(28 days)
TECA™ ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles (TECATM ELITE Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user.
TECATM ELITE Needles consist of a stainless steel tube with a conductive core. A polyesterimide isolative coating resides between the core and the stainless steel tube. The exterior surface of the needle is dipped in a low-friction lubricant. TECATM ELITE Needles are passive devices, and do not contain electrical hardware components or software.
The following device modifications were made to the TECATM ELITE Needles: Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials.
The provided document is a Special 510(k) Premarket Notification for TECA™ ELITE Disposable Concentric Needles. This document details device modifications and performance testing for demonstrating substantial equivalence to a predicate device, rather than a study proving new acceptance criteria for a novel device or AI. As such, information regarding AI-specific criteria, human reader studies, or training set details will not be available.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" as one might expect for a new device establishing clinical efficacy. Instead, it details verification and validation activities conducted to demonstrate that the modified device continues to meet its predetermined specifications and applicable standards. The acceptance criteria are implicitly derived from these standards and internal requirements.
| Acceptance Criteria (Implicit from Standards/Requirements) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Compliance with ISO 10993-1: 2009 for patient-contact materials. | - Verification results indicated compliance. |
| - Comparison to predicate devices (K991522, K033173) for core material. | - Comparison made; deemed compliant. |
| - Comparison to predicate device (K111131) for low friction lubricant. | - Comparison made; deemed compliant. |
| Packaging Integrity: | |
| - Seal Strength (ASTM F88-07). | - Verification results indicated compliance with predetermined specifications. |
| - Seal Leaks (ASTM F1929-04). | - Verification results indicated compliance with predetermined specifications. |
| Sterile Hypodermic Needles: | |
| - Compliance with ISO 7864:1993 (for single use). | - Verification results indicated compliance with predetermined specifications. |
| Functional Performance (Internal Requirements): | |
| - Lubricant performance. | - Verification results indicated compliance. |
| - Insertion force. | - Validation results indicated compliance. |
| - Recording characteristics (noise and impedance). | - Validation results indicated compliance. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are described as "Performance testing was performed on device characteristics... in accordance with internal requirements and the applicable portions of the following Standards." This implies the testing was conducted internally, likely prospective, to evaluate the specific modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This type of information is not relevant or included in the provided document. The device is a medical needle for electromyography, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" establishment in a clinical study context. The performance assessments are based on engineering standards and physical/electrical measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device's performance evaluation does not involve clinical interpretation or a "ground truth" to be adjudicated by multiple experts.
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. The device is a passive, single-use needle electrode, not an AI system or an imaging modality that would involve a multi-reader multi-case study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering and biocompatibility standards (e.g., ISO 10993-1, ASTM F88, ASTM F1929, ISO 7864) and the predetermined specifications of the device itself and its predicate. There is no clinical or pathological "ground truth" in the traditional sense for these types of manufacturing and design verification tests.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this device, a method for establishing its "ground truth" is irrelevant.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).