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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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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 Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used.

The Riptide™ Aspiration Pump is an externally powered electromechanical device capable of generating a vacuum designed for drawing fluids and thrombus into the Riptide™ Collection Canister during interventional procedures. It is intended for general suction use in hospitals or clinics and is not intended for transport or field applications. The Riptide™ Aspiration Pump includes a receptacle that holds the Riptide™ Collection Canister with Intermediate Tubing in place. The intermediate tubing is connected to the vacuum inlet port.

The Riptide™ Aspiration Pump package includes the following:

• Riptide™ Aspiration Pump (LMT-RAP)
• Region specific power cord for connection to earthed receptacle.
• Riptide™ Aspiration Pump User's Manual

The following item is required for use with Riptide™ Aspiration Pump (packaged separately):

• Riptide™ Collection Canister with Intermediate Tubing (LMT-RCT)

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single use. The Riptide™ Collection Canister is the repository for aspirated material. The Riptide™ Canister is placed into the receptacle of the Riptide™ Aspiration Pump as shown in Figure 3. The Intermediate Tubing is then connected to the vacuum inlet port.

Here's an analysis of the Riptide™ Aspiration Pump's acceptance criteria and the study proving it, based on the provided document:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical trial data. Therefore, the device's acceptance criteria are framed in terms of meeting established standards and matching the performance of a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Riptide™ Aspiration Pump are primarily based on compliance with international standards for medical electrical equipment and medical suction equipment, as well as demonstrating equivalent performance to the predicate device.

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

The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only.

The Easycess Aspiration Pump is a medical device intended for general suction use in hospitals or clinics. The study provided in the document focuses on bench testing to demonstrate its substantial equivalence to a predicate device, the Penumbra Pump MAX (K122756).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes bench testing, which typically does not involve patient data. The tests were performed on the Easycess Aspiration Pump itself to verify its physical and mechanical performance. Therefore, there is no specific "sample size" of patient data for a test set in the traditional sense, nor data provenance related to country of origin or retrospective/prospective collection as one would find in clinical studies.

The testing was conducted according to the FDA special control guidance document: Guidance Document for Powered Suction Pump 510(k)s, and the ISO 10079-1:2022 Medical suction equipment - Part 1: Electrically powered suction equipment.

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

There is no mention of experts or their qualifications being used to establish a ground truth. Since this was bench testing of a hardware device's performance characteristics, the "ground truth" was the objective measurement of the device against established engineering and safety standards (e.g., ISO, IEC, FDA guidance).

4. Adjudication Method for the Test Set

As there were no human readers or interpretations involved in establishing a ground truth for a test set (it was objective bench testing), there was no adjudication method applied.

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

No, an MRMC comparative effectiveness study was not done. The study presented here is focused on the device's adherence to technical standards and its substantial equivalence based on bench testing.

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

The Easycess Aspiration Pump is a hardware medical device; it is not an algorithm-based device or an AI system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the bench testing was established by objective engineering specifications, regulatory standards (ISO 10079-1:2022, IEC 60601-1, IEC 60601-1-2), and FDA guidance documents for powered suction pumps. These are physical and mechanical performance metrics rather than clinical outcomes or expert interpretations.

8. The Sample Size for the Training Set

As this is a hardware medical device and not an AI/ML algorithm, there is no concept of a "training set" for an algorithm.

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

Again, since there is no training set, this question is not applicable.

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The Neptune S Waste Management System is indicated for use in procedures where collecting and disposing of fluid waste and capturing suctioned tissue specimens is desired. It is intended to be used in operating rooms, pathology, surgical centers, procedure rooms, and for endoscopic procedures, such as colonoscopies, esophagogastroduodenoscopies (EGDs), and bronchoscopies.

The Neptune S Waste Management System includes subject devices Neptune S Rover and V2 Manifolds, previously 510k cleared Neptune 2 Docker, and supporting accessories.

