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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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