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Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:

1st layer: Insulation material: Tan fabric
2nd layer: Double sides adhesive tape
3rd layer: Conductive film (Carbon Film)
4th layer: Self-adhesive conductive hydrogel
5th layer: Plastic release film
Connection: Leadwire/Snap button

The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.

However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours).
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes.
The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter.
The electrodes placement in IceCap Product line is done accordingly to the 10/20 system.
The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors.
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.

The IceCap product line does not perform comparative effectiveness studies with human readers or standalone algorithm performance studies. The device is a cutaneous electrode, and its evaluation focuses on safety and performance according to relevant standards, not on AI-driven diagnostic accuracy.

Here's a breakdown of the acceptance criteria and supporting studies for the IceCap product line:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for specific test sets (e.g., for fit-to-form, impedance, or usability tests). It mentions that the "clinical data were not necessary to determine substantial equivalence," indicating that animal or human subject testing for diagnostic or comparative effectiveness was not performed as a primary means of establishing substantial equivalence for this type of device.

The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective. The studies primarily involve non-clinical performance and safety testing.

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

As this device is an EEG electrode, the primary "ground truth" for its performance is its ability to meet electrical and biocompatibility standards, and to effectively acquire EEG signals as confirmed by non-clinical tests. There is no mention of human experts being used to establish a ground truth for a diagnostic outcome, as the device itself does not provide diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. The evaluation performed is based on compliance with harmonized standards and engineering tests, not on human-based adjudication of diagnostic outcomes.

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 IceCap product line is an EEG electrode, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers are not relevant to its clearance.

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

Not applicable. The device is a hardware component (EEG electrode) and does not involve a standalone algorithm for performance evaluation in a diagnostic context.

7. The type of ground truth used

The ground truth used for evaluating the IceCap product line is based on established engineering standards and regulatory requirements for medical devices, particularly for cutaneous electrodes. This includes:

• Performance standards: e.g., electrical impedance, signal integrity (implied by "general quality of signal").
• Safety standards: e.g., electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability for medical electrical equipment in the home healthcare environment (IEC 60601-1-11).
• Biocompatibility standards: (ISO 10993-1) for materials in contact with the patient.
• Functional tests: Fit-to-form, usability for installation.
  The "truth" is whether the device meets these specified, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set.

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

Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set or ground truth for training.

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Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired.

The Delphi MCS Electrode Cap is made of elastic textile material, preserving the shape and size. The cap provides the exact position of the electrodes on the head without the need for additional measurements and adjustments. Large holes are provided for ventilation and access to the electrodes and patient's skin. The cap is fixed to the head with a chinstrap. The Cap is available in the following sizes: XL 60-66cm, XL/L 57-63cm, L 54-60cm, L/M 51-57cm, M 48-54cm. The textile caps sizes are identifiable by the color material or seam and marking according to international system 10-20.

The Ag/AgCl electrodes are designed to provide minimal polarization and long-term stability of the signal. The conductive surface of the electrodes which is housed inside the electrode base does not have direct skin contact; an electrically conductive substance (hydrogel) is used inside the electrode base for improved conductivity.

Delphi Cap electrodes are thin cup Ag/AgCl sintered electrode for EEG recording. The electrodes are designed for maximum comfort while the patient in a supine position. The design of this electrode is suitable for conducting combined TMS-EEG studies. The Ag/AgCl sintered electrode material guarantees minimum polarization and long-term signal stability, as well as an increased electrode life.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study that proves a device meets such criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the document describes the substantial equivalence claim for a new medical device, the "Delphi MCS Electrode Cap," in comparison to a predicate device, the "Electro-Cap System."

The document primarily focuses on demonstrating that the new device shares the same intended use and similar technological characteristics as the predicate device, and that any differences do not raise new safety or effectiveness concerns.

Here's a breakdown of what is provided, and what is missing based on your request:

Information Present (related to device evaluation):

• Device Name: Delphi MCS Electrode Cap
• Intended Use: "Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired."
• Performance Data (Non-Clinical Bench Tests):
  • Biocompatibility: Cytotoxicity, Sensitization, Irritation (per ISO 10993 standards)
  • Electrical safety (per IEC 60601-1)
  • Use cycle reliability and durability testing (resistance, noise, impedance, durability, repeated cleaning cycles)
  • AC Impedance
  • Offset Voltage
  • Combined offset instability and internal noise
  • Bias current tolerance
  • Shelf Life
  • Conductive connection compliance
• Conclusion of Performance Tests: "The results of the performance bench testing support the safety profile of the device and demonstrate that the device functions as intended." (This indicates the device met some internal performance objectives for these bench tests, but specific acceptance criteria and detailed quantitative results are not provided.)

