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Interferential Stimulation can be used 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
• Maintain or increase range of motion
• Increase local blood circulation

Neuromuscular Stimulation can be used in the following applications:

• · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
• · Prevention or retardation of disuse atrophy
• · Muscle-re-education

The Avid CT2, Model AV-CT20A is a combination therapy device. Like its predicate Avid IF2, it 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 primary difference between the two devices is the addition of user- adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.

The provided text is a 510(k) summary for a medical device called the "Avid CT2 Neuromuscular and Interferential Stimulation System." It aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain the information requested in the prompt regarding acceptance criteria for device performance studies, sample sizes, expert involvement, or MRMC studies. This type of information is typically found in clinical study reports or validation documents, not in a 510(k) summary focused on demonstrating equivalence through comparison to predicate devices' specifications and functionalities.

The document primarily focuses on bench testing and electrical output comparisons to establish substantial equivalence, rather than human-in-the-loop performance studies or clinical effectiveness trials that would involve the detailed data collection and analysis described in the prompt.

Therefore, I cannot extract the requested information from this document. The prompt's requirements pertain to performance studies, especially those involving human interaction or clinical outcomes, which are not detailed in this 510(k) summary.

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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 BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand.

The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.

The BioniCare Hand System, Model BIO-2000 is portable, rechargeable, battery-operated, single Channel device that utilizes a voltage regulated output circuit to generate a spike-shaped Monophasic pulse with adjustable amplitude of 0 - 15 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator (BioniCare® Stimulator).

Please note that the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining strict acceptance criteria for a novel device. The "clinical study results and summary" section describes a study done to support the device's efficacy, but it doesn't establish explicit acceptance criteria in the format typically seen with a novel AI/medical device.

Based on the information provided, here's a breakdown of the closest approximations to your requested points:

A. Table of "Acceptance Criteria" and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense (e.g., minimum sensitivity or specificity targets). Instead, it presents effect sizes from a clinical study to demonstrate the device's efficacy in conditions for which it seeks indications. The "acceptance" is implicitly tied to these observed effect sizes being considered favorable and robust enough to support the intended use, especially when compared to benchmarks like the effect sizes of NSAIDs.

B. Sample Size and Data Provenance for the Test Set

• Sample Size: 82 patients were enrolled in the study. (66 females, 16 males)
• Data Provenance: The study was a "prospective, multi center, open-label study." The patients were "entered from the investigating physicians practice, without advertising." The document does not specify the country of origin of the data, but given the FDA submission, it's highly likely to be U.S.-based.

C. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their specific qualifications for the "test set" (clinical study data). However, it mentions "physician global assessment" as an efficacy outcome, implying that the assessing physicians served as experts in evaluating the patient's condition. Their qualifications are implicitly that they are "investigating physicians" capable of diagnosing and managing osteoarthritis.

D. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data. It was an "open-label study."

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI or imaging device where human reader interpretation would be assisted by AI. The clinical study evaluated the device's direct effect on patients.

F. Standalone Performance

The "standalone performance" of the device is implicitly represented by the clinical study results described in section A and B. The device operates independently on the patient, and the study measures its direct therapeutic effect. There is no "human-in-the-loop" interaction in the typical sense of interpreting AI outputs.

G. Type of Ground Truth Used

The ground truth or primary outcome measures were based on:

• Patient-reported pain (VAS scale)
• Patient global assessment
• Physician global assessment
• Validated functional assessment questionnaire (DASH score)
• Objective physical measurements (pinch force, grip strength using JAMAR Hand Assessment Kit)

These are clinical outcomes and patient self-assessments, commonly used in clinical trials for pain and functional improvement.

H. Sample Size for the Training Set

The document does not mention a training set. This device is a physical therapeutic device (a stimulator), not a machine learning or AI algorithm that requires a training set. The clinical study described served as the primary evidence for its efficacy for regulatory submission.

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

As there is no mention of a training set for this device, this question is not applicable.

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The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy .
• Increases local blood circulation .
• Muscle re-education •
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Interferential Stimulation can be used in the following applications:

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

Pulsed Direct Current stimulation can be used in the following applications:

• Reduction of edema (under negative electrode)
• Relaxation of muscle spasm
• . Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Muscle re-education
• Maintaining or increasing of range of motion

The T.E.A.R. Tech 3 IF/Muscle Stimulator is a device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device. The device produces a low electrical current that is transmitted via lead wires to electrodes placed on 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 keypad.

This 510(k) summary does not contain details about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) submission for an Interferential/Muscle Stimulator (T.E.A.R. Tech 3). It focuses on establishing substantial equivalence to previously cleared devices based on design, composition, and intended use.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies, as that information is not present in the provided text. The document primarily describes the device, its indications for use, and its substantial equivalence to other predicate devices, which is typical for a 510(k) summary seeking market clearance.

