(160 days)
The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.
The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.
The provided document is a 510(k) summary for the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit. It does not contain the detailed performance study information typically associated with AI/ML-based medical devices or diagnostic tools that would have "acceptance criteria" and "reported device performance" in the way an AI model would be evaluated.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Precision Medical 2200 liquid oxygen system K041122) and the results of general performance and mechanical/climatic testing.
Therefore, I cannot directly provide answers to all the requested categories, as they are not applicable to the type of device and submission described. However, I can extract the relevant information from the document as it pertains to the device's validation.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- The document states: "The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas; Mechanical / Climatic, Device Performance."
- It does not provide a table with specific quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy, duration of oxygen delivery under certain conditions) or corresponding measured performance values. This type of detail is usually found in the full 510(k) submission, not the summary.
- Acceptance Criteria (General): The device functions as intended to deliver supplemental oxygen at set rates.
- Reported Device Performance (General): The device successfully passed mechanical/climatic and device performance tests.
- Specifics of Acceptance Criteria/Performance: Not provided in this summary.
Applicability of other questions for this type of device:
The remaining questions (2-9) are typical for the evaluation of AI/ML algorithms or diagnostic devices where "ground truth" establishment, expert review, and statistical analysis of performance against a reference standard are critical. For a purely mechanical device like a portable liquid oxygen unit, these concepts are not directly applicable in the same way.
- No "test set" in the context of images or patient data for AI.
- No "experts" establishing ground truth for disease presence.
- No "adjudication method."
- No "multi-reader multi-case (MRMC) comparative effectiveness study" as there's no human interpretation component to be assisted by AI.
- No "standalone" algorithm performance study.
- No "ground truth" in the diagnostic sense (pathology, outcomes data). The "ground truth" for this device would be its ability to physically deliver oxygen accurately and safely, validated through engineering and functional tests.
- No "training set" as this is a mechanical device, not an AI model.
Summary based on the provided text for a general medical device, not an AI/ML device:
The document describes the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Mechanical / Climatic integrity and function | Successfully passed tests in Mechanical / Climatic areas. |
| Device Performance (e.g., oxygen delivery) | Successfully passed tests in Device Performance areas, indicating it is "safe and effective." |
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to the Precision Medical 2200 liquid oxygen system (K041122). |
(Note: Specific quantitative values for criteria and performance are not included in this 510(k) summary.)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This device undergoes engineering and functional testing, not a clinical "test set" in the diagnostic data sense. Details on the number of units tested are not in this summary.
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. The "ground truth" for this mechanical device is established through engineering specifications and verified by technical testing, not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for this type of device validation.
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 mechanical device, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. There is no algorithm or AI component in this mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering/Functional Specifications: The "ground truth" for this device would be its adherence to established engineering specifications for oxygen production, flow rates, pressure regulation, and mechanical durability. This is verified through direct measurement and physical testing.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).