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Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.

Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.

Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.

Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Coaxial Biopsy Needle is used with biopsy needles to quide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.

All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices.

This submission is a 510(k) Pre-Market Notification for a traditional medical device (a biopsy needle), not an AI/ML-enabled device. As such, the information provided does not include the details typically found in submissions for AI/ML devices regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, non-clinical bench testing (biocompatibility, packaging, shelf life), and the assertion that "Bench testing is sufficient to demonstrate performance of the device. No preclinical testing of the subject device is necessary" and "Performance Test is sufficient to demonstrate safety and effectiveness of the subject devices with the predicate devices."

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, training/test set details, expert ground truth establishment, or clinical study methodologies (like MRMC) from this document.

The document discusses the following types of tests and their conformity:

1. Acceptance Criteria and Device Performance (Summary of Non-Clinical Testing):

The acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity for an AI model. Instead, they are met by demonstrating compliance with recognized consensus standards and by comparing performance to predicate devices. The "reported device performance" is essentially that the device passed these tests and met the design requirements.

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

• This information is not applicable and not provided in the context of this traditional medical device submission. The "test set" here refers to physical devices undergoing bench testing, not a dataset for an AI model.
• The data provenance would be that the tests were conducted by the manufacturer according to specified standards.

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

• Not applicable as this is not an AI/ML device requiring expert-labeled ground truth for a test set. Ground truth for the device's performance is established through objective physical and chemical testing against established standards and comparisons to predicate devices.

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

• Not applicable. This concept is relevant for AI/ML model training/testing, not for physical device bench testing.

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 is not an AI/ML device used for reading or interpretation.

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

• Not applicable. This is a physical biopsy needle, not an algorithm.

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

• Ground truth for this device's performance is based on pre-defined engineering specifications, material properties, sterility assurance levels, biocompatibility standards, and functional requirements (e.g., puncture force, resistance to breakage, sample integrity). It is not derived from clinical outcomes or expert consensus on image interpretation.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. No machine learning training set is involved.

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The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

This document is a 510(k) Premarket Notification from the FDA regarding the "M Series Phototherapy Equipment." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new, innovative device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a novel diagnostic or AI-driven device, is not present in this document.

The document indicates that the M Series Phototherapy Equipment's performance data is "the same as or very similar to that of the claimed predicate device." It also states that the lamps and construction are the same, and the primary difference is an updated indication for use and intended use. This implies that the device is not being evaluated for new performance outcomes requiring extensive clinical studies with specific acceptance criteria that would typically be detailed in a submission for a novel technology. Instead, it relies on the established safety and effectiveness of its predicate devices.

Based on the provided text, the following information can be extracted/inferred:

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

   • This document does not specify quantitative acceptance criteria or detailed performance metrics for the M Series Phototherapy Equipment itself. The basis for clearance is substantial equivalence to predicate devices.
   • Implied "Performance": The document states: "The M Series phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same." This implies that its performance is accepted as equivalent to the predicates (ClearLink Controlled Phototherapy Equipment K182215 & 1 Series Phototherapy Unit K100378).

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

   • No specific "test set" or associated sample size is mentioned, as this is not a study validating a new performance claim. The submission relies on a comparison to predicate devices, not on new clinical data demonstrating specific performance numerically.

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

   • Not applicable, as no new test set requiring expert ground truth establishment for a novel performance claim is described.

4. Adjudication method for the test set:

   • Not applicable.

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 device is phototherapy equipment, not an AI or diagnostic tool.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable, as new performance claims requiring ground truth establishment are not the basis of this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the previously cleared predicate devices.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

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M Series Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR). Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

Note: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide.

The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010.

The proposed devices and the existed devices share same intended use, design principle and technical specifications. The main modification of the proposed devices is adding a SpO2 module, which was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269 at 12/21/2005. It is an independent module installed within the patient monitor, without any other modifications, and shall be used with the specified accessories, which are listed in following table.

Here's an analysis of the provided text regarding the acceptance criteria and study for the M Series Patient Monitor (K131876).

