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The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.

The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.

Here's a breakdown of the acceptance criteria and study information for the Oxy2Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria for the Oxy2Pro mask was that its performance for FiO2 (fraction of inspired oxygen) and EtCO2 (end-tidal carbon dioxide) should not be statistically significantly less than the predicate device (K172365) at the tested flow rates.

The study results demonstrate the following:

The document concludes that the "Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria."

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

• Sample Size for Test Set: Not explicitly stated in terms of a number of masks or subjects. The document mentions "testing was completed under simulated conditions at various flow rates." This implies a series of measurements were taken at different flow rates, but the number of devices tested or repetitions of each test is not specified.
• Data Provenance: The testing was "completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device." It was performed by an "Accredited third-party testing" organization. The location of this organization and whether the data is retrospective or prospective is not specified. Given the context of a 510(k) submission, it is likely prospective testing specifically conducted for this submission.

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

N/A. This information is not relevant or applicable to the type of performance testing described. The "ground truth" (or reference standard) in this context is the measured FiO2 and EtCO2 values under controlled simulated conditions, using calibrated equipment. It does not involve expert interpretation or consensus.

4. Adjudication Method for the Test Set

N/A. As the testing involved objective measurements under simulated conditions, there was no need for an adjudication method by experts.

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

N/A. This type of study is typically performed for AI/image analysis devices where human readers provide interpretations. The Oxy2Pro is a medical device for oxygen delivery and CO2 sampling, and its performance is evaluated objectively through physical measurements, not human interpretation.

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

N/A. This concept is for software algorithms. The Oxy2Pro is a physical device; its performance is standalone in the sense that it functions physically to deliver oxygen and sample gas.

7. Type of Ground Truth Used

The ground truth used was simulated conditions with true baseline EtCO2 at 5%. This implies a controlled environment where the actual concentration of inspired oxygen and exhaled CO2 was known and measured with high precision using reference instruments.

8. Sample Size for the Training Set

N/A. The Oxy2Pro is a physical medical device, not an AI or machine learning algorithm, so there is no training set in this context.

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

N/A. As there is no training set, this question is not applicable.

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This device is intended to provide a means for sampling end tidal carbon dioxide with the option to deliver supplemental O2 therapy to patients for up to 24 hours.

Southmedic's CO2/02 Nasal Cannula incorporates sampling nares that channel expired carbon dioxide to a capnograph. A port located between the two nares is used to deliver oxygen to the patient as needed from an oxygen source. Its unique design delivers 02 to both the nose and mouth area. This device when in use involves surface contact to the patient's intact skin. There is also gas pathway contact between patient and tubing/nasal cannula. Contact is considered limited exposure (up to 24 hours).

The provided text describes several studies conducted to support the substantial equivalence of the Southmedic CO2/O2 Nasal Cannula. The studies focus on biocompatibility and performance.

1. Table of Acceptance Criteria and Reported Device Performance

• Negligible: >0 to 0.4
• Slight: 0.5 to 1.9
• Moderate: 2 to 4.9
• Severe: 5 to 8 | The test subject received a Primary Irritation Index Score of 0 in all areas.
  Conclusion: Since no skin irritation was observed in the test subjects, this test demonstrates that Southmedic's CO2/O2 Nasal Cannula is composed of materials that are a non-irritant to skin. |
  | Performance - End Tidal CO2 Measurement | End tidal CO2 values for Southmedic Nasal Cannula shall not be statistically different, or shall vary less from the true end tidal CO2 value than the predicate products. | The end-tidal CO2 values for the Southmedic CO2/O2 Nasal Cannula was not statistically different, or varied less from the true end tidal CO2 value than predicate products. A comparison of variances of the end tidal CO2 measurements from the actual value for all four devices indicates that the Southmedic nasal cannula has the least variance from true value when compared to the three predicate devices within 95% confidence intervals.
  Conclusion: The Southmedic CO2/O2 Nasal Cannula met the predetermined acceptance criteria of the test and performs equally to, or better than, the predicate devices. |

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

• Biocompatibility Studies (Cytotoxicity, Sensitization, Irritation):