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The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.

The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.

This 510(k) summary describes a new medical device, the Target Sterile Electrode, and compares it to a predicate device, the Surgi-Stim Sterile Electrode, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device, Surgi-Stim Sterile Electrode. The study aims to demonstrate that the new Target Sterile Electrode performs equivalently or better than the predicate for these properties.

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

The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The comparison is based on material specifications and performance characteristics, suggesting laboratory testing rather than clinical study on patient data.

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

This document does not describe the use of experts to establish ground truth. The comparison is based on objective material and physical property evaluations.

4. Adjudication Method

This document does not describe any adjudication method as it's not a study involving subjective assessments.

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

No. This document does not describe a multi-reader multi-case comparative effectiveness study. The device is a cutaneous electrode, not an imaging or diagnostic device requiring human interpretation of results.

6. Standalone (Algorithm Only) Performance Study

No. This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is based on objective physical and material properties and performance specifications of the predicate device. For instance, the "ground truth" for impedance is "Less Than 100 Ohms," and for wire removal force, it's "More Than 5 Pounds of Force."

8. Sample Size for the Training Set

This document does not specify a training set sample size. The comparison is based on characterization of the new device against an existing predicate.

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

This document does not describe a training set or how its ground truth was established, as this is a device equivalence submission based on material and performance comparison rather than an AI/machine learning model. The 'ground truth' for comparison purposes is the established specifications and performance of the predicate device.

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The TENS is used for 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

The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.

The provided text is a 510(k) summary for the "Fast Start® TENS" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and reported device performance in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections (sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable or not available in this type of submission.

Here's a breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The submission's core argument is about substantial equivalence to a predicate device, implying that its performance is acceptable if it functions similarly to the already approved predicate. No specific performance metrics or acceptance thresholds are detailed.

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

This information is not provided. This 510(k) summary does not describe a clinical study or a separate performance evaluation with a "test set" in the context of device performance against specific metrics. It relies on the similarities to the predicate device.

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

This information is not provided. The submission does not describe a process of establishing ground truth with experts for a test set.

4. Adjudication Method for the Test Set

This information is 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

This information is not applicable/not provided. This device (Transcutaneous Electrical Nerve Stimulator) is a physical medical device, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to its approval.

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

This information is not applicable/not provided. As explained above, this is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. The submission argues for substantial equivalence based on technical characteristics and indications for use, not by comparing performance against a "ground truth" derived from patient outcomes or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a hardware product, not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided.

Summary of the Study and Device Acceptance (Based on K041092 Document):

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the new device is "substantially equivalent" to an already legally marketed device (the predicate device). Approval is based on meeting this substantial equivalence rather than explicit, new acceptance criteria and a performance study against those criteria.

• Acceptance Criteria (Implied): The primary "acceptance criterion" is that the new device (Fast Start® TENS) is substantially equivalent to the predicate device (Classic TENSTM, K020437) in terms of indications for use, technical characteristics, and device specifications. This means it should not raise any new questions regarding safety and effectiveness.
• Study That Proves Substantial Equivalence: The submission itself constitutes the "study." It does not present a clinical trial or performance data in the traditional sense. Instead, it makes a reasoned argument by:
  • Comparing Indications for Use: The Fast Start® TENS has the same indications for use as the Classic TENS: "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."
  • Comparing Technical Characteristics and Device Specifications: The document states that "This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications." It further mentions the Fast Start® TENS has "three modes of operation: Conventional, Burst, and Modulated" and "twelve pre-set and two customized programs," implying these are comparable or represent standard TENS functionalities also found in the predicate or are generally accepted.
  • Conclusion: The submission concludes that "Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation... It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards."

In essence, the "proof" for this 510(k) is the detailed comparison to an already approved device, asserting that the new device is functionally and technically similar enough not to warrant new, extensive performance testing.

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The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:

• Relaxation of muscle spasms .
• Prevention or retardation of disuse atrophy ●
• Increases local blood circulation ●
• . Promotes muscle re-education and range of motion
• . Maintaining and increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Stimulators have one additional indication for use:

• Provides symptomatic relief and management of post surgical, acute, or chronic . pain
  The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device combining the functionality of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators in one device which produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

This submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the submission, K030507 for the T.E.A.R. Tech3, is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as existing, approved devices, and does not raise new questions of safety or effectiveness. It does not typically involve extensive clinical trials or the establishment of new performance acceptance criteria as would be seen for novel devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission (e.g., a PMA or De Novo classification) that would present new performance data.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics