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Single use device that is indicated for use as an accessory with sterile 1 mL-long staked needle 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 needle sticks. The devices can be used on a wide range of patients including children and adults.

This submission is provided for modifications to the predicate device, which includes design changes and a plunger rod raw material change. For details, please refer to Attachment 1 for Design Modifications Rationale. The Safe'n'Sound® Staked Passive Delivery System – Cone Version is a single use anti-needle stick accessory for use with sterile 1 mL-long staked needle prefilled ISO Standard glass syringes. It fits with 1 mL-long staked syringes with a maximum needle length of 1/2" and consists of a subassembly (body, cone, sleeve, and spring) and a loose plunger rod.

The provided document is a 510(k) summary for the Safe'n'Sound® Staked Passive Delivery System - Cone Version. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study protocols, sample sizes for training or test sets, information on ground truth establishment, or expert involvement in adjudication for a medical image analysis or diagnostic AI device.

The document outlines performance testing in general terms: "Bench testing has been performed on the Safe'n'Sound® Staked Passive Delivery System - Cone version. It confirmed the product functions as intended and is substantially equivalent to the predicate device. Biocompatibility testing performed demonstrates that the product meets ISO 10993-5 and ISO 10993-10 requirements." It also mentions "Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound® Staked Passive Delivery System - Cone version could be used safely and effectively to shield needles inside the protection device after use."

Since this is a submission for a piston syringe accessory and not an AI/ML medical device for diagnosis or image analysis, many of the requested categories (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, or specific acceptance criteria for diagnostic performance) are not applicable or are not detailed in the provided text.

Based on the nature of the device (a mechanical accessory for syringes), the "acceptance criteria" would primarily revolve around functional performance, safety, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity.

Therefore, I cannot populate most of the requested table and information as it pertains to AI/ML device studies. I will address what can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Due to the nature of the device and the provided document, the following sections cannot be answered with specific details as they pertain primarily to diagnostic AI/ML studies and are not documented here for this mechanical device.

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

• The document mentions "Bench testing" and "Simulated clinical use testing" but does not specify sample sizes for these tests or data provenance.

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 as the device is a mechanical accessory, not a diagnostic tool requiring expert interpretation for "ground truth".

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

• This is not applicable for a mechanical device.

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

• This is not applicable as the device is a syringe accessory, not an AI diagnostic tool that assists human readers.

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

• This is not applicable as the device is a mechanical accessory, not an algorithm.

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

• For a mechanical device like this, "ground truth" would be established via engineering specifications, functional requirements, and safety standards (e.g., successful needle shielding, no accidental sticks, material integrity). The document does not detail the specific methodology for establishing this "ground truth" beyond stating successful testing.

8. The sample size for the training set

• This is not applicable as there is no "training set" for a mechanical device in this context.

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

• This is not applicable as there is no "training set" for a mechanical device.

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