Missing Information (as per your request):

1. A table of acceptance criteria and the reported device performance: While non-clinical tests are listed, the specific acceptance criteria for each test (e.g., maximum allowed impedance, specific thresholds for cytotoxicity) and the quantitative reported performance of the Delphi MCS Electrode Cap against these criteria are not provided in this document. The document only states that the tests were "successful" and "support the safety profile" and "demonstrate that the device functions as intended."
2. Sample sized used for the test set and the data provenance: Not applicable to the type of non-clinical bench testing reported.
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 bench testing, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study would be relevant for devices that involve human interpretation of output (e.g., AI for image diagnosis), which is not the primary function of an EEG electrode cap.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is an electrode cap, not an algorithm.
7. The type of ground truth used: Not explicitly stated for each bench test, but implied to be based on established standards and physical/electrical measurements.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily address the safety and technical similarity of the Delphi MCS Electrode Cap to a predicate device through non-clinical bench testing. It does not detail specific acceptance criteria for clinical performance or diagnostic accuracy, nor does it describe a clinical study comparing its effectiveness or AI-assisted performance against human readers.

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The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate).

Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Electrode Pad (K241512), focusing on the requested information.

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI-powered medical device. Therefore, much of the requested information, particularly concerning AI device performance metrics, human reader studies, and detailed ground truth establishment for a test or training set, is not present in this type of document because the device is a simple "Electrode Pad" and not an AI-enabled diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes performance testing for a non-AI hardware device (an electrode pad). Therefore, the concept of a "test set" in the context of machine learning, with associated data provenance, is not applicable here. The tests conducted are non-clinical, laboratory-based tests on the physical device components and batches of manufactured electrodes. The document does not specify general "sample sizes" for all tests, but implies testing was sufficient to meet standard requirements. The provenance of the data is from the manufacturer's internal testing.

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

Not applicable. As this is a physical medical device, not an AI diagnostic tool, there is no "ground truth" derived from expert interpretation for a test set. Acceptance is based on meeting technical specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 pad, not an AI system. No MRMC study was conducted.

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

Not applicable. This is a physical electrode pad, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• International Standards: Adherence to standards like ISO 10993 series for biocompatibility, ASTM F1980-16 for accelerated aging, and AAMI/ANSI ES 60601-1 / IEC 60601-2-2 for electrical safety and impedance.
• Predicate Device Specifications: Demonstrating performance within ranges or equivalent to a legally marketed predicate device (K182111 DL Adhesive Electrode) for key parameters such as impedance and adhesion.
• Design Specifications: The device met its own design specifications.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.

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

Not applicable, as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth establishment.

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The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.

Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation. Through the Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction. Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device. Wave Electrode is available in two different models: Mod. AE02-50, with notch filter centred on the 50 Hz frequency; Mod. AE02-60, with notch filter centred on the 60 Hz frequency

This document is a 510(k) Premarket Notification from BionIT Labs Srl for their Wave Electrode (AE02-60; AE02-50) devices, seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or performance studies in the way you might expect for a novel device or AI/ML algorithm.

Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and functional compatibility with a specific prosthetic hand. The performance is assessed by meeting these standards and ensuring the device operates as intended alongside the "Adam's Hand®" prosthetic hand.

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

This information is not provided in the document. The non-clinical performance data refers to "internal testing" and testing by "an accredited laboratory," but specifics on sample sizes, types of data (e.g., specific scenarios, duration), provenance, or study design are omitted.

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/not provided as there is no mention of a ground truth established by experts in the context of diagnostic or interpretive performance for an AI/ML algorithm. The device is a cutaneous electrode for EMG signal detection, and its performance is evaluated against engineering and biological safety standards, not against an expert-derived ground truth for an interpretation task.

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

This information is not applicable/not provided. As explained above, there's no mention of a ground truth derived from expert adjudication for interpretive tasks.

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 or mentioned. This type of study is typically relevant for AI/ML-driven diagnostic or interpretive devices that assist human readers. The Wave Electrode is a hardware device for signal acquisition, not an AI/ML diagnostic tool.

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

No standalone algorithm-only performance study was done or mentioned. The device itself is hardware. The document states it is an "analog device and has no on-board programmable electronics (FW and or PEMS)."

