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This device is intended for aspiration and injection of fluids including Insulin. The needle protection device covers the needle after use to help prevent needle sticks.

The Portex® Hypodermic Needle-Pro® Fixed Needle Syringe is a graduated hypodermic syringe with a permanently affixed needle and integral needle safety sheath. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. The syringe is used to inject fluids into the body. The Insulin syringe barrel is graduated in U-100 Insulin units and the TB syringe is graduated in milliliters (ml). After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. The needle enters the protective sheath and is contained within the sheath. The device is then discarded into a sharps container.

The provided text describes a medical device, the "Portex® Hypodermic Needle-Pro® Fixed Needle Syringe," and its regulatory clearance process, including studies conducted to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria with numerical targets or detailed study results that would allow for a table of acceptance criteria and reported device performance.

The document highlights the types of studies conducted and their general conclusions, but without specific metrics, it's impossible to fill out the table and provide the granular detail requested for many of the questions.

Here's a breakdown of what can be extracted and what information is missing:

Missing Information:

• Specific Acceptance Criteria: The document mentions "similar performance specifications based on the applicable standards," but does not list these standards or their specific benchmarks (e.g., maximum activation force, retention force after activation, sterility assurance levels, leakage rates, etc.).
• Quantitative Performance Data: There are no numerical results (e.g., success rates, failure rates, device activation times, force measurements) from the bench testing or simulated clinical use studies.
• Sample Sizes (for test set, training set): While "simulated clinical use studies were conducted," the number of participants or simulated uses is not provided. The term "bench testing" implies a set of tests, but not the quantity of devices used.
• Data Provenance (country of origin, retrospective/prospective): Not specified.
• Number and Qualifications of Experts for Ground Truth: Not mentioned, as the studies are focused on device function and safety features, not expert interpretation of diagnostic images or outcomes.
• Adjudication Method: Not applicable given the nature of the device and studies described.
• MRMC Comparative Effectiveness Study: Not conducted, as this is for diagnostic algorithms, not mechanical devices.
• Standalone (algorithm only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth: The "ground truth" here is the functionality of the device (e.g., successful needle shielding, fluid delivery) as measured in bench tests and simulated use. It's not a diagnostic ground truth (like pathology or outcomes data).
• How Ground Truth for Training Set was Established: Not applicable as there's no "training set" in the context of an algorithm. For a physical device, development and internal testing (analogous to "training") would precede the formal validation studies, but specific ground truth establishment for this phase isn't detailed here beyond general "bench testing."

Based on the provided text, here is what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states "Simulated clinical use studies were conducted," but does not give the number of trials or devices tested. Similarly, "Bench testing confirms..." does not include sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the studies were conducted by Smiths Medical ASD, Inc., a U.S. company with a facility in Keene, NH, USA. The nature of these studies ("bench testing," "simulated clinical use") implies prospective testing for the purpose of this 510(k) submission.

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 studies described are focused on the mechanical and functional performance of a physical device (e.g., needle shielding, fluid delivery), not on diagnostic interpretation or expert consensus on clinical findings. Therefore, no "ground truth" experts in the typical sense (e.g., radiologists) would be used for this type of validation.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks, which is not the nature of these studies.

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:

• No. An MRMC comparative effectiveness study is used to evaluate the impact of AI on human diagnostic performance. This device is a physical medical instrument (syringe with safety features), not an AI algorithm, so such a study was not performed.

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

• No. This question applies to algorithms. The studies described are for a physical device, demonstrating its functionality and safety features.

7. The type of ground truth used:

• The "ground truth" for these studies is the direct functional performance and safety demonstration of the device as measured in:
  • Bench testing: Verifying "performance specifications" against applicable standards and comparison to the predicate device. This would involve objective measurements (e.g., force, dimensions, leakage, activation success).
  • Simulated clinical use studies: Demonstrating that the "device could be used effectively with the needle shielded inside the protection device after use." This would involve observing successful activation of the safety mechanism and proper use of the syringe.

8. The sample size for the training set:

• Not applicable/Not specified. This question typically refers to the data used to train an AI algorithm. For a physical device, there isn't a "training set" in this sense. Device development would involve design, prototyping, and internal testing, which might be considered analogous to iterative "training," but specific data sets labeled as "training sets" are not mentioned.

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

• Not applicable due to the nature of the device (physical medical instrument, not an AI algorithm). Ground truth for early-stage development of a physical device would be based on engineering specifications, regulatory guidelines, and internal quality control measurements.

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