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Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.

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

Therefore, I cannot provide the requested table and details based on the input document. The document primarily focuses on the regulatory clearance process and states that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't necessitate new clinical study data for FDA clearance in this instance.

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Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel. The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").

H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BM

I'm sorry, but without further documentation in your provided text beyond this 510(k) summary, I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the only thing provided is a letter from the FDA regarding a particular device. This letter does not contain information on acceptance criteria, device performance, study details, ground truth establishment, or training set specifics.

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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").

H&L Full Automatic (NIBP) Blood Pressure Monitor

The provided text is a 510(k) premarket notification letter from the FDA for a non-invasive blood pressure measurement system (HL888BA). It confirms substantial equivalence but does not contain details about specific acceptance criteria, study design, or performance metrics beyond the general function of measuring blood pressure and heart rate.

Therefore, most of the requested information cannot be extracted from the given document.

Here's what can be gathered, and what cannot:

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

• Cannot be determined from the provided text. The document states the device measures systolic, diastolic blood pressure, and heart rate, but it does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.

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

• Cannot be determined from the provided text.

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)

• Not applicable/Cannot be determined from the provided text. This type of device (non-invasive blood pressure monitor) typically does not rely on expert consensus for "ground truth" in the same way an imaging AI device would. Its accuracy is usually validated against a reference standard (e.g., a mercury sphygmomanometer) and not expert interpretations.

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

• Not applicable/Cannot be determined from the provided text. No adjudication method would be relevant for this type of device's validation.

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

• Not applicable/Cannot be determined from the provided text. This is a standalone diagnostic device. There is no "human reader" component or AI assistance involved in the measurement process itself.

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

• Yes, implicitly. A blood pressure monitor fundamentally operates as a standalone device to measure blood pressure and heart rate. Its performance evaluation would be based on its ability to accurately measure these parameters without human interpretation during the actual measurement. However, the results of such a study are not provided.

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

• Cannot be determined from the provided text. For a blood pressure monitor, the ground truth would typically be established by a validated reference method, such as a mercury sphygmomanometer or an invasive arterial line, which is then used to compare the device's readings. The document does not specify this.

8. The sample size for the training set

• Not applicable/Cannot be determined from the provided text. This is a non-AI medical device; therefore, there isn't a "training set" in the context of machine learning. The device is based on established oscillometric principles.

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

• Not applicable. See point 8.

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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BF. Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888BF). It does not contain any information regarding acceptance criteria, study details, or performance data for the device.

Therefore, I cannot extract the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Ask a specific question about this device

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor

This document is a 510(k) clearance letter for a non-invasive blood pressure measurement system, the HL888AF. It does not contain the detailed study results, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.

Here's what can be inferred and what is missing:

Based on the nature of a 510(k) submission for a non-invasive blood pressure monitor, the acceptance criteria and study would typically revolve around accuracy and precision compared to a reference method.

Information that CANNOT be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not present in the clearance letter. For a blood pressure monitor, acceptance criteria would typically involve mean difference and standard deviation of differences when compared to a reference measurement (e.g., intra-arterial measurement or a validated oscillometric device), often following standards like ISO 81060-2.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a blood pressure monitor, as physical measurements are the ground truth, not expert interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a diagnostic device that outputs a numerical reading, not an image interpreted by multiple readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is standalone in terms of generating the blood pressure reading. The "human-in-the-loop" here is the user applying the cuff and reading the display. The performance study would evaluate the device's accuracy in producing these readings.
7. The type of ground truth used: While not explicitly stated, for a NIBP device, the ground truth would typically be established by a reference measurement method, often intra-arterial blood pressure monitoring or simultaneous measurement with another independently validated oscillometric device, as per relevant standards (e.g., ISO 81060-2).
8. The sample size for the training set: Not applicable based on the information provided. For blood pressure monitors, while there might be internal algorithm development, the "training set" concept isn't typically discussed in the same way as for AI/machine learning models in image analysis. The validation is against a reference method.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred:

• The device being cleared is a "Non-invasive blood pressure measurement system" (HL888AF).
• It measures "Systolic, Diastolic blood pressure and heart rate using the oscillometric method."
• It is an "over-the-counter device" intended for "adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6")."
• The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This implies that the performance data submitted (though not included here) met the generally accepted standards for NIBP monitors and demonstrated comparable safety and effectiveness to the predicate.

To get the specific details of the acceptance criteria and the study, you would need to access the full 510(k) submission (K032913), which is usually available through the FDA's public records, though often requires a Freedom of Information Act (FOIA) request for the complete documentation.

Ask a specific question about this device

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888RA

The provided text is a 510(k) premarket notification decision letter from the FDA to Health & Life Corporation, Ltd. for their HL888RA noninvasive blood pressure measurement system. The document confirms that the device is substantially equivalent to legally marketed predicate devices and is approved for market.

Crucially, the acceptance criteria and the study proving the device meets those criteria are not detailed in this document. This letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the specific information requested about the acceptance criteria or the study from the provided text.

The document does offer some general information about the device and its intended use:

• Device Name: H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name: HL888RA
• Regulation Name: Noninvasive blood pressure measurement system
• Method: Measures Systolic, Diastolic blood pressure and heart rate using the oscillometric method.
• Intended Use: For adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").
• Type of Use: Over-the-counter use.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the 510(k) submission itself which would contain the performance data and acceptance criteria used for substantial equivalence.

Ask a specific question about this device

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888JF

This document is a 510(k) premarket notification approval letter for the HL888JF Non-invasive Blood Pressure Measurement System. It is an approval letter and does not contain detailed information about acceptance criteria or the specific study details that would prove a device meets acceptance criteria.

The letter acknowledges that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device meets the regulatory requirements for safety and effectiveness similar to already approved devices, but the letter does not present the specific acceptance criteria or the detailed study results used for that determination.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory approval and classification of the device rather than the technical details of its performance testing.

Ask a specific question about this device

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the device name, trade name, indications for use, and regulatory information, but it does not detail performance acceptance criteria or the results of a study.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study.

Ask a specific question about this device

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel . . . : ー The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888HA. Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888HA). It does not contain a study report or detailed information about the acceptance criteria and performance of the device beyond its classification and indication for use. Therefore, I cannot provide the requested information about the study that proves the device meets specific acceptance criteria based on this document.

The document indicates:

• Device Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (Trade Name: HL888HA)
• Regulation Number: 21 CFR 870.1130 (Non-invasive Blood Pressure Measurement System)
• Regulatory Class: Class II
• Indications For Use: Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. Intended for adult patients whose arm circumference is between 24-32 cm.

To answer your request, a separate study report or a more detailed submission document (which is not provided) would be needed.

Ask a specific question about this device

Measures automatically human's Systolic , Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.

The intended for use of this over-the-counter device is for adult patients with arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

Not Found

The provided text is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL 888). It does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology referenced in your numbered list.

The letter primarily addresses the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines general compliance requirements but does not provide performance metrics or details of any clinical or technical study conducted to support the claim.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not present.
4. Adjudication method: Not present.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not present.
6. Standalone performance: Not present.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document is a regulatory communication, not a technical report or study summary.

Ask a specific question about this device