(12 days)
The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.
Not Found
The provided text is a 510(k) premarket notification approval letter for the A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure Monitors. This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical study report or a more technical submission.
Therefore, I cannot directly extract the detailed information requested in the prompt. The document explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This implies that the device's performance was compared to a predicate device, but the specifics of that comparison, including acceptance criteria and study details, are not present in this regulatory letter.
Based on the provided text, the following information is either not present or cannot be determined:
- A table of acceptance criteria and the reported device performance: Not available. The letter only states that the device is "substantially equivalent" to a predicate, not specific performance metrics or acceptance criteria for those metrics.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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. This device is an ambulatory blood pressure monitor, not an AI-powered diagnostic imaging tool, so MRMC studies in this context are irrelevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but as a blood pressure monitor, its "standalone" performance is its core function. No algorithm-only performance in the context of interpretation is mentioned.
- The type of ground truth used: Not available. For a blood pressure monitor, the "ground truth" would typically refer to a validated reference method for blood pressure measurement, but this is not detailed in the letter.
- The sample size for the training set: Not applicable and not available. As an oscillometric blood pressure monitor, it uses a physiological algorithm rather than a machine learning "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable and not available.
Information that can be inferred or is directly stated (but does not fulfill the core request):
- Indications for Use: The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.
- Regulatory Class: Class II (Two)
- Product Code: 74 DXN
- Device Type: Ambulatory Blood Pressure Monitors
To answer the questions posed, the relevant document would be the detailed 510(k) submission itself or a clinical validation report, which would describe the testing protocols and results against recognized standards (e.g., AAMI, BHS protocol for blood pressure monitors) that define acceptance criteria.
§ 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).