(87 days)
The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients in hospitals, medical facilities, and subacute environments.
The Tango M2, a microprocessor based blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango M2 has the ability to make blood pressure and saturation measurements at predetermined intervals (normally from a schedule determined by the physician), or on demand. Additionally, the TangoM2 has the ability to make an Oscillometric blood pressure determination at the command of the operator while the patient is stationary.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SunTech Medical Tango M2 Blood Pressure Monitor:
Unfortunately, the provided text does not contain the detailed acceptance criteria or the specific study results that comprehensively prove the device meets these criteria in the format requested. The document is primarily a 510(k) summary for a Special 510(k) submission, focusing on establishing substantial equivalence for a modified device rather than presenting a de novo performance study.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text. The document states that the Tango M2 has been tested to applicable standards and requirements, and these tests "have indicated passing results," but it does not specify what those acceptance criteria were for blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method) or the actual results achieved.
2. Sample size used for the test set and the data provenance:
This information is not provided. The 510(k) summary does not detail a specific clinical test set for performance validation, as it is a Special 510(k) based on modifications to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As no detailed performance study is presented, there's no mention of experts establishing a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This is not applicable to this device. The Tango M2 is a blood pressure monitor, not an AI-assisted diagnostic imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone blood pressure monitor ("algorithm only" in the sense that it automatically determines blood pressure). However, the document does not present a standalone performance study with specific results. It references "Korotkoff sounds to determine blood pressure," which is the underlying method, but no detailed performance numbers are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the provided document. For blood pressure monitors, the "ground truth" during validation typically involves a reference standard method like invasive arterial line measurements or auscultation by trained observers (often two observers blinded to each other's readings and the device reading), following protocols like ISO 81060-2. The document infers a reliance on established methods by stating "uses Korotkoff sounds to determine blood pressure," which is a standard method for reference.
8. The sample size for the training set:
This information is not applicable and not provided. Blood pressure monitors using Korotkoff sounds are typically based on established physiological principles and signal processing, not on machine learning models requiring extensive "training sets" in the modern AI sense.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the reasons mentioned above.
Summary of available information:
The document states that the Tango M2 is a non-invasive blood pressure monitor that uses Korotkoff sounds and an optical finger sensor for oxygen saturation. It measures and displays systolic and diastolic blood pressure, and optionally SpO2, for adult patients during cardiac or exercise stress testing under physician supervision.
The basis for regulatory acceptance is substantial equivalence to predicate devices (Tango+ K053209 and Tango K970629). The crucial statement regarding performance is: "The Tango M2 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The listed standards are:
- IEC 60601-1:2005: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2007: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
While these standards cover safety and EMC, they don't explicitly define blood pressure measurement accuracy acceptance criteria (which would typically be covered by standards like ISO 81060-2 or AAMI SP10). The document implicitly relies on the fact that the specifications and measurement ranges are the same as the predicate devices, which were previously cleared based on their performance.
In conclusion, this 510(k) summary provides evidence of safety and EMC compliance and asserts substantial equivalence, but it does not present a detailed performance study with specific acceptance criteria and outcome data as you've requested for a new device's performance validation.
§ 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).