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The FLOCAP is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The FLOCAP has a visual indicator to visually detect the end of exhalation.

For use up to 24 hours.

For patients greater than 15 kg (33 lbs.)

Environment of use - hospital, sub-acute, pre-hospital, transport

The proposed FLOCAP is comprised of several components:

• Housing with standard 15 mm / 22 mm fittings to connect to ventilatory assist devices and a face . mask or endotracheal tube
• . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH
• . A spinner / vane which spins when there is expiratory flow. It is to detect presence of expiratory flow

The FLOCAP device, a colorimetric CO2 detector, was deemed substantially equivalent to the predicate device, Mercury Medical STAT CO2 (K021576), based on non-clinical performance testing and comparative specifications.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests. The summary indicates "comparative specifications" and "specific tests related to the device" were performed. The testing seems to be bench testing against the predicate's specifications rather than a clinical study with a patient test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical ground truth establishment by experts is not described for the non-clinical performance testing.
3. Adjudication method for the test set: Not applicable.
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: An MRMC comparative effectiveness study was not performed. This is a non-AI medical device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Standalone performance was assessed through various non-clinical bench tests (e.g., color change response time, leakage, minimum static flow indication, anti-fog, shelf-life, drop test, duration of use, burst pressure, compliance, pressure drop, internal volume, usability).
6. The type of ground truth used: For the bench testing, the "ground truth" was established based on engineering specifications, physical measurements, and comparison to the predicate device's characteristics and performance parameters.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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The MaxMixing Block is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer device. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.

The MaxMixing Block uses the well known technology of two compensated thorpe tube flowmeter to control and measure medical grade air and oxygen at an accurate flow rate as per a calibrated reference pressure (50 psig +/- 5 psig). The two gases are then mixing block for continuous air/oxygen delivery at oxygen concentrations of 21 - 100% as prescribed. There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use. There are differences with respect to mixers, in that the subject device has a wider pressure differential tolerance requirement since Oxygen concentration is much less affected by pressure differential as compared to the blender predicate devices. The blender predicate devices have a single gas failure alarm which is intended to indicate narrow pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen. The subject device also has a single gas failure alam which indicates a broader pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen.

The MaxMixing Block device is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture. The stated accuracy for oxygen concentration measurement is at least +/- 3%.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance:

The document mentions that both the subject device (MaxMixing Block) and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. While the provided text doesn't contain a specific table detailing "acceptance criteria" versus "reported device performance" for the MaxMixing Block itself, it states that
"Non-clinical functional and performance tests for substantial equivalence testing and the results are noted in the attached table."
However, this "attached table" is not provided in the input text. Therefore, the specific performance data against explicit acceptance criteria cannot be directly extracted here. We can infer the primary acceptance criterion is related to oxygen concentration accuracy based on the comparison to predicate devices.

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

• Sample Size for Test Set: Not specified in the provided text. The document refers to "non-clinical functional and performance tests" but does not give details about the size or nature of the test set.
• Data Provenance: Not specified. It's a non-clinical test, so there's no mention of country of origin of data or whether it's retrospective or prospective with human subjects.

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

Not applicable. The study involved "non-clinical functional and performance tests" and no clinical studies were performed. Therefore, no human experts were involved in establishing ground truth for a test set in a clinical context.

4. Adjudication Method for the Test Set:

Not applicable. Since no clinical studies were performed and no human experts established ground truth, there was no adjudication method.

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

No. The document explicitly states: "No clinical studies were performed". Therefore, no MRMC comparative effectiveness study was conducted.

6. Standalone Performance Study:

Yes, a standalone study was done in the form of "non-clinical functional and performance tests". The device was evaluated on its own merits against expected performance, as indicated by the comparison to predicate devices.

7. Type of Ground Truth Used:

The ground truth for the non-clinical performance tests would likely be based on:

• Reference standards/calibrated instruments: For measuring gas flow and oxygen concentration to verify the accuracy of the MaxMixing Block.
• Engineering specifications and design requirements: To ensure the device operates within defined parameters.

8. Sample Size for the Training Set:

Not applicable. This is a medical device (mixer) employing "well known technology". Unless it utilizes Machine Learning/AI, there is typically no "training set" in the conventional sense for such devices. The document explicitly states "No clinical studies were performed" and also notes "There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use." This further supports the absence of a training set for an AI/ML model.

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

Not applicable, as there was no training set for an AI/ML model.

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The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver a set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

The MaxO2 CU is a combination of a continuous use oxygen monitor and a venturi oxygen dilution system in one device. An analogous device could be assembled by attaching a wall mount oxygen flow meter to a commercially available venturi and attaching the venturity a standard in-line oxygen analyzer. The MaxO2 CU offers this set-up to the clinician in one package. There are two models, one with adjustable flow and adjustable FiO2. The other has fixed flow and adjustable FiO. The flow adjustment is accomplished by adjusting the flow of oxygen through the venturi orifice. The adjustable oxygen % is accomplished by adjusting the flow of oxygen into the region surrounding the venturi orifice. This oxygen is drawn into the venturi stream in place of room air, increasing oxygen content in the mixture. The oxygen analyzer electronics, sensor, and programming are identical to the MaxQ+ predicate K040484.

