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Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.

VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height.

Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases.

The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.

The provided text is a 510(k) premarket notification for the Vecttor VT-300 device, which is a transcutaneous electrical nerve stimulator for pain relief. The document mainly focuses on demonstrating substantial equivalence to a predicate device (Vecttor VT-200) based on technological characteristics and non-clinical performance testing.

Crucially, this document states: "No clinical tests are being submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence."

This means that the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically related to clinical performance (e.g., human reader performance, ground truth establishment, sample sizes for medical imaging AI/ML models), is not present in this document.

The "acceptance criteria" presented are related to the device's technical specifications and compliance with recognized standards, not its clinical efficacy or AI/ML performance.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to a different type of device clearance (hardware-based equivalence) and explicitly states the absence of clinical test data.

If the prompt were for an AI/ML medical device, the information requested would be highly relevant. However, for this specific device (a TENS unit), the clearance pathway does not require such studies to demonstrate substantial equivalence if predicate devices exist and technical specifications can be shown to be equivalent or safer.

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Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.

Not Found

This document is a 510(k) clearance letter for the ETD4000 Transcutaneous Electrical Nerve Stimulator for Pain Relief. It does not contain information typically found in a study proving a device meets acceptance criteria, such as performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements for marketing the device and includes the "Indications for Use" for the ETD4000.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them based on the provided text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:

• -Symptomatic relief of post-surgical and/or post traumatic acute pain
• -Symptomatic relief of chronic intractable pain
  -Relaxation of muscle spasms
  -Maintaining and increasing range of motion
  -Increases local blood circulation

The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.

The provided document is a 510(k) Premarket Notification for the Avid IF2 Interferential Stimulator, Model AV-IF19A. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample size, expert involvement, adjudication methods, MRMC studies, standalone performance), and ground truth establishment cannot be extracted from this document.

This document describes a device based on well-established technology (transcutaneous electrical nerve stimulation for pain relief) and demonstrates its similarity to previously cleared devices. It relies on device specification comparison and waveform analysis to prove substantial equivalence, not clinical performance data derived from patient studies or AI algorithm validation.

However, I can extract the information that is present, which primarily revolves around the comparative specifications used to demonstrate "equivalency" rather than "acceptance criteria" for a novel performance claim.

Here's an attempt to frame the available information in the context of your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicates)

The "acceptance criteria" in this context are not typically quantitative metrics for clinical performance for a novel claim but rather a demonstration that the new device's technical specifications and operational characteristics are substantially equivalent to predicates. The study proving this involves comparing the new device's outputs and functionalities to those of the predicate devices.

Table 1: "Acceptance Criteria" (Substantial Equivalence Parameters) and Reported Device Performance

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

This 510(k) summary describes a submission for the Gemore IF True Sine Interferential Stimulator (Models GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF). The submission aims to demonstrate substantial equivalence to a predicate device (Gemore IF TENS, Model GM322IF, K032719).

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific "acceptance criteria" in terms of measurable performance metrics and then report the device's achievement against these in a table format. Instead, it relies on demonstrating compliance with recognized standards and similarity to the predicate device to establish substantial equivalence.

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

The summary does not provide details on a specific "test set" in the context of clinical or performance data for the device. The testing mentioned largely refers to engineering verification and validation against standards and comparisons to the predicate device's specifications. Thus, there is no disclosed sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance "test set" in the sense of patient data.

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

This information is not provided in the submission. The submission focuses on substantial equivalence through engineering changes and compliance with standards, not on clinical performance evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As there is no clinical or performance "test set" with ground truth established by experts discussed, an adjudication method is not applicable here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that context.

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

This refers to an "algorithm only" performance study, typically for AI or software-based diagnostic devices. The Gemore IF stimulator is a physical electrical stimulation device. While it has firmware/software, the primary "performance" is the electrical output. The summary indicates "software verification has been carried out according to the FDA software guidance," but this is about the software itself functioning correctly, not about a standalone clinical performance evaluation of an algorithm in the sense of AI.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic or prognostic devices is not directly applicable or detailed in this submission. The "truth" for this submission revolves around:

• Compliance with engineering standards: The device's electrical output and safety features meet established international and voluntary standards (e.g., ANSI/AAMI. NS4-1985, IEC 60601-1, IEC 60601-1-2).
• Verification of software functionality: The software operates according to design and FDA guidance.
• Substantial equivalence to the predicate: The device's intended use and fundamental technological characteristics are equivalent to the previously cleared predicate device, despite stated modifications.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an electrical stimulator, not a machine learning or AI-based device that would typically involve a "training set" for model development.

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

This information is not applicable and not provided. As there is no AI/ML component with a training set, the establishment of ground truth for such a set is not relevant to this submission.

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Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on acupressure points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain. Once these electrodes are placed, the machine determines the appropriate stimulation intensity by automatically measuring body temperatures through the use of two specially designed Thermistors placed on the fingers during a testing sequence. The VT-200 delivers four channels of current from dual output jacks through Treatment Leads and Electrodes which are positioned on the patient's body according to treatment protocols.

