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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.

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The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.

The device is a combination scalpel blade and handle incorporating a sharps injury protection feature. There are two product options -(1) a totally disposable unit and (2) a metal handle with disposable blade and guard - our "reposable" product. The totally disposable unit uses a plastic handle while the reposable product has a stainless steel handle.

The provided document is a 510(k) summary for the PersonnaPlus Safety Scalpel System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria, a comprehensive study design with sample sizes, expert qualifications, adjudication methods, or MRMC studies.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "successful simulated user study was conducted according to FDA guidance document Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA Document Issued on: December 31, 2002."

However, it does not provide a specific table of acceptance criteria or the quantitative results (e.g., number of accidental injuries, rate of successful guard deployment) from this simulated user study. The "reported device performance" is broadly stated as enhancing safety and being substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions a "simulated user study," but does not specify the sample size (e.g., number of users, number of simulated procedures) used for this test.

• Sample Size for Test Set: Not specified.
• Data Provenance: The study was a "simulated user study," implying it was conducted in a controlled environment, likely in Australia (country of origin of OMI Manufacturing Pty Ltd) or the USA (where FDA guidance applies). It would be considered prospective as it's a study specifically conducted for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a simulated user study on a safety scalpel, "ground truth" might refer to expert observation of proper use, safety feature deployment, or assessment of simulated injury events. However, no details are given.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the simulated user study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. MRMC studies are typically for evaluating diagnostic imaging or AI performance where multiple readers interpret cases. This device is a surgical scalpel with a safety feature, so an MRMC study is not directly applicable in its traditional sense. The study conducted was a "simulated user study" focusing on sharps injury prevention.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the PersonnaPlus Safety Scalpel System is a physical medical device (scalpel) with a mechanical safety feature, not an algorithm or AI. Its performance inherently involves human interaction (user handling).

7. The Type of Ground Truth Used

For the "simulated user study," the "ground truth" likely involved:

• Expert observation/assessment: Healthcare professionals or trained observers evaluating the proper use of the scalpel, the successful deployment of the safety feature, and the absence of simulated sharps injuries.
• Performance metrics related to sharps injury prevention: This would likely involve quantifiable outcomes like the number of successful activations of the safety mechanism, the rate of inadvertent exposures, or compliance with safe disposal protocols.

However, the document does not explicitly state the specific type of ground truth or how it was established beyond "a successful simulated user study."

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device, not an AI or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above (not an AI/algorithm).

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