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Intended Use: AS-XXXX Suction Pump is intended to be used to remove bodily fluids from a patient's airvay or respiratory system.

The AS-XXXX (FAMILY SERIES) suction pump is a portable AC-powered suction pump. The AS-XXXX (FAMILY SERIES) suction pump creates a negative pressure (vacuum) that draws fluids through a disposable suction catheter that is connected by suction tubing to a collection container. The suctioned fluids are then trapped in the collection container for proper disposal. The device must only be used on the order of a physician. If practiced outside of the hospital setting, the care giver must be trained by a certified healthcare professional and the training must be recorded and documented. The AS-XXXX (FAMILY SERIES) suction pump consists of an on/off switch, a pump unit, a power cord, a collection container, relief valve, pressure adjustment knob, pressure gauge, microbial filter, long intermediate tubing, short intermediate tubing, and suction tubing. Disposable suction catheters are not packaged with this device and must be purchased separately.

The provided text describes the acceptance criteria and the study for the Ding Hwa AS-XXXX (Family Series) Suction Pump.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly states: "Ding Hwa AS-XXXX Suction Pump is substantially equivalent and meets the same acceptance criteria as the predicate device, EMG Suction Unit SUA01-AXX 510(k)112421. Non-clinical performance testing includes IEC 60601-1, 3rd Ed. MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE, IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility and ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements. All results of the testing met acceptance criteria." |

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

This information is not provided in the document. The document refers to "non-clinical performance testing" and the results meeting "acceptance criteria," but does not detail the methodology, sample sizes, or data provenance for these tests beyond citing the standards. This device is a hardware product (suction pump), not an AI device, so typical AI study parameters like "test set" and "data provenance" often don't apply in the same way.

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 applicable for this type of medical device (a suction pump) and is not provided in the document. The "ground truth" for a suction pump would be its adherence to established performance and safety standards, not expert consensus on diagnostic images or other data typically associated with AI.

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

This information is not applicable for this type of medical device and is not provided in the document.

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

This information is not applicable for this type of medical device (suction pump). MRMC studies are typically for medical imaging diagnostics or similar AI-assisted interpretation, which is not relevant here.

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

This information is not applicable for this type of medical device. The device is a physical pump, not an algorithm.

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

The "ground truth" for this device's performance is established through compliance with recognized international and national standards for medical electrical equipment and suction equipment, specifically:

• IEC 60601-1, 3rd Ed. (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements.

The device also based its "ground truth" on substantial equivalence to a predicate device (EMG Suction Unit, Model SUA01-AXX Series 510(k)112421), implying its performance matches that of an already cleared device.

8. The sample size for the training set

This information is not applicable for this type of medical device. "Training set" is a concept related to machine learning and AI, not mechanical medical devices like a suction pump.

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

This information is not applicable for this type of medical device.

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The Basic and Dominant Flex Suction Pumps are indicated for vacuum extraction, aspiration during flexible endoscopy and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside.

The Medela Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela Basic and Dominant Flex are user friendliness and simple cleaning.

Medela Basic and Dominant Flex cover the 4 main functions of

• Powerful and high suction capacity .
• Rapid vacuum build-up .
• Low vibrations and quiet .
• Design; smooth surface and easy to . use and clean

The Medela Basic provides a fixed airflow of 30 l/m and the Medela "Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 I/m.

All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located.

Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version.

A variety of reusable and disposable accessories are available for use with the Medela ` Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

The provided text describes a 510(k) summary for the Medela Basic and Dominant Flex Suction Pumps. It aims to demonstrate substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, the submission does not contain information typically found in a study designed to prove a device meets specific acceptance criteria using defined performance metrics, sample sizes, expert ground truth, or MRMC studies. Instead, it focuses on comparing the new device's technological characteristics and intended use to previously cleared predicate devices.

