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Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long 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® Luer Lock Passive Delivery System is an anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes. It fits with needles 1" long maximum, and consists of a body assembly and a loose plunger rod.

The Safe'n'Sound® Luer Lock Passive Delivery System is and anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes and is intended to protect healthcare professionals, patients who self-inject doctor prescribed medication, and individuals that assist self-injecting patients, from accidental needlesticks. The device can be used on a wide range of patients including children and adults.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the bench testing or simulated clinical use testing. It generally states that "Bench testing has been performed" and "Simulated clinical use testing has been performed."

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, "simulated clinical use testing" suggests a prospective, controlled environment, rather than retrospective real-world data.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned (bench testing, simulated clinical use testing) would likely involve technical personnel and possibly healthcare professionals for the simulated use, but specific details are absent.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance is provided. This device is a mechanical accessory, not an AI-powered diagnostic or assistive tool.

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 anti-needlestick accessory, not an algorithm or software.

7. The Type of Ground Truth Used

Based on the description of the testing, the "ground truth" for this device would be established through:

• Engineering specifications and objective measurements: For bench testing, ensuring the device components function as designed and meet specific technical parameters.
• Observational data/expert assessment: For simulated clinical use, verifying that the device effectively shields the needle and can be used safely and effectively by users in a controlled environment.

8. The Sample Size for the Training Set

This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets.

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

This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets or associated ground truth establishment.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device's performance was assessed through two primary types of studies:

1. Bench Testing: This confirmed that the "product functions as intended" and demonstrated substantial equivalence to predicate devices in "general technological features and principle of operation." This testing would have involved evaluating mechanical integrity, activation mechanisms, and general functionality. Biocompatibility testing (meeting ISO 10993-5 and ISO 10993-10) was also performed as part of the bench tests.
2. Simulated Clinical Use Testing: This testing confirmed that the device "could be used safely and effectively to shield needles inside the protection device after use." This likely involved users (potentially healthcare professionals or simulated users) performing injection actions with the device and verifying that the needle retraction/shielding mechanism activated correctly to prevent needlesticks.

Based on the results of these tests, the manufacturer concluded that "the Safe'n'Sound® Luer Lock Passive Delivery System is substantially equivalent to predicate devices currently marketed under the Food, Drug and Cosmetic Act" and "raises no new issues of safety or effectiveness."

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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

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.

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