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HL888V is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

HL868JM is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

Both HL888V and HL868JM are manual inflate type blood pressure monitors for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of the over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 ~13 inches (approx.23cm-33cm) and for home use.

HL868JM features a Risk Category Indicator additionally. After measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Here's a summary of the acceptance criteria and study information for the Full Automatic (NIBP) Blood Pressure Monitor, Models HL888V and HL868JM, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The devices (HL888V and HL868JM) were found to be compliant with the ANSI/AAMI SP-10:2002+ A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers. This standard likely sets the specific acceptance criteria for blood pressure monitor accuracy. The 510(k) summary references the predicate device's accuracy which is assumed to be the target for the new devices.

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided document. The statement "All the relevant activities were performed by designate individual(s)" suggests a clinical study was conducted. However, the exact number of participants is not disclosed.
• Data Provenance: Not explicitly stated. Given that the manufacturer is Health & Life Co., Ltd. from Taiwan, R.O.C., the study might have been conducted in Taiwan, but this is not confirmed. The document does not specify whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves comparison against a reference standard, often conducted by trained technicians or clinicians, but details on the number and qualifications of experts are not provided in this summary.

4. Adjudication method for the test set:

• Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for measurement and comparison, which would inherently include methods for handling discrepancies, but the specific adjudication method is not mentioned.

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:

• A MRMC comparative effectiveness study was not performed. This device is a standalone blood pressure monitor and does not involve AI assistance or human readers for diagnostic interpretation.

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

• Yes, a standalone performance evaluation was done. The study was conducted to demonstrate the accuracy of the blood pressure monitor itself in accordance with the ANSI/AAMI SP-10 standard. The device's oscillometric method is an algorithm that processes pressure oscillations to determine blood pressure values without human intervention in the measurement process.

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

• The ground truth would have been established by comparing the device's measurements against a recognized reference standard for blood pressure measurement, typically auscultatory measurement by trained observers using a mercury sphygmomanometer or an equivalent validated non-invasive method, as prescribed by the ANSI/AAMI SP-10 standard.

8. The sample size for the training set:

• Not applicable. As a medical device that does not employ machine learning or AI models with a "training set" in the computational sense, there is no training set sample size to report. The device's underlying oscillometric algorithm is a classic engineering principle, not a trained AI model.

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

• Not applicable, as there is no training set in the context of this device's technology.

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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.

Not Found

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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Measures automatically human beings 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 24cm-44cm (approx. 9.4" to 17.5").

Not Found

Please note: The provided document is a 510(k) clearance letter from the FDA. It does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methods, MRMC studies, etc.) that would typically be found in a submission or a clinical study report. The letter confirms that the device, an H&L Full Automatic (NIBP) Blood Pressure Monitor, has been found substantially equivalent to a predicate device.

Therefore, the following response will indicate where information is not present in the provided document.

Acceptance Criteria and Study Details for H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM)

The provided FDA 510(k) clearance letter (K050587) confirms that the H&L Full Automatic (NIBP) Blood Pressure Monitor is substantially equivalent to a predicate device. However, this letter does not contain the specific acceptance criteria or the detailed description of the study that demonstrated the device met these criteria.

To provide a hypothetical example of what such information might look like for a non-invasive blood pressure (NIBP) monitor, and based on common regulatory and industry standards like ISO 81060-2 (which specifies requirements for clinical validation of NIBP devices), the following sections are structured to show what would typically be expected in a complete submission.

1. Table of Acceptance Criteria and Reported Device Performance

(This information is NOT present in the provided 510(k) clearance letter. The table below provides an example of typical acceptance criteria for a non-invasive blood pressure monitor based on standards like ISO 81060-2, and hypothetical performance values.)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): This information is not provided in the 510(k) clearance letter.

  • (Hypothetical Example based on ISO 81060-2: Typically, a clinical validation study for an NIBP device would require a minimum of 85 participants for accuracy testing, with careful consideration for age, gender, arm circumference, and blood pressure ranges to ensure a representative sample.)

• Data Provenance: This information is not provided in the 510(k) clearance letter.

  • (Hypothetical Example: "Prospective data collected at a single clinical site in Taiwan. Participants were recruited based on inclusion/exclusion criteria to ensure a diverse range of blood pressures and arm circumferences.")

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: This information is not provided in the 510(k) clearance letter.

  • (Hypothetical Example based on NIBP validation standards: Typically, two trained observers are used for simultaneous auscultatory measurements to establish reference blood pressure. These observers are trained and certified according to specific protocols.)

• Qualifications of Experts: This information is not provided in the 510(k) clearance letter.

  • (Hypothetical Example: "Two independent, trained and certified observers, typically nurses or clinical technicians, experienced in auscultatory blood pressure measurement. They underwent specific training and demonstrated proficiency and inter-observer reliability prior to the study, using a mercury sphygmomanometer with a Y-tube and dual stethoscope.")

