Search Results

The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording.

This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.

Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.

The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.

The provided text describes the 510(k) premarket notification for the Grass® MR Conditional/CT Cup Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance. As such, many of the requested details regarding AI/ML device performance studies (e.g., sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance) are not applicable or present in this specific regulatory submission.

The document primarily details the physical and functional characteristics of the electrodes and their compliance with safety standards and predicate device equivalency, particularly concerning MR conditional features.

However, I can extract the closest applicable information related to "acceptance criteria" and "device performance" based on the provided text, interpreting "performance" in the context of the device's electrical and physical properties as assessed for medical device regulatory submission.

Here's an attempt to fill in the table and answer the questions based on the provided non-AI/ML medical device submission:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

Study Details (Based on available information for a non-AI/ML device submission):

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to "non-clinical testing" and "bench verification & validation" performed on the physical device. The sample sizes for these tests (e.g., how many electrodes were tested for resistance or MR compatibility) are not explicitly stated.
   • Data provenance: "Internal requirements and specifications," "accredited MR testing laboratory on behalf of Natus Medicals." The country of origin is not specified for the test data, but the applicant's address is Ireland. The tests conducted are "non-clinical" bench tests, not clinical studies, thus the retrospective/prospective distinction for patient data is not applicable.

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

   • This question is not applicable as the device is a physical medical electrode, not an AI/ML algorithm requiring expert ground truth for image or diagnostic interpretation. The "ground truth" here is established by physical measurement standards (e.g., resistance, impedance) and compliance with relevant ISO/IEC/ASTM standards. The "experts" would be the engineers and technicians performing and verifying these standard-based tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for physical device testing against predefined engineering and safety standards. Adjudication methods are typically employed in clinical studies or expert labeling tasks for AI/ML datasets.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for AI/ML devices that assist or replace human readers in diagnostic tasks. The Grass® MR Conditional/CT Cup Electrodes are physical electrodes for recording biosignals, not an AI/ML diagnostic tool.

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

   • Not applicable. This device is not an algorithm. Bench testing for its physical and electrical properties was performed, which could be considered analogous to "standalone" performance for a physical device (i.e., its intrinsic properties were measured without human interaction influencing the measurement itself, beyond setup).

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

   • The "ground truth" for this device's performance validation is based on established engineering and safety standards (e.g., IEC 60601-1, ASTM D4169, FDA Guidance for Cutaneous Electrodes for Recording Purposes). Performance metrics like resistance and impedance have objectively defined acceptable ranges. For MR compatibility, the "ground truth" is determined by measurements against the specified MR environment conditions.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device

The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

The Allergan Botox Needle Electrode is used in EMG applications to record EMG activity while allowing injection of medication. The Allergan Botox Needle Electrode is a sterile, disposable, monopolar needle electrode with attached lead wire. The needle shaft is insulated so the needle records signals received only from the tip. The needle hub is designed to allow for precise manipulation of the electrode.

The provided text describes a 510(k) premarket notification for the "Allergan Botox Needle Electrode." This document focuses on demonstrating substantial equivalence to a predicate device (K973444 Teca Myoject Disposable Needle Electrode) through non-clinical performance data. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance tests conducted to show the device's functional equivalence and safety/effectiveness compared to its predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

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 the exact sample sizes (number of units tested) for each non-clinical performance test. It only states "Pass" for each test.

The data provenance is from Natus Manufacturing Limited, Ireland, the manufacturer submitting the 510(k). The tests are non-clinical performance tests, typically conducted in laboratory settings.

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 is a non-clinical performance study of a physical device (needle electrode). The "ground truth" for these tests is established by engineering and quality control standards (e.g., precise measurements, material specifications, mechanical strength tests, and biocompatibility standards like ISO 10993). Therefore, human expert review in the sense of clinical image interpretation or diagnosis is not applicable. The expertise involved would be in manufacturing, quality assurance, materials science, and biomedical engineering.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human interpretation or subjective assessment that would require adjudication. The tests are objective measurements and compliance checks against established engineering and safety standards.

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. This 510(k) submission is for a medical device (a needle electrode), not an AI-powered diagnostic or assistive tool that would involve human readers. The study performed is a non-clinical performance comparison to a predicate device, focusing on physical and functional characteristics.

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

Not applicable. This is for a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance relies on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards) for medical devices. For instance, needle length must fall within a specified range, resistance must be below a certain threshold, and materials must demonstrate biocompatibility through standardized tests. It's objective performance against predefined technical criteria rather than subjective clinical "ground truth."

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode

Here's a breakdown of the acceptance criteria and the study information for the Natus Manufacturing Limited Myoject™ Luer Lock Needle Electrode, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Teca Myoject Disposable Needle Electrode K973444) through a comparison of characteristics and performance testing. There isn't a direct "acceptance criteria" table with specific pass/fail metrics explicitly stated alongside the new device's performance in a quantitative manner for most characteristics. Instead, the "Discussion of Differences" column in Table 5A (starting on page 5) serves as the primary mechanism for demonstrating equivalence and addressing performance.

However, for Biocompatibility and Bench Testing, the performance is reported against established ISO and ASTM standards.

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

• Sample Size for Test Set: The document does not explicitly state specific sample sizes for each of the performance tests (tensile, coating thickness, leak, tip geometry, penetration, Luer Lock verification). It refers to "Performance Testing" and "Bench Testing" being performed. For biocompatibility tests, details are provided on the methods (e.g., L929 cells for cytotoxicity, rabbit for intracutaneous reactivity, mouse for local lymph node assay), but the exact number of test items or animals used is not specified in this summary.
• Data Provenance: The studies were conducted by Natus Manufacturing Limited, which is based in Ireland. The nature of these tests (biocompatibility, bench testing) usually implies controlled laboratory settings rather than patient data. Therefore, the data Provenance is the manufacturer's internal testing. Not retrospective or prospective patient data.

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

• This is not applicable as the studies described are non-clinical performance tests (biocompatibility and bench testing) and technical comparisons to a predicate device. The "ground truth" is established by adherence to recognized international standards (ISO, ASTM) for materials, design, and manufacturing quality, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable, as this refers to non-clinical performance and design verification tests, not clinical studies with human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic electromyograph needle electrode, not an image-based diagnostic AI device that would typically involve an MRMC study. The comparison is primarily against a predicate device's design specifications and performance standards through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a medical instrument (needle electrode), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating the device's acceptable performance and substantial equivalence is based on:
  • Adherence to International Standards: ISO 10993 series (Biocompatibility), ISO 2859-1 (Sampling), ASTM F 1980 (Sterile Barrier).
  • Predicate Device Specifications: The Teca Myoject Disposable Needle Electrode (K973444) serves as the primary benchmark for comparison of design and technological characteristics.
  • Design and Performance Specifications: The device's own predetermined specifications for physical characteristics and functional performance (e.g., tensile strength, leak integrity, penetration force).

8. The Sample Size for the Training Set:

• Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set.

Ask a specific question about this device

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.

Ask a specific question about this device