(180 days)
The Med-Lok™ Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
The Med-Lok is a hypodermic needle with protection device that allows full use of the needle and covers the needle after use to help prevent needle sticks and touch contamination.
The provided text describes the 510(k) summary for the Med-Lok Safety Needle. However, it does not contain the detailed information necessary to complete a comprehensive table of acceptance criteria and reported device performance, nor does it describe specific studies with the requested level of detail. The document emphasizes substantial equivalence to a predicate device based on technological characteristics, indications for use, and general performance testing.
Here's an attempt to answer your questions based only on the provided text, highlighting what is missing:
1. Table of acceptance criteria and reported device performance
The document states: "Performance Testing: Testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent. These tests included extensive laboratory testing." and "Clinical Testing: Simulated clinical use studies were conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use."
This indicates that acceptance criteria likely revolved around demonstrating functionality and effectiveness in preventing needle sticks, but the specific metrics or thresholds for these criteria are not provided in the text. Therefore, a table cannot be fully constructed.
Acceptance Criteria | Reported Device Performance |
---|---|
Specific functional metrics for needle use and shielding effectiveness (e.g., force to activate shield, percentage of successful shield activations, resistance to accidental shield deactivation, etc.) | "Functions as intended" |
Specific clinical effectiveness metrics (e.g., 100% successful shielding in simulated use, or a defined percentage) | "Could be used effectively with the needle shielded inside the protection device after use." |
Specific safety criteria related to prevention of needle sticks (e.g., rate of accidental needle sticks during simulated use) | "Covers the needle after use to help prevent needle sticks." |
2. Sample size used for the test set and the data provenance
The text mentions "extensive laboratory testing" and "Simulated clinical use studies."
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text implies prospective testing (laboratory and simulated clinical use).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes performance and simulated clinical use studies, not a diagnostic or AI-driven system requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. The document describes performance and simulated clinical use studies, not an assessment requiring adjudication of interpretations.
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
Not applicable. This device is a mechanical safety needle, not an AI-driven diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical safety needle, not an AI-driven system. The "standalone" performance would refer to the device's mechanical function by itself, which is what the "extensive laboratory testing" likely evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the ground truth would have been the successful mechanical function of the device (e.g., deployment of the safety mechanism, fluid aspiration/injection capabilities). For the simulated clinical use studies, the ground truth would have been the successful and effective operation of the device by users in a simulated environment, specifically that "the device could be used effectively with the needle shielded inside the protection device after use." This is based on observation of the device's function rather than a diagnostic 'truth'.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI system.
§ 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).