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The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.

Here's an analysis of the provided text regarding the EGG system's acceptance criteria and study data:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device for a new Electrogastrography (EGG) system. It does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the typical AI/ML study components you've requested.

The document is a US FDA 510(k) Notification, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of technical specifications, intended use, and safety/performance characteristics rather than new clinical trials with defined acceptance criteria and statistical endpoints, especially for low-risk devices.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and where information is missing:

Electrogastrography (EGG) System - Acceptance Criteria and Study Information

Note: This 510(k) submission primarily establishes substantial equivalence to a predicate device. It does not describe a standalone clinical performance study with predefined acceptance criteria as would be typical for a novel AI/ML device or a device requiring new clinical validation. The "acceptance criteria" here implicitly refer to the device performing comparably to the predicate and meeting general safety and electrical standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k), explicit acceptance criteria are not stated in a quantitative performance table. Instead, the "performance" is implicitly deemed acceptable if the device is substantially equivalent to the predicate and adheres to relevant standards.

Key Implication: The "acceptance criteria" are generally met by demonstrating that the device functions correctly, adheres to electrical safety standards (EN 60601-1, etc.), and provides equivalent or improved data capture and processing capabilities compared to the predicate device for its intended use.

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

• Sample Size: Not specified. The document states, "Clinical trials are not performed." It implies that performance was assessed through engineering verifications and comparisons to the predicate device's specifications and functionality rather than a clinical "test set" with patient data.
• Data Provenance: Not applicable, as formal clinical test data, in the sense of patient studies, were not conducted for this 510(k).

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

• Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This device is an EGG system, not an AI-based interpretation tool for human readers.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. The device measures and processes physiological signals. Its performance is related to the accuracy and reliability of these measurements and processing, which are verified through engineering tests and comparison to the predicate, not in an "algorithm-only" performance study.

7. The type of ground truth used

• Type of Ground Truth: For the device itself, the "ground truth" for verification would primarily be:
  • Engineering Specifications: Ensuring hardware and software perform according to design (e.g., gain settings, frequency filtering, digital resolution).
  • Predicate Device Performance: The predicate device (3CPM EGG Machine) serves as the benchmark for "truth" in terms of clinical utility and output characteristics.
  • Regulatory Standards: Compliance with electrical safety and EMC standards (EN 60601-1, etc.) acts as a form of "ground truth" for safety.
  • "Verifications results show that the enhanced system performs as its predicate system." This statement implies the predicate's established performance is the de facto ground truth.

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device.

In summary: The provided 510(k) document is for an Electrogastrography (EGG) system seeking substantial equivalence to a predicate. It relies on non-clinical performance data (engineering verifications, adherence to standards, and feature comparison to the predicate) to demonstrate equivalence rather than a clinical trial with predefined acceptance criteria against new patient data. Therefore, most of the questions related to AI/ML device validation are not applicable.

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The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.

The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.

The provided document is a 510(k) submission for the Polygram 98 pH Testing System (incl. bile). It describes a device that measures pH and bile reflux in the gastrointestinal tract. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical performance data with acceptance criteria in the way a novel AI/ML device might.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance from a clinical trial or a standalone algorithm assessment. Instead, it focuses on demonstrating equivalence to a predicate device. The modifications primarily involve the addition of bile measurement capabilities and software updates.

The document lists "Calculated parameters" for both pH and Bile analysis, which are effectively the output of the system. These include various measurements like:

• Maximum, Minimum
• Duration of period
• Number of (acid/bile) refluxes
• Number of long (acid/bile) refluxes
• Longest (acid/bile) reflux
• Total time (pH below 4 / bile above 0.14)
• Fraction time (pH below 4 / bile above 0.14)
• Symptom index
• Symptom Association Probability

For pH, it also lists "Scoring Normals" like DeMeester & Johnson, Bolx-Ochoa, and Infant normals. For Bile analysis, it explicitly states "No scoring system exists for Bile analysis." This indicates that while the system measures bile, there aren't established clinical thresholds or scoring systems for it, unlike pH.

The primary "acceptance criterion" implicit in a 510(k) submission is substantial equivalence to the predicate device. The document states:

• "Verifications results show that the enhanced system performs as its predicate system." (referring to non-clinical performance data)
• "This new system does not raise any new safety or performance issues."

Therefore, a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) is not provided because the submission's focus is on demonstrating that the new features (bile measurement and software) do not negatively impact the safety or effectiveness of the previously cleared pH system and that the bile measurement functionality is appropriately described and safe.