Neptune S Rover is a mobile device, plugged into a standard 15A hospital-grade AC power outlet and is used to suction and collect waste fluids during surgical or nonsurgical procedures. It can also be used to collect tissue specimens suctioned during these procedures. The Rover provides fluid waste management, fluid volume measurement and contains features designed to specifically aid with tissue specimen collection, including an array of lighting features and a flat worksurface. It was designed with a smaller footprint to accommodate smaller operating rooms or procedure rooms, particularly endoscopy suites.

The manifolds are non-sterile, single-use disposables, that act as an interface between the Rover canister and standard medical grade suction tubing. They facilitate the collection of surgical tissue and the removal of fluid waste.

The provided text describes the non-clinical and clinical tests performed for the Neptune S Waste Management System to establish its safety and effectiveness.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics with corresponding reported device performance values for non-clinical tests. Instead, it generally states that "All requirements were met and no new issues of safety or effectiveness were raised" for various non-clinical test items like intended use/user needs, safety, general requirements and performance, software, electrical/mechanical/thermal safety, electromagnetic compatibility, and shipping.

However, for the clinical test (PMCF survey), specific performance rates are provided:

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

• Sample size for the clinical test set: Not explicitly stated as a number of patients or procedures. It refers to "retrospective clinical data collected through Post Market Clinical Follow-up (PMCF) survey of predicate device." Without further detail, the exact sample size cannot be determined from this document.
• Data provenance:
  • Country of origin: Not specified.
  • Retrospective or prospective: Retrospective ("retrospective clinical data collected through Post Market Clinical Follow-up (PMCF) survey").

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

This information is not provided in the document. The clinical data used was a PMCF survey of a predicate device, which implies real-world usage rather than a controlled study with expert ground truth establishment for a test set in the context of AI/ML performance evaluation.

4. Adjudication method for the test set

This information is not applicable as the clinical data was a PMCF survey, not a study involving human readers and AI for ground truth 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

There is no indication that an MRMC comparative effectiveness study was performed or that the device involves AI assistance for human readers. The device is a waste management system, not an imaging or diagnostic AI tool.

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

This is not applicable as the device is a physical medical device (waste management system) and not an algorithm or AI product.

7. The type of ground truth used

For the non-clinical tests, the ground truth was based on design specifications, risk analysis, and conformance to standards (e.g., IEC 60601-1, IEC 62304).

For the clinical data (PMCF survey), the "ground truth" was based on observed operational performance of the predicate device in real-world clinical procedures, specifically looking at waste fluid and debris removal success rates and the occurrence of adverse events. It is outcome-based, related to the device's functional performance in a clinical setting.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI/ML model that undergoes training with a dataset.

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

This is not applicable as there is no training set for an AI/ML model mentioned.

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The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.

The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications.

The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.

The provided text is a 510(k) Premarket Notification for the Acare Suction Unit, model ASU-200. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy through studies with ground truth established by experts.

Therefore, the information requested about acceptance criteria and studies (especially those involving expert ground truth, sample sizes for training/test sets, MRMC studies, or standalone performance of an AI algorithm) is not applicable to this type of device and submission.

The document describes performance testing conducted to ensure safety and functionality in comparison to predicate devices, but this is engineering and compliance testing, not a clinical study to assess diagnostic performance.

Here's an attempt to populate the table and address the questions based solely on the provided text, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance

Details of the "Study" (Non-Clinical Testing) that proves the device meets acceptance criteria:

The "study" described is a series of non-clinical, engineering, and compliance tests. The goal was to demonstrate that the Acare Suction Unit, model ASU-200, is as safe and effective as its predicate devices, primarily through meeting established international and national standards for medical electrical equipment.

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

• Sample Size: Not applicable. These were engineering and compliance tests performed on the device itself, not on a dataset or patient samples. Typically, one or a few units are tested to demonstrate compliance.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting to specific engineering standards.

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

• Not applicable. There was no ground truth established by experts in a clinical or diagnostic sense. The "ground truth" was the compliance with published international and national standards (e.g., IEC 60601-1-2, ANSI/AAMI ES 60601-1, ISO 10079-1, IEC 60529). Compliance was assessed by engineering testing.