Overview:

This 510(k) submission is for modifications to an existing M Series Patient Monitor (K100046). The primary modification is the inclusion of a Masimo SpO2 module, which itself was previously cleared by the FDA (K053269). Therefore, the provided information focuses on demonstrating that the integrated device meets safety and performance standards, particularly for the SpO2 function, and is substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily compares the proposed device's performance characteristics to the predicate device (K100046) and the standalone Masimo SpO2 module (K053269) rather than explicitly stating "acceptance criteria" in a separate section with specific numerical targets. However, the implicit acceptance criterion is that the proposed device performs at least as well as or identically to the predicate devices for each physiological parameter.

Below are the performance characteristics presented as a comparison, where "Same" indicates the proposed device meets the predicate's specification, and the specific numbers represent the reported performance for the proposed device (which is equivalent to the predicate).

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

The document does not explicitly state the sample size used for the clinical or non-clinical test set. It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

For the Masimo SpO2 module, the text states its accuracy has been "verified comply with the declaration of specification" and refers to its prior clearance (K053269). This suggests that the clinical data supporting the SpO2 performance would have been part of the K053269 submission, not newly generated for K131876. Therefore, the provenance of that data would be from the original Masimo clearance study. The K131876 submission itself primarily relies on equivalence to the previously cleared Masimo module and adherence to standards.

No details are provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text. For a device like a patient monitor, ground truth for physiological parameters is typically established through recognized calibrated reference devices or invasive measurements, rather than expert consensus on interpretation. For SpO2, this would involve co-oximetry and controlled hypoxia studies. Since this submission relies on equivalence to a previously cleared module, the details of how ground truth was established would reside in the original Masimo K053269 submission.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a patient monitor measuring physiological parameters, "adjudication" in the sense of multiple experts reviewing an output is less applicable than direct comparison against a known reference standard (gold standard).

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

A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device. MRMC studies are typically used for diagnostic devices where human interpretation (readers) of images or data is a critical component, and the AI's role is to assist or replace that interpretation. This patient monitor provides direct physiological measurements.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The entire device (including the Masimo SpO2 module) functions as a standalone measurement device. Its performance, as specified in the tables (e.g., SpO2 accuracy, PR accuracy), is its standalone algorithm-only performance. The "human-in-the-loop" aspect is the clinician interpreting and acting upon the displayed physiological data, but the measurement itself is autonomous. The verification of compliance with specifications effectively serves as the standalone performance study.

7. Type of Ground Truth Used

For patient monitors measuring vital signs, the ground truth is typically established using:

• Calibrated Reference Devices: For parameters like NIBP, temperature, and respiration, highly accurate, independently calibrated devices serve as the reference.
• Invasive Measurements (Gold Standard): For SpO2, the gold standard for accuracy verification involves controlled desaturation studies where arterial blood samples are taken and analyzed by a co-oximeter. This likely formed the basis for the Masimo SpO2 module's original clearance (K053269).
• Physiological Stimuli: For ECG, a calibrated ECG simulator is used.

The document implicitly refers to these types of ground truth by mentioning compliance with standards like ISO 9919:2005 for pulse oximeters, which mandates specific testing methodologies against reference standards.

8. Sample Size for the Training Set

The document does not report a sample size for a training set. This is because the device is a measurement instrument incorporating a previously cleared, established Masimo SpO2 module. While the Masimo module itself would have been developed using some form of training data (e.g., spectral data to train its algorithms to differentiate oxygenated from deoxygenated blood and motion artifacts), this detail is not provided in a 510(k) summary for a subsequent device integrating it. The focus of this K131876 submission is on integrating the module and ensuring overall device safety and performance according to relevant standards.

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

As no training set is discussed or implied for the M Series Patient Monitor itself in this submission, this information is not provided. The embedded Masimo SpO2 module's original development would have involved establishing ground truth for its algorithms, likely through clinical trials with subjects experiencing varying levels of oxygen saturation, with reference measurements from co-oximeters.

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The mVisum Alert Alarm Management System is software intended for use to display status and alarm events from other medical devices and patient information systems and associated physiological and other patient information. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm and physiological information to mobile healthcare providers.

The mVisum Alert Alarm Management System is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

The mVisum Alert Alarm Management System is a software based secondary alarm notification system that transmits alarms, text and physiological waveform data from patient monitoring devices to a graphical display. This could be either on a PC or on a mobile device carried by a trained professional in a hospital environment. It is also capable of transmitting alarms and physiological waveforms to clinician smartphones that operate on the cell phone data network. The system receives alarm conditions from patient monitoring networks through industry standard HL-7 or XML formats and transmits the notification including any waveform data to the client software component. The client software component can then display the text and the physiological waveform information to the clinician.

