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The primary intended use of the EasySafe® Retracting Needle Syringe is to inject fluid into, or withdraw fluid from the body. The secondary intended uses are:

1. to help prevent sharps injuries when using the product for its primary intended use, and;
2. to help reduce wasted medication when using the product for its primary intended use.

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Here's an analysis of the provided text regarding the EasySafe™ Retracting Needle Syringe, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for EasySafe™ Retracting Needle Syringe

Note: This device is a medical syringe, not a software or AI-powered device. Therefore, many of the typical questions for AI/software (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable here. The focus is on physical device performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size (Simulated Use Studies): Over 1,500 injections/fluid withdrawals were administered across two simulated use studies.
• Data Provenance: The text does not explicitly state the country of origin. Given the manufacturer (Saf-T-Med, Inc. based in Barrington, IL) and the FDA submission, it is highly probable the studies were conducted in the United States. The studies were prospective as they were described as "simulated use studies" performed "to test the effectiveness" and "to test the safety" of the product.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a physical syringe, not an algorithmic diagnostic device requiring expert interpretation for ground truth.
• For the simulated use studies, "a wide variety of clinicians" were used, but their qualifications other than being "clinicians" are not further specified.
• For the focus groups, "twenty clinicians" provided feedback. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device testing scenario (simulated use, bench testing), an adjudication method in the context of diagnostic interpretation (like 2+1 radiology review) is not relevant. The "ground truth" for effectiveness was successful completion of the procedures, and for safety, the absence of reported injuries.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Performed. The studies described are not MRMC studies. They focus on the performance and safety of the device itself, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only)

• Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance metrics described (e.g., successful injections, no injuries) are the standalone performance of the physical device.

7. Type of Ground Truth Used

• Observed Performance/Outcome:
  • Effectiveness: "All injections/withdrawals were successfully completed" (direct observation of successful procedure execution).
  • Safety: "No injuries of any kind were reported" (direct observation/reporting of adverse events).
  • Bench Testing: Conformance to ISO standards, comparability to predicate devices, graduation accuracy, needle guard puncture resistance (measured physical properties).
  • Biocompatibility: Laboratory test results.
  • Sterilization/Pyrogenicity: Laboratory test results confirming SAL and acceptable pyrogenicity.
  • Clinician Feedback: Subjective assessment from clinicians in focus groups and during simulated use regarding ease of use and safety features.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and development of the syringe would have involved engineering and design iterations, but these are distinct from an algorithmic training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The primary intended use of the EasySafe™ Retracting Needle Syringe is to inject fluid intramuscularly (IM) into the body. The secondary intended uses are:

1. to help prevent sharps injuries when using the product for its primary intended use, and;
2. to help reduce wasted medication when using the product for its primary intended use.

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The provided text describes the safety and effectiveness of the EasySafe™ Retracting Needle Syringe (K973792).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

2. Sample size used for the test set and data provenance

• Sample Size (Effectiveness & Safety): Over 1,000 IM injections were administered.
• Data Provenance: The study was a "simulated use study." The geographic origin of the study is not explicitly stated, but the manufacturer is based in Illinois, USA. The study appears to be prospective (a "recent simulated use study").

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• Experts (Effectiveness & Safety - Simulated Use): "A wide variety of clinicians" participated. The exact number and their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.
• Experts (Effectiveness - Focus Groups): "Twenty clinicians" indicated no impediments. Their specific qualifications are not detailed.

4. Adjudication method for the test set

• The text does not describe an adjudication method for the simulated use study. The assessment of "successfully completed" injections and "no injuries of any kind" likely came directly from the clinicians observing or participating in the simulated use, without a separate adjudication process mentioned.

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

• There is no MRMC comparative effectiveness study mentioned in the provided text. This study pertains to a medical device (syringe), not an AI/imaging diagnostic tool that would typically involve human readers.

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 physical medical instrument (syringe), not an algorithm or AI. The performance tests ("bench testing") represent a form of standalone testing against established physical standards.

7. The type of ground truth used

• Effectiveness: Direct observation of injection completion in a simulated setting.
• Safety (Injuries): Direct observation and reporting of injuries in a simulated setting.
• Bench Testing (Effectiveness & Safety): Compliance with "applicable performance standards established by the International Standards Organization (ISO)" and "comparability with legally-marketed predicate devices for a variety of safety factors." This indicates a ground truth based on established engineering and regulatory standards.
• Biocompatibility, Sterilization, Pyrogenicity: Laboratory test results against specified standards (e.g., SAL of 10^-6).

8. The sample size for the training set

• This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require training sets.

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

• This question is not applicable for the same reason as above.

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