(42 days)
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. The device is to be used by a health care professional only.
The Human Subcutaneous Injector system consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
The provided text describes a 510(k) summary for the Human Subcutaneous Injector system (HSI 500) and its substantial equivalence to predicate devices, but it does not include detailed studies or specific acceptance criteria with reported device performance numbers. The summary states:
"The performance characteristics are substantially equivalent to the Bi-3M according to test protocols conducted for dosage accuracy, penetration, force, focus, sound, and stream quality. Safety tests performed for contamination were successful."
This indicates that tests were performed, but the actual acceptance criteria (e.g., "dosage accuracy must be within X%") and the specific results (e.g., "dosage accuracy was Y%") are not provided in the document.
Therefore, I cannot fully complete the requested table and many of the study-related questions based only on the provided text.
However, I can extract what is implied and explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/General) | Reported Device Performance (Implied/General) |
|---|---|---|
| Dosage Accuracy | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Penetration | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Force | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Focus | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Sound | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Stream Quality | Substantially equivalent to predicate device (Bi-3M) | Performance characteristics are substantially equivalent to Bi-3M |
| Contamination | Successful, meeting safety standards | Safety tests for contamination were successful |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified, but implied to be from tests conducted by the submitter (Regulatory/Clinical Consultants, Inc. for Felton International). The country of origin and whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The assessment appears to be based on technical performance metrics against a predicate device, not expert human interpretation.
4. Adjudication method for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in image analysis or similar diagnostic contexts. This device's testing relates to physical performance.
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 not an AI-assisted diagnostic device, nor does the document describe a human-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a fluid injector system, not an algorithm. The testing described relates to the device's physical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence was the performance characteristics of the predicate device, Felton International's Bi-3M. The "test protocols" conducted would have measured the HSI 500's performance against these established characteristics for dosage accuracy, penetration, force, focus, sound, and stream quality.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).