The mVisum system only reads alarm information and does not change it or modify it in any way. It does not diagnose alarms but transmits what the Patient Monitoring System determines to be an alarm.

The provided text describes the mVisum Alert Alarm Management System and its 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information regarding ground truth establishment as requested.

The document states:

• "Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis."

This is a general statement about testing but lacks the specifics needed to answer the questions about acceptance criteria and the study that proves the device meets them. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices for its intended use as a secondary alarm notification system, rather than presenting a performance study with detailed metrics against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions using only the provided text.

Here's an overview of what can be extracted and a clear indication of what information is missing:

Description of the Acceptance Criteria and Study (Based on available information):

The provided 510(k) summary for the mVisum Alert Alarm Management System does not detail specific quantitative acceptance criteria or a dedicated clinical study proving the device meets them. Instead, it relies on system-level and regression testing, along with a hazard analysis, to demonstrate performance, functionality, and safety. The primary method for clearance appears to be substantial equivalence to predicate devices (GE / Data Critical Corporation Statview System and GE Web Viewer, Pocket Viewer, Cellular Viewer) based on its technological characteristics and intended use as a secondary alarm notification system. The device's function is to transmit existing alarms and physiological data, not to generate or interpret diagnostic information.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. (The device transmits data from "patient monitoring devices," but no specific dataset or its origin for testing is mentioned.)
• Retrospective/Prospective: Not specified in the provided text.

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

• Number of Experts: Not applicable. The device is a secondary notification system; it does not perform diagnostic functions that would require expert-established ground truth for its performance. It simply relays alarms from primary monitoring systems.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. (As above, this is a relay system, not a diagnostic or interpretive device that would require adjudication of findings.)

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

• MRMC Study: No. The device is not an AI-assisted diagnostic tool; it is a system for transmitting alarms and physiological data. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant to this device's function and was not conducted or reported.
• Effect Size: Not applicable.

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

• Standalone Performance Study: The document describes "system level and regression tests" to establish performance and functionality. While these tests evaluate the software's ability to transmit data, they are not presented as a standalone diagnostic performance study in the way this question typically implies (e.g., sensitivity/specificity for disease detection). The device's primary function is data relay, not independent diagnostic assessment.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated as "ground truth" for a diagnostic purpose. The system's "truth" is whether it accurately receives and transmits the alarm events and physiological data as determined by the primary patient monitoring systems. The device does not establish its own diagnostic ground truth.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is not described as using machine learning or AI that would involve a training set. It is a software system for data transmission.

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

• Ground Truth Establishment for Training Set: Not applicable. (No training set is mentioned as part of the device's development or testing.)

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M Series Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

It has the alarming function with audio and visual alarming, which may raise the user attention of system error and exceeding the pre-set limit of physiological parameter, and data storage function, which can replay the data and alarming event.

The device is driven by AC or DC power supply.

The provided text describes a 510(k) submission for the M Series Patient Monitor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or an AI/algorithm component.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI component, as this information is not present in the given document.

The document only states that:

• "Laboratory testing was conducted to validate and verify that M Series Patient Monitor met all design specifications, including electrical safety, EMC, biocompatibility, specification."
• "Results of these tests demonstrate compliance to the requirements of all consensus standards."

Without further details on these "design specifications" or "consensus standards" and the specific results of "laboratory testing," I cannot create the table or answer the other detailed questions you've posed. The document is a regulatory submission for a patient monitor and not a clinical study report for an AI device.

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M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.

This 510(k) submission (K963123) for the M&R Reusable Electrodes is a premarket notification for a Class II medical device, seeking to demonstrate substantial equivalence to a predicate device (Medi-Source, Inc. GeoHesive Reusable Electrodes K903402). The provided documents do not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or algorithm-driven metrics, as typically seen with AI/ML devices.

Instead, the acceptance criteria are implicit in the demonstration of substantial equivalence to the predicate device. For this type of device (reusable electrodes for TENS/NMES), substantial equivalence is primarily established by comparing device characteristics, materials, intended use, and safety features.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of submission provided.