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

Given the nature of the device (cutaneous electrode), the "ground truth" implicitly refers to:

• Engineering specifications and recognized standards: Performance is measured against criteria for electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993 series).
• Intended function: The ability to "detect, process, and transmit physiological signals" and operate as intended "in conjunction with 'Adam's Hand®' prosthetic hand."

There is no mention of ground truth related to medical diagnoses, pathology, or outcomes data, as these are not relevant to the function of a cutaneous EMG electrode.

8. The sample size for the training set

This information is not applicable/not provided. The Wave Electrode is described as an analog device without programmable electronics or software. Therefore, there is no AI/ML algorithm that would require a "training set."

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

This information is not applicable/not provided for the same reasons as point 8.

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The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The CAIs Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals.
It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAIx and CAI software of CAI Monitoring System.
The CAIs sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable.
Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box.
The hydrogel used in the sensors is designed for single use by one patient.

The provided text describes a 510(k) premarket notification for a device named "CAIs Sensor (CAIs-001)". However, the document does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML algorithm or a performance study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device ("Covidien BIS Sensors") based on:

• Indications for Use Comparison: Stating that both devices are applied to the skin for recording electrophysiological signals (e.g., EEG).
• Technological Comparison: Claiming the CAIs Sensor has similar major characteristics affecting safety and performance as the predicate device.
• Non-Clinical Tests: Biocompatibility testing (per ISO 10993 standards), usability engineering, risk analysis (within the CAI Monitoring System), and bench testing for electrical, adhesive performance, and shelf life (per FDA guidance, ANSI/AAMI EC12, and IEC 60601-2-2).

Crucially, the document explicitly states: "Clinical studies were not performed."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or any details related to MRMC or standalone performance studies, as these aspects are not present in the provided text. The device is a cutaneous electrode, not an AI/ML diagnostic or predictive device with performance metrics based on algorithms.

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This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired. Patient population from infants up to any age.

WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in Chin-strap (placed under the chin). Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "WaveGuard Net EEG Cap." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven system.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" requested in the prompt are typically associated with performance validation studies for software or AI/ML-based medical devices, often requiring clinical or technical performance metrics against a defined ground truth.

This 510(k) summary primarily addresses:

• Device Description: What the device is (EEG electrode cap with saline-soaked electrodes).
• Intended Use: For routine clinical EEG settings.
• Comparison to Predicate Device: How it's similar and different from a previously cleared device (WaveGuard EEG Cap K110223). Key differences noted are electrode material (Coated Ag vs. Sintered Ag/AgCl), cap material (Silicone Mesh vs. Lycra), and Magnetic Resonance compatibility (MR unsafe vs. MR safe).
• Non-Clinical Testing: This section refers to performance standards and biocompatibility testing for the device itself (like electrical safety, material safety), not against an AI/algorithm's predictive accuracy or diagnostic performance. The listed standards (e.g., ISO 10993 series, 21 CFR PART 898) relate to safety, material characteristics, and electrical performance of electrodes/cables.

Therefore, based on the provided text, it is not possible to extract the information requested in the prompt, as the document does not describe a performance study for an AI/algorithm-driven device with accuracy, sensitivity, or specificity metrics.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance for an AI/algorithm. The document discusses performance standards for an electrode cap (e.g., electrical safety, biocompatibility), not a software's classification or prediction accuracy.
2. Sample size used for a test set or data provenance for an AI/algorithm validation.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
4. Adjudication method for an AI/algorithm test set.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a physical electrode cap, not an AI or software assistant for human readers.
6. Information on standalone (algorithm-only) performance. Again, this is a physical device.
7. The type of ground truth used in the context of an algorithm's performance. The "ground truth" for this device would relate to its physical and electrical properties meeting specified standards.
8. Training set sample size for an AI/algorithm.
9. How ground truth for the training set was established for an AI/algorithm.

The document's "Performance Data / Summary of Non-Clinical Testing" section refers to:

• 21 CFR PART 898—Performance Standard for Electrode Lead wires and Patient Cables: This regulation sets electrical safety and performance standards for the physical components of the EEG cap.
• Biocompatibility testing (ISO 10993 series): This ensures the materials in contact with the patient are safe (non-toxic, non-irritating, etc.).

These are standard regulatory requirements for all medical devices like EEG caps, not specific to the validation of AI/ML software.

