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510(k) Data Aggregation
(88 days)
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.
| Acceptance Criteria (Functional/Intended Use Equivalence) | Reported Device Performance (Matching Predicate) |
|---|---|
| Ability to receive and record up to 22 bioparameters. | The BIOSACA is able to receive and record up to 22 bioparameters. |
| Record 16 parameters from two headboxes (AC and/or DC). | Records 16 from two headboxes, AC and/or DC. |
| Record 3 parameters from pulse oximeter. | Records 3 from the pulse oximeter. |
| Record 3 parameters from sensor pad. | Records 3 from the sensor pad. |
| Capable of recording, displaying, monitoring, printing, and storage of human bioparameters (brain, heart, muscle activity, eye movement, breathing, body movements). | The BIOSACA 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. |
| Designed for stationary, ambulatory, and mobile operation. | The BIOSACA is designed for stationary, ambulatory and mobile operation. |
| Usable in patient's home, hospital, or other environments. | May be used in either the patient's home, the hospital or other environments. |
| Intended for use on an adult population. | The BIOSACA unit is intended for use on an adult population. |
| Not intended as life support or vital signs monitoring in intensive care units. | It is not intended for use as life support equipment such as vital signs monitoring in intensive care units. |
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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(79 days)
The BIOSACA equipment is indicated for use in the recording, displaying, printing and storage of biological and non-biological signals for sleep monitoring, neurological disorder and epilepsy investigations as a visual aid to the physician. Biological signals include Electroencephalography (EEG), Electromyography (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and mobile operation and may be used in either the patient's home or the hospital. Biological signals are encountered which can be recorded directly from the patient. Non-biological signals are recorded using indirect methods such as flow of air (breathing), blood pressure, etc. The equipment is suitable for home use as the patient needs only a minimal amount of instructions for home use. The system has no lights or sounds that could confuse the patient. Signals may be stored for later analysis or may be viewed directly in conjunction with the recording. When monitoring, the operator sees the signals at the same time as they are recorded. The Biosaca unit is intended for use on an adult population and at home or in health care facilities. The unit 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 a portable 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. 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.
Here's an analysis of the provided text regarding the Biosaca device, focusing on acceptance criteria and study information.
It's important to note that the provided documents (510(k) summary and FDA clearance letter) are regulatory documents, not a scientific study report. As such, they do not present detailed scientific study methods, acceptance criteria with numerical targets, or study results in the manner one would find in a peer-reviewed publication or a detailed clinical trial report. The 510(k) process primarily demonstrates substantial equivalence to predicate devices, focusing on similar intended use, technological characteristics, and safety/effectiveness profiles, rather than rigorously proving performance against pre-defined numerical thresholds in a clinical study.
Therefore, many of the requested details about specific acceptance criteria and study methods are either not explicitly stated or not applicable in the context of the provided materials.
Analysis of Biosaca Device Information
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided 510(k) summary does not contain specific, quantitative acceptance criteria or detailed device performance metrics typically found in a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.
| Acceptance Criterion (Hypothetical for a typical performance study) | Reported Device Performance (Based on provided documentation) |
|---|---|
| Accuracy of Bioparameter Recording | The device is stated to be "a biological signal recorder able to receive and record up to 22 bioparameters" including EEG, ECG, EMG, EOG, blood pressure, breathing, and body movements. The 510(k) process suggests the device is considered substantially equivalent to predicate devices (Compumedics Sleep Monitoring System, Embla) for these recording functions, implying comparable accuracy. No specific numerical accuracy metrics (e.g., % agreement, sensitivity, specificity, measurement error) are provided. |
| Functional Equivalence to Predicate Devices | The core acceptance was FDA's determination of "substantial equivalence" to predicate devices (Compumedics Sleep Monitoring System, K955841; Embla, K971813) for the stated indications for use (recording, monitoring, display, print, store, and transfer bioparameters like brain, heart, muscle activity, eye movement, blood pressure, breathing, and body movements, for sleep monitoring, neurological disorder, and epilepsy investigations). This implies that its functionality and safety are comparable to these already marketed devices. No specific functional performance test results are included. |
| Safety | The device is not intended for life support and is suitable for home use, with minimal patient interaction and no confusing lights or sounds. The FDA clearance implies that the device has met general controls provisions related to safety (e.g., manufacturing practice, labeling). No direct safety study results or adverse event rates are reported in this summary. |
| Usability/Ease of Use (for home use) | "The equipment is suitable for home use as the patient needs only a minimal amount of training and it has no lights or sounds that could confuse the patient." This is a qualitative statement of intent and design, acting as an implicit "acceptance criterion." No formal usability study results are provided. |
| Compatibility/Interoperability | Accepts inputs from "two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad." This indicates its compatibility with standard physiological sensors. No specific compatibility test results (e.g., data format validation, signal integrity from different sensors) are detailed. |
| Regulatory Compliance | The FDA's substantial equivalence determination itself is the primary evidence that the device meets regulatory "acceptance criteria" for marketing in the US, subject to general controls. The letter confirms compliance with various regulatory requirements (e.g., registration, listing, manufacturing practice, labeling). No specific test results demonstrating compliance with particular standards (e.g., electrical safety, EMC) are listed here, though such testing would typically be part of a 510(k) submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The provided documents describe device characteristics and regulatory equivalence, not a clinical study involving a test set with human subjects.
- Data Provenance: Not applicable in the context of the provided text, as no specific test set data is presented. The 510(k) relies on comparison to predicate devices, which would have had their own historical data supporting their market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No specific test set with ground truth established by experts is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied by the provided documents. The Biosaca is a signal recorder, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: Not explicitly described as a formal study. The device itself performs data recording functions. Its "standalone" performance would relate to its ability to accurately capture and store bioparameters. The substantial equivalence determination suggests that its recording capabilities are comparable to predicate devices. However, no specific performance metrics from such a study are provided.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No specific ground truth for a performance study is described. The device's "ground truth" would be the actual physiological signals themselves, and the device's performance would be assessed by how accurately it records these signals. This level of detail is not in the provided documents.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Biosaca is a hardware device for recording physiological signals. It does not appear to utilize machine learning or AI algorithms that would require a "training set" in the conventional sense. Its functionality is based on established electronics and signal processing principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.
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