(291 days)
Single use devices that are 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 needlesticks. The devices can be used on a wide range of patients including children and adults.
The Safe'n'Sound Passive Delivery System is an antineedlestick accessory for use with sterile prefilled ISO Standard glass syringes. It fits 1 mL long staked needle syringes, and consists of a body assembly and a loose plunger rod.
The provided document describes the "Safe'n'Sound Passive Delivery System," an antineedlestick accessory for prefilled syringes. However, it does not explicitly state acceptance criteria in a quantitative manner (e.g., specific percentages for sensitivity, specificity, accuracy, or failure rates) or present a formal study with a detailed methodology, sample sizes, and statistical results in the way typically required for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
- Technological Characteristic Comparison: Stating similarity in general technological features and principle of operation, with minor differences deemed insignificant based on testing.
- Performance Testing: Bench testing confirmed the product functions as intended.
- Biocompatibility Testing: Demonstrated meeting ISO 10993-5 and ISO 10993-10 requirements.
- Clinical Testing: Simulated clinical use testing confirmed safe and effective needle shielding.
Given this, I cannot fully complete the requested table and details as if it were a typical AI/ML device study with precise acceptance criteria and performance metrics. I will interpret the available information to best fit the request.
Acceptance Criteria and Study Details for Safe'n'Sound Passive Delivery System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Report) | Reported Device Performance |
|---|---|
| Functional as intended (e.g., proper activation, needle shielding) | Confirmed by Bench Testing. Device functions as intended. |
| Biocompatibility (non-toxic, non-irritating, non-sensitizing) | Meets ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) requirements. |
| Safe and Effective Needle Shielding (in simulated clinical use) | Confirmed by Simulated Clinical Use Testing. Device safely and effectively shields needles inside the protection device after use. |
| Substantial Equivalence to predicate device (UltraSafe® Passive Delivery System) | Based upon design, technology, performance, functional testing, and intended use, the device is substantially equivalent to the predicate device. |
| No New Issues of Safety or Effectiveness | No new issues of safety or effectiveness are raised by the device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) in the context of an AI/ML study.
- Bench Testing: No specific sample size is provided. The testing confirmed intended function.
- Simulated Clinical Use Testing: No specific sample size is provided. The testing confirmed safe and effective needle shielding.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the information provided. The study described relies on bench testing and simulated clinical use, not expert-labeled ground truth for an AI algorithm. The evaluation is based on device performance against physical and biological standards.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" requiring expert adjudication for ground truth establishment. Performance was assessed through physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI system on human reader performance in diagnostic tasks, which is outside the scope of this device (a physical anti-needlestick accessory).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the "Safe'n'Sound Passive Delivery System" is a physical medical device, not an AI algorithm. Its performance is inherent to its mechanical design and function.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Physical Functionality: Whether the device physically performed its intended action (e.g., successful shielding, proper activation) as determined by engineering and performance tests.
- Biological Standards: Compliance with recognized biocompatibility standards (ISO 10993-5 and ISO 10993-10) for material safety.
- Predicate Device Performance: Comparison to the known performance and safety profile of the legally marketed predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This device is not an 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 training set for an AI/ML algorithm.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).