Here's an analysis of the provided 510(k) notification for the VT-200 Interferential Current Therapy Device, focusing on the acceptance criteria and the study that proves the device meets them:

Summary of Acceptance Criteria and Device Performance:

Based on the provided text, the VT-200 device's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and its compliance with recognized safety standards. There are no performance metrics specified in terms of clinical efficacy (e.g., specific pain reduction percentages) that would commonly be found for drug trials or more complex medical devices.

Study Information:

It's important to note that the provided 510(k) summary does not describe a clinical study with human subjects to evaluate the therapeutic efficacy of the VT-200. Instead, it relies on proving substantial equivalence to a legally marketed predicate device (Dynatron STS) and demonstrating compliance with recognized electrical and electromagnetic safety standards.

Therefore, for categories related to clinical study design, sample size, ground truth, experts, and MRMC studies, the answer will be that this information is not applicable or not provided in the given document, as these types of studies were not conducted or reported for this 510(k) submission.

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

   • Not applicable / Not provided. The "performance testing" mentioned refers to functional and design verification/validation against engineering standards, not a clinical test set with patient data.

2. 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 / Not provided. No clinical ground truth was established by experts for a test set in this submission.

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

   • Not applicable / Not provided. No test set requiring expert adjudication was described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was not done. This device is an electrical stimulation therapy device, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

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

   • Not applicable. This question typically applies to AI/software as a medical device for diagnostic or interpretive purposes. The VT-200 is a physical therapy device; its "automation" refers to internal software logic for adjusting stimulation intensity, not a standalone diagnostic algorithm.

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

   • Not applicable / Not provided for clinical efficacy. For the engineering performance testing, the "ground truth" would be the specifications and requirements defined by the IEC standards.

7. The sample size for the training set:

   • Not applicable / Not provided. There is no mention of a "training set" in the context of machine learning or AI development for this device. The device's internal software "automatically measuring body temperatures" for intensity adjustment is a programmatic function, not a learned model in the typical AI sense that would require a training set.

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

   • Not applicable / Not provided. As no training set was described, the method for establishing its ground truth is also not applicable.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. It is intended for use on the order of a physician only.

The Everyway IF-908 Interferential stimulator is the device which generates the small ture-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved

The Everyway IF-809 interferential stimulator consists mainly of two parts: the stimulus generator, and electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief

The stimulation current is generated in such a way that the frequency in channel 1 is fixed, but frequency in channel 2 is adjustable. Also the output amplitude is also adjustable. Those adjustable parameters could provide user some stimulation output change depending upon the condition of patients according to the prescription of physician. In general IF-908 is the prescribtion device, which needs the physician instruction for stimulation treatment.

IF-908 provides two different alternative power supply system. 9V internal battery, 9V rechargeable battery pack charged by adaptor. The operator may recharge 9V battery pack for long term use via the power rechargeable battery system of IF-908. The battery pack can not be charged during operation via using 9V battery pack power.

The provided document is a 510(k) summary for the Everyway Interferential Stimulator, model IF-908. It indicates that no clinical studies were conducted to prove the device meets acceptance criteria. Instead, the device's safety and effectiveness were demonstrated through substantial equivalence to a predicate device and non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics from such studies. The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with relevant non-clinical standards.

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

Not applicable. No clinical test set was used. The substantial equivalence determination relies on comparisons of technical characteristics and non-clinical testing.

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

Not applicable. No clinical test set with a ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. The document explicitly states: "No particular Clinical Test was conducted for Everyway Interferential Stimulator, model IF-908."

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

Not applicable. This device is an interferential stimulator, not an algorithm-based diagnostic or therapeutic tool that would typically undergo standalone algorithm performance testing.

7. The Type of Ground Truth Used

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "truth" for this submission is based on fulfilling the requirements for substantial equivalence to a predicate device through non-clinical testing and technical specification comparison.

8. The Sample Size for the Training Set

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

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

Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.

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The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

MAX-IF1000 Interferential Stimulator

The provided text is a US FDA 510(k) clearance letter for the MAX-IF1000 Interferential Stimulator. It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily:

• Identifies the device and applicant.
• States that the device has been found substantially equivalent to a legally marketed predicate device.
• Outlines general regulatory requirements for marketed devices (e.g., registration, labeling, good manufacturing practice).
• Provides contact information for various FDA divisions.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory clearance document, not a scientific study report or clinical trial summary.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or the relevant sections from a 510(k) submission that details performance testing.

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The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

This device, the INF 4160 PLUS, is being cleared through a 510(k) submission, which means it asserts substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with specific acceptance criteria as might be seen for novel devices.

Based on the provided document, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements." and "The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance."

The primary "study" or demonstration of meeting acceptance criteria for this 510(k) submission is the comparison to the predicate device (IF-4000 [510(k) No.: K952683]) and compliance with relevant safety and EMC standards. There was no clinical testing performed for this device, as explicitly stated in section 8. The conclusion relies on the similarity in operating principle, intended use, and power sourcing to the predicate device, along with adherence to non-clinical standards and quality system requirements.