  • Cytotoxicity: Three samples of the Southmedic device were tested. Control samples (positive and negative) were also used.
  • Sensitization (Guinea Pig Buehler): Involved Guinea Pigs (number not explicitly stated, but implied to be sufficient for control and test groups). Data provenance is from Nelson Labs (an independent laboratory).
  • Irritation (Rabbits): Involved Rabbits (number not explicitly stated, but implied to be sufficient for control and test subjects). Data provenance is from Nelson Labs (an independent laboratory).
  • Provenance: All biocompatibility testing was "contracted to an independent laboratory" (Nelson Labs). The nature of these tests (animal models) implies prospective testing under controlled lab conditions.

• Performance Study (End Tidal CO2 Measurement):

  • Test Subjects: Southmedic's CO2/O2 Nasal Cannula and three predicate devices (Salter Labs #4706, Hudson RCI BiFlow 1850, UnoMedical/Hospitak 368E).
  • Sample Size: "4 samples x 4 tests per sample x 3 respiratory settings x 4 oxygen flow rate settings = 144 tests total." This refers to testing configurations rather than biological subjects.
  • Provenance: "comparative performance bench test against predicate devices was contracted from an independent laboratory" (Piper Laboratory). This is a prospective bench study using a "Harvard Respiratory pump and mannequin head to simulate patient conditions."

3. Number of Experts and Qualifications for Ground Truth

• Biocompatibility Studies: The ground truth for these studies (e.g., cytotoxicity score, presence/absence of sensitization, irritation index) is established by the methods and observations of the independent laboratory (Nelson Labs) performing the tests according to recognized standards (USP 87, ANSI/AAMI/ISO 10993-5, ISO 10993 Part 10). The qualifications of the personnel performing these lab tests are implied by their adherence to these standards, but specific expert qualifications (e.g., 'toxicologist with 10 years of experience') are not provided.
• Performance Study: The "true end tidal CO2 value" in the performance study refers to the simulated CO2 value set by the test apparatus with the Harvard Respiratory pump. The accuracy of measurements against this simulated "true value" is the ground truth. There is no mention of human experts establishing this ground truth, rather it's based on the controlled parameters of the simulation.

4. Adjudication Method for the Test Set

• Biocompatibility Studies: The adjudication method for these studies involves direct measurement and assessment of biological reactions (scores for cytotoxicity, observation for sensitization, irritation index calculation) as per the specified ISO and USP standards. This typically involves trained lab personnel following standardized protocols, not necessarily an "adjudication panel" in the clinical sense.
• Performance Study: The performance study measured end-tidal CO2 values against a simulated "true" value. There is no mention of an adjudication method involving experts for this test. The statistical analysis of the variance of measurements directly against the known simulated value served as the comparison.

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

No MRMC comparative effectiveness study was done. The device is a nasal cannula, and the studies performed are bench and biocompatibility tests, not clinical or diagnostic interpretation studies involving human readers.

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

The device (CO2/O2 Nasal Cannula) is a physical medical device, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable. The performance study evaluates the physical device's ability to accurately sample CO2 and deliver O2 under simulated conditions.

7. Type of Ground Truth Used

• Biocompatibility Studies: Ground truth is based on standardized biological assays (e.g., cell culture reactions for cytotoxicity, animal responses for sensitization and irritation) interpreted against established regulatory and scientific criteria (USP, ISO standards).
• Performance Study: Ground truth is based on controlled simulated conditions using a mechanical respiratory pump and a mannequin head, where the "true end tidal CO2 value" is a predefined parameter of the simulation.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device and not an AI/ML model for which data models are trained. The studies described are for verification and validation of the device's physical properties and performance.

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

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

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The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes.

The SMDIA-1000 MDI adaptor is single patient use, disposable.

The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of prescribed aerosol medications dispensed by meter dose inhalers (MDI). The SMDIA-1000 is connected to ventilator tubing and the MDI connected when drug delivery into the circuit is required. The SMDIA-1000 adaptor may also be connected to the endotracheal tube.

