(136 days)
The Focus™ Echogenic Nerve Stimulating Needle is intended for locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques using a Peripheral Nerve Stimulator and/or ultrasound guidance.
The Focus Needle is a sterile, single use FEP-coated stainless steel needle with a B Bevel tip. The needle contains black marker bands every 10 mm to aid in placement and echogenic dimpling on the distal 10 mm to enhance visibility under ultrasound guidance. An insulated wire is attached to the stainless steel cannula and can be connected to a peripheral nerve stimulator unit. The device will be available in the following gauge sizes: 22 and 23.
The provided document describes a medical device, the Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle, and its 510(k) clearance process. However, it does not contain information regarding acceptance criteria, specific device performance metrics, or a formal study comparing the device to acceptance criteria in the format usually associated with a clinical or performance study.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the Focus Needle to predicate devices based on technological characteristics and intended use.
- Verification Testing: A list of engineering and quality control tests performed to demonstrate reliable design and performance.
- Animal Model Evaluation: A general statement about verifying electrical current application to stimulate a nerve in an animal model.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the specific questions about sample sizes, ground truth establishment, or multi-reader studies, as these types of detailed studies are not described.
Here's an analysis of what can be extracted or inferred from the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed reported performance metrics (e.g., in terms of sensitivity, specificity, accuracy, or performance against a defined threshold). It lists verification tests that were performed to demonstrate reliable design and performance, implying that the device met the internal specifications for these tests, but the specific criteria and results are not reported.
| Acceptance Criteria (Inferred from Verification Tests) | Reported Device Performance |
|---|---|
| Mechanical/Physical Integrity: | |
| Air leakage under vacuum | Met (Implied) |
| Fluid leakage under pressure | Met (Implied) |
| Force to remove protector | Met (Implied) |
| Needle to hub bond strength | Met (Implied) |
| Wire to electrical connector bond | Met (Implied) |
| Wire tensile strength | Met (Implied) |
| Wire to hub tensile strength | Met (Implied) |
| Cannula break strength | Met (Implied) |
| Penetration force | Met (Implied) |
| Biocompatibility: | |
| Biocompatibility testing | Met (Implied) |
| Sterilization: | |
| Sterilization testing | Met (Implied) |
| Functional Performance (Nerve Stimulation/Visibility): | |
| Electrical current application can stimulate a nerve | Verified in an animal model |
| Enhanced visibility by ultrasound (due to dimpling) | Implied by design |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "an evaluation in an animal model" but does not give a sample size for this animal study or any other performance test. The other tests listed are more akin to engineering verification or quality control tests, for which "test sets" in the context of clinical performance are not typically defined.
- Data Provenance: The animal study would be prospective (conducted specifically for this submission). Country of origin is not specified, but the applicant (Cook Incorporated) is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a study involving expert readers or ground truth established by experts for performance evaluation. The animal model likely used physiological responses or direct observation of nerve stimulation to verify function, not expert consensus on image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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:
- No. This device is a modified needle, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed/described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a physical medical instrument (a needle), not an algorithm or software. "Standalone" performance as typically understood for AI/software devices is not applicable. The device's "standalone" performance relates to its mechanical integrity, biocompatibility, sterilization, and its ability to conduct electricity and be visible under ultrasound, which were verified by the listed tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal model, the ground truth for nerve stimulation would likely have been direct physiological response (e.g., muscle contraction, evoked potentials) or direct visualization of nerve activation, performed by veterinary or surgical specialists. For the engineering tests, "ground truth" is typically defined by engineering specifications and objective measurements (e.g., measured force, visual inspection for leakage).
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Summary of the "Study" described:
The document describes verification testing and an animal model evaluation rather than a formal clinical study with acceptance criteria and statistical analysis of performance against a ground truth dataset. The focus of the submission is on demonstrating substantial equivalence to predicate devices by showing that the new device shares similar technological characteristics and performs its intended functions reliably, based on engineering tests and a general functional evaluation in an animal model. These tests confirm the physical properties, safety (biocompatibility, sterilization), and basic functional aspects (nerve stimulation).
§ 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).