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

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

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

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

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

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

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

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

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

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The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

Wrap Accessory Electrodes with GMX-ABSBELT01、GMX-ABSBELT02、GMX-WRIST01、 GMX-ELBOW01、GMX-LEG 01、GMX-ANKLE01、GMX-KNEE01、GMX-FOOT PAD 01、 GMX-GLOVES 01、SHOULDER01、GMX-NCK01, are intended to be used with legally Marketed transcutaneous electrical nerve stimulators or powered muscle stimulators which could be used in place of traditional cutaneous electrode patches. The different series of model means different placement of the Wrap Accessory Electrodes. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the "Wrap Accessory Electrodes" to legally marketed predicate devices. This type of submission relies on demonstrating that a new device is as safe and effective as an already cleared device, rather than proving absolute safety and effectiveness through extensive clinical trials.

As such, the document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets such criteria. The device in question is a passive accessory (electrodes) used with electrical stimulating devices, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document.

However, based on the provided text, we can extract information regarding the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the "study" (non-clinical testing) from the document's perspective:

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

The document doesn't present a formal table of "acceptance criteria" for performance in the typical sense of AI/ML metrics (e.g., sensitivity, specificity, AUC). Instead, it shows a comparison to predicate devices and lists various electrical performance parameters. The "acceptance criteria" are implied to be that the proposed device performs similarly to or within acceptable ranges of the predicate devices for safety and basic electrical functionality.

• 500Ω: TENS 1:112, TENS 2: 114, STIM1:116, STIM2:116, STIM3:76, STIM4: 70 V
• 2kΩ: TENS 1: 250, TENS 2: 240, STIM1: 250, STIM2: 250, STIM3: 158, STIM4: 146 V
• 10kΩ: TENS 1: 300, TENS 2: 286, STIM1: 310, STIM2: 308, STIM3: 278, STIM4: 276 V
  Maximum Output Current:
• 500Ω: TENS 1: 224, TENS 2: 228, STIM1: 232, STIM2: 232, STIM3: 152, STIM4: 140 mA
• 2kΩ: TENS 1:125, TENS 2: 120, STIM1: 125, STIM2: 125, STIM3:79, STIM4: 73 mA
• 10kΩ: TENS 1: 30, TENS 2: 28.6, STIM1: 31, STIM2:30.8, STIM3: 27.8, STIM4: 27.6 mA
  Pulse period: 20~200 mSec
  Frequency:
• TENS 1: 33, TENS 2: 5, STIM1:37, STIM2:25, STIM3: 5, STIM4: 50 Hz
  Maximum Phase Charge (500Ω):
• TENS 1: 11, TENS 2: 11, STIM1: 11.4, STIM2: 10.6, STIM3: 22.8, STIM4: 20.4 µC
  Maximum Charge Density (500Ω):
• TENS 1: 0.024, TENS 2: 0.01, STIM1:0.027, STIM2: 0.021, STIM3: 0.021, STIM4: 0.059 mA/cm²
  Maximum Average Power Density (500Ω):
• TENS 1: 1.33, TENS 2: 0.554, STIM1: 1.54, STIM2: 1.13, STIM3: 0.793, STIM4: 2.01 mW/cm² |
  | - Compliance with basic safety and essential performance standards | IEC 60601-1-11:2020, IEC 60601-2-10:2012 +A1:2016+A2:2023, IEC 60601-1-6:2010+A1:2013+A2:2020. |
  | - Hot spot test | Conducted (results not detailed but stated to meet predefined acceptance criteria). |
  | - Maximum/Minimum resistance value | Conducted (results not detailed but stated to meet predefined acceptance criteria). |

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

• Sample Size: Not explicitly stated as a "sample size" in the context of a clinical test set. The testing refers to individual units of the Wrap Accessory Electrodes for non-clinical performance and safety evaluations. The document implies a sufficient number of devices were tested to draw conclusions on performance and safety compliance.
• Data Provenance: The testing was conducted by Gymmax Technology Shenzhen Co., Ltd., which is based in China. The data would be from laboratory testing of the physical devices. This is not a retrospective or prospective human data study in the medical sense.

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

Not applicable. This is not a study assessing diagnostic performance where expert ground truth is required. The "ground truth" for these tests are objective measurements against established engineering and medical device standards (e.g., ISO, IEC).

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

Not applicable. No human adjudication is mentioned or required for these types of engineering and safety tests.

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. This is not an AI/ML device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a passive accessory device, not an algorithm.

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

The "ground truth" here is compliance with recognized international and national standards for medical devices, specifically for electrical safety, biocompatibility, and intended performance of cutaneous electrodes. This is established through objective physical and electrical measurements, and laboratory biological tests, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable.

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Glide is to be used exclusively for exoprosthetic fittings of the upper limb.

