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Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic 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 needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.

This submission is provided for modifications to the predicate device, which includes design changes and addition of an optional loose extended finger flange. Details are provided in Table 1 hereafter.

The Safe'n'Sound® Staked Passive Delivery System - Plajex® Version is a non-sterile single use anti-needle stick accessory for use with Plajex® sterile prefilled ISO Standard plastic syringes. It fits with Plajex® 1 mL-long staked syringes with a maximum needle length of ½". It consists of a subassembly with a loose plunger rod and an optional loose extended finger flange. The proposed device will be assembled along with the prefilled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the body protecting the user from potential sharps needle stick injury.

The device is made of molded plastic and have a stainless steel spring.

The provided text describes a 510(k) premarket notification for the Safe'n'Sound® Staked Passive Delivery System - Plajex® version, which is an anti-needle stick accessory for prefilled syringes. This document primarily focuses on demonstrating substantial equivalence to a predicate device through design changes, bench testing, biocompatibility testing, and simulated clinical use studies.

However, the document does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a diagnostic AI/ML device study. Instead, the performance testing focuses on showing the device functions as intended and is substantially equivalent to a predicate device, primarily addressing mechanical and safety aspects of a medical device, not diagnostic accuracy.

Therefore, for your specific requests, much of the information, particularly points 2-5, 7-9 which pertain to AI/ML device studies, is not present in the provided text. I will answer what is available and indicate when information is not provided.

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

The document states that performance testing was conducted according to ISO standards, but it does not specify quantitative acceptance criteria or detailed reported device performance in a table format.

Acceptance Criteria and Reported Device Performance (as inferred from the document):

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

The document does not specify the sample sizes (number of devices tested) for the performance, biocompatibility, or simulated clinical use studies. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective.

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 to the type of device and studies described. The "ground truth" here would relate to the physical and functional performance of the medical device, not diagnostic interpretations by experts.

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

This is not applicable to the type of device and studies described. Adjudication methods are typically used in clinical studies involving human interpretation or assessments, which is not the focus of these engineering and performance tests.

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 such study was conducted or described. This type of study is relevant for AI/ML diagnostic devices, not for a physical sharps injury prevention device. The comparison here is between the new device and a predicate device in terms of safety and effectiveness, not human reader performance.

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

This concept is not applicable to this physical medical device. This device is an accessory to a syringe and its performance is inherently tied to its mechanical function and human interaction during use.

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

The "ground truth" for this device's performance would be derived from:

• Reference standards in the ISO norms (e.g., specific force required, shielding effectiveness).
• Visual inspection or mechanical measurement of device functionality (e.g., successful needle shielding).
• Biocompatibility assessments based on established biological response criteria.
• The established safety and effectiveness profile of the predicate device for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm that requires a training set.

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

This is not applicable as there is no AI/ML algorithm that requires a training set.

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