regulatory class.
• Substantial Equivalence Determination: The FDA's finding that the device is equivalent to existing legal devices.
• Regulatory Requirements: Information about general controls (registration, listing, GMP, labeling, misbranding, adulteration), additional controls for Class II/III devices, Quality System (QS) regulation, medical device reporting, Unique Device Identification (UDI) system, and contact information for regulatory advice.
• Indications for Use: The stated purpose and target user group for the device.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The letter does not include details on:

• Specific performance acceptance criteria for the device itself (e.g., suction pressure, battery life, noise levels).
• Any studies or test results demonstrating the device meets such criteria.
• Information about test set sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies (like MRMC studies) as these are typically associated with performance data for more complex or AI/imaging devices, not simple mechanical devices like a nasal aspirator.

For a device like a baby nasal aspirator, the "acceptance criteria" and "proof of meeting them" would typically involve:

• Bench testing: Measuring suction pressure, flow rate, durability, material biocompatibility, and safety (e.g., absence of sharp edges, proper battery compartment sealing).
• Biocompatibility testing: To ensure materials are safe for contact with human tissue.
• Electrical safety testing: If powered, to ensure it meets relevant electrical safety standards.
• Usability testing: To ensure it can be safely and effectively used by the intended users (parents or caregivers).

However, none of these specific test results or their underlying methodologies are detailed in the provided FDA clearance letter. The letter signifies regulatory clearance based on a review of the submitted documentation, which would have included these types of test reports, but it does not reproduce them within the letter itself.

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The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.

Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.

The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.

However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.

Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.

Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)

1. Table of Acceptance Criteria and Reported Device Performance

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Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).

[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.

The provided FDA 510(k) clearance letter and summary for the "Cary" device ([K251111](https://510k.innolitics.com/search/K251111)) primarily discuss non-clinical performance testing to demonstrate substantial equivalence to a predicate device. This document does not describe a clinical study (e.g., MRMC or standalone human-in-the-loop study) involving human readers or expert panels for establishing ground truth, as would typically be seen for AI/ML-driven diagnostic devices. Instead, the testing focuses on the physical and functional performance of the suction pump itself against recognized consensus standards.

Therefore, many of the requested points regarding clinical study design, expert panels, ground truth, and MRMC studies are not applicable based on the provided text.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with implied or explicit acceptance criteria based on industry standards and comparison to the predicate device.

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The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.

The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.

The provided FDA 510(k) clearance letter for the AIRO Suction Unit (AIRO-01) is for a powered suction pump. Such devices are typically evaluated based on their physical and functional performance rather than AI/ML algorithm performance.

Therefore, many of the requested categories related to AI/ML specific studies (like MRMC studies, sample sizes for AI training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.

Here's a breakdown of the available information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states the device was tested to ISO 10079-1 and ISO 10079-4, and all applicable clauses were successfully executed, meeting the established criteria. However, the specific quantitative acceptance criteria and detailed performance results are not explicitly provided in the excerpt. We can infer the performance from the device description and the ISO standards it complies with.

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The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

The differences between BC026, BC025, and BC023 are as follows:

1. BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
2. BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
3. BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
4. BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
5. In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.

The provided FDA 510(k) clearance letter and summary for the Electric Nasal Aspirator do not contain specific acceptance criteria for device performance such as sensitivity, specificity, accuracy, or other diagnostic metrics. This device is a powered suction pump and not a diagnostic device that would typically have such performance criteria. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical safety and performance testing.

Therefore, many of the requested fields cannot be extracted directly from the provided text as they pertain to clinical performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment) that were explicitly not performed.

Here's the information that can be extracted, and an explanation for what cannot:

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

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The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.

The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "ATMOS C 051 Thorax," a powered suction pump for thoracic drainage. While it discusses performance tests and adherence to various standards, it does not contain the detailed clinical study data typically found in a clinical trial report or a comprehensive technical submission.

Therefore, I cannot extract answers for many of your specific questions related to acceptance criteria, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set details from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance bench testing, software validation, biocompatibility testing, human factors validation, and risk management.

