(218 days)
VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).
The VacLok™ AT Vacuum Syringe is a general piston syringe constructed using a barrel, plunger, piston seal, and locking mechanism. It is designed to lock in any position along the length of the barrel with the capability of holding a vacuum when the cam locking mechanism is engaged.
The provided text is a 510(k) summary for the Merit VacLok™ AT Vacuum Syringe, a medical device. This document focuses on demonstrating the device's substantial equivalence to predicate devices, primarily through performance bench testing against recognized international standards and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth in an AI/ML context.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract information related to the acceptance criteria and performance testing that was conducted for this physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device complies with FDA-recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." Specific acceptance criteria values are not explicitly listed in a table, but the areas of testing and the general statement of compliance serve as the "reported device performance."
| Category | Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|---|
| ISO 7886-1:1993 | (Implicitly, the requirements of the standard for each test) | All tests met the established acceptance criteria for intended use. |
| Cleanliness | ||
| Limits for acidity or alkalinity | ||
| Limits for extractable metals | ||
| Lubricant | ||
| Tolerance on Graduation | ||
| Capacity | ||
| Graduation Scale | ||
| Barrel | ||
| Piston/Plunger Assembly | ||
| Nozzle | ||
| Performance - Freedom from air and liquid leakage past piston | ||
| ISO 594-2:1998 | (Implicitly, the requirements of the standard for each test) | All tests met the established acceptance criteria for intended use. |
| Gauging | ||
| Liquid leakage | ||
| Air leakage | ||
| Separation force | ||
| Unscrewing torque | ||
| Ease of assembly | ||
| Resistance to overriding | ||
| Stress cracking | ||
| Vacuum Performance Testing | All tests met the established acceptance criteria for intended use. | |
| Air Leakage (Annex B of ISO 7886-1) | ||
| Vacuum Hold (Annex B of ISO 7886-1, 2 minutes) | ||
| Biocompatibility Testing | (Implicitly, the requirements of the ISO 10993 series and related FDA guidance) | All tests demonstrated biocompatibility for the specified contact type and duration. |
| Cytotoxicity | ||
| Sensitization | ||
| Irritation | ||
| Acute Systemic Toxicity | ||
| Pyrogenicity | ||
| Hemolysis | ||
| USP Physicochemical |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of syringes) used for each bench test. The data provenance is also not detailed beyond the statement that testing was performed by the manufacturer against international standards. It's inherent to this type of device submission that testing is done in a controlled laboratory setting (prospective testing of manufactured devices), rather than using clinical patient data. The country of origin for the data (testing lab location) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is a medical device (syringe) performance evaluation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical records. The "ground truth" for the device's performance is established by the specifications and acceptance criteria of the referenced ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no human interpretation or subjective assessment being adjudicated. Device performance is measured objectively against predefined standards.
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
This question is not applicable as the device is a physical syringe, not an AI system.
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 syringe, not an algorithm. Bench testing evaluates the device's performance standalone relative to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on the objective technical specifications and acceptance criteria outlined in recognized international consensus standards (e.g., ISO 7886-1, ISO 594-2) and the FDA's guidance documents for biocompatibility and sterilization.
8. The sample size for the training set
This question is not applicable as there is no "training set" in the context of a physical medical device. Manufacturing processes are subject to quality controls and design validation, but not a data-driven "training" as in AI/ML.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 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).