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

The document explicitly states: "Clinical trials have not been performed." This means there is no test set in the sense of patient data used to evaluate the clinical performance of the device or its new features. The evaluation relies on non-clinical verification and a comparison of technical features to the predicate device.

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

Since no clinical trials were performed and no specific test set was evaluated for clinical performance, there were no experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a measurement system, not an AI-assisted diagnostic tool for human readers, and no MRMC study was performed.

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

The device is a "system" (Bilitec 2000 hardware + Polygram 98 software) that measures physiological parameters. It does not contain an "algorithm" in the AI/ML sense that would have a standalone performance evaluated for accuracy, sensitivity, specificity, etc. The software analyzes and displays the data collected by the hardware. The documentation states "Verifications results show that the enhanced system performs as its predicate system," referring to non-clinical technical verifications.

7. The Type of Ground Truth Used

Given that clinical trials were not performed, there's no ground truth established from pathology, expert consensus, or outcomes data for the new components of the device. The "ground truth" for the predicate device's pH measurements would have been established historically but is not detailed here. For the added bile measurement, the system reports absorbance units, and the document notes that "No scoring system exists for Bile analysis," implying that clinical "ground truth" thresholds or diagnostic criteria for bile reflux were not established or leveraged at the time of this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable, as there is no training set.

Summary regarding this specific document:

This 510(k) submission is for a device that is primarily an updated version of an existing physiological measurement system, adding the capability to measure bile reflux. The regulatory pathway chosen (510(k)) primarily requires demonstrating substantial equivalence to a predicate device, and for this submission, no clinical trials were conducted to assess the performance of the new features against specific clinical acceptance criteria or ground truth. The assessment relies on non-clinical verification that the "enhanced system performs as its predicate system" and that it "does not raise any new safety or performance issues." The lack of specific performance metrics, clinical test sets, or expert evaluations is typical for 510(k) submissions of this nature, especially when the changes are characterized as modifications to an existing device rather than a fundamentally new technology requiring de novo clinical validation.

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The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.

The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:

• Neuro Free Run EMG
• Neuro Motor Nerve Conduction
• Neuro Sacral Reflex
  The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.
  The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.

This 510(k) summary describes a software update (Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1) and does not contain detailed acceptance criteria, performance data from a specific study, information on sample sizes, expert involvement for ground truth, or adjudication methods typically found in studies for new medical devices establishing clinical efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.

However, based on the provided text, here's a breakdown of what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neuro Urodynamic Suite. Instead, it relies on demonstrating equivalence to a predicate device. The primary performance claim is that the "enhanced system performs as its predicate system."

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified. The verification results are mentioned as "in-house" testing (Section 8), implying internal testing rather than external or patient-specific clinical data.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a new performance study. The evaluation relies on verification of the software's functionality and comparison to a predicate device.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. No adjudication method is mentioned as there's no described study involving multiple interpretations for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states: "Clinical evaluation not performed." (Section 8). Therefore, no MRMC study, human-in-the-loop performance, or effect sizes of AI assistance are reported.

6. Standalone Performance Study (Algorithm Only):

• A standalone performance study was conducted, but it's referred to as "Verifications results" and "in-house" testing (Section 7 and 8). The exact methodology, metrics, and quantitative results of this "verification" are not provided in detail. The claim is that it performs as the predicate system. It's an algorithm-only evaluation as it's a software update.

7. Type of Ground Truth Used:

• The ground truth for the "verification results" is not explicitly defined in terms of clinical outcomes or pathology. Given that it's a software update for electrophysiological testing, the "ground truth" for the verification likely refers to whether the software accurately processes and displays expected electrophysiological signals and calculates parameters correctly, compared to a known good reference or the predicate device's behavior. It's a functional and performance comparison against the predicate, not a clinical diagnostic accuracy assessment.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This device is a software program for signal processing and parameter calculation in electrophysiology, not an AI/ML model that typically requires a training set of data.

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

• Not applicable/Not specified. No training set is described for this device.

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The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.

The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.

The provided 510(k) summary for the Medtronic Esophageal Manometry System (K992713) does not describe specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/ML or new complex device submission. Instead, it relies on a comparison to a predicate device and verification results.

