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The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe aids in the prevention of accidental needle sticks. The CoverTip™ Safety Syringe employs a sheath that covers the sharp needle upon completion of the injection.

The CoverTip Safety Syringe is a standard piston syringe which incorporates a passive sharp safety needle covering feature. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp after removal. The sheath effectively blunts the end of the needle.

The provided text details a 510(k) summary for the CoverTip Safety Syringe, establishing its substantial equivalence to predicate devices, rather than an acceptance criteria and a study proving device meeting those criteria in the way typically seen for clinical performance studies of AI/diagnostic devices. The document focuses on regulatory approval based on comparison to existing legally marketed devices, not on specific performance metrics with defined acceptance thresholds as one would expect for a new diagnostic or AI-driven medical device. Therefore, many of the requested fields cannot be directly extracted or are not applicable.

However, I can interpret some of the information given the context of a 510(k) submission, particularly regarding "performance data" demonstrating equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices. The performance data presented focuses on showing that the safety feature functions as intended and is comparable to existing safety syringes.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Performance data presented" and "Performance testing conducted," but does not specify the number of units or tests performed.
• Data Provenance: Not specified. It's highly likely to be internal laboratory testing performed by the manufacturer (Medisys Technologies, Inc.) or an accredited testing facility, typically done prospectively as part of device development. The country of origin for the testing is not mentioned, but the manufacturer is based in the USA.

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

• Number of Experts: Not applicable. This type of device (a safety syringe) does not rely on expert interpretation of data to establish a "ground truth" in the way a diagnostic imaging device would. The "ground truth" for its performance would be objective measurements of its mechanical function (e.g., successful sheath deployment, blunting force, fluid delivery accuracy).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no expert interpretation involved in establishing ground truth for this device's performance tests, no adjudication method would be used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. An MRMC study is relevant for diagnostic devices where human readers interpret medical cases, and the study aims to measure the impact of an AI tool on reader performance. This device is a medical instrument, not a diagnostic tool requiring human interpretation of medical cases.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• Standalone Study: Yes, in the sense that the "Performance testing" mentioned is inherently a standalone evaluation of the device's mechanical and functional properties. The syringe's safety mechanism operates automatically ("automatically deploys a plastic cover"), so its performance is evaluated independent of a human operator's cognitive input regarding the safety feature's function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "Performance testing," the ground truth would be established through objective physical measurements and engineering specifications. This includes:
  • Verification of proper mechanical deployment of the sheath.
  • Measurement of needle blunting effectiveness (e.g., force required to penetrate a test material with and without the sheath).
  • Dimensional analysis.
  • Fluid delivery accuracy confirmation.
  • Conformance to relevant international standards (e.g., ISO standards for syringes).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical product, not an AI or machine learning algorithm that requires a "training set" of data. Its design and manufacturing are based on engineering principles and material science.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of this mechanical device. Design validation and verification are based on engineering specifications and testing, not data-driven machine learning.

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