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Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.

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This is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory clearance based on substantial equivalence to a predicate device. It does not contain the detailed performance study results that would typically be present for an AI/ML device or a novel medical device requiring extensive clinical trials to prove its performance against acceptance criteria.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types. These types of details are not typically found in a 510(k) clearance document for a device like a blood pressure monitor, which usually relies on established standards and bench testing.

The document confirms the following:

• Device Name: Rossmax Automatic Blood Pressure Monitor, Model MO701k
• Intended Use: To measure systolic, diastolic, and pulse rate for adult individuals in a home environment.
• Regulatory Classification: Class II (two), Product Code DXN.

To answer your prompt thoroughly, I would need a different type of document, such as a detailed clinical study report or a dedicated performance evaluation report for the device.

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S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate. The cuff circumference is 13.5~22cm for adult individual in a home environment.

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While the provided text describes the FDA's clearance of the Rossmax S380 and K350 Blood Pressure Monitors (K052727), it does not contain the detailed information required to fulfill your request regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document is a clearance letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for market entry, but it does not intrinsically detail the technical performance studies and their specific results that led to this determination.

Here's a breakdown of why I cannot provide the requested information from this document:

• No Acceptance Criteria Table or Reported Performance: The document is a regulatory approval letter, not a performance study report. It does not list specific acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or the actual performance metrics achieved by the device in testing.
• No Information on Sample Size, Data Provenance, Experts, or Adjudication: These details are typically found in the clinical or performance study reports submitted to the FDA, which are not part of this clearance letter.
• No MRMC, Standalone, or Ground Truth Details: The document does not discuss MRMC studies, standalone algorithm performance, or how ground truth was established for any testing.
• No Training Set Information: Similarly, details about the training set size or how its ground truth was established would be in a technical report, not an FDA clearance letter.

To obtain the information you're looking for, you would typically need to:

1. Access the full 510(k) submission: Sometimes, the FDA makes portions or summaries of 510(k) submissions publicly available. These often include more detailed information about performance testing.
2. Refer to the manufacturer's documentation: The device's official instructions for use or technical specifications would likely contain greater detail on its performance claims and the standards it meets.
3. Look for published clinical studies: If the device has been the subject of independent clinical research, those papers would contain the requested methodological details.

In summary, the provided FDA clearance letter K052727 confirms the market approval of the Rossmax S380 and K350 Blood Pressure Monitors but does not contain the specific performance study details, acceptance criteria, or methodological information you requested.

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The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")

Rossmax Automatic Blood Pressure Monitor, model CardioCare 1000i

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request using only the provided text. The document confirms that the device, Rossmax Automatic Blood Pressure Monitor, Model CardioCare 1000i, is substantially equivalent to legally marketed predicate devices for measuring systolic, diastolic, and pulse rates in adults with a specific arm circumference. However, it does not detail the technical studies or their results that would underpin this equivalence.

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Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.

Not Found

This FDA 510(k) clearance letter for the Rossmax MediPro Model 100f, 200f, and 300f Blood Pressure Monitors does not contain the detailed information required to fulfill the request. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device and does not provide specifics about the acceptance criteria, study methodology, or performance data.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This type of detailed study information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

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Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Rossmax MediPro Model 10 and 60, and MediCare Model 10 and 60 Blood Pressure Monitors. This type of document does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulation name, regulatory class, and product code. It also includes an "Indications for Use Statement" which specifies that the devices are "Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment."

To answer the requested questions, one would need to review the actual 510(k) submission (which is typically a much larger document than this clearance letter) or the clinical study reports submitted as part of that application. The clearance letter itself does not provide the specific performance data or study methodology.

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Ask a specific question about this device

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To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Rossmax Automatic Wristwatch Blood Pressure Monitor, model ZA3

The provided text is a 510(k) clearance letter from the FDA for the "Rossmax Automatic Wristwatch Blood Pressure Monitors, Z-series." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

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To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Rossmax Automatic Wristwatch Blood Pressure Monitor. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed study information typically requested for AI/ML device performance.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document. The device in question is a traditional medical device (blood pressure monitor), not an AI/ML powered device, so concepts like "training set," "AI without human-in-the-loop," and "MRMC comparative effectiveness study" are not applicable.

Here's a breakdown of what can be gleaned:

1. A table of acceptance criteria and the reported device performance

The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision) for the device. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device's performance is deemed acceptable because it meets the same standards as existing devices on the market.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. For a blood pressure monitor, the "ground truth" would typically come from a reference standard (e.g., a mercury sphygmomanometer following specific protocols), not expert consensus in the way it's used for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

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

No such study was conducted or mentioned, as this is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as it is a physical blood pressure monitoring device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

While not explicitly stated, for a blood pressure monitor, the ground truth would typically be established using a reference standard measurement device (e.g., a mercury sphygmomanometer) in a controlled clinical setting, adhering to validated measurement protocols.

8. The sample size for the training set

This information is not available in the provided document. This device does not use an AI/ML training set.

9. How the ground truth for the training set was established

This information is not available in the provided document, as it's not an AI/ML device with a training set.

In summary, the provided FDA 510(k) letter confirms that the Rossmax Automatic Wristwatch Blood Pressure Monitor (model Z44) has been found substantially equivalent to a predicate device for measuring systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. The device is limited to patients over 18 years old with a wrist circumference between 5.3 to 7.7 inches. However, the document does not contain the detailed study design and performance metrics typically associated with AI/ML device evaluations.

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