Search Results

The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.

The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.

The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.

The provided documents are a 510(k) premarket notification letter for a device called RESPALERT and its Indications for Use. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

The device, RESPALERT, is described as a peak flow monitor that indicates lung condition through the presence or absence of a whistle, rather than providing a quantitative reading. The indications for use state it's for adults with respiratory diseases to monitor their status.

Therefore, I cannot provide the requested information from the given text.

However, based on the nature of the device (a simple whistle-based peak flow indicator), a hypothetical description of acceptance criteria and a study design might look something like this:

Hypothetical Acceptance Criteria and Study Design for RESPALERT (not found in the provided text)

Given that the RESPALERT's function is to produce a whistle if the lung condition is "under control" (presumably above a set peak flow threshold) and no whistle if treatment is necessary or ineffective (below the threshold), the acceptance criteria would likely focus on the device's accuracy in detecting this binary state.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 150 patients (e.g., 75 with controlled respiratory conditions, 75 with uncontrolled conditions requiring intervention).
• Data Provenance: Prospective, multi-center clinical trial conducted in several clinics and hospitals across the USA.

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

• Number of Experts: 3 independent pulmonologists.
• Qualifications of Experts: Each pulmonologist had at least 15 years of experience in diagnosing and managing chronic respiratory diseases, board-certified in Pulmonary Medicine.

4. Adjudication Method

• Adjudication Method: 2+1. If two pulmonologists agreed on a patient's lung status (controlled vs. uncontrolled based on spirometry and clinical assessment), that was established as the ground truth. If there was disagreement between the first two, the third pulmonologist's assessment would serve as the tie-breaker.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: Not applicable. The RESPALERT is a diagnostic aid providing a binary signal (whistle/no whistle), not an imaging device or AI-driven interpretive system that improves human reader performance in complex image analysis. It's a direct patient monitoring tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, this is essentially what the primary accuracy study assesses. The device's performance (whistle/no whistle) is directly compared to the clinical ground truth without any human interpretation of the device's output influencing the assessment of the device's accuracy.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus on clinical status, primarily supported by objective lung function data (e.g., spirometry, specifically Peak Expiratory Flow (PEF) measurements) taken simultaneously or within a very short timeframe of the RESPALERT use. For example, a patient would be deemed "uncontrolled" if their PEF was below a predefined "action plan" threshold corresponding to their set whistle level on the RESPALERT, as determined by their physician.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of this device. The RESPALERT is a mechanical device with a fixed set point, not a machine learning algorithm that requires a training set. Its "setting" is calibrated to a specific PEF threshold on a lung function apparatus.

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

• Ground Truth for Training Set: Not applicable. The "training" for this device involves its initial calibration by a medical professional using a standard lung function apparatus (e.g., spirometer) to set the whistle threshold, not a data-driven training process in the AI sense.

Ask a specific question about this device

The Harwill Medical Cervitula is a disposable cervical spatula that is used to collect endo and ectocervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Harwill Medical Cervitula is not intended for use in pregnant women.

The Harwill Medical Cervitula is a disposable cervical spatula.

The provided text is related to an FDA 510(k) clearance for a medical device (Harwill Medical Cervitula Cervical Spatula) and does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for an AI/algorithm-based device.

Therefore, I cannot fulfill the request as the necessary information is not present in the given text. This document is a regulatory approval letter and indications for use, not a detailed study report.

Ask a specific question about this device

The Harwill Medical U-Klip Umbilical Clamp is a device used to compress the umbilical cord.

Harwill Medical U-Klip Umbilical Clamp

The provided text is a response letter from the FDA regarding a 510(k) premarket notification for the Harwill Medical U-Klip Umbilical Clamp. This type of document does not contain information about acceptance criteria or a study proving device performance in the typical sense of a clinical or performance study report.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce..."

This means the device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new study proving specific performance metrics against pre-defined acceptance criteria as would be found in a clinical trial or performance verification study for a new, novel technology.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from the provided text. The letter confirms the device's clearance for marketing based on substantial equivalence to a predicate device.

Ask a specific question about this device

The Whistle Watch is a peak flow meter that has been designed to enable asthmatic children to check their respiratory status.

The Whistle Watch is a peak flow meter

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Whistle Watch." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory approval document, not a study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device