Search Results

The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries.

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.

The OMI Retractable Safety Syringe is a Sterile, Non Toxic, Non Pyrogenic, Latex Free, Single Use, automatically activated anti-stick piston syringe with integral needle. Available in 1ml, 3ml and 10ml sizes with various needle sizes.

The OMI Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the plunger immediately after patient injection. Needle retraction is activated by the syringe user.

The primary intended use is to administer safe and accurate subcutaneous and intramuscular injections. The secondary intended use is to retract and contain the contaminated needle after injection for the purpose of aiding in the prevention of accidental needle stick injuries.

The provided text is a 510(k) summary for the OMI Retractable Safety Syringe, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with defined performance metrics. Therefore, it does not contain the detailed information typically found in a clinical study report.

Based on the provided text, here's what can and cannot be answered regarding acceptance criteria and a study proving device performance:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the OMI Retractable Safety Syringe (e.g., maximum force for activation, retraction success rate, etc.). Instead, it focuses on compliance with voluntary standards and the functional description of the device's safety feature.

The reported "performance" described is the device's ability to "retract the contaminated needle inside the plunger immediately after patient injection" and its intended use to "administer safe and accurate subcutaneous and intramuscular injections" and "aid in the prevention of accidental needle stick injuries."

While the document lists compliance with several ISO and EN standards (ISO6009, ISO7864, ISO7886-1, ISO7886-4, ISO10993, EN550/ISO11135), these are general standards for hypodermic needles, syringes, biological evaluation, and sterilization, rather than specific performance acceptance criteria for the safety mechanism itself. To understand the specific performance requirements, one would need to consult these standards directly.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the 510(k) summary. A 510(k) submission generally relies on demonstrating equivalence through comparison to a predicate device and adherence to recognized standards, which might involve internal testing, but the details of such testing (sample sizes, provenance, study design) are not typically included in the summary provided to the public.

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):

This information is not applicable/provided. The 510(k) summary does not describe a study involving expert assessment of a "test set" or the establishment of "ground truth" in the way one would for diagnostic imaging or AI devices. The focus is on the physical and functional characteristics of a medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided for the reasons stated above.

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/provided. This type of study (MRMC, AI assistance) relates to diagnostic or AI-powered devices, which the OMI Ret retractable Safety Syringe is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided for the reasons stated above. The "ground truth" for a safety syringe would primarily relate to its mechanical function, sterility, and biocompatibility, which are verified through engineering tests and compliance with standards rather than expert consensus on a "case set."

8. The sample size for the training set:

This information is not applicable/provided. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

This information is not applicable/provided for the reasons stated above.

Ask a specific question about this device