4. Adjudication method for the test set:

• Not applicable. This was not a study requiring adjudication of expert interpretations. Compliance was determined by whether the device's performance met the specified thresholds and requirements of the safety and performance 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:

• Not applicable. This device is a suction unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This refers to AI algorithm performance studies, which are not relevant to a medical suction unit.

7. The type of ground truth used:

• Not applicable in the conventional sense of medical imaging/diagnostic studies. The "ground truth" for this submission was the defined requirements and specifications within the referenced international and national safety and performance standards (e.g., maximum vacuum pressure, flow rate thresholds, EMC limits, electrical safety parameters, IP code requirements).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. As above, no training set or associated ground truth was established for this device.

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The IntelliCartTM System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

The IntelliCart™ System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospitals, pathology labs, surgical outpatient centers, and doctor's offices. The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac). Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste. Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available. The IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments.

This document describes the IntelliCart™ System, a self-powered suction/vacuum pump. The provided text is a 510(k) Summary for regulatory submission. It details the device's characteristics, intended use, and comparison to a predicate device, focusing on non-clinical performance data.

Here's the breakdown of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several standards and test types with "Predetermined Acceptance Criteria" and "Results" for both the predicate device and the K190789 IntelliCart™ System. In all cases, the acceptance criteria are simply "Yes" indicating the standard is applicable, and the results are "Pass".

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

The document does not specify sample sizes for any of the tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance data. The tests described are laboratory performance and engineering tests, not clinical studies involving patient data.

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 and therefore not available in the provided text. The "ground truth" in this context refers to engineering and performance specifications and regulatory standards (e.g., passing IEC 60601-1). These are established through design, manufacturing, and testing processes against predefined criteria, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This is not applicable for the type of non-clinical performance testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus on ground truth. The tests here are objective measurements against fixed criteria.

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

There is no MRMC comparative effectiveness study mentioned in the document. This device is a medical suction pump, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is an electro-mechanical system, not an algorithm, and the tests described are for its functional performance and safety, not for standalone algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is the predetermined acceptance criteria derived from recognized national and international standards (e.g., IEC 60601-1, ISO 10079-1) and FDA guidance documents. These are objective engineering and performance specifications.

8. The Sample Size for the Training Set

This is not applicable. The IntelliCart™ System is not an AI/Machine Learning device that requires a training set. The software verification and validation refer to traditional software development and testing, not AI model training.

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

This is not applicable as there is no training set for an AI/Machine Learning algorithm mentioned in the document.

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

ZOOM Canister
The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.

ZOOM Aspiration Tubing
The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.

There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.

Here's a breakdown of the acceptance criteria and study information for the ZOOM™ Aspiration Pump, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing for the device. For these types of tests (e.g., electrical safety, electromagnetic compatibility, performance standards), the concept of "sample size" in the same way as a clinical study (e.g., number of patients) isn't directly applicable. Instead, it refers to the number of units tested. However, the document does not specify the number of units of the ZOOM™ Aspiration Pump, ZOOM™ Canister, or ZOOM™ Aspiration Tubing that were tested for each criterion.

The data provenance is non-clinical bench testing conducted by the manufacturer, Taiwan Biomaterial Co., Ltd. (TWBM). There is no mention of country of origin for specific test data in terms of patient populations or retrospective/prospective studies, as these are not relevant for the described tests.

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

This information is not applicable to the type of testing described. The listed acceptance criteria are based on established international and national standards (e.g., IEC, ISO, ANSI/AAMI). Compliance with these standards is determined by objective measurements and test procedures, not expert consensus on labels or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., images) requires reconciliation among experts to establish a "ground truth" or reference standard. The testing here involves objective measurements against predefined engineering and performance standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a hardware device like an aspiration pump.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone study in the context of an algorithm's performance was not done. "Standalone" refers to the performance of an AI algorithm intrinsically, without human interaction. The ZOOM™ Aspiration Pump is a physical medical device, not an AI algorithm. Its performance is measured directly against physical and functional standards.

