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510(k) Data Aggregation
(265 days)
The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.
The provided document describes the Endoscopy Oxygen Mask (K220533) and its substantial equivalence to a predicate device, the Panoramic Oxygen Mask (POM) (K172365). The acceptance criteria for the new device are primarily demonstrated through comparative non-clinical testing against the predicate device, showing similar performance in key aspects.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each performance metric. Instead, it relies on demonstrating similarity or equivalence to the legally marketed predicate device (K172365) through non-clinical comparative testing. The performance is reported in terms of this similarity.
| Acceptance Criteria (Inferred from Comparison to Predicate) | Reported Device Performance (Endoscopy Oxygen Mask) |
|---|---|
| Indications for Use: Single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes for non-intubated, spontaneously breathing patients > 30 kg. | Similar to predicate. |
| Patient Population: Non-intubated spontaneously breathing patients (Adults to Children). | Similar to predicate. (Note: Subject device tested for Adults, whereas predicate was for Adults to Children). |
| Environment of Use: Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases, and scope access (Hospital, sub-acute, clinic, physician offices, pre-hospital). | Similar to predicate. |
| Duration of Use: Single patient, disposable, < 24 hours. | Similar to predicate. |
| Mode of Operation: O2 delivery through standard oxygen supply tubing and simultaneous exhaled gas monitoring via a gas sampling line connected from mask to capnography or oxygen only delivery. Slit access ports for introduction of a scope. | Similar to predicate. |
| Gas Sampling Connection: Luer slip fit. | Similar to predicate. |
| Profile: Over the nose / mouth. | Similar to predicate. |
| Face Strap: Yes. | Similar to predicate. |
| Entrainment Vents: One-way valves to prevent rebreathing. | Similar to predicate. |
| %CO2 accuracy and Respiration rate: Tested at different simulated patient settings for breath rate, Tidal Volume at different CO2 concentrations with waveforms with similar performance to predicate. | Performed similarly to the predicate, with the proposed device performing better, but no claim made other than equivalence. |
| Biocompatibility: External Communicating (indirect), Tissue contact; Surface Communicating (direct), Skin contact; Limited duration of use (< 24 hours) as per ISO 10993-5, ISO 10993-10, ISO 18562-2. | Similar to predicate. Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and particulate matter testing performed. |
| Shelf-life: Equivalent to predicate's shelf-life. | 1 year accelerated age testing (Predicate had 3 years real-time). Implies similarity in shelf-life characteristics. |
| FiO2 results: Similar across the range of tests. | Similar across the range of tests. The differences did not have a pre-defined clinical criteria and are reported as relative performance for clinician guidance. |
| Internal Volume: No adverse impact on comparative performance. | Subject device has a larger internal volume (314 ml for adult vs. predicate's 198 ml for adult), but this difference does not impact comparative performance and provides more access. |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of number of patients or clinical samples because it describes non-clinical comparative performance testing using simulated patient settings. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective study design as this was not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study was non-clinical and did not involve human experts establishing ground truth for a test set. Performance metrics were based on simulated parameters and physical measurements.
4. Adjudication method for the test set
This information is not applicable as there was no test set requiring expert 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
This information is not applicable. This device is an Oxygen Mask with Gas Sampling, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a medical device, not an algorithm. The performance testing was for the device itself in simulated environments.
7. The type of ground truth used
For %CO2 accuracy and Respiration rate, the "ground truth" was established by simulated patient settings at different breath rates, tidal volumes, and known CO2 concentrations.
For Biocompatibility, the "ground truth" was established by standards such as ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 18562-2.
8. The sample size for the training set
This information is not applicable. There was no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set.
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