(205 days)
EZ-ASSIST-FILL is intended to assist the user with refilling a portable liquid oxygen tank. The device is for use in homes or clinics. The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.
EZ-ASSIST-FILL is designed to support any combination of portable and reservoir units that use downward pressure to effect the transfer connection. EZ-ASSIST-FILL consists of a telescoping spring arm assembly mounted on a fiberglass base plate using pivot which allows the spring arm to rotate through 90 degrees to swing over the portable unit when in refill position. The entire unit is held in place by the weight of the reservoir, which rests entirely on the base plate. There is no need to remove the reservoir from EZ-ASSIST-FILL between uses.
Here's a breakdown of the acceptance criteria and the study details for the EZ-ASSIST-FILL, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The EZ-ASSIST-FILL holds the portable oxygen tank in place without any manual intervention. | All EZ-ASSIST-FILL devices tested held the portable oxygen tank in place without any manual intervention. |
| The portable tank is successfully filled when using the EZ-ASSIST-FILL. | All EZ-ASSIST-FILL devices tested resulted in the portable tank being successfully filled. |
| All devices pass the "EZ-ASSIST-FILL Production Unit Repeatability Test." | All devices passed the test. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document states that "EZ-ASSIST-FILL devices were tested," implying multiple units, but a specific number is not provided.
- Data Provenance: The study was a bench test conducted by the submitter (Assist Fill, LLC), not clinical data from patients. The country of origin for the data is not explicitly stated but would presumably be the location where Assist Fill, LLC conducted their testing. It is a prospective test in the sense that units were tested according to a pre-defined protocol.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth was based on the direct observation and measurement of the device's functionality during bench testing against predetermined criteria, rather than expert interpretation of data.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The results of the bench test were objectively measured against technical specifications, not subject to human expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This device is a physical daily activity assist device, not an imaging or diagnostic device that would typically involve human readers. Clinical testing was explicitly stated as not performed.
6. Standalone Algorithm Performance
- Standalone Performance Done? Yes, in the sense that the device's performance was evaluated purely on its own mechanical function during the bench test, without human intervention during the filling process once the device was in position. However, it's not a "standalone algorithm" in the typical sense of AI/software performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was objective functional criteria established for the device's operation. This involved verifying that the device held the tank in place without manual intervention and that the tank was successfully filled.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical assist device, not an AI/machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.