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Dantec™ DCN Disposable Concentric Needle Electrodes 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.

The Dantec™ DCN Disposable Concentric Needle Electrodes are designed as an electrical bipolar recording device for use in electromyography. The Dantec™ DCN Disposable Concentric Needle Electrode consists of an insulated core wire located inside a stainless steel cannula. The hub has a raised bevel indicator, allowing the user to always know the direction of the recording surface. A coaxial hub allows easy connection between needle and the electrode cable.

Acceptance Criteria and Device Performance Study for Dantec™ DCN Disposable Concentric Needle Electrodes

This document describes the acceptance criteria and the study proving that the Dantec™ DCN Disposable Concentric Needle Electrodes meet these criteria, based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dantec™ DCN Disposable Concentric Needle Electrodes are primarily demonstrated through equivalence to the predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) and successful completion of various performance tests.

2. Sample Size Used for the Test Set and Data Provenance

The document describes several non-clinical tests to demonstrate device performance and substantial equivalence.

• Mechanical Testing (Hub/Cover tensile, Needle/Hub tensile, Impedance):
  • Sample Size: For Needle/Hub tensile, performance results show a "Mean (lbf)" suggesting multiple samples were tested, but the exact number is not explicitly stated. For Impedance, "All samples pass" indicates that multiple samples were tested, and "Attribute data - 100% Pass" implies a robust assessment.
  • Data Provenance: The tests were conducted by Natus Manufacturing Limited as part of the 510(k) submission for a new device. This represents prospective testing of the manufactured device. The country of origin for the data is Ireland, where Natus Manufacturing Limited is located.
• Tip Geometry-Grind Measurements:
  • Sample Size: Similar to tensile testing, "Mean" values for Pencil Point Height and Facet Angle suggest multiple units were measured, but the specific number is not provided.
  • Data Provenance: Prospective testing conducted by Natus Manufacturing Limited (Ireland).
• Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Endotoxin):
  • Sample Size: For Endotoxin levels, "three tested lots" were evaluated. For other biocompatibility tests, the sample size (number of devices or extract samples) is not explicitly stated but implied to be sufficient for standard ISO 10993 testing.
  • Data Provenance: Prospective testing conducted according to ISO 10993 series standards, likely by a certified lab. The provenance is associated with the test sponsor, Natus Manufacturing Limited (Ireland).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of device (disposable concentric needle electrodes) does not typically involve human expert interpretation of results to establish "ground truth" in the way image analysis or diagnostic algorithms do. The performance is assessed against engineering specifications, material properties, and biological safety standards. Therefore, the concept of "experts establishing ground truth" in a clinical/interpretive sense is not applicable here.

Instead, the "ground truth" is derived from:

• Established international standards (e.g., ISO 10993 for biocompatibility, ASTM F 1980 for aging).
• Engineering specifications for mechanical and electrical properties.
• Material science principles for component selection.
• Predicate device characteristics for demonstrating substantial equivalence.

The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Natus Manufacturing Limited, along with personnel at independent testing laboratories, who are qualified in their respective fields to design, conduct, and interpret these types of tests against the established standards and specifications.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or performance evaluations where there can be inter-reader variability in interpreting diagnostic results, often involving human readers and a gold standard. Since the tests described are primarily bench testing and biocompatibility evaluations against predefined acceptance criteria and standards, a formal adjudication method for the "test set" is not relevant. The results are quantitative measurements or qualitative compliance assessments against specified thresholds or documented standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging or similar interpretive tasks. The Dantec™ DCN Disposable Concentric Needle Electrode is a medical device for recording biopotential signals (EMG, nerve potential) and its performance is evaluated through physical, electrical, and biological safety testing, not through human interpretation of cases or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This also relates to AI/software as a medical device. The Dantec™ DCN is a physical needle electrode, not an algorithm. Its function is to acquire signals, not to interpret them or provide diagnostic output independently.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the Dantec™ DCN Disposable Concentric Needle Electrodes consists of:

• Engineering Specifications and Design Requirements: These are the predefined performance targets for mechanical strength, electrical impedance, and physical dimensions established during the device design phase.
• Applicable International and National Standards: Including ISO 10993 series for biocompatibility, USP <161> for endotoxin, ISO 2859-1 for sampling, and ASTM F 1980 for accelerated aging. Compliance with these standards serves as a form of ground truth for safety and performance.
• Predicate Device Characteristics: For many aspects (materials, dimensions, sterilization, intended use), the characteristics and established performance of the legally marketed predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) serve as the "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning algorithms. Since the Dantec™ DCN Disposable Concentric Needle Electrodes are a physical medical device and not an AI/ML algorithm, there is no training set in this context. The manufacturing process and device design are optimized through engineering principles, quality control, and adherence to established standards, rather than through iterative training with a dataset.

9. How the Ground Truth for the Training Set was Established

As there is no training set for this device, the question of how its ground truth was established is not applicable.

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