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Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.

The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.

While the provided text describes the HUMIDIFLOW™ Humidifier and its substantial equivalence to predicate devices, it does not contain the detailed information required to fill out all the acceptance criteria and study details as requested. The summary focuses on technological characteristics and biocompatibility, not performance metrics directly tied to numerical acceptance criteria.

However, I can extract the available information and indicate where details are missing based on the prompt's requirements.

Here's a breakdown of what can be inferred and what is explicitly not available in the provided text:

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

The document states: "Performance characteristics that could be affected by the installation of the HUMIDIFLOW™ were identified for the various oxygen concentrators for which HUMIDIFLOW™ would be installed. The device was also measured for humidity output. All testing indicates that the device is substantially equivalent to the predicate device."

This statement implies that some performance metrics related to "humidity output" were measured and compared. However, it does not provide specific numerical acceptance criteria (e.g., minimum humidity level, maximum humidity variability) or the reported device performance against those criteria. It only states that the device was found to be "substantially equivalent" to the predicate.

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

• Sample size for the test set: Not specified.
• Data provenance: Not specified. (The testing was likely internal to Porous Media Corporation, but no details are given.)

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)

This type of information is generally relevant for studies involving subjective interpretation (e.g., medical imaging). For a device like a humidifier, "ground truth" would typically refer to objective measurements using calibrated equipment (e.g., hygrometers). The document does not describe the use of human experts to establish ground truth for performance.

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

Not applicable as there's no indication of human expert interpretation or a need for adjudication in the context of humidifier performance testing presented.

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

• MRMC study: Not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools, which the HUMIDIFLOW™ is not.
• Effect size of human readers: Not applicable.

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

The HUMIDIFLOW™ is a physical device, not an algorithm. Therefore, "standalone" performance testing would refer to the device's intrinsic mechanical and humidification performance. The document states that "The device was also measured for humidity output," indicating standalone testing, but no specific results are provided beyond the general claim of substantial equivalence.

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

For a humidifier, ground truth would be established through objective physical measurements of humidity, temperature, and potentially airflow using calibrated sensors and instrumentation. The document implies this type of measurement was done ("measured for humidity output") but doesn't detail the specific methods or equipment used to establish this "ground truth."

8. The sample size for the training set

This is not applicable as the HUMIDIFLOW™ is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence primarily through technological characteristics and biocompatibility, rather than detailed quantitative performance studies with specific acceptance criteria and outcome measurements typical for AI/ML devices or complex diagnostic tools.

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Porous Media oxygen concentrator filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, patient care facility, etc.

Room air is drawn into the compressor through the bacterial intake filter. From the compressor, the air passes through the compressor filter, if one is installed on the machine, and proceeds to the sieve beds. The sieve beds condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.

This 510(k) summary describes Replacement Oxygen Concentrator Filters manufactured by Porous Media. The submission focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis of the acceptance criteria and study information provided, framed around a typical AI/medical device study structure, even though this submission is for physical filters and not an AI device. I will address each point from your request using the provided text.

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

For these oxygen concentrator filters, "acceptance criteria" are primarily based on demonstrating identical technical specifications and intended use to legally marketed predicate devices. The "reported device performance" is the direct assertion of these identical specifications. The submission is a comparison study, not a performance study against predefined thresholds for a novel device.

The study essentially proves the device meets the "acceptance criteria" by showing a feature-by-feature match with the predicate devices, thereby establishing substantial equivalence, which is the primary regulatory pathway for 510(k) devices. There is no independent performance study detailed here, as the performance is assumed to be equivalent to the predicate.

The following points are typically relevant for AI/algorithm-based medical devices. Since this submission is for physical filters, these specific questions regarding AI algorithms and ground truth methods are not directly applicable to the provided text. I will address them by stating their non-applicability or reinterpreting them in the context of a physical device.

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

• Not Applicable: This submission is for physical filters. There is no "test set" in the context of an AI algorithm evaluation. The "data" here refers to the specifications of the predicate devices and the filters themselves. The comparison is against published and known specifications of existing, approved devices. No specific "sample size" of devices was tested for this submission beyond the comparison to the existing designs. The data provenance is essentially from the design and manufacturing specifications of both the predicate devices and the Porous Media filters. No geographical or retrospective/prospective distinction is relevant here.

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: There is no "ground truth" in the AI sense for these physical filters. The "ground truth" for the comparison is the published, legally established specifications of the predicate oxygen concentrator filters, which are accepted by the FDA. The experts involved would likely be engineers, quality control specialists, and regulatory affairs personnel from Porous Media and potentially consultants verifying the comparison, but not "experts establishing ground truth" in a diagnostic sense.

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

• Not Applicable: No adjudication method is described or required for comparing physical device specifications. The comparison is a direct, objective matching of technical parameters.

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 submission for physical filters, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• Not Applicable: This is for physical filters, not an independent algorithm.

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

• Not Applicable (in the AI sense): For this submission, the "ground truth" is the established technical specifications and performance characteristics of the legally marketed predicate devices, as approved by the FDA in their original 510(k) clearances. This is a regulatory "ground truth" rather than a clinical one.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI device.

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

• Not Applicable: As there is no AI training set, there is no ground truth establishment for it.

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• The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
• The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
• The device is intended for adult population only. .

DPB30 Disposable Pre-bypass Filter

The provided text is a 510(k) clearance letter from the FDA for a medical device called "DPB30 Disposable Pre-bypass Filter." This document does not contain information about acceptance criteria, clinical study results, or detailed performance data.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that for a 510(k) submission, the manufacturer focused on demonstrating that their device is as safe and effective as existing, legally marketed devices, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given document. The document only covers:

• Device Name: DPB30 Disposable Pre-bypass Filter
• Intended Use: For use only with non-cellular fluid in the extra-corporeal circuit prior to the initiation of cardiopulmonary bypass. Designed for single use and intended for the adult population only.
• Regulatory Class: II (Two)
• Product Code: 74 JOW

To answer your questions about acceptance criteria and a study proving the device meets them, I would need a different type of document, such as a clinical study report or a detailed summary of safety and effectiveness (SSE) for a PMA (Premarket Approval) device, or a more comprehensive 510(k) summary that includes performance data.

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• . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
• THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.

Not Found

This is a 510(k) premarket notification for a disposable cardiopulmonary pre-bypass filter, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. There is no mention of an AI/ML component or study involving such.

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THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.

One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a respiratory filter and does not discuss acceptance criteria, device performance studies, or details about training and test sets as typically seen in AI/ML device submissions.

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