Here's a breakdown of why the requested information is largely absent or not directly applicable to this type of submission, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not presented in the context of a de novo study the device meets. The submission primarily compares the new device's specifications (flow, maximum vacuum) to predicate devices and asserts equivalence.

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

Not applicable. The submission does not describe a clinical study with a "test set" in the sense of patient data or samples used to evaluate device performance against clinical endpoints. The "non-clinical tests" mentioned (Risk Analysis, Software Validation, Electrical Safety, etc.) are engineering and regulatory compliance activities, not clinical performance studies on a specific dataset.

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

Not applicable. No multi-reader, multi-case study with ground truth established by experts is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing."

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

Not applicable. This device is a powered suction pump, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not applicable. There is no clinical study described that required a "ground truth" (e.g., pathology, outcomes data) to evaluate diagnostic or therapeutic accuracy. The closest concept is the "Bench Testing" which verified engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

Not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) submission which focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through a comparison of technological characteristics, intended use, and adherence to relevant voluntary standards. It explicitly states that no clinical testing was performed on the new device, and thus, does not detail studies designed to establish and meet specific performance acceptance criteria in the manner requested.

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The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.

The VOLTERA Powered Suction Pump, S1001-3 Series is a lightweight, suction device intended for wound management via application of continual or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.

The provided text describes a 510(k) submission for the VOLTERA Powered Suction Pump S1001-3 Series. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, not on a study proving the device meets specific acceptance criteria in a clinical setting with human-in-the-loop performance.

Here's an analysis of the provided information relative to your request:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported performance alongside those criteria in a table format. Instead, it states that "All the test results demonstrate the performance of VOLTERA Powered Suction Pump meets the requirements of its pre-defined acceptance criteria and intended uses." This implies that the device successfully met internal criteria for various tests.

However, the "Substantial Equivalence Determination" section (excerpt 2) provides a comparison chart of specifications between the proposed device and two predicate devices. While not "acceptance criteria" in the traditional sense of a clinical study, these specifications serve as performance benchmarks for demonstrating equivalence.

Note on "Acceptance Criteria" for Medical Devices: For 510(k) submissions, "acceptance criteria" often refer to the successful completion of specific predefined non-clinical tests (e.g., electrical safety, electromagnetic compatibility, risk management, mechanical performance) to demonstrate that the device performs as intended and is as safe and effective as a legally marketed predicate device. The document explicitly states these types of tests were performed and met requirements.

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

The provided text does not mention a "test set" in the context of clinical data for performance evaluation. The testing described is "in vitro and in vivo preclinical physical and mechanical tests." These are likely engineering and lab tests, not clinical studies with human subjects. Therefore, sample size and data provenance in terms of human subjects are not applicable here.

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. Given the nature of the non-clinical testing described, the "ground truth" would be established by technical specifications, established test methods, and industry standards, rather than expert clinical consensus on images or outcomes.

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

Not applicable, as no clinical test set with human subject data and expert adjudication is 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:

Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

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

The device is a physical powered suction pump. The concept of "standalone algorithm performance" (without human-in-the-loop) typically applies to software or AI-driven devices. While the pump operates independently (standalone in a functional sense), this question is usually framed in the context of AI/software. If interpreting "standalone performance" as the device operating independently without constant human intervention, then yes, the pump is designed to operate in a standalone manner to apply negative pressure. However, this is not performance of an algorithm.

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

The "ground truth" for the non-clinical tests would be defined by the specifications and performance standards set by relevant international standards (IEC 60601-1-1, IEC 60601-1-2, ISO 14971:2007) and the performance of the predicate devices. For example, if a test was to measure maximum vacuum, the "ground truth" would be the required -200 mmHg, and the device's output would be compared against that.

8. The sample size for the training set:

Not applicable. This submission concerns a physical medical device, not a machine learning 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 for this device.

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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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The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.

The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for dilation and irrigation of joint capsules with a fluid. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on settings chosen by the user. If desired, both flow and manage hald and joint proodividually adjusted. The device is used as part of a system that includes the unit, a footswitch and tubing, and can support integrated use of a shaver.