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

• Test Set Sample Size: Not applicable. No clinical test set was used, as no clinical testing was performed.
• Data Provenance: Not applicable. Since no clinical testing was conducted, there's no data provenance from patient samples to report. The evidence relies on technical comparisons and compliance with engineering standards.

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

• Not applicable. No clinical test set or ground truth established by experts for clinical performance was used.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical test set was used, there was no adjudication method employed.

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-powered device, and no MRMC study was conducted.

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

• No. This is a medical device (Interferential Stimulator) and not an algorithm or AI product. Its performance is inherent in its electrical signal generation and delivery, not in an 'algorithm-only' sense.

7. The type of ground truth used

• The "ground truth" in this context is established by regulatory standards and successful clearance of the predicate device. The fundamental premise is that if the new device is sufficiently similar to a previously cleared device and meets applicable non-clinical safety standards, it is considered safe and effective.
  • Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the predicate device, IF-4000 (K952683).
  • Regulatory Standards: Compliance with EN60601-1 (Safety) and EN60601-1-2 (EMC) serves as a ground truth for physical and electrical safety.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no training set in that sense.

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

• Not applicable. As there is no training set, there is no ground truth for a training set to establish.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

The provided text is a 510(k) summary for the IF series True sine interferential stimulator, Model: WL-2206D. It primarily focuses on demonstrating substantial equivalence to a predicate device (WL-2206B) and does not contain detailed information about a specific study comparing performance against acceptance criteria in the way envisioned by the request. The submission emphasizes non-clinical tests and compliance with standards rather than human-data performance studies.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table as typically seen for AI/diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to voluntary standards and the claim of substantial equivalence to the predicate device.

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

• Sample size for test set: Not applicable and not provided. The submission focuses on non-clinical engineering and software verification/validation, not a clinical "test set" in the context of device performance on human data.
• Data provenance: Not applicable. The tests are engineering and software validations.

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 and not provided.
• Qualifications of experts: Not applicable and not provided.

4. Adjudication method for the test set:

• Adjudication method: Not applicable and not provided.

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, an MRMC study was not done. This device is an interferential stimulator, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that sense.

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

• Standalone performance: Not applicable. The device itself is a stimulator; there isn't a standalone "algorithm" for performance evaluation in isolation from the device's function. The "software verification" mentioned confirms the software functions as designed within the device.

7. The type of ground truth used:

• Type of ground truth: The "ground truth" for this submission is adherence to engineering standards, functional specifications, and documented software requirements. There isn't a "ground truth" derived from patient outcomes, pathology, or expert consensus in the context of a clinical performance study.

8. The sample size for the training set:

• Sample size for training set: Not applicable and not provided. This device does not involve machine learning or AI models developed using training sets of data.

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

• Ground truth for training set: Not applicable as there is no training set mentioned or implied.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The WL-2206B and WL-2106E are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IF series True sine interferential stimulator:

First, it is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating new efficacy or specific performance metrics with acceptance criteria, as one might find for a novel or higher-risk device.

Based on the information provided, here's a breakdown:

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

The document does not provide a specific table of acceptance criteria with detailed performance metrics for the device's clinical efficacy (e.g., pain reduction scores, percentage of patients achieving a certain relief level). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device and compliance with relevant standards.

Therefore, the table would look like this, highlighting the lack of specific quantitative clinical performance criteria in this type of submission:

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

• Sample Size for Test Set: The document does not describe a clinical test set with human subjects as part of its substantial equivalence argument. The "verification and validation tests" mentioned are likely engineering and performance bench tests rather than clinical trials.
• Data Provenance: Not applicable, as there's no mention of a clinical test set with human data.

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

• Not applicable. There's no mention of a test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for the engineering tests would be derived from physical measurements and specifications compared against the standards.

4. Adjudication method for the test set:

• Not applicable, as there's no mention of a human-reviewed test set requiring adjudication.

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 device is an interferential stimulator, which is a physical therapy device. It does not involve "readers" or "AI assistance" in the context of diagnostic imaging analysis. Therefore, an MRMC study is not relevant to this device.

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

• Not applicable. This is not an AI-driven or algorithmic diagnostic device. The device's "performance" is its ability to generate electrical current as specified and safely, not an interpretation of data by an algorithm.

7. The type of ground truth used:

• The de facto "ground truth" for this submission is the predicate device (WL-2206A2 K060975). The new devices are considered substantially equivalent if they meet the same specifications and perform safely and effectively as the predicate device, and comply with relevant voluntary standards (ANSI/AAMI, EN 60601-1, EN 60601-1-2) for electrical safety and performance.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable, as there is no training set for this device.

In summary:

This 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with established performance and safety standards, rather than presenting a novel clinical study with quantitative performance metrics and acceptance criteria for a new clinical claim. The "study" mentioned refers to "verification and validation tests" which are typically engineering and bench tests to confirm the new device's technical specifications and safety are comparable to the predicate and comply with recognized standards.

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