(6 days)
The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
Not Found
The provided text is an FDA 510(k) clearance letter for the Ivy Biomedical Model 3000 Patient Monitor. It does not contain the detailed information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) summary typically includes a brief description of the device, its intended use, a comparison to a predicate device, and a summary of performance data (often in the form of a statement of substantial equivalence). However, it generally does not provide the granular technical details or study methodologies you're asking for.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This heavily implies that the clearance was based on demonstrating equivalence to an existing device, rather than a novel study with specific acceptance criteria that would then be detailed.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size used for the test set and data provenance: Not present.
- Number of experts used to establish ground truth and qualifications: Not present.
- Adjudication method: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size: Not present.
- Standalone (algorithm only) performance: Not explicitly discussed, as this is a patient monitor, not an AI algorithm in the context you're suggesting.
- Type of ground truth used: Not present.
- Sample size for the training set: Not present (and likely not applicable in the context of this type of device and clearance).
- How the ground truth for the training set was established: Not present.
The only information that can be extracted related to the device and its use is from the "Indications for Use Statement" (Attachment 3):
- Device Name: Ivy Biomedical Model 3000
- Indications for Use: "The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring."
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).