However, I can provide information on what is explicitly stated or can be inferred from the document regarding the acceptance criteria and the nature of the study.

Here's what can be extracted:

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

The document mentions that "Performance tests were carried out to ensure that the subject device functions as intended and meet design specifications." and "Risk analysis was carried out based on acceptance criteria established in accordance with ISO 14971." However, the specific numerical acceptance criteria or the direct reported performance values for each criterion are NOT provided in this summary.

The document lists the following categories of performance tests conducted with "no unexpected results or significant deviations":

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

The document primarily describes bench testing and validation activities rather than a typical clinical study with a "test set" of patient data. Therefore, the concept of sample size as it applies to patient data is not relevant here. The "tests" refer to engineering and quality assurance activities. No country of origin for data or retrospective/prospective nature is mentioned as it's not a clinical data study.

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)

This information is not provided as there is no mention of clinical "ground truth" derived from expert interpretation in this document. The tests performed are technical and engineering-focused (e.g., flow rates, vacuum levels, battery performance), with human factors validation likely involving usability experts or human factors engineers, but their specific qualifications and number are not detailed.

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

This information is not provided as it's relevant for clinical adjudication of medical images or diagnoses, not for the technical bench testing described.

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

No MRMC study was conducted or mentioned. This device is a powered suction pump, not an AI-assisted diagnostic tool.

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 physical medical device (suction pump), not a software algorithm or AI.

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

The "ground truth" for the tests mentioned are engineering specifications, international standards (IEC, ISO), and regulatory guidance documents (FDA guidance). For example, for flow rate, the "ground truth" would be the measured flow rate compared against the predefined design specification. For human factors, it would be the assessment of safety and effectiveness of use against defined usability goals and risk analysis.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no "training set."

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

This question is not applicable for the reason stated above.

In summary, the provided document details a 510(k) submission for a non-AI medical device (powered suction pump). The "studies" proving it meets acceptance criteria are predominantly non-clinical bench tests and validation activities against established engineering specifications, international standards, and regulatory guidelines, rather than clinical trials that generate patient data and require expert ground truth establishment.

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The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.

The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps
• Grafts

RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.

Based on the provided text, the document is a 510(k) summary from the FDA for a medical device called "RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port." This document does not describe an AI/ML device or its performance criteria. It pertains to a physical medical device used for negative pressure wound therapy.

Therefore, I cannot provide the requested information as the document does not contain details regarding acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets those criteria. The original text only mentions non-clinical tests (simulated wound model tests, human factors validation, biological evaluation) and explicitly states "No clinical performance data was necessary" for this particular device.

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Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.

The Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of clinical or comparative studies with a patient population. Instead, the performance evaluations were conducted through verification testing of the device's technical specifications.

• Sample Size: The document doesn't explicitly state the number of units tested for suction vacuum and noise. However, it indicates that "For Model S2, no individual differences exceed the spective tolerance of suction vacuum and noise after the cleaning and disinfection procedure," implying multiple units or multiple measurements were taken to confirm consistency.
• Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be bench-top engineering verification rather than a clinical study.

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

Not applicable. The ground truth for this device's performance is based on engineering specifications and direct physical measurements (suction vacuum and noise levels) rather than expert interpretation of clinical findings.

4. Adjudication Method for the Test Set:

Not applicable. As a bench-top engineering verification, there was no subjective judgment from experts requiring an adjudication method. The measurements against the specified tolerances determined success or failure.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Geon (S2) Nasal Aspirator is a therapeutic/extraction device, and its performance is evaluated based on physical parameters like suction and noise, not diagnostic accuracy requiring human interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, the testing described is a standalone performance evaluation of the device. The device's performance (suction vacuum and noise) was measured directly on the device itself without human intervention in operating it beyond standard use, or human interpretation of outputs.

7. Type of Ground Truth Used:

The ground truth used was engineering specifications and direct physical measurements. The device's suction vacuum was measured in kPa and its noise level in dB, and these measurements were compared against pre-defined tolerance ranges established by the manufacturer.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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