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The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.

I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria and study details as requested. The document is a 510(k) summary for an Oxygen Concentrator, which primarily compares the subject device to a predicate device and outlines non-clinical tests performed. It does not contain sections detailing acceptance criteria for specific performance metrics with reported results, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, types of ground truth used, or details about the training set.

The document states:

• "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, there is no information about a study that would include elements like test set sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this oxygen concentrator.

The "Performance Comparison" table in the document provides technical specifications and comparisons to the predicate device, but these are not presented as "acceptance criteria" with "reported device performance" in the format typically used for studies validating diagnostic or AI-based devices. The reported values are descriptive technical specifications rather than outcomes from a performance study against predefined acceptance criteria.

Therefore, I cannot provide the requested table and details because the provided text does not contain a study demonstrating device performance against explicitly defined acceptance criteria in the manner you described.

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The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.

The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages. The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.

Here's a breakdown of the acceptance criteria and study information for the K130001 device, the Foshan Care Medical Technology Co., Ltd. SU01A Suction aspirator, based on the provided text:

Important Note: This device is a traditional medical suction unit and not an AI/ML-powered device. Therefore, many sections related to AI performance, ground truth establishment, reader studies, and training sets are not applicable (N/A) for this submission. The analysis below reflects this.

1. Table of Acceptance Criteria and Reported Device Performance

This device's "acceptance criteria" are based on compliance with established medical device standards and equivalence to a predicate device. Performance is demonstrated through meeting these standards and showing comparable attributes to the predicate device.

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

• Sample Size for Test Set: N/A. No specific "test set" of patient data or images was used as this is a hardware device submission focused on engineering standards and equivalence.
• Data Provenance: N/A. The evaluation is based on engineering testing protocols for compliance with international standards, rather than clinical data.

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

• Number of Experts: N/A. No ground truth was established by experts for a test set in the context of clinical performance, as no such clinical studies were performed.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. No test set requiring expert adjudication was used.

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

• MRMC Study Done? No. This device is a physical suction aspirator; MRMC studies are not applicable.
• Effect Size: N/A.

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

• Standalone Study Done? N/A. This is a hardware device; algorithm-only performance is not relevant.

7. Type of Ground Truth Used

• Type of Ground Truth: N/A. For hardware devices like this, the "ground truth" for performance is typically defined by adherence to engineering specifications and international performance and safety standards, rather than clinical outcomes or expert consensus on clinical findings.

8. Sample Size for the Training Set

• Sample Size for Training Set: N/A. This is a hardware device and does not involve AI or algorithms that require training sets.

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

• How Ground Truth for Training Set Was Established: N/A. No training set was used.

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The Foshan Care Medical Nebulizer Compressor, Model K Y WH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-31100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KY WH2001 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.

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The provided document is an FDA 510(k) clearance letter for a Medical Nebulizer Compressor. It does not contain any information regarding the acceptance criteria, study details, or performance metrics for the device as outlined in your request.

The letter primarily focuses on the substantial equivalence determination for the nebulizer compressor to a predicate device, as per FDA regulations.

Therefore, I cannot provide the requested information about acceptance criteria and study details based on the given text. The document is essentially a regulatory approval letter and not a technical or clinical study report.

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The CARE ZY5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.

The CARE ZY5BA is an AC power electrically operated device. The unit separates oxygen from room air (ambient air), which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room. It will not affect the normal amount of oxygen in user's room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized valve and protected from over pressurization by the compressor's pressure relief valve. Oxygen provided by the CARE ZYSBA Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or oxygen mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the CARE ZY5BA contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operate the device conveniently according the instructions.

Acceptance Criteria and Device Performance Study (CARE ZY5BA Oxygen Concentrator)

This medical device submission is for an oxygen concentrator, not an AI-powered diagnostic device. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to the evaluation of algorithms for diagnostic accuracy.

The acceptance criteria for this device are based on its substantial equivalence to a predicate device and compliance with relevant performance and safety standards.

1. Acceptance Criteria and Reported Device Performance

The key "performance" for an oxygen concentrator relates to its ability to reliably produce oxygen and meet safety standards. The document outlines these by demonstrating compliance with established standards and substantial equivalence to a predicate device.

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

Not applicable. This submission focuses on the performance and safety of a medical device (oxygen concentrator), not on the evaluation of a diagnostic algorithm or AI model requiring a "test set" in the context of image analysis or similar diagnostic applications. The testing involved physical device performance and compliance with engineering and safety standards.

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

Not applicable. There is no diagnostic "ground truth" to be established by experts for this type of device. The "ground truth" is defined by the technical specifications and performance standards for oxygen concentrators.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" in the diagnostic sense, no adjudication method was used.

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

No. This type of study is for evaluating the comparative effectiveness of human readers, often aided by AI, in diagnostic tasks. For an oxygen concentrator, this is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an oxygen concentrator, a physical piece of medical equipment, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by:

• Engineering Specifications and Design Requirements: The device must meet its intended design specifications for oxygen purity, flow rate, pressure, and operational parameters.
• International and Industry Standards: Compliance with standards such as ASTM F1464, ISO 8359 (for oxygen concentrators), IEC 60601-1 series (for electrical safety), and ISO 14971 (for risk management) defines the acceptable performance and safety.
• Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML algorithm requiring training data, there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, not "training" in the AI sense.

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

Not applicable, as there is no training set for this type of device.

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