Search Results
Found 6 results
510(k) Data Aggregation
(540 days)
Ask a specific question about this device
(155 days)
The PMX COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The PMX COMPACT RESUSCITATOR provided in reusable models and in the disposable models.
manual resuscitators incorporating a bag and valve
The provided document is a 510(k) clearance letter for the PMX Compact Resuscitator, classifying it as an Emergency Manual Ventilator. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics of the new device in the same way an AI/ML device submission would.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This is expected for a traditional medical device like a manual resuscitator, where performance is typically evaluated through bench testing, materials compatibility, and comparison to established standards and the predicate device's performance, rather than complex clinical studies with ground truth establishment and expert consensus as seen in AI/ML solutions.
Ask a specific question about this device
(188 days)
Ask a specific question about this device
(51 days)
Ask a specific question about this device
(85 days)
The Cheen Houng 0-20 Cm H2O PEEP Valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
The Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are similar in intended use, design, material selection, performance and function to Life Design PEEP FLO PEEP Valves which are currently legally and safely marketed in the United States.
The provided document is a 510(k) summary for the Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves. This document asserts the substantial equivalence of the device to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria for a novel device.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information is not available within this 510(k) summary.
The document states:
"The Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are similar in intended use, design, material selection, performance and function to Life Design PEEP FLO PEEP Valves which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced. Therefore, it is our conclusion that the Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are safe and effective for their intended function."
This statement indicates that the submission relies on the established safety and effectiveness of a predicate device ("Life Design PEEP FLO PEEP Valves") due to the substantial equivalence of the new device. It does not present a de novo study with specific acceptance criteria and performance data for the Cheen Houng PEEP Valve itself.
Ask a specific question about this device
(213 days)
The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
Exhaled Air Pulmonary Resuscitators
The provided text is a 510(k) summary for the "Pocket Rescue" Exhaled Air Pulmonary Resuscitator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study data with acceptance criteria and performance metrics in the way a new, high-risk device might.
Based on the provided document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary states, "The Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are similar in intended use, design, material selection, performance and function to Exhaled Air Pulmonary Resuscitators which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced." This indicates a comparison to a predicate device's existing performance, but no specific acceptance criteria or new performance data for the Pocket Rescue are detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission is a 510(k) for substantial equivalence, not a report of a new clinical study with a specified test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. There is no mention of an expert panel or ground truth establishment relevant to a clinical study for this device.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. A 510(k) for a device like a manual resuscitator is unlikely to involve an MRMC study.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a manual resuscitator, not an AI algorithm.
7. Type of Ground Truth Used
This information is not provided. Given the nature of the device and the 510(k) submission, a "ground truth" as typically understood in AI/imaging studies is not relevant here.
8. Sample Size for the Training Set
This information is not applicable. The device is a manual medical tool, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
Summary of Device and Approval Process:
The Cheen Houng Enterprise Co., Ltd. "Pocket Rescue" Exhaled Air Pulmonary Resuscitator was granted 510(k) clearance (K970688) by the FDA on September 26, 1997. The basis for clearance was a demonstration of substantial equivalence to existing legally marketed Exhaled Air Pulmonary Resuscitators. The submission argues that the device is "similar in intended use, design, material selection, performance and function" and introduces "no new technological characteristics that could affect safety or effectiveness."
The indicated use for the Cheen Houng Pocket Rescue is "for mouth to mask ventilation of a nonbreathing adult," with an optional oxygen port. This process relies on a comparison to a predicate device's established safety and effectiveness, rather than new, independent clinical trials with explicit acceptance criteria and performance data for the submitted device itself.
Ask a specific question about this device
Page 1 of 1