The provided document is a 510(k) summary for the KARL STORZ ARTHROPUMP POWER Irrigation/Suction Pump. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI/software device.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Test results show that all specifications have been met." However, it does not provide a table of
specific acceptance criteria or quantitative performance metrics (e.g., accuracy, precision, etc.) for the device. The focus is on functional, performance, and safety testing to demonstrate that the device meets its design specifications, but these specifications are not detailed in the summary.

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

Not applicable. The document does not describe a test set in the context of an AI/software device evaluation. Performance testing mentioned is for the physical device's function, performance, and safety, not for evaluating an algorithm's output on a dataset.

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

Not applicable. This information is relevant for AI/software devices where human experts establish ground truth for testing.

4. Adjudication method for the test set:

Not applicable. This is typically used in the context of expert review of AI/software outputs.

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

No, an MRMC study was not done. The device is an irrigation/suction pump, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an AI/software algorithm. The device itself is a physical pump with software control. The document mentions "microprocessor controlled dual peristaltic pump technology" and that "both roller pumps are software controlled," but this refers to the operational control of the pump, not an AI algorithm performing a diagnostic or analytical task.

7. The type of ground truth used:

Not applicable. The "ground truth" concept as applied to AI/software performance (e.g., pathology, outcomes data) is not relevant for this device. The "ground truth" for this device would be its correct physical function, pressure maintenance, and flow rates according to engineering specifications.

8. The sample size for the training set:

Not applicable. This device is not an AI/software algorithm that requires a training set.

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

Not applicable.

Summary:

The KARL STORZ ARTHROPUMP POWER is a medical device (an irrigation/suction pump) that utilizes microprocessor-controlled software to manage its mechanical functions. The provided 510(k) summary focuses on demonstrating its substantial equivalence to existing predicate devices (FMS Duo and Karl Storz Arthropump Plus).

The "study" or testing described within this document is typical for a hardware device with embedded software:

• Non-Clinical Performance Data: "The KARL STORZ ARTHROPUMP POWER has been tested for function, performance and safety. Test results show that all specifications have been met."

This statement indicates that the device underwent engineering and functional testing to verify that it meets its pre-defined design specifications for parameters like pressure control, flow rates, and safety mechanisms. However, the exact specifications and the detailed results of these tests are not provided in this summary. The acceptance criteria would be those specific engineering and functional specifications, and the "study" is the internal design verification and validation testing conducted by the manufacturer.

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The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.

The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid.

The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.

The provided 510(k) summary for the ATMOS C361/C451 Suction Pump™ is for a medical device and therefore does not include information pertaining to algorithm performance, acceptance criteria, ground truth, or study details typically found in AI/ML device submissions. This document is a traditional 510(k) for a hardware device and evaluates substantial equivalence to a predicate device based on technological characteristics and intended use, not on AI-driven performance metrics.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The C361/C451 Suction Pump does not raise any new issues of safety, efficacy, or performance of the product."
• "The 510(k) for the ATMOS C361/C451 Suction Pump™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device."

These statements indicate that the device was evaluated against existing standards and a predicate device (NOUVAG AG - VACUSON 40 AND VACUSON 60) based on its physical and functional characteristics, not on data-driven performance metrics for an algorithm.

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The Genadyne A4 Powered Suction Pump is intended for general suction use in hospitals or clinics.

The Genadyne A4 powered suction pump is a portable suction device that is intended for general suction use in hospitals or clinics. The Genadyne A4 comes with a canister and a power adapter to charge the battery.

The provided 510(k) summary for the Genadyne A4 Powered Suction Pump does not describe a study involving acceptance criteria or the performance of an AI device. This document is for a medical device that generates suction and is a standard 510(k) premarket notification for a Class II device.

