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The intended use of the ABP-lite is to detect, diagnose, and monitor hypertension.

The ABP-lite is a 24-hour Ambulatory Blood Pressure Monitoring System (ABPMS) which obtains and stores the results of repeated determinations of blood pressure and heart rate during the activities of ordinary daily living. The ABP-lite system also manages a patient data base. The ABP-lite ABPMS includes a pneumatic cuff (worn by the patient), Data Recorder Unit (worn by the patient -- collects blood pressure ("BP") and heart rate ("HR") data), Remote Control Unit (LCD display of BP and HR data as well as error codes, patient control functions of event button and stop ongoing test). Interface Unit (interface between Remote Control Unit and PC), and ABPM-Soft Analyzer (proprietary custom software used for initial setup of Data Recorder, plus download, processing and printing of collected data).

The ABP-lite system weighs 13 ounces and is 21 cubic inches in size. The ABP-lite system uses the Korotkoff and oscillometric methods of blood pressure measurement with blood pressure cuff and microphone technology. Safety systems include an emergency pressure release system and watchdog timer.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NewMed ABP-lite, structured to answer your specific questions.

Important Note: The provided document is a 510(k) summary from 1996. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with extensive statistical analysis and specific performance metrics against pre-defined acceptance criteria, as would be expected for modern medical device submissions. Therefore, many of your requested details may not be explicitly available in this type of document.

Acceptance Criteria and Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated with numerical thresholds (e.g., "accuracy of +/- 5 mmHg"). Instead, the document relies on demonstrating substantial equivalence to a predicate device (NewMed ABP 1000i). The "performance" is therefore implied to be similar to or within acceptable limits of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Due to the nature of a 1996 510(k) summary, which emphasizes substantial equivalence, the "study" referred to is primarily non-clinical testing to demonstrate this equivalence rather than a detailed, standalone clinical trial designed to prove specific numerical acceptance criteria.

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

   • Sample Size: Not specified. The document only mentions "non-clinical testing performed on the ABP-lite blood pressure monitor." There is no mention of a human subject test set.
   • Data Provenance: Not specified. Given it's non-clinical testing, it likely refers to bench testing, engineering verification, and perhaps internal comparative measurements rather than clinical data from a specific country.
   • Retrospective/Prospective: Not specified, but likely refers to a series of internal verification and validation activities conducted as part of the device development.

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

   • Not applicable/Not specified. The "ground truth" in this context would likely be reference measurements from a calibrated standard or the predicate device itself during comparative testing. No human experts are mentioned for establishing ground truth for this non-clinical testing.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. This typically applies to clinical studies involving human interpretation or expert review, which is not described.

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

   • No, an MRMC study was not done. The document describes a comparison to a predicate device, but this is a device-to-device comparison, not a study evaluating human reader performance with and without AI assistance.

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

   • Yes, implicitly. The "non-clinical testing" and the statement that the devices "perform identically" refer to the automated measurement capabilities of the ABP-lite itself in comparison to the predicate, without human intervention in the measurement process. The device's algorithm performs the blood pressure and heart rate measurements independently.

6. The Type of Ground Truth Used:

   • For this 510(k) submission, the "ground truth" for demonstrating performance was the performance of the predicate device (Nissei/NewMed ABP 1000i) as established through prior regulatory clearance, and presumably, calibrated measurement standards for bench testing. The primary claim is substantial equivalence to this predicate.

7. Sample Size for the Training Set:

   • Not applicable. The ABP-lite is an ambulatory blood pressure monitor that uses established Korotkoff and oscillometric methods. It does not appear to employ machine learning or AI algorithms requiring a training set in the modern sense. The "software in the data recorder unit was designed using off-the-shelf software programs" and "custom configured," suggesting standard programming rather than a data-driven training approach.

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

   • Not applicable, as there's no indication of a training set for an AI/ML model.

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