(331 days)
The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.
The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.
The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.
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I apologize, but the provided text from the FDA 510(k) summary for the Ivy Biomedical Systems, Inc. 7810 Cardiac and Respiratory Synchronization Monitor does not contain the specific details required to answer your full request regarding acceptance criteria and study design.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but it does not include a detailed scientific study, acceptance criteria, or performance metrics from such a study for the device itself.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- 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, and the effect size: Not available. This type of study is typically for AI-assisted diagnostic tools, and the 7810 monitor is described as a basic cardiac monitor providing trigger pulse outputs for third-party systems.
- If a standalone performance study was done: While the FDA clearance implies some testing was done to demonstrate substantial equivalence, the details of such a standalone performance study (including specific metrics and acceptance criteria) are not in this document.
- The type of ground truth used: Not available.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
What the document does tell us:
- Device Name: 7810 Cardiac and Respiratory Synchronization Monitor
- Intended Use: "The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization."
- Patient Population: Pediatric and adult patients undergoing diagnostic imaging and related procedures. The "Patient Population" section further states it's for "adult, geriatric, pediatric and neonatal patients."
- Contraindications: Not for life support, home monitoring, or MRI environment. Also, not for performing cardiac diagnostics.
To obtain the detailed performance data, acceptance criteria, and study information you're looking for, you would typically need to consult the complete 510(k) submission, the device's user manual, or scientific publications from the manufacturer (if any R&D studies were published). The provided document is merely the FDA's clearance letter.
§ 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).