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The BIO SA CA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements.

The B I 0 5 A C A is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible.

The B I 0 5 A C A unit is intended for use on an adult population. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The BIOSACA is a multi-functional and an ambulatory recording device. It is an ambulatory system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. Function The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad,

This document is a 510(k) summary for the BIOSACA device, a biological signal recorder. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the BIOSACA device. Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the B | 0 S A C A from Biosys AB (K984580), and Embla, Flaga hf. (K971813).

Therefore, a table of acceptance criteria and reported device performance as typically understood for a novel performance study cannot be created from this document. The "performance" described leans more towards the functional capabilities and intended use matching the predicate devices.

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

This information is not provided in the 510(k) summary. A 510(k) submission primarily relies on demonstrating equivalence through technical characteristics, performance data (often bench testing), and sometimes clinical data from the predicate device itself, rather than a new clinical study with a defined test set.

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

This information is not provided. As no specific clinical test study with a ground truth is described, the concept of experts establishing ground truth for a test set is not applicable to the content of this summary.

4. Adjudication Method for the Test Set

This information is not provided. Since no specific clinical test study with a test set is described, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The BIOSACA is a signal recording device, not an AI-assisted diagnostic tool, so such a study would not be typically performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

A standalone performance study (algorithm only) was not done or not described. The device is a biological signal recorder, not an algorithm with independent diagnostic capabilities. Its "performance" is in its ability to accurately record and display signals, not to generate diagnoses independently.

7. Type of Ground Truth Used

The type of ground truth used is not applicable for this 510(k) summary as no specific clinical performance study with a defined ground truth for diagnostic accuracy is presented. The "ground truth" for a signal recorder would generally relate to the accuracy and fidelity of the recorded signals compared to the actual physiological events, which would be established through engineering validation and bench testing, rather than expert consensus on diagnostic outcomes, pathology, or outcomes data in a clinical trial context.

8. Sample Size for the Training Set

This information is not provided. The device is a signal recorder, not an AI/ML model that would typically have a "training set" in the context of machine learning.

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

This information is not provided and is not applicable. Since the device is a biological signal recorder and not an AI/ML model, there is no "training set" or ground truth for a training set in the machine learning sense. The device's functionality is based on established engineering principles for capturing and processing bioelectrical signals.

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