(45 days)
The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.
The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
This document is a 510(k) summary for a medical device called the "Flexible Introducer Cannula." It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence.
Based on the provided text, there is no information available about acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's performance, nor a study proving such criteria are met.
The document is a regulatory submission focused on establishing substantial equivalence for a physical medical device (anesthesia conduction needle), not a software or AI/ML-driven device that would typically have performance metrics and acceptance criteria for classification or detection tasks.
Here's a breakdown of why this information is not present and what is discussed instead:
-
Acceptance Criteria and Reported Device Performance: This device is a physical instrument. The "acceptance criteria" here are related to physical and technical characteristics and safety/effectiveness as compared to a predicate device, rather than statistical performance metrics for a diagnostic or AI system. The document states:
- "The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device."
- "The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device."
- No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported.
-
Sample size for the test set and data provenance: Not applicable. There is no mention of a "test set" in the context of diagnostic performance data. The "testing performed" would likely refer to engineering validation and verification tests (e.g., materials testing, sterility, functionality) and comparison of physical attributes to the predicate.
-
Number of experts and their qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for this device would be its physical conformance to specifications and its biological safety, established through standard engineering and biocompatibility testing.
-
Adjudication method: Not applicable.
-
MRMC comparative effectiveness study: Not applicable. There is no mention of human readers or AI assistance.
-
Standalone performance study: Not applicable in the context of AI/ML. All the documentation describes the device's standalone characteristics and function.
-
Type of ground truth used: For a physical medical device like this, "ground truth" means demonstrating the device meets design specifications, material properties, biocompatibility, and functional requirements. This is typically established through engineering tests, material science analysis, and preclinical studies where relevant. The summary provided does not detail these specific tests, but rather states that "testing was performed."
-
Sample size for the training set: Not applicable. This is not an AI/ML device.
-
How ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a traditional medical device (anesthesia conduction needle). It establishes substantial equivalence to a predicate device through comparison of physical and technical characteristics and intended use, rather than through performance metrics typically associated with AI/ML or diagnostic devices. Therefore, the specific questions regarding acceptance criteria, study details, and ground truth establishment in the context of AI/ML or diagnostic performance are not addressed by this document.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).