Search Results

Blood Pressure Monitor, KUBE/Kinetik Branded BPM1K Series is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Non-Invasive Blood Pressure Measurement System

The provided text is a 510(k) premarket notification letter from the FDA to Harvard-Medical-Devices Limited regarding their KUBE/Kinetik Branded BPM1K Series blood pressure monitor. While it confirms the device's substantial equivalence to a predicate device and outlines regulatory obligations, it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and detailed study information based on the text provided. This document is an FDA approval letter, not a study report or a detailed summary of the testing performed.

Ask a specific question about this device

Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.

Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series

The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Type Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.

Therefore, I cannot provide the requested information from the given input. The letter primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory compliance requirements. It does not delve into the specific technical performance or study results.

Ask a specific question about this device

The digital thermometer is intended to measure body temperature either orally or axillary (under the arm).

Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series

This FDA 510(k) clearance letter for a Digital Thermometer (K092557) does not contain the specific information required to complete your request.

The provided document is primarily an administrative letter granting clearance based on substantial equivalence to a predicate device. It confirms that the device can be legally marketed but does not detail the technical study results, acceptance criteria, or performance data you are asking for.

To answer your questions thoroughly, you would typically need access to the actual 510(k) summary or the full submission, which would include sections on performance testing, clinical performance (if applicable), and statistical analyses.

Therefore, under the constraints of the provided text:

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

• Not available in the provided text. The letter does not describe any specific acceptance criteria or performance metrics for the thermometer.

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

• Not available in 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 available in the provided text. As this is a digital thermometer, the ground truth would likely be a reference thermometer, not expert-derived interpretations.

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

• Not available in the provided text. (Not applicable for a thermometer performance study).

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 in the provided text. This is a digital thermometer, not an AI-assisted diagnostic tool for human interpretation.

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

• Not applicable in the provided text. The device itself is standalone in its function as a thermometer, but no "algorithm-only" performance as typically understood in AI/imaging is discussed.

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

• Not available in the provided text. For a thermometer, the ground truth would typically be established using a calibrated reference thermometer, but this is not stated in the document.

8. The sample size for the training set

• Not available in the provided text. (Not typically relevant for a simple electronic thermometer, which is not usually 'trained' in the machine learning sense).

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

• Not available in the provided text. (Not typically relevant for a simple electronic thermometer).

Ask a specific question about this device

Kinetik BPM1 Series is for use at home and is a non-invasive blood pressurement system intended to measure the diastolic and systelle blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Not Found

This is a 510(k) clearance letter for a non-invasive blood pressure measurement system (Kinetik BPM1 Series). The document states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. The document is primarily a regulatory clearance, not a performance study report.

Ask a specific question about this device

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

IR Ear Thermometer HMIRET-002/Kinetik Branded IET-1 Series

The provided text describes an FDA 510(k) premarket notification for an IR Ear Thermometer. It does not contain the specific details about acceptance criteria, device performance, or the study used to prove the device meets those criteria. The document is primarily an FDA clearance letter, confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. This information would typically be found in the 510(k) summary or a more detailed technical report submitted to the FDA, which is not present in the provided text.

Ask a specific question about this device