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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.

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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.

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Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only.

Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.

The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

This document describes the premarket notification for Bio Protech, Inc.'s Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, and Disposable Hypodermic Needle Electrodes. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating similar performance characteristics to predicate devices and adherence to relevant standards. The "Substantial Equivalence Chart" (Pages 5-7) directly compares the new device with predicate devices across various characteristics.

For "Performance", the report states:

• Acceptance Criteria (Implied): Equivalent penetration and friction force to predicate devices, and electrical properties conforming to DIN 13097. Assurance of functionality during the shelf life through aging tests. Optimal bevel and burr for sharpening, and electrical continuity and isolation of all poles.
• Reported Device Performance:
  • Disposable Concentric Needle electrodes: "Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product."
  • Disposable Hypodermic Needle electrodes (under the "Performance" row for Concentric, but appears to relate to Hypodermic based on context within the table): "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
  • Disposable Monopolar Needle electrodes / EP Needle electrodes: "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"

The overall conclusion states: "The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device."

Summary of Studies and Information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • The document does not specify the sample sizes used for the bench testing (penetration, friction force, electrical properties, aging, EO residual, biocompatibility).
   • Data Provenance: The accelerated aging testing was conducted by KTR (Korea Testing and Research Institute). Biocompatibility evaluations were performed for manufactured and sterilized Bio Protech electrodes. The provenance of the specific test samples (e.g., country of manufacture) is not detailed beyond the company's location in Republic of Korea. All testing appears to be prospective testing of the Bio Protech device.

3. 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 studies are bench performance and material characterization tests, not studies requiring expert interpretation of medical images or patient data to establish ground truth.

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

   • This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring adjudication of medical interpretations.

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 MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or described in this document. This device is a disposable needle electrode, not an imaging or diagnostic AI device.

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

   • No standalone algorithm performance study was conducted. This device is a physical medical device (needle electrodes), not an algorithm or AI.

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

   • For the performance testing, the "ground truth" or reference was based on established industry standards (e.g., DIN 13097 for mechanical and electrical properties, ASTM F 1980 for aging, ISO 10993 for biocompatibility, ISO 10993-7 for EO residuals) and direct comparison to the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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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.

• 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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Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Needle Electrodes are passive devices used for recording, monitoring and stimulation during EEG, EMG, nerve conducting studies and IONM. The Needle Electrodes have different tip shapes for performing different recording and stimulating procedures.

The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.

The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.

The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.

Here's a breakdown of the acceptance criteria and study information for the Disposable Monopolar and Subdermal Needle Electrodes (K130136), based on the provided 510(k) summary:

This device is a Class II medical device (Needle Electrode, product codes GXZ and IKT) and its approval is based on establishing Substantial Equivalence (SE) to predicate devices, rather than a clinical effectiveness study with strict acceptance criteria often seen in AI/algorithm-driven devices. Therefore, the "acceptance criteria" here refer to meeting the characteristics and performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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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.

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.

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TECA™ elite Disposable Monopolar 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 TECAT™ elite Disposable Monopolar 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. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.

The provided text describes the 510(k) Premarket Notification for CareFusion's TECA™ elite Disposable Monopolar Needles. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing the performance of a novel AI/ML device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, sample sizes, expert ground truthing, MRMC studies, or training sets is not applicable here.

However, I can extract information related to the device's characteristics and the testing performed to show its compliance.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on verifying that the modified TECA™ elite Needles comply with predetermined specifications and applicable standards, specifically referencing ISO 10993-1 for biocompatibility and ISO 7864 for performance. The "acceptance criteria" here are implied by these standards and the internal requirements, and the "reported device performance" is a general statement of compliance.

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

This is not applicable as the study described is a device modification verification, not a clinical study with a specific test set of patient data. The testing involved bench performance and biocompatibility assessments of the physical device and its materials.

3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts

This information is not provided and is not applicable to the type of device verification described. Ground truth for clinical outcomes or diagnostic accuracy by experts is not relevant here.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves bench tests and biocompatibility assessments, not clinical data requiring adjudication.

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 passive, disposable electromyograph needle, not an AI-powered diagnostic tool that would typically undergo such a study to evaluate human reader improvement with AI assistance.

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

No, this is not an AI/ML algorithm. It's a physical medical device.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" was established by compliance with the ISO 10993-1 standard and comparison of direct patient contact materials. For performance testing, the "ground truth" was established by compliance with internal requirements and the ISO 7864 standard for sterile hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable. There is no training set.

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The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.

BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The provided text describes BIONEN Needle Electrodes (Disposable Concentric, Disposable Monopolar/Subdermal, and Disposable Monopolar Needle Electrodes) and summarizes the non-clinical tests performed to demonstrate their functionality and safety, asserting substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with quantifiable metrics for device performance (e.g., sensitivity, specificity, accuracy, or precision in signal recording) nor a study that directly proves the device meets such criteria through a clinical validation or comparative effectiveness study.

Instead, the document focuses on compliance with established standards for medical devices and material safety, and performance characteristics related to the physical integrity and electrical properties of the electrodes.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully extracted as they are not present in the provided text.

Here's a breakdown of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio, diagnostic accuracy) are not explicitly stated, nor are comparative performance values against the predicate devices for these aspects. The document focuses on performance related to physical attributes and safety.

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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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Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.

A diagnostic electromyography 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). The needle electrodes are for single patient only.

This 510(k) premarket notification is for a Disposable EMG Needle Electrode, a Class II medical device. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel performance against acceptance criteria through a clinical study. As such, the information typically found in acceptance criteria and efficacy studies is not present in this document.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a new, performance-based device. This 510(k) summary is for a device seeking substantial equivalence, meaning its safety and effectiveness are established by showing it is as safe and effective as a legally marketed predicate device. The focus is on demonstrating similar design, materials, packaging, and technological characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific test set, sample size, or data provenance because it is a 510(k) submission based on substantial equivalence. It does not present results from a clinical trial or performance study that would typically involve a test set.

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 information is not applicable and not provided. No "ground truth" was established for a test set as there was no study comparing the device's performance to a known truth.

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

This information is not applicable and not provided. There was no adjudication method as there was no performance study involving a test set and human readers.

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

An MRMC comparative effectiveness study was not performed and is not described in this document. The device is an electrode, not an AI-assisted diagnostic tool.

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

A standalone performance study was not performed and is not described. The device is a physical electrode, not a standalone algorithm.

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

This information is not applicable and not provided. No "ground truth" was used in a performance study.

8. The sample size for the training set

This information is not applicable and not provided. This document does not describe the development of an algorithm or AI model that would require a training set.

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

This information is not applicable and not provided. There was no training set for which a ground truth needed to be established.

Summary of the K091410 Submission:

This 510(k) premarket notification by Spes Medica s.r.l. for their "Disposable EMG Needle Electrodes" is a Class II medical device submission seeking substantial equivalence. The core argument for safety and effectiveness is that the device is "similar in design, materials, packaging and other technological characteristics" to several legally marketed predicate devices (e.g., MEDICOTEST A/S Neuroline, AMBU A/S Neuroline, MEDELEC Disposable Needle Electrode, etc.).

The document describes the device's intended use: "Recording muscle activity for Electromyography (EMG) applications. For single patient use only." It also notes a specific use case for the hypodermic version: "injection of the Botulinum Toxin into a muscle, while recording electromyography activity."

The FDA's letter (AUG 11 2009) confirms that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means that, in the context of this 510(k), the device indirectly meets "acceptance criteria" by being deemed as safe and effective as existing products, without requiring independent performance studies with acceptance criteria or ground truth.

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