(253 days)
The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.
The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.
Here's an analysis based on the provided document regarding the acceptance criteria and study for the Bidop 7:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical study data for establishing sensitivity, specificity, or detailed performance metrics against a clinical ground truth for a novel AI/ML device. The "study" here refers to the testing performed to demonstrate compliance with standards and equivalence to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study. Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration of substantial equivalence to a predicate device (Smartdop 45, K050601).
| Acceptance Criteria (Implied by Regulatory Compliance & Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Safety: | - Designed to meet IEC 60601-1 (Medical electrical equipment 2007) |
| Electrical Safety | - Designed to meet IEC 60601-1-2 (Electromagnetic compatibility 2007) |
| Electromagnetic Compatibility | - Designed to meet IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2007-08) |
| Ultrasonic Safety & Performance | - Designed to meet FDA Marketing Clearance of Diagnostic Ultrasound Systems and Transducers guidance. |
| Diagnostic Ultrasound Equivalence | - Designed to meet ISO 14971 (Application of risk management to medical devices 2007-10-01). |
| Risk Management | - Designed to meet FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices guidance. |
| Cybersecurity | - "The conclusion drawn from these tests is that the Bidop 7 non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device." |
| Efficacy/Performance: | - Qualitative information: Color visual display of waveform shapes (PPG, Doppler). |
| Qualitative Display | - Quantitative information: Aid in obtaining systolic segmental blood pressures (ABI, TBI), additional quantitative measurements for Doppler blood flow velocity waveforms. |
| Quantitative Measurement Accuracy | - Detection of arterial and venous blood flow in the extremities, and fetal heart sounds. |
| Intended Use Performance | - Displays bi-directional velocity waveforms, numerical data, and fetal heart rate with heartbeat indicator. |
| Display Features | - Operated with 2, 5, 8, and 10 MHz probes. |
| Probe Compatibility | - "The general method of device construction and technology are identical" to the predicate (Smartdop 45, K050601), with the only noted difference being the absence of an integrated printer in the Bidop 7. |
| Substantial Equivalence to Predicate | - "Bidop 7 non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device." |
| Software Life Cycle: | - Designed to meet IEC 62304 (Medical device software – Software life cycle processes 2006-05). |
| Software Development Compliance |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of an efficacy study with a specified sample size or data provenance (e.g., country of origin, retrospective/prospective). The testing described relates to engineering and regulatory compliance with standards, and comparison to the predicate device in terms of technology and indications for use. No patient data or clinical study data is detailed for an independent test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication method is described.
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
Not applicable. The Bidop 7 is a cardiovascular blood flowmeter, not an AI-assisted diagnostic imaging device for which MRMC studies comparing human readers with and without AI assistance would typically be conducted. The document does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Bidop 7 is a medical device that produces diagnostic information (waveforms, numerical data, fetal heart rate) for interpretation by a human clinician. It is not an algorithm performing a standalone diagnostic task without human involvement. The document describes laboratory and engineering tests for compliance with standards and equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in AI/ML performance evaluation (e.g., against pathology or clinical outcomes) is not discussed in this 510(k) summary. The comparison is primarily against specifications in standards and the performance characteristics of an existing predicate device. The underlying principle of operation (Doppler effect, photoplethysmography) itself is the "truth" that the device is designed to measure.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product developed with training data.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML product developed with training data.
Summary of the Study (as described in the document):
The "study" presented in this 510(k) summary primarily consists of engineering verification and validation testing to ensure the Bidop 7 complies with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971) and FDA guidance for ultrasound systems and cybersecurity. The core of the submission demonstrates substantial equivalence to the predicate device, the Smartdop 45 (K050601), rather than a de novo clinical efficacy study. The document asserts that the general method of device construction and technology are identical, leading to the conclusion that the Bidop 7 is equivalent in safety and efficacy. No clinical trial data or performance metrics on a patient cohort are provided here; the focus is on technical compliance and equivalence.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).