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Single use devices that are indicated for use as an accessory with pre-filled 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 SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (< 24 h) as per ISO 10993 Biological evaluation of medical devices- Part 1: Evaluation and testing.

The provided text describes the 510(k) summary for the UltraSafe Passive Needle Guard, a medical device designed to prevent accidental needlesticks. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. The "acceptance criteria" are implied by the performance data and the conclusion of substantial equivalence.

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

• Sample Size for Test Set: The document does not explicitly state the sample size for the "bench testing" or "simulated use studies." It refers to "test procedures, test protocols, and reports" being maintained within the Quality System, but the specific number of units tested is not provided in this summary.
• Data Provenance: The studies are described as "Bench testing" and "simulated use studies." The document implies these were conducted in-house by Safety Syringes, Inc., as they state, "Safety Syringes, Inc. maintains a Quality System compliant with 21 CFR 820..." and "The firm uses the standard elements of design control..." The data is prospective as it pertains to the evaluation of a new device. There is no mention of country of origin for the data or whether it was retrospective.

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

• This information is not applicable to this type of device and study. The testing involves evaluating the mechanical function and safety features of a needle guard, not the interpretation of medical images or diagnostic results that would require expert consensus for ground truth. The "ground truth" here is objective mechanical performance (e.g., does the guard lock?) and adherence to safety standards.

4. Adjudication Method for the Test Set

• This is not applicable as the evaluation is based on objective mechanical testing and adherence to standards, not human interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical data (e.g., radiologists reading images) to assess the impact of AI on reader performance. The UltraSafe Passive Needle Guard is a mechanical safety accessory, not a diagnostic tool requiring human interpretation in its primary function.

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

• This question is not applicable as the device is a mechanical safety accessory, not an algorithm or AI system. Its performance is inherent in its design and mechanical function, not a software component.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation of the UltraSafe Passive Needle Guard is based on objective mechanical performance criteria and compliance with established standards.
  • For functionality: Confirmation that the guard slides forward, covers, and locks over the needle as designed.
  • For biocompatibility: Meeting the requirements of ISO 10993.
  • For safety: Not activating prematurely and providing protection against sharps injury as defined by FDA guidance and ISO 23908.

8. The Sample Size for the Training Set

• This question is not applicable as the UltraSafe Passive Needle Guard is a mechanical device, not an AI or machine learning system 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 point 8.

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