(51 days)
The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The Otter Safety Syringe is an integrated needle and piston syringe with an innovative anti-needlestick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques meenanism. "The atternechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows that the needle has been crushed within the syringe barrel. After standard techniques for injection, the plunger is withdrawn completely into the barrel. A forward compression of the plunger again and the needle is crushed within the puncture-resistant barrel. This renders the needle unusable and safe from accidental needle sticks.
The provided text is a 510(k) summary for the Otter Safety Syringe and does not contain detailed information about specific acceptance criteria or the study that comprehensively proves the device meets those criteria in a quantitative sense as typically expected in a comprehensive testing report. The summary states that "clinical testing in China and simulated use testing in per remails by qualified healthcare professionals proved the Otter Safety Syringe performs reliably and in accordance with the high expectations for safety syringes set by FDA and healthcare organizations." However, it does not provide the specific performance metrics, acceptance criteria, or the study methodology and results.
Therefore, I cannot fully complete all sections of your request based on the provided input. I will extract the information that is present and indicate where the information is missing.
Acceptance Criteria and Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding reported device performance values. It generally states that the device "performs reliably and in accordance with the high expectations for safety syringes set by FDA and healthcare organizations" and "has been shown to meet internationally recognized standards for syringe performance and labeling characteristics."
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (General Statement) |
|---|---|
| Reduces risk of sharps injuries | Performs reliably, reduces risk of sharps injuries, and renders the needle unusable and safe from accidental needle sticks by crushing it within the syringe barrel. |
| Prevents syringe reuse | Non-reusable, as the needle is crushed within the barrel. |
| Meets internationally recognized standards for syringe performance | Device has been shown to meet these standards. |
| Meets high expectations for safety syringes set by FDA and healthcare organizations | Device performs reliably and in accordance with these expectations. |
Study Details
Due to the limited information in the 510(k) summary, much of the detail for the study cannot be provided.
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: "Clinical testing in China" and "simulated use testing in per remails by qualified healthcare professionals." This indicates both prospective clinical data and simulated use data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Described as "qualified healthcare professionals." Specific qualifications (e.g., years of experience, specialty) are not provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
4. 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:
- No MRMC study mentioned. This device is a physical safety syringe, not an AI-assisted diagnostic tool, so such a study would not be applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Based on "clinical testing" and "simulated use testing," the ground truth would likely be based on observed performance and assessments by "qualified healthcare professionals" regarding successful needle retraction, crushing, and prevention of reuse, as well as the absence of accidental needle sticks. Specific methodologies for establishing this ground truth (e.g., direct observation, incident reports) are not detailed.
7. The sample size for the training set:
- Not applicable as this is a physical device, not a machine learning algorithm requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).