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Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only.

The Ambu Neuroline Disposable Inoject needle electrode is a Single Patient needle electrode for Electromyography (EMG) guided injections. The needle electrode is designed for Botulinum Toxin therapy and nerve block procedures. The Ambu Neuroline Disposable Inoject needle is manufactured in different lengths and diameters. The Ambu Neuroline Disposable Inoject needle is connected to the EMG equipment through a touch proof connector with a pre-attached cable. The Ambu Neuroline Disposable Inoject needle electrode is a sterile product. Ambu Neuroline Disposable Inoject needle electrodes consist of a coated needle made from stainless steel. The Ambu Neuroline Disposable Inoject needle electrode is used with a reference electrode and a ground electrode.

Here's an analysis of the provided text regarding the Ambu Neuroline Disposable Inoject Needle Electrode (K093825), focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a direct measurement of "device performance" in terms of clinical outcomes or specific numerical metrics. Instead, the justification for clearance relies on substantial equivalence to predicate devices and verification of functionality through non-clinical testing.

Given the information, the acceptance criteria are implicitly tied to meeting product specifications and demonstrating safety and effectiveness comparable to predicate devices. The reported "performance" is that it meets these implicit criteria.

• Penetration force
• Friction force
• Electrical properties
• Mechanical properties
  These tests reportedly verified the functionality and fulfilled product specifications. (Conclusion from non-clinical tests stated that the device fulfills product specifications set for the design.) |
  | Biocompatibility | The device passed the following tests based on ISO 10993-1:
• Cytotoxicity assay in vitro
• Contact hypersensitivity in the guinea pig Maximization study
• Intracutaneous test in the rabbit
• Systemic Injection test in the mice
  This ensures biological safety and appropriate levels of biocompatibility. |
  | Safety and Effectiveness (Relative to Predicate Devices) | Concluded to be a safe and effective Inoject needle electrode and comparable to the predicate devices based on non-clinical verification and biocompatibility tests. (This is the overarching conclusion required for 510(k) clearance via substantial equivalence). |
  | Maintenance of Functionality over Shelf Life (Aging) | Aging tests were performed to verify and ensure the functionality during the shelf life of the product. |
  | Intended Use and Indications for Use Match Predicate | The device has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Inoject needle electrode (K001869, assuming this is the primary predicate) and other predicate devices (K071185, K973444, K002992). The intended use is "Electromyography (EMG) guided injections" and indications for use are "EMG Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only." |

Regarding the study proving the device meets acceptance criteria:

The provided document describes a submission for a 510(k) premarket notification, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving de novo clinical efficacy through a standalone study.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set. The submission relies on non-clinical laboratory tests for functional verification and biocompatibility tests. The sample sizes for these specific lab tests (e.g., number of needles tested for penetration force, number of animals in biocompatibility studies) are not provided in this summary.
• Data Provenance: The data provenance for the non-clinical and biocompatibility tests would be internal laboratory studies conducted by Ambu A/S. The document does not specify a country of origin for the non-clinical data, but Ambu A/S is based in Denmark. These were retrospective studies in the sense that they were performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of submission (510(k) for an EMG needle electrode), ground truth is not established by a panel of clinical experts in the context of diagnostic agreement. The "ground truth" for the non-clinical tests would be the pre-defined product specifications and international standards (e.g., ISO 10993-1 for biocompatibility). Compliance with these objective criteria is assessed by engineers and laboratory personnel, not clinical experts for ground truth establishment.

4. Adjudication method for the test set

• Not applicable. There was no clinical adjudication process described, as no clinical test set requiring expert interpretation was conducted. The "adjudication" for non-clinical tests is against pre-defined performance specifications.

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. An MRMC comparative effectiveness study was not performed. This device is a passive medical instrument (a needle electrode), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

• No. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests (penetration force, friction force, electrical, mechanical properties): The ground truth is the pre-defined engineering specifications and performance requirements for the device.
• For the biocompatibility tests: The ground truth is established by international standards (ISO 10993-1) and the specific biological endpoints measured in the in vitro and in vivo assays (e.g., cell viability for cytotoxicity, skin reaction for hypersensitivity).

8. The sample size for the training set

• Not applicable. As this is not an AI/machine learning device, there is no "training set" in the computational sense. The device's design is based on established engineering principles and prior iterations of similar devices.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set. The design and manufacturing process are validated against the product specifications and regulatory standards.

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