(93 days)
ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer)
When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS 1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management.
The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results.
The device provides values. It is the physician responsibility to make proper judgment based on these numbers.
The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.
Prescription Use X
ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).
When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management.
The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results.
The device provides values. It is the physician responsibility to make proper judgment based on these numbers.
The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.
{
"acceptance_criteria_study": {
"1_acceptance_criteria_and_performance_table": [
{
"Criterion": "Data management",
"Acceptance Criteria Met?": "YES",
"Reported Device Performance": "YES"
},
{
"Criterion": "Historical test results",
"Acceptance Criteria Met?": "YES",
"Reported Device Performance": "YES"
},
{
"Criterion": "Operating system",
"Acceptance Criteria Met?": "Windows",
"Reported Device Performance": "Windows"
},
{
"Criterion": "Results screen",
"Acceptance Criteria Met?": "PC",
"Reported Device Performance": "PC"
},
{
"Criterion": "Displayed data",
"Acceptance Criteria Met?": "SpO2%, HRV analysis, photoelectrical Plethysmography analysis, conductance values, body composition and Blood pressure.",
"Reported Device Performance": "SpO2%, HRV analysis, photoelectrical Plethysmography analysis, conductance values, body composition and Blood pressure."
},
{
"Criterion": "Data acquisition",
"Acceptance Criteria Met?": "Direct acquisition and/or upload from the device",
"Reported Device Performance": "Direct acquisition and/or upload from the device"
},
{
"Criterion": "Data analysis",
"Acceptance Criteria Met?": "Memory",
"Reported Device Performance": "Memory"
},
{
"Criterion": "Data analysis (other entry)",
"Acceptance Criteria Met?": "YES",
"Reported Device Performance": "YES"
},
{
"Criterion": "Indication for use",
"Acceptance Criteria Met?": "clinical settings",
"Reported Device Performance": "clinical settings"
}
],
"2_sample_size_and_data_provenance_test_set": "The provided document is a 510(k) summary for a software device (ANS1 Software). It describes the software's intended use and compares it to a legally marketed predicate device (ES Complex Software). The focus of this submission is to demonstrate substantial equivalence based on the software's data management capabilities and functionalities, rather than a clinical performance study with a 'test set' in the traditional sense of diagnostic accuracy. Therefore, information on sample sizes for a test set and data provenance (country of origin, retrospective/prospective) for a clinical performance study are not applicable or provided in this regulatory document. The submission relies on software verification and risk management.",
"3_number_and_qualifications_of_experts_ground_truth": "The document describes a Special 510(k) submission for software, focusing on safety and effectiveness through comparison to a predicate device and software verification. It does not mention the establishment of ground truth by human experts for a performance study. Clinical judgment remains with the physician, who is intended to review, analyze, and evaluate the historical test results provided by the software. Therefore, the concept of experts establishing ground truth for a test set is not applicable here.",
"4_adjudication_method_test_set": "The nature of this 510(k) submission (software for data management, not a diagnostic algorithm) does not involve a clinical performance study requiring adjudication of a test set. The document focuses on demonstrating substantial equivalence to a predicate device and fulfilling software verification requirements. Thus, no adjudication method is described or relevant.",
"5_mrmc_comparative_effectiveness_study": "No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned or appears relevant to this 510(k) summary. The device is a data management software, not a diagnostic aid that directly impacts human reader performance in interpreting images or clinical signals where an 'AI vs without AI assistance' effect size would be measured.",
"6_standalone_performance_study": "This 510(k) is for a data management software. While 'software verification' is mentioned, a standalone performance study in the context of diagnostic accuracy (i.e., algorithm-only performance without human-in-the-loop) is not described. The software's function is to upload, analyze, and display data from other cleared devices for healthcare professionals to review. Its 'performance' is assessed through data management capabilities and software specifications, not typically through standalone diagnostic accuracy metrics.",
"7_type_of_ground_truth_used": "Given that the device is data management software and not a diagnostic algorithm, the concept of 'ground truth' in the context of clinical pathology or outcomes data is not directly applicable. The 'ground truth' for this type of submission lies in the accurate processing and display of data generated by associated cleared medical devices (TM-Oxi, SudoPath, ES-BC). The 'truth' of the data itself originates from these input devices, and the software's role is to manage and present it reliably.",
"8_sample_size_training_set": "As this is a 510(k) for data management software rather than a machine learning or AI algorithm involving a 'training set' in the typical sense, information on a sample size for a training set is not provided or applicable. The software's functionality is based on established data processing and display, not on learning from a dataset.",
"9_how_ground_truth_for_training_set_was_established": "Since the device is data management software and not an AI/ML algorithm that undergoes a training phase, there is no 'training set' or 'ground truth for a training set' to establish. The document focuses on software verification and comparison to a predicate device's functionalities."
}
}
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).