7. The Type of Ground Truth Used:

The "ground truth" for the performance criteria is defined by the specifications and acceptable ranges established within the referenced national and international standards (e.g., IEC 60601-1-2, ISO 10079-1, IEC 60529, ANSI/AAMI ES60601-1, ISO 10993-1). Compliance is determined by objective measurements meeting these predefined limits.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. The ZOOM™ Aspiration Pump is a physical device, and its development and testing do not involve machine learning training sets.

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

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

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TWBM Pump is intended for general suction use in hospitals or clinics.

The TWBM Pump is intended for general suction use in hospitals or clinics where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. The TWBM Canister is an accessory to the TWBM Pump and the removed body fluids are collected in it. The TWBM Pump is an AC powered oil-less positive displacement pump capable of delivering up to 29 inHg (737 mmHg) of vacuum to draw fluid and small particles. The TWBM Pump has a plastic casing fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and one sliding canister holder. The TWBM Canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The TWBM Canister should be placed in the in-built sliding canister holder, and connect the TWBM Canister with the TWBM Pump via the connectors of the canister tubing prior to use. Both, the TWBM Pump and the TWBM Canister, are provided non-sterile and are packaged separately.

The provided document describes the predicate comparison for the TWBM Pump and its substantial equivalence determination to the Penumbra Pump MAX™. It outlines acceptance criteria and test results for non-clinical performance and regulatory compliance.

Here's an analysis based on your request:

Acceptance Criteria and Reported Device Performance

Key takeaway: The document states that "All the test results from the performance testing passed the acceptance criteria set forth by the respective standards."

Further Information (Based on the provided document)

• Sample size used for the test set and the data provenance: The document does not specify the number of units (sample size) for the TWBM Pump and TWBM Canister that were subjected to the performance and EMC testing. The provenance of the data is from laboratory testing conducted by Taiwan Biomaterial Co., Ltd. (TWBM) and implied third-party testing for compliance standards. The document doesn't mention country of origin for data in terms of patient data, as this is a non-clinical submission. It is a non-clinical (bench) study rather than a study involving patient data.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a non-clinical (bench) study for device performance and regulatory compliance, not an AI/imaging device. Therefore, the concept of "ground truth" as established by medical experts (e.g., radiologists) for diagnostic accuracy is not applicable here. The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., ISO 10079-1, IEC 60601-1-2). Testers/engineers conducted the tests against these pre-defined standards.

• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among medical experts for image interpretation or diagnosis. For bench testing, results are objective (pass/fail against a standard).

• 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 focuses on the safety and performance of a physical medical device (suction pump) and its substantial equivalence to a predicate device through non-clinical testing, not an AI or imaging diagnostic device.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this non-clinical study is the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 10079-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60529). The device's performance was measured against these engineering and safety benchmarks.

• The sample size for the training set: Not applicable. This is a non-clinical submission for a physical device, not an AI model that requires a training set.

• How the ground truth for the training set was established: Not applicable, as no training set was used.

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The DV-300 is intended for general suction use in hospitals or clinics.

The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection.

The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock.

The DV-300 must only be used on the order of a physician.

This document describes the Cliq Aspirator DV-300, a powered suction pump, seeking 510(k) clearance. The focus of the document is on the device's substantial equivalence to a predicate device and its performance and safety testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states that "Full test reports can be found in Section 16 of this submission." However, Section 16 is not provided in the given text. Therefore, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) cannot be determined from the provided excerpt.

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

This information is not provided in the given document. The acceptance criteria largely relate to technical specifications and physical performance of the device and its components, rather than diagnostic accuracy that would typically require expert ground truth.

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

This information is not provided in the given document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the performance tests.

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 as the device (Cliq Aspirator DV-300) is a powered suction pump, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable as the device is mechanical, not an algorithm. The reported performance is standalone with respect to the device's physical attributes and functionality.

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

The "ground truth" for the performance tests appears to be based on engineering and physical measurements, compliance with international standards (IEC, ISO), and functional assessments against predefined technical criteria. For usability-related criteria, it would likely be based on internal testing and possibly user feedback, but the specific methodologies are not detailed.

8. The sample size for the training set:

This is not applicable as the device is a physical medical device (suction pump), not a 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 reason as above.

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