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not provided in the 510(k) clearance letter.
  • (Hypothetical Example based on NIBP validation standards: For reference auscultatory blood pressure, the average of the two trained observers' readings is typically used, provided their readings are within a pre-defined tolerance (e.g., within 4 mmHg). If the difference exceeds this tolerance, a third observer might be used, or the measurement might be discarded.)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: This type of study is typically performed for imaging devices where human interpretation is a key component, often comparing AI-assisted reading to unassisted reading. For a non-invasive blood pressure monitor, an MRMC study is not applicable as the device provides a direct measurement, not an interpretation of a complex image or signal requiring human-in-the-loop assessment in the same way. The validation focuses on the accuracy of the device's measurement compared to a reference standard.
  • Therefore, no MRMC study was done or is relevant for this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: For a non-invasive blood pressure monitor, the "standalone performance" refers to the accuracy of the device's measurement itself, without human intervention in the measurement process (beyond proper setup). The clinical validation study (as described hypothetically in section 1 and 2) is precisely a standalone performance assessment. The device measures blood pressure automatically and displays the result.
  • Therefore, yes, a standalone performance study (i.e., the clinical validation study) was done to demonstrate the accuracy of the device's automatic measurements against a reference standard. The results would be compared against the acceptance criteria.

7. The Type of Ground Truth Used

• Type of Ground Truth: This information is not provided directly in the 510(k) clearance letter, but for NIBP devices, there's a standard method.
  • (Hypothetical Example based on NIBP validation standards: The ground truth would be established by simultaneous, independent, trained-observer auscultatory measurements using a mercury sphygmomanometer (or an appropriately validated non-mercury reference device) with a bifurcated stethoscope, following strict protocol guidelines (e.g., those from ISO 81060-2 or AAMI). This method provides a "clinical reference standard".)

8. The Sample Size for the Training Set

• Training Set Sample Size: This information is not provided in the 510(k) clearance letter.
  • For a device like this, the "training set" might refer to data used for algorithm development and calibration during the R&D phase. This is typically internal data not submitted as part of the 510(k) clinical validation study. The 510(k) focuses on the final, locked algorithm evaluated on an independent test set.
  • Therefore, the concept of a "training set" sample size for the regulatory submission of an NIBP device's clinical performance is not directly applicable in the same way it would be for an AI/ML product where the model is continuously learned from data. The clinical validation uses a test set for the final device.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth: As explained above, for an NIBP monitor, the concept of a formally established "ground truth" for a "training set" in the context of a regulatory submission is not typically relevant. The device's algorithm for detecting oscillometric pulses and deriving SBP/DBP is developed using engineering principles and internal validation data during development.
  • If any internal "training" or calibration data were used, the ground truth would likely have been established through a similar process as the clinical validation (i.e., comparison to reference auscultatory measurements) but for internal development and optimization purposes rather than regulatory demonstration of safety and effectiveness.
  • This information is not provided and generally not required in a 510(k) for this type of device.

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Measures automatically human beings 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 24cm-44cm (approx. 9.4" to 17.5").

Not Found

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to fulfill the request regarding acceptance criteria and study descriptions.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
5. Information about a standalone (algorithm only) performance study.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
7. The sample size for the training set.
8. How the ground truth for the training set was established.

The document primarily focuses on the regulatory clearance for the device, stating its indications for use and confirming its substantial equivalence to a predicate device. It briefly mentions that the device "Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method," but it does not provide performance metrics, study details, or acceptance criteria.

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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 24-44cm (approx. 9.4" to 17.5").

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.

This looks like a 510(k) clearance letter for a non-invasive blood pressure monitor. Such letters generally do not contain detailed information about acceptance criteria or specific study results as they primarily confirm substantial equivalence to a predicate device.

Therefore, the requested information cannot be extracted from the provided text.

Here is a summary of why the information is unavailable:

• Acceptance Criteria and Device Performance: The document is a clearance letter, which determines substantial equivalence. It does not contain performance data, clinical trial results, or specific acceptance criteria. These would typically be found in the 510(k) submission itself, not the clearance letter.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set, etc.: All these categories relate to a detailed study design and results, which are not part of the FDA's clearance decision letter. The letter confirms the device is substantially equivalent to a predicate, based on information provided in the original 510(k) submission, but does not reiterate or summarize the study specifics.

To obtain this information, one would need to access the full 510(k) submission for K043186, which is usually a much more extensive document.

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Measure 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 24-44cm (approx. 9.4" to 17.5").

H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888EA, HL888CF, HL888GF, HL888QA

This document is a 510(k) clearance letter for a non-invasive blood pressure measurement system, specifically a blood pressure monitor. It does not contain the acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices. It states the indications for use of the device: "Measure 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 24-44cm (approx. 9.4" to 17.5")."

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted with the 510(k) application, which would detail the performance data and acceptance criteria used to demonstrate substantial equivalence.

Without such a document, I cannot provide the requested information, including:

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. If an MRMC study was done and the effect size
6. If standalone performance was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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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 with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ) .

Not Found

The provided text is a 510(k) summary for a blood pressure monitor. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the format requested.

The document primarily focuses on the FDA's decision regarding the substantial equivalence of the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL888" to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code. It also includes the intended use for the device.

Therefore, I cannot extract the requested information from the provided text.

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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.

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