Here's an analysis of the provided text regarding the MaxO2 CU device's acceptance criteria and documented performance.

1. Table of Acceptance Criteria and Reported Device Performance

                             implied performance goal for the device. The
                             predicate device may have set a benchmark.
                            | 90% of final value in ~ 15 seconds @ 23C |

| Accuracy | Not explicitly stated as "acceptance criteria" but
implied performance goal for the device. The
predicate device may have set a benchmark.
| + 3% full scale |
| Linearity error | Not explicitly stated as "acceptance criteria" but
implied performance goal for the device. The
predicate device may have set a benchmark.
| < 3% of reading |
| Drift | Not explicitly stated as "acceptance criteria" but
implied performance goal for the device. The
predicate device may have set a benchmark.
| < 1% oxygen over 8 hours |
| Humidity influence | Not explicitly stated as "acceptance criteria" but
implied performance goal for the device. The
predicate device may have set a benchmark.
| +3% full scale |
| Humidity conditions | 0-95% RH non-condensing | 0-95% RH non-condensing |
| Pressure influence | Proportional to changes in atmospheric pressure | Proportional to changes in atmospheric pressure |
| Operating temperature | 15 - 40°C | 15 - 40°C |
| Storage temperature | -15 to 55°C | -15 to 55°C |
| Recommended storage temperature | -20 to 55°C | -20 to 55°C |
| Battery life | Not explicitly stated as "acceptance criteria" but
implied performance goal. | 5000 hours (user replaceable) |
| Sensor life | Not explicitly stated as "acceptance criteria" but
implied performance goal. | >900,000 % oxygen hours |

Note: The document lists "Device Attributes" with specific values. While not explicitly termed "acceptance criteria," for a 510(k) submission, these values represent the performance the manufacturer claims to meet and which the FDA reviews for substantial equivalence to predicate devices. The absence of specific "acceptance criteria" numbers often means the device is being compared to the predicate's established performance without a formal, new testing standard being defined for this submission beyond maintaining functional equivalence.

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

The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission refers to performance specifications (e.g., accuracy, response time) but does not detail the studies conducted to verify these specifications for this specific device. This is common in 510(k) submissions where substantial equivalence is demonstrated primarily through comparison to predicate devices, and underlying performance data might be referenced from internal testing or previous submissions for the predicate.

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

The document does not mention any experts or ground truth establishment relevant to a clinical or performance test set. The device is an oxygen analyzer, and its performance characteristics (accuracy, linearity) would typically be verified against calibrated reference gases or standards, not through expert consensus on medical imagery or patient outcomes.

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

As there is no mention of a clinical or performance test set involving human interpretation, there is no adjudication method described. This device measures gas concentration, a quantitative physical parameter.

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

No MRMC comparative effectiveness study was done or is mentioned. This device is an oxygen analyzer, not an AI diagnostic tool that assists human readers.

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

The document does not describe a standalone algorithm performance study. The device itself is a standalone physical instrument for measuring oxygen concentration. The performance metrics listed (accuracy, drift, response time) are inherent to the device's function, not an algorithm in the AI sense.

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

The "ground truth" for verifying the performance attributes of an oxygen analyzer (like Display Range, Accuracy, Linearity error, Drift) would typically be based on calibrated reference gases with known oxygen concentrations, or highly accurate laboratory instruments. The document does not explicitly state the methodology for establishing this ground truth, but it would be a metrological standard, not clinical expert consensus or pathology.

8. The sample size for the training set

The document does not refer to a training set. This device is an electro-mechanical oxygen analyzer; it does not utilize machine learning or AI models that require a training set.

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

As there is no training set, there is no discussion of how its ground truth was established.

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The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture. The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.

The provided documents (K040484) describe a 510(k) premarket notification for the MAXO2+ oxygen analyzer by Maxtec, Inc. The submission outlines the device's intended use and general characteristics but does not include details about specific acceptance criteria or a study proving that the device meets such criteria.

Therefore, based on the information provided, it is not possible to complete the requested table and answer the questions related to the device's acceptance criteria and performance study. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Caradyne - OxiCheck - K023565) rather than presenting a detailed performance study with acceptance criteria.

Missing Information:

The provided text does not contain any information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

Conclusion:

The provided 510(k) documents for the Maxtec MAXO2+ are primarily a regulatory submission demonstrating substantial equivalence. They do not contain the detailed technical validation study information that would be necessary to answer your specific questions regarding acceptance criteria, study design, and performance metrics.

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