Here's a breakdown of the information based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as a set of quantified performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be implicit in the claim of "equivalence" to the predicate device and the successful verification of enhanced technical features.

| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| Functional Equivalence to Predicate Device | "Verifications results shows that the enhanced system performs as its predicate system." The device is intended to record, store, view, and analyze data online in the GI tract to assist in the diagnoses of GI disorders, which is the "Same" as the predicate. |
| Increased Performance (Technical Features) | The new device offers enhanced performance in: |
| * Number of Channels | Up to 16 (Predicate: Up to 16) - Self-contradictory in table, previous predicate showed "up to 16", modified device showed "4-16 channels" and explanation states "Enhanced performance". This implies the modified device consistently handles 4-16 channels well. |
| * Sampling rate | 105-1674 Hz (Predicate: 1/128 to 128 Hz) |
| * Power supply | 24 V DC (Predicate: 9-12 V DC) - accommodates 110-230 V Power Supply in one. |
| * Measuring range | -2.5 Vpm, 5 % to 2.5 Vpm 5% (Predicate: 0-9 pH) |
| * Insulation | HCPL-0710. NMV 2405S, and safety power supply: class I (Predicate: Burr Brown722 dual isolated DC/DC converter); with isolation within each module of 4 channels. |
| * Current consumption | Max 0.8 A (Predicate: 260 mA nom standard (8bit)) |
| * Communication | USB (Universal Serial Bus) (Predicate: Optical serial RS 232); "Enhanced performance (band width)" |
| * Resolution | 22 bit (Predicate: 8 bit) |
| * Operating system | Windows 98 (Predicate: Windows 3.11, 95) |
| Safety | "doesn't raise any new safety or performance issues." The device complies with EN 60601-1, UL 2601-1, and CAN/CSA C22.2 No.610.1-M90. |

Study Proving Acceptance Criteria:

The document explicitly states: "Clinical trials are not performed."

The justification for equivalence and performance relies on non-clinical performance data verification. The "Verifications results shows that the enhanced system performs as its predicate system." This implies internal testing and validation of the hardware and software components to ensure they meet their design specifications and function comparably or with enhancements to the predicate. No further details on the specifics of this verification study (e.g., test protocols, results metrics, sample sizes for verification) are provided in this summary.

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

• Test set sample size: Not specified. The document states "Clinical trials are not performed" and relies on "Verifications results" (non-clinical data). This means there wasn't a "test set" in the context of patient data in a clinical study.
• Data provenance: Not applicable, as clinical trials were not performed. The data underpinning the "verifications results" would be engineering and performance test data generated internally by the manufacturer, Medtronic Functional Diagnostics A/S in Denmark.

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)

Not applicable. Since clinical trials were not performed and there was no patient-specific "test set" to establish a ground truth for diagnostic accuracy, no experts were used for this purpose in the context of this submission. The "ground truth" for the non-clinical verification would be the expected performance based on engineering specifications and comparison to the predicate device's known characteristics.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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 comparative effectiveness study was done. The device described appears to be a data acquisition and analysis system, not an AI-assisted diagnostic tool that directly impacts human reader interpretation in a measurable way (like an AI algorithm for image analysis). The "analysis" provided by the system is based on calculated parameters from physiological signals, not interpretation of complex images or data that typically requires an MRMC study for AI evaluations.

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

This refers to a standalone performance evaluation of a diagnostic algorithm. The Esophageal Manometry System is a measurement and analysis system for physiological signals, not a standalone diagnostic algorithm in the sense of AI/ML. The "analysis" it performs (e.g., LES location, resting pressure, amplitude, duration, velocity) are calculations based on the acquired signals. The performance of these calculations would have been "verified" as part of the non-clinical performance data, ensuring their accuracy and consistency. However, no specific standalone algorithm performance study, as understood for AI, is described.

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

For the "Verifications results" (non-clinical performance data), the "ground truth" would be engineering specifications, expected physical measurements, and the known performance/output of the predicate device. For example, testing the sampling rate would involve inputting known frequency signals and verifying the system's output. For calculated parameters, the ground truth would be established by mathematical correctness and consistency with the predicate device's calculations.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that utilizes a training set in the conventional sense.

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

Not applicable, as there was no training set for an AI/ML algorithm.

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The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes. * expanded indication for use due to the Anorectal Manometry Suite.

The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes. The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests. The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum: Sphincter Profile, Resting Pressure, Rectal Balloon test, Balloon Expulsion Test, Squeeze Test, Recto-Anal Inhibitory Test. The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.

The provided 510(k) summary for the "Anorectal Manometry Suite for Duet / Duet MultiP" does not contain specific acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for a machine learning or AI-driven device.

