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The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.

The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.

The provided documentation describes the 1cc Insulin SafePro Safety Syringe and its substantial equivalence to predicate devices, rather than a study involving acceptance criteria and device performance in the context of an AI or diagnostic device.

Therefore, many of the requested fields cannot be filled, as the document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic tool. The "performance" discussed relates to design and material equivalence, as well as the safety features of the syringe itself.

Here's an attempt to extract relevant information, with an emphasis on what cannot be answered given the nature of the document:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a study for a diagnostic or AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily shown through the comparison matrix and claims of identical design and materials.

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

Not applicable. This is not a study involving a test set of data for an AI or diagnostic device. The "testing" referred to is material testing and simulated use studies for a physical device, which were previously conducted on predicate devices. There is no mention of a "test set" in the context of data for an algorithm.

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)

Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI or diagnostic device. The "ground truth" for a physical device like this is typically established through adherence to engineering standards, material specifications, and regulatory requirements.

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

Not applicable. There is no test set or adjudication method described for an algorithm or diagnostic 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 document pertains to a physical medical device (syringe with a safety feature), not an AI or diagnostic device requiring human reader interaction.

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

Not applicable. This device is a physical syringe, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness is largely based on:

• Material compatibility and safety standards: Established through prior testing of identical materials in predicate devices (K012726, K022063).
• Functional performance standards: Demonstrated by the physical design and features being identical to previously cleared devices.
• Substantial Equivalence: Comparison to legally marketed predicate devices (K980580, K012726) that have already met regulatory requirements.
• Guidance documents: The comparison matrix was developed in accordance with the "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".

8. The sample size for the training set

Not applicable. There is no training set for an AI or diagnostic algorithm described.

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

Not applicable. There is no training set mentioned in the context of this device.

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The primary indicated use for the SafePro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid.

The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.

Acceptance Criteria and Study for SafePro* Plus Safety Syringe

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 500 SafePro* Plus Safety Syringes were evaluated.
• Data Provenance: The study was a "simulated use study," implying it was a prospective study conducted specifically for this submission. The text does not specify the country of origin of the participants.

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

The provided text does not mention experts being used to establish a "ground truth" for the simulated use study. Instead, the study involved "50 participants" who evaluated the syringes and provided "positive responses." It also reported that "no sharps injuries or failures of the safety mechanism occurred." This suggests that the "ground truth" was based on direct observation of safety mechanism functionality and user feedback, rather than expert judgment on complex cases.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. Since there's no mention of multiple experts establishing ground truth, a formal adjudication process (like 2+1 or 3+1) would not be applicable here. The outcomes (no injuries, no failures, positive responses) appear to be directly observed and collected.

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

No, an MRMC comparative effectiveness study was not done. The study described is a simulated use study focusing on the device's functionality and safety, not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

N/A (Not Applicable). The SafePro* Plus Safety Syringe is a physical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The ground truth used in this study was based on:

• Direct observation of device performance and safety: "No sharps injuries or failures of the safety mechanism occurred."
• User feedback/satisfaction: "Positive responses from the Evaluators regarding functional and performance aspects."

This is not a traditional "expert consensus," "pathology," or "outcomes data" in the typical diagnostic sense, but rather a direct assessment of device functionality and user experience.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the SafePro* Plus Safety Syringe is a physical device, not an AI/ML model. Therefore, there is no training set.

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

As there is no training set, this question is not applicable.

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The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.

Here's an analysis of the provided text regarding the 1cc SafePro Safety Syringe, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the simulated use study. Instead, it describes the outcome of the study as supporting the claim.

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

• Test Set Size: 500 1cc SafePro® Safety Syringes were evaluated by 50 participants. This implies a test set of 500 syringes, evaluated by users.
• Data Provenance: The study was a "Simulated Use Study." The document does not specify the country of origin of the data or if it was retrospective or prospective, but "simulated use" generally implies a prospective study conducted in a controlled environment designed to mimic real-world usage.

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

No external experts are mentioned as establishing ground truth for the simulated use study results. The study directly assessed the performance of the device (occurrence of sharps injuries, safety mechanism failure, and user feedback). The "evaluators" were the participants, whose direct experience constituted the data for this specific study.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for the simulated use study. The outcomes (sharps injuries, mechanism failure) appear to be direct observations, and customer requirements were assessed through "positive responses from the Evaluators." This suggests direct reporting rather than a consensus or adjudicated process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No MRMC comparative effectiveness study is mentioned. This device is a medical instrument (syringe), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical instrument, not an algorithm. Its performance is intrinsically linked to human interaction (human-in-the-loop, in this context meaning operation by a user).

7. The Type of Ground Truth Used

For the simulated use study, the "ground truth" was established by direct observation of events (sharps injuries, safety mechanism failure) and user feedback on functional and performance aspects. This can be categorized as observed outcomes and user satisfaction data.

8. The Sample Size for the Training Set

No training set is mentioned. This device is a physical product, not an AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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