Search Results

The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure. These masks are intended for use with spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for nominvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate.or severe dyspnea; elevated respiratory rates, labored breathing; or paradoxical breathing).

Hsiner's NIPPV Masks are intended to provide a patient interface between a conventional mechanical ventilator system and the patient for applications of non-invasive ventilation. The comection to the ventilator utilizes standard 22mm conical connections complying with ISO 5356-1. The interface with the patient's facial contours utilizes a soft, pliable seal that ensures that a good seal is achieved to deliver the pressurized gasses with minimal unintentional leakage, Unintentional gas leak around the face is minimized by the mask base to improve the closeness of fit to the skin. Soft, clastic headgear insures a tight comfortable fit against the face.

The Esiner NIPPY Masks are modifications to their CPAP/VPAP Masks (K063268). These masks differ from the CPAP/VPAP mask only in that the vents and anti-asphyxiation valves have been removed.

The provided document is a 510(k) summary for A Hsiner Company NIPPV Masks. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample size for test/training set, number of experts, adjudication method, MRMC study, how ground truth was established, effect size with/without AI assistance) is not applicable or cannot be extracted from this document as no clinical test was performed.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No clinical test was performed for this device. The performance evaluation focused on bench testing the device and comparing its physical properties and in-vitro performance to predicate devices and established standards.

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. No expert ground truth was established for a clinical test set as no clinical test was performed.

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

• Not applicable. No adjudication method was used as no clinical test was performed.

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. This document describes a medical device (NIPPV masks), not an AI algorithm. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For the performance evaluation, "ground truth" was established by standardized laboratory measurements following protocols described in FDA's July 1995 guidance document "Draft Reviewer Guidance for Ventilators," ASTM 1100-90, and ISO 17510-2 (2007). These standards define acceptable ranges or methods for measuring parameters like resistance to flow, exhaust flow, CO2 rebreathing, FIO2, and swivel leakage.

8. The sample size for the training set

• Not applicable. No training set was used as this is a physical medical device, not a machine learning model.

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

• Not applicable. No training set was used.

Ask a specific question about this device

Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

The BFE/VFE filters, manufactured by Hsiner, ITD are disposable, single-use barrier type, bi-directional devices supplied to the customer packaged and non-sterile. These filter devices are fabricated with a filtering medium that is highly effective at reducing the numbers of both bacterial and viral contaminates present in a patient's exhaled gas. The devices are designed to minimize the resistance to air flow. They consist of two molded plastic housings enclosing a disk of filter media. The Hsiner filtered HME device also includes a reticulated foam that captures heat and moisture from the patient's breath.

The provided text is a 510(k) summary for the Hsiner Filters and Filtered HME, which are disposable bacterial/viral filters for breathing circuits. The document focuses on establishing substantial equivalence to predicate devices. It does not contain sections detailing acceptance criteria, study methodologies, or performance data in the format of a clinical study report.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text. The document is a regulatory submission summary and focuses on the declaration of substantial equivalence to existing devices rather than a detailed presentation of performance data from a specific study against acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance. The document mentions the devices are "equivalent in design and performance" to predicate devices, implying performance testing was done, but does not provide details of such tests beyond stating BFE/VFE filters are "highly effective."
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance (as this is a physical device, not an AI algorithm).
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document is a declaration of intent to market and a statement of substantial equivalence based on the device's design and intended use being similar to existing cleared devices. It does not describe a study in the way outlined in your request.

Ask a specific question about this device

The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

The Hsiner's nebulizers are used to administer various aerosol treatments in both the homecare and hospital settings. They are intended to only be use with FDA-approved drugs upon the specific direction of a physician. These devices neither uses specific drug nor is it distributed with such drugs. These nebulizers generate respirable sized aerosols that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction ad baffling.

The provided text describes a 510(k) submission for a nebulizer bottle, but it fundamentally lacks any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on the administrative aspects of a 510(k) submission, including:

• Submitter Information: Hsiner Company, LTD.
• Device Name: Nebulizer Bottle
• Classification Information: Product Code CAF, Regulation Number 868.5630, Class 2.
• Substantial Equivalence: Listing two predicate devices (Hsiner Jet Nebulizer K052811 and Hsiner Bottle K070948).
• Device Description: General description of how nebulizers work and their intended use.
• Intended Use: Administering aerosol treatments to adult and pediatric patients with FDA-approved drugs.
• Comparison to Predicate Devices: Stating equivalence in design and performance to predicate devices.
• FDA Correspondence: The FDA's letter of substantial equivalence.
• Indications for Use Statement.

Therefore, I cannot populate the requested table or sections because the provided text does not contain any details regarding:

1. Acceptance criteria: No specific performance metrics or thresholds are mentioned.
2. Reported device performance: No data on the device's actual performance (e.g., aerosol particle size, delivery rate) is provided.
3. Study design: No mention of a study conducted to demonstrate performance.
4. Sample size: No information on test sets or training sets.
5. Data provenance: No details about the origin of any data.
6. Experts for ground truth: No mention of experts or their qualifications.
7. Adjudication method: Not applicable as no ground truth is established.
8. MRMC comparative effectiveness study: No such study is mentioned.
9. Standalone performance: No standalone algorithm performance is discussed.
10. Type of ground truth: Not applicable.
11. Training set details: No training set is mentioned.