This submission is for a software suite that expands the functionality of an existing urodynamics system (Duet/Duet MultiP) to include anorectal manometry. The core of the submission focuses on establishing substantial equivalence to a predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439) based on similar intended use, technology, and features, with a key difference being that the new device only records and calculates basic parameters (max, min, duration) rather than performing complex analysis or comparison to normal values.

Therefore, the following information cannot be extracted from the provided text in the context of typical AI/ML device evaluations:

1. Table of acceptance criteria and reported device performance: No such criteria or performance metrics are defined for the anorectal manometry suite in this document. The device's performance is not evaluated against quantitative thresholds.
2. Sample size used for the test set and data provenance: Not applicable. There's no test set described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device that humans would use to improve their reading.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a software suite that enables the recording and display of physiological signals, not an algorithmic diagnostic tool.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence and performance assessment:

• Assessment of non-clinical performance data for equivalence: "Verifications results shows that the enhanced system performs as its predicate system." This statement broadly indicates that the system's basic functions (recording pressure and EMG) were verified to operate correctly, similar to the predicate device. However, specific performance metrics or acceptance criteria are not detailed.
• Assessment of clinical performance data for equivalence: "Clinical evaluation not performed." This confirms that no clinical studies were conducted to evaluate the device's diagnostic accuracy or performance in a patient population. The equivalence is based on the technical similarity and intended use.
• Ground Truth for Equivalence: The primary "ground truth" for this submission is the established function and safety of the predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439). The new device is deemed substantially equivalent because its intended use, measurement capabilities (recording pressure and EMG), and the fundamental technology for capturing these signals are similar, and its lack of complex analysis a simpler, and thus presumably a safer, claim than the predicate.

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The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies. This process is known as electromyography (EMG).

The disposable monopolar needle electrode is designed for single use only. The stainless steel needle electrode is insulated with a special PTFE coating to ensure minimal friction between the needle and the tissue. The tip of the conically sharpened needle is uninsulated and serves as recording area. The sterile electrode is individually sealed and delivered in sets of 48 pcs. In a hygienic and practical package ready for use package. The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.

Here's an analysis of the provided 510(k) summary for the K990375 device, addressing the requested information:

Device: 13 S Series Disposable Monopolar Needle Electrodes

Description of Device: The device is a disposable, single-use monopolar needle electrode used for electromyography (EMG). It consists of a PTFE-coated stainless steel needle with an uninsulated tip for recording, a larger hub for ergonomic grip, and a connector for electrical signal transfer.

Acceptance Criteria and Study Details

This 510(k) submission is for a Special 510(k) Notification, indicating modifications to a previously cleared predicate device (13 R Series Disposable Monopolar Electrodes, K915741). The primary goal of a Special 510(k) is to demonstrate that the changes do not adversely affect the safety or effectiveness of the device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to the predicate device, rather than establishing novel performance metrics.

The "acceptance criteria" are implied to be that the enhanced device performs at least as well as the predicate device in relevant non-clinical tests and that the changes do not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Test Set Sample Size: The submission does not specify numerical sample sizes for non-clinical testing. It generally refers to "Verifications results" and "The results of these tests."
• Data Provenance: The data is generated from laboratory testing (e.g., mechanical testing, biocompatibility studies, sterilization validation) performed by Medtronic Functional Diagnostics A/S and/or its vendors. This is prospective testing conducted specifically for this submission. The country of origin of the data is implicitly Denmark, where the manufacturer is located, and potentially the locations of the testing facilities (e.g., Maersk Medical A/S for sterilization).

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

• This device is not an AI/ML diagnostic or image-based device. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation or diagnosis is not applicable.
• The "ground truth" for the non-clinical tests (e.g., biocompatibility, mechanical strength) is established by the specifications and standards (e.g., ISO 10993, EN 556) themselves and the results of the validated test methods. The "experts" would be the qualified laboratory personnel conducting and interpreting these tests, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study involving human interpretation of 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 type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a medical device (needle electrode) used to facilitate a diagnostic procedure, not to perform the diagnosis itself or interpret complex data.
• The submission explicitly states: "Clinical evaluation not performed."

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

• Not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used:

• For non-clinical performance (mechanical, electrical, material): Engineering specifications, standardized test methods, and compliance with recognized industry standards (e.g., for pull strength, exposed length, recording area).
• For biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., cytotoxicity, intracutaneous, sensitization tests) as per ISO 10993 and USP 23, where biocompatibility is the 'ground truth'.
• For sterility: Validation of the sterilization process demonstrating a Sterility Assurance Level (SAL) of 10^-6, compliant with EN 556.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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