Glide is a surface electromyography (EMG) electrode and control system intended to be used with an upper limb prosthesis. Glide detects surface EMG signals using IBT Electrodes V2 placed on the user's skin. These signals are processed by Glide and are used to drive the upper limb prosthesis.

Glide is compatible with industry standard domes. Glide does not have any direct skin contacting parts. Glide is compatible with most hands, wrists, and elbows that accept industry standard inputs. Glide accepts power from the prosthesis batteries and outputs control signals to hands, wrists, and other prosthetic components. The components of Glide are assembled into the prosthesis by a certified prosthetist or trained technician according to the individual needs of the amputee. Glide is a reusable single patient use device.

Glide does not replace or modify any functionality of connected prosthetic components.

Adjustments to the Glide components can be performed through Bluetooth data transfer using the IBT Control Application. The IBT Control Application runs on the iPad OS platform and allows the prosthetist to adjust the settings of the system, such as assignment of input filtered signal to prosthesis movements, adjustment of gains, etc.

Glide components:

• Core2 Controller (90010)
• Output Cable (90020-XX)
• IBT Remote Dome Electrodes (upto 8)
• Electrode Cables
• IBT Control Application
• Core2 Fabrication Kit (94001)
• Documentation
• Dome Fabrication Kit (optional)

This document describes the Glide device, an electromyography (EMG) electrode and control system for upper limb prostheses, and its comparison to a predicate device for FDA 510(k) clearance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics (like sensitivity, specificity, accuracy, or specific thresholds for latency, signal-to-noise ratio). Instead, it relies on demonstrating compliance with recognized performance standards and successful completion of internal verification and validation testing, implying that passing these tests constitutes meeting the acceptance criteria for safety and effectiveness.

General Performance and Acceptance Status: The Glide device passed all internal testing regimens and relevant performance standards.

Note regarding predicate device comparison: For software V&V and Design V&V, the document states "As with any device, the predicate would also have been tested to determine if user and device requirements are met. There is no publicly available information on the same." This indicates the comparison is based on the expectation that the predicate met similar internal standards, rather than direct public data.

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

The document does not explicitly state the sample size for any specific performance tests (e.g., number of users, number of devices tested, or duration of tests). It generally refers to "Internal Testing Regimen" and "Validation testing on Glide."

The data provenance is internal, from Infinite Biomedical Technologies, LLC. No country of origin of the data is specified beyond the manufacturer's location (Baltimore, MD, USA). The studies appear to be prospective in nature, performing tests on the Glide device to gather data for submission.

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

The document does not specify the number or qualifications of experts used to establish ground truth for testing. The validation tests (e.g., "Patient Use of UI," "Practitioner Use of UI") imply user testing, but details on how success was evaluated or if independent experts were involved in defining successful outcomes are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating test results. The implication is that internal teams and standard testing procedures determined pass/fail outcomes.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any studies evaluating the effect size quantifying human reader improvement with or without AI assistance. The Glide device is an EMG control system for prostheses, not an AI diagnostic imaging tool that would typically involve human "readers."

6. Standalone Performance Study

The information provided focuses on the standalone performance of the Glide system (algorithm and hardware together) through various verification and validation tests and compliance with performance standards. The results listed in the "Performance Data" section (e.g., "Installation of Core2," "Battery Life," "Lifetime and Reliability Testing") are all indicative of standalone algorithmic and system performance. The "IBT Control Application" runs on an iPad OS platform, and its software verification and validation is part of the standalone performance assessment.

7. Type of Ground Truth Used

The ground truth used for the tests appears to be based on device functionality and compliance with engineering/performance standards. For example:

• Engineering specifications: (e.g., successful installation, battery life, lifetime and reliability)
• User interaction/usability: (e.g., UI use by patient and practitioner, patient use of prosthetic component)
• Regulatory standards: (e.g., IEC/EN 60601 series for safety, essential performance, EMC).
• Physical testing: (e.g., packaging drop test).

The ground truth is not related to expert consensus, pathology, or outcomes data in a clinical diagnostic sense, but rather to the successful and safe operation of the medical device as per its design and intended use.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The Glide device functions as a real-time control system for prostheses, processing electromyography (EMG) signals. While such systems may involve machine learning or signal processing algorithms, the document focuses on the performance verification of the final device, rather than the training phase of any underlying algorithms. It states that "Glide processes inputs from two to eight electrodes to drive a prosthesis into multiple movements without the use of traditional triggers and/or calibration," and uses "vector summation control." This implies a deterministic or rule-based control scheme, or a pre-trained model where the training details are not elaborated.

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

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described.

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