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Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient

Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use.

This document is a 510(k) premarket notification for a medical device called Exsalta, a powered suction pump. The FDA has reviewed the submission and determined the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed acceptance criteria for specific performance metrics or a study demonstrating that the device meets those criteria with statistical significance. Instead, it broadly states that "The subject device met all performance criteria" based on non-clinical testing.

Here's an analysis of what information is present and what is missing, structured according to your request:

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

The document provides some specifications for the Exsalta device and compares them to its predicate (Medela Vario 8/18/ci Suction Pumps K153663). However, it does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific performance tests. It lists specifications and general compliance with standards.

Note: The "Reported Device Performance" column reflects what the document states the device features or complies with, rather than quantitative results from a specific study against predefined acceptance criteria. The document claims "The subject device met all performance criteria" after listing non-clinical tests.

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

• Sample Size: This information is not provided in the document. The filing is for a physical medical device (powered suction pump), not an AI/software device that would typically have a test "dataset" for performance evaluation in the context of your request. The testing mentioned (Shelf-life/Aging, Software V&V, IEC 60601-1, IEC 60601-1-2, ISO 10079-1:2015) refers to engineering and quality assurance tests on the device hardware and software. It does not involve a "test set" of patient data as assumed by the prompt.
• Data Provenance: Not applicable, as there's no patient data "test set" involved in this type of device clearance based on the provided text.

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 this is a hardware medical device (a suction pump), there wouldn't be a "ground truth for the test set" established by experts in the context of clinical interpretation or diagnosis. Performance is evaluated against engineering specifications and international standards through non-clinical testing.

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

• Not applicable. There is no "test set" requiring adjudication in the context of clinical agreement or AI output.

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. The document explicitly states: "No human clinical testing was performed." and "No animal testing was performed." This device is a powered suction pump, not an AI or imaging device where MRMC studies would typically be conducted.

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

• Not applicable in the context of AI performance. While "Software Verification and Validation" was performed, this refers to the embedded software controlling the pump's mechanical functions, not a standalone AI algorithm for interpretation or diagnosis.

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

• Not applicable. For this device, "ground truth" would relate to the physical and electrical safety and performance of the pump itself, verified through engineering tests against industry standards (e.g., ISO 10079-1 for medical suction equipment, IEC 60601-1 for electrical safety).

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve machine learning or a training set.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and compliance with recognized non-clinical performance and safety standards. It does not provide information about clinical studies, expert-adjudicated test sets, or AI performance metrics, as these are not relevant to the type of device being cleared. The device met "all performance criteria" through non-clinical testing, but specific acceptance thresholds and detailed test results are not included in this summary.

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The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.

The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.

Here's a summary of the acceptance criteria and study information for the NAPA LP-15 Airway Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The study to prove the device meets acceptance criteria was a non-clinical study involving laboratory testing.

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

• Sample Size: Not explicitly stated in terms of number of devices tested. It refers to "the monitor" (singular), implying at least one device was subjected to various tests.
• Data Provenance: The tests were "laboratory tested," indicating they were conducted in a controlled environment as part of the device's premarket submission. No information about country of origin, retrospective or prospective data is provided as it was non-clinical testing.

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

• Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a clinical study involving expert interpretation of data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a study requiring adjudication of expert opinions.

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

• No. The submission explicitly states: "No clinical tests were submitted." An MRMC study would be a type of clinical study.

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

• While the device is a technical product, "standalone performance" in the context of AI/algorithms typically refers to its diagnostic accuracy compared to ground truth without human intervention.
• This device is an airway pressure monitor that displays readings and provides alarms. Its performance is measured directly against physical standards for accuracy and functionality, not against a "ground truth" derived from human interpretation.
• The "standalone performance" in this context is demonstrated by meeting the specified engineering and safety standards (e.g., pressure measurement accuracy), which was indeed done.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was established by calibrated reference sources for pressure measurements and the requirements outlined in the various referenced international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 14971, IEC 62304, and manufacturer's technical file for biocompatibility).

8. The Sample Size for the Training Set:

• Not applicable. This device is hardware with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 standards, which involves verification and validation against requirements, not training on a dataset.

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

• Not applicable, as there was no "training set" for an AI/ML algorithm. The "ground truth" for the software development was its established requirements (from the device specification) and relevant standards (IEC 62304).

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