The information provided describes a comparison to a predicate device to establish substantial equivalence for regulatory approval, focusing on physical and performance characteristics of the suction pump itself, not on an AI system's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device. The document simply lists technical specifications and intended use of a physical suction pump.

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The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.

The ASA01 Heavy Duty Suction Pump is an AC-powered, stand-alone device, designed to collection of nonflammable fluid materials in medical applications.

The provided text describes a 510(k) submission for the ASA01 Heavy Duty Suction Pump, but it does not contain specific acceptance criteria or a study proving the device meets them in the way typically expected for an AI/CADe device.

This device is a physical medical device (a suction pump), not an AI or software-controlled device for diagnostic imaging or similar applications. Therefore, many of the requested categories (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "ground truth" in the context of image interpretation, "training set size") are not applicable to this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating "substantial equivalence" to a predicate device (K052650 Pioneer U601 Series Aspiration) rather than meeting precise performance metrics derived from a clinical study for diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance (as far as applicable to this type of device):

Study Details (as applicable)

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

   • Test Set Sample Size: Not applicable in the context of a "test set" for AI/CADe performance. The evaluation was primarily through bench testing and compliance with standards.
   • Data Provenance: Not applicable for a physical suction pump. The testing was laboratory-based.

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

   • Not applicable. "Ground truth" in the AI/CADe sense (e.g., expert interpretation of images) is not relevant for a physical suction pump's functional testing.

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

   • Not applicable. This concept applies to human reader consensus for diagnostic truth, which is not part of this device's evaluation.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not a physical suction pump.

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

   • No, a standalone (algorithm only) study was not done. This device does not involve an "algorithm" in the AI sense. Its performance is inherent to its physical operation.

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

   • Not applicable. The "ground truth" for a suction pump would be its ability to achieve certain vacuum pressures, flow rates, and maintain sterility, as measured by calibrated equipment and adherence to engineering specifications and standards.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, 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.

Summary for this specific device:

The ASA01 Heavy Duty Suction Pump is a basic physical medical device. Its acceptance criteria and proof of performance are based on engineering bench testing, compliance with relevant industrial and medical device standards (IEC, ISO), hazard analysis, and demonstrating "substantial equivalence" in technological characteristics and intended use to a legally marketed predicate device (K052650 Pioneer U601 Series Aspiration). Concepts related to AI/CADe performance evaluation (like ground truth, test sets, training sets, reader studies) are not relevant to this submission.

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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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The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:

1. Suction: 9 liters/min,
2. Maximum Vacuum: 200 mmHg
3. Noise: 35 dba,
4. Weight: 2.8 kg
5. Operation: Continuous and Intermittent
6. Dimensions: 290mmX359mmX130mm
   The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.
   The NovaSpine Powered Suction Pump PRO-I is composed of two parts:
7. The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
8. The consumable/disposable components such as:
   a. Collection canister (secretion container),
   b. Related hoses (tubing)
   c. Hose connectors
   d. Filters
   e. Other accessories as detailed in the operating manual

The NovaSpine Powered Suction Pump PRO-I is a medical device. The provided text, a 510(k) summary, describes its characteristics and regulatory clearance, but does not contain information about a study that proves the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to other legally marketed devices, rather than presenting a performance study with detailed acceptance criteria and results. The "Device Description" section lists several specifications, which likely serve as the device's inherent design and performance characteristics, but these are not presented as "acceptance criteria" against which a study was performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study as requested, because the provided text does not describe such a study or associated acceptance criteria.

Here's what can be extracted from the text regarding the device specifications:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present explicit "acceptance criteria" tested in a study. Instead, it provides the device's technical specifications. If we interpret these specifications as the intended performance characteristics, the table would look like this:

The following information cannot be provided as it is not present in the given text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices, which typically involves comparing technical specifications, intended use, and safety/effectiveness profiles without necessarily requiring new clinical performance studies against formal acceptance criteria for every new device. It's a common pathway for Class I and II medical devices.

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