Here's a breakdown based on the provided information:

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

The "acceptance criteria" here are the characteristics of the predicate device, and the "reported device performance" is how the M&R Reusable Electrodes compare to those characteristics. The submission aims to show that the new device is as safe and effective as the predicate.

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

• Not Applicable. This submission does not describe a performance study with a test set of patient data. The "study" is a comparison of product characteristics to a legally marketed predicate device.

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

• Not Applicable. There is no "ground truth" established by experts for a test set in this type of submission. Substantial equivalence relies on engineering and material comparisons, and adherence to known safety principles for transcutaneous electrical stimulation.

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

• Not Applicable. No test set or human adjudication for performance is described.

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 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

• Not Applicable. This device is an electrode, not an algorithm.

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

• Implicit "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) and generally accepted scientific principles for transcutaneous electrodes. The M&R Reusable Electrodes demonstrate substantial equivalence by using similar materials, having similar indications for use, and presenting similar safety characteristics.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. No training set as per AI/ML context.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the substantive comparison presented in the "Device Comparison Chart" within the 510(k) submission. This chart systematically compares the M&R Reusable Electrodes to the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) across various critical characteristics:

• Number of Models: The M&R device offers significantly more models (37 vs 3), indicating broader options but not necessarily performance difference.
• Electrode Sizes/Shapes: M&R offers a wider variety of sizes and shapes, which fall within the same functional category as the predicate.
• Electrode Construction: Both devices utilize common materials (polyester, polyethylene foam, tricot, vinyl, conductive films with or without Ag/AgCl coating, biocompatible adhesive, biocompatible gel) that are well-established in the industry for such applications. The M&R device provides a broader range of material combinations but remains within accepted norms.
• Stimulator Compatibility: Both devices are compatible with "Common, marketed TENS & NMES devices," establishing functional equivalence.
• Lead Wire Connector Types: M&R offers the same standard connector type as the predicate and an additional standard type, ensuring compatibility.
• Labeled as reusable or single-use disposable?: Both are labeled as "Reusable/for single-patient, multiple-application use."
• Indications For Use: Both are intended for "TENS and NMES," with M&R specifying a broader range of common stimulation modalities falling under TENS/NMES.
• Stated potential adverse reactions: Both list "Skin irritation," indicating similar safety profiles.

Conclusion from the "Study": The comparison demonstrates that the M&R Reusable Electrodes are substantially equivalent to the predicate device. While they offer more variety in models, sizes, shapes, and construction materials, these differences do not raise new questions of safety or effectiveness. The fundamental technological characteristics, intended use, stimulator compatibility, reusability, and potential adverse reactions are either identical or functionally equivalent to the predicate, thus "proving" they meet the implicit acceptance criteria for safety and effectiveness for a Class II device of this type through the substantial equivalence pathway.

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M&R Disposable Electrodes are intended for single-patient/singleapplication use in TENS ("traditional" TENS, microcurrent TENS, etc.) and NMES ("traditional" NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.

M&R Disposable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., cloth with biocompatible adhesive, conductive rubber, and biocompatible conductive gel). The electrodes have a direct lead wire pin connection design and are compatible with all standard, marketed TENS and NMES stimulation devices.

The provided text describes a 510(k) premarket notification for M&R Disposable Electrodes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the information typically requested in a study design and results section is not explicitly available in this document.

However, I can extract information related to the comparison with predicate devices, which serves as the basis for demonstrating equivalence.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, the "acceptance criteria" are typically met by demonstrating that the new device shares fundamental technological characteristics and has similar or identical intended use, design, and performance features to the predicate devices. The "performance" is implicitly deemed acceptable if substantial equivalence is proven.

No explicit quantitative performance metrics or acceptance criteria are presented in the document itself. The comparison table focuses on qualitative and quantitative characteristics for substantial equivalence.

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

This document does not describe a "test set" in the context of a clinical performance study. The 510(k) submission relies on a comparison to predicate devices, which are already legally marketed. There is no mention of a new clinical study with a specific sample size, data provenance, or study design.

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. No "test set" or explicit "ground truth" establishment by experts is described for this 510(k) submission.

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

Not applicable. No "test set" or adjudication method is described.

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 is not an AI-enabled device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI-enabled device, and no standalone algorithm performance study is mentioned.

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

Not applicable in the context of a new clinical study. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI-enabled device requiring a training set.

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

Not applicable. This is not an AI-enabled device.

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