(382 days)
The Kingon P2 is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
The Kingon P2 oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. In brief, after the device takes the room air, the molecular sieve packed in a sealed container can absorb nitrogen in the air, and the oxygen still exists in gaseous form that can be collected by specially designed pipelines and deliver to patients. When the environmental air pressure decreases, exhaust of the vacuum container occurs and nitrogen will be released from the molecular sieve. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it. In this way, Kingon P2 device can concentrate the oxygen in the air to produce a pulse of oxygen between 87-96% in purity.
This is a 510(k) premarket notification for a medical device, specifically the Kingon Portable Oxygen Concentrator P2. The document focuses on demonstrating substantial equivalence to a predicate device (Philips Respironics SimplyGo Portable Oxygen Concentrator) rather than outlining acceptance criteria and a detailed study proving performance against those criteria.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating equivalence to the predicate device and adherence to various safety standards. It doesn't explicitly list "acceptance criteria" for performance in the same way an AI/ML device might have clinical performance metrics, but rather shows the device "Pass"ed various bench tests and biocompatibility tests against established standards.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Tests | Adherence to relevant IEC and ISO standards for medical electrical equipment and oxygen concentrators. | Pass (for all listed standards) |
| Oxygen Concentration | At least 87% (maximum 96%) over the rated environmental range (identical to predicate). | Same (Implied to meet this, as it's directly compared to the predicate with "Similar") |
| Equivalent Flow rates | 10-40 BPM (increments of 5BPM) | 10-40BMP increments of 5BPM |
| Dose at Specified Flow | 10.5mL per setting (with 20BPM) | 10.5mL per setting (with 20BPM) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11, IEC 60601-1-8 | Pass |
| Oxygen Concentrator Safety | ISO 80601-2-69, ISO 80601-2-67 | Pass |
| EMC | IEC 60601-1-2, 47 CFR Part 15, subpart B | Pass |
| Battery Safety | IEC 62133, ST/SG/AC.10/11/Rev.6/Section 38.3 | Pass |
| RF Immunity | AIM standard 7351731 | Pass |
| Biocompatibility | Adherence to ISO 10993 and ISO 18562 standards | Pass (for all listed tests) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "Performance testing provided in this submission," but doesn't detail the number of devices or units tested for the various bench and biocompatibility tests. These are typically engineering tests on a small batch of devices, not clinical trials with human subjects.
- Data Provenance: The device manufacturer is Qingdao Kingon Medical Science and Technology Co., Ltd in China. The reports for the listed tests (e.g., GZME, SHES, SDWH, ESU) indicate that testing was likely conducted by various accredited testing laboratories, potentially in China (GZME implies Guangzhou, SHES implies Shanghai, SDWH implies Shandong Weihai) or third-party labs recognized for these standards. The tests are bench and lab-based, not clinical data from patients.
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 or not provided. The "ground truth" for a physical device like an oxygen concentrator is typically established by physical measurements against engineering specifications and regulatory standards using calibrated equipment, not by human expert consensus or clinical assessment of outcomes.
4. Adjudication method for the test set:
This information is not applicable or not provided. Adjudication typically refers to resolving disagreements among human readers/experts, which isn't relevant for the type of bench and biocompatibility testing described.
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. An MRMC study is relevant for AI/ML-driven diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Kingon P2 is a physical medical device (an oxygen concentrator) and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The Kingon P2 is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Engineering Specifications and Standard Requirements: The "ground truth" for the performance tests (e.g., oxygen concentration, flow rates, electrical safety, acoustic noise) would be the device meeting its design specifications and adhering to the limits set by the referenced international and national standards (IEC, ISO, CFR).
- Laboratory Analysis: For biocompatibility tests, the ground truth is established through laboratory analyses (e.g., in vitro cytotoxicity, skin sensitization, irritation tests) that demonstrate the materials are safe for biological contact based on established protocols in standards like ISO 10993 and ISO 18562.
8. The sample size for the training set:
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
In summary, the provided document is a 510(k) submission focusing on substantial equivalence of a physical medical device to a predicate device, rather than a performance study report for an AI/ML product. Therefore, many of the questions are not relevant or cannot be answered from the text. The "studies" mentioned are bench tests and biocompatibility assessments to regulatory standards.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).