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Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.

This 510(k) summary describes a modification to an existing medical device, the Safety Syringes UltraSafe Delivery System/Needle Guard devices, which are anti-needlestick accessories for pre-filled ISO Standard glass syringes. The modification is an expansion of the Indications for Use to include self-injecting patients and those who assist them, beyond the original limitation to healthcare professionals.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a formal table of acceptance criteria or specific quantitative performance metrics for the device. Instead, it describes a qualitative assessment related to the expanded user group.

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

• Sample Size: The document does not specify the exact sample size used for the "testing" mentioned. It refers to "typical nonhealthcare users" without providing a number.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a premarket notification for a US FDA approval, it's highly likely the testing was conducted in the US. The "testing" appears to be a prospective assessment of user comprehension and device interaction.

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

The document does not describe the use of "experts" to establish ground truth for the usability testing with non-healthcare personnel. The assessment appears to be based on the ability of the users themselves to perform the task as intended. If "ground truth" refers to the correct execution of the device's function, it's implied that the device design and IFU served as the standard.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Given the nature of the evaluation (user comprehension and device interaction), it's unlikely a formal adjudication process (like 2+1 or 3+1) was used as would be common in diagnostic AI studies. The "testing" would more likely involve observation and direct assessment of task completion and understanding.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and their performance is compared with and without AI assistance. This device is an anti-needlestick accessory, not a diagnostic tool requiring interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This concept is relevant for AI algorithms. The device itself is a physical accessory designed to be used by humans. The "testing" mentioned focuses on human-in-the-loop performance, specifically the ability of non-healthcare users to correctly use the device.

7. Type of Ground Truth Used

The "ground truth" for the "testing" described is implicitly the intended and correct use of the device as per its design and Instructions for Use (IFU). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device study. Instead, it's about evaluating user compliance and understanding.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. This document describes a physical medical device. Therefore, there is no "training set" in the context of AI/ML. The device's design would have undergone engineering and design validation, but not "training" in the computational sense.

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

As there is no "training set" in the AI/ML context for this device, a method for establishing its ground truth is not applicable or described. The performance of the device itself (e.g., its anti-needlestick effectiveness) would have been established through prior design verification and validation activities for the original device, likely involving engineering tests, material compatibility tests, and potentially simulated use tests. However, the document focuses only on the change in Indications for Use and the associated human factor/usability testing for the new user population.

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The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.

UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.

The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.

The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).

The provided text describes a 510(k) submission for the UltraSafe Passive™, X-Series, Needle Guard. The submission focuses on demonstrating substantial equivalence to a predicate device, the UltraSafe® Injection System Needle Guard - B-Series, rather than establishing de novo acceptance criteria associated with a specific diagnostic performance outcome.

Instead of traditional diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), the study evaluates the safety, performance, and usability of the new passive device compared to the manually activated predicate device through a controlled simulated clinical use test.

Here's an analysis of the "acceptance criteria" and the study based on the provided text:

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

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

• Sample Size: Not explicitly stated beyond "nurses involved in this study" and "study participants." The exact number of nurses is not provided.
• Data Provenance: The study was a "controlled simulated clinical use test." It is prospective in nature, as it involved active participation of users with the device. The country of origin is not specified but given the company information (Carlsbad, CA, USA) and the FDA submission, it can be inferred that the study was likely conducted in the USA.

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 is not applicable in the context of this device. The "ground truth" here is subjective user feedback and comparative assessment by "nurses" on safety, performance, and usability, rather than an objective diagnostic or clinical outcome requiring expert consensus for ground truth establishment.

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

Not applicable. There was no "ground truth" to adjudicate in the traditional sense of diagnostic accuracy. The study involved user ratings and comparisons.

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 device is a mechanical safety accessory, not an AI or imaging device that would involve human "readers" interpreting cases. The study was a comparative user evaluation of a medical device's safety features and usability.

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

Not applicable. This device is a physical accessory where "human-in-the-loop performance" (i.e., use by healthcare professionals) is its primary mode of operation and evaluation.

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

The "ground truth" was established through user evaluation and comparative ratings by nurses during a simulated clinical use test. It's based on subjective feedback and direct comparison of the new device (X-Series) against the predicate device (B-Series) on parameters of safety, performance, and usability. There is no objective medical ground truth (like pathology or clinical outcomes) being assessed for this type of device.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of mechanical device evaluation. The "iterative user evaluations" conducted by Safety Syringes, Inc. prior to the controlled simulated clinical use test might be considered analogous to developmental testing, but not a formal "training set" in the context of AI/machine learning.

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

Not applicable as there was no formal "training set" with ground truth in the traditional sense for this device.

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