This document describes the regulatory submission for the Southmedic SMDIA-1000, an adaptor for intermittent delivery of aerosol medications from Metered Dose Inhalers (MDIs) when connected to ventilator or tracheal tubes. The submission aims to demonstrate substantial equivalence to predicate devices, not an AI device. As such, information regarding AI-specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," and sample sizes/ground truth for training/test sets, is not applicable or present in this document.

Here's the breakdown of the provided information relevant to acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily established through comparative performance testing against predicate devices and adherence to internal pass/fail criteria for various engineering tests.

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

• Particle Characterization via Cascade Impactor: 3 samples with 3 different drugs were tested for the proposed device (SMDIA-1000). The predicate used 3 drug types, 1 sample each.
• Other Performance Testing (Simulated life cycle, environmental, operational, drop, canister activation, connection trial, inter- and intra-sample variability): Not explicitly stated, but the document mentions "same sample testing for intra-sample variability" for simulated life cycle, implying repeated tests on the same units. The exact number of units or test cycles for these other tests is not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based prospective engineering/performance studies rather than clinical studies with patient data.

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

Not applicable. This is a submission for a physical medical device (an MDI adaptor), not an AI device or diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., particle size distribution, durability under stress, material biocompatibility) and comparison to established predicate device functionality, not expert consensus on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as the tests are objective engineering and performance evaluations.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers are interpreting images or data. This document pertains to a physical medical device where effectiveness is demonstrated through engineering performance and substantial equivalence to a predicate.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the SMDIA-1000 appears to be:

• Objective Engineering Measurements: Particle size distribution (via Cascade Impactor), durability (simulated life cycle, drop tests), functional integrity (operational, canister activation, connection trials).
• Biocompatibility Testing: Adherence to ISO 10993 standards for cytotoxicity, irritation, and sensitization.
• Predicate Device Performance: The performance of the predicate devices (K991355 - RTC-22-D and K091111 - RTC-24V) served as the benchmark for demonstrating substantial equivalence. The predicate performance would also have been established through similar objective engineering and biocompatibility tests.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable, as this is not an AI/machine learning device.

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To deliver oxygen to patients in low to medium concentrations and provide a means to sample expired gases

The Southmedic OxyArm CO2 is an oxygen delivery device with a headset and oxygen delivery port, which is placed in front of the patient vs. nasal cannula or over their mouth and nose. It also contains a port for taking a sample of expired gases, to measure exhaled end-tidal carbon dioxide. It is connected to a standard oxygen source and the sampling tubing to a standard end-tidal carbon dioxide monitor.

The provided document describes a 510(k) premarket notification for the "OxyArm CO2" device, an oxygen delivery and expired gas sampling mask. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a dedicated study.

Therefore, many of the requested details, such as specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable or not present in the provided text because the device's approval is based on equivalence, not novel performance validation requiring such rigorous testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a novel device might. Instead, it compares attributes of the proposed device to predicate devices to establish substantial equivalence. The "Performance" section within the comparison table implicitly serves as the acceptance criteria, where the proposed device is deemed equivalent if it "Yields comparable CO2 waveforms and values at various flow rates of oxygen" and is "Capable O2 % concentration at various flows."

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

The document does not describe a specific clinical or performance test set with a stated sample size. The approval is based on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of attributes and intended use. There is no mention of specific data provenance (country, retrospective/prospective) for a direct device performance study.

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

Not applicable. No external experts were used to establish ground truth in the context of a performance study for this 510(k) submission. The FDA reviews the provided information and determines substantial equivalence.

4. Adjudication method for the test set

Not applicable. No formal adjudication method involving multiple experts was performed as there was no independent test set demanding such a process.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an oxygen delivery and gas sampling mask, not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. The OxyArm CO2 is a physical medical device, not an algorithm, so standalone performance in this context is irrelevant.

7. The type of ground truth used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this 510(k) submission is the established performance and safety profiles of the legally marketed predicate devices. The new device demonstrates that its attributes and performance are comparable to these existing devices, thus inferring its safety and effectiveness.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no training set in that context.

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

Not applicable. See point 8.

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