The 510(k) summary only states that the device is "equivalent in design and performance" to the predicate devices. This implies that the performance characteristics expected would be similar to those of the predicate devices, but it does not provide the actual data or the acceptance criteria used to prove this equivalence for the new device. A 510(k) notice typically refers to detailed testing reports, which are usually not included in the public 510(k) summary document itself.

Ask a specific question about this device

The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.

The provided 510(k) submission for the Hsiner Company CPAP Masks does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The submission primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use. There is no mention of a clinical or performance study with detailed methodologies (sample sizes, expert involvement, adjudication, etc.) in the provided text.

Therefore, I cannot fulfill your request for the tables and study details based on the given input, as this information is not present in the document.

The document states: "The Hsiner CPAP/VPAP Masks is equivalent in design, materials and performance to the Predicate devices. All the predicate devices utilize the same principles of operation and have the same intended use." This suggests that the substantial equivalence argument relies on the inherent characteristics of the device and its similarity to already approved devices, rather than a separate performance study with acceptance criteria.

Ask a specific question about this device

The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.

The PEEP valve is an adjustable, spring actuated valve which when placed into a circuit provides positive end expiratory pressure for the patient. The PEEP vale is provided in two pressure ranges and several connector sizes complying wit ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

The provided text is a 510(k) summary for the Hsiner Company Resuscitator/PEEP Valve. It details the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study report with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or human-in-the-loop studies.

Instead, the submission states that the Resuscitator complies with ASTM and ISO standards, and the PEEP valve complies with ISO standards for conical connectors, implying that the acceptance criteria are adherence to these established standards. The basis for clearance is substantial equivalence to existing legally marketed devices, not a de novo study proving new performance metrics.

Therefore, many of the requested details about a specific study and its acceptance criteria cannot be extracted from this document, as such a study (in the sense of defining new performance metrics and testing against them) was not the basis for this 510(k) submission.

Here's an attempt to answer the questions based solely on the provided text, highlighting what is not available:

Acceptance Criteria and Device Performance

Study Information (Based on Substantial Equivalence, not a de novo performance study)

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

   • Test set sample size: Not applicable or not specified. The submission relies on adherence to established international standards and substantial equivalence, not a new test set generation with a specific 'sample size' of patients or cases.
   • Data provenance: Not applicable. The "study" here is demonstrating compliance with existing standards and comparing to predicate devices.

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

   • Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission. The "ground truth" for the device's performance is defined by the ASTM and ISO standards themselves and the performance of the predicate devices.

3. Adjudication method for the test set:

   • Not applicable. There was no explicit "test set" in the context of expert review for clinical performance.

4. 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. This device is a manual medical instrument (resuscitator, PEEP valve), not an AI/software device.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • For the Resuscitator: Adherence to ASTM 940-93 and ISO 8382:1988 performance specifications.
   • For the PEEP Valve: Adherence to ISO 5356-1 connector standards and the established performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI or machine learning model that requires a training set.

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

   • Not applicable. No training set was used.

Ask a specific question about this device

The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.

This submission describes the Hsiner Jet Nebulizer, a device used to administer aerosol treatments. The primary evidence provided is a substantial equivalence claim based on performance testing comparing it to legally marketed predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence by demonstrating that the Hsiner Jet Nebulizer's performance characteristics are not significantly different from predicate devices. The specific acceptance criteria are implicitly that the performance metrics of the Hsiner Jet Nebulizer should be not significantly different from those of the predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices or experimental replicates. The testing was conducted "in-vitro" and involved "any of the drugs tested," implying multiple drug types were used with the device and predicate devices.
• Data Provenance: In-vitro testing. No specific country of origin for the data is mentioned, but the submitter is from Taiwan, ROC, and the preparer of submission is from the US. The testing was conducted according to the FDA's "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)," which indicates a standard, controlled laboratory environment for the testing.

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

Not applicable. This device submission relies on objective, in-vitro physical performance measurements rather than expert human interpretation or clinical data. The "ground truth" is established by direct measurement against physical standards derived from the performance of predicate devices and industry guidance.

4. Adjudication method for the test set

Not applicable. As noted above, this submission relies on objective physical measurements, not human interpretation requiring adjudication.

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. This is a medical device for drug delivery, not an AI-assisted diagnostic tool requiring human reader studies.

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

Not applicable. This is a mechanical nebulizer, not a software algorithm. The "standalone performance" is the in-vitro performance of the device itself.

7. The type of ground truth used

The ground truth is derived from objective in-vitro performance measurements of the device and predicate devices, as specified by the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." This involves physical properties like particle size distribution (MMAD, GSD, Respirable Fraction), drug delivery capability (Respirable Mass), and operational parameters (Treatment Time, Operating pressures). The acceptance criteria are based on demonstrating that these parameters are not significantly different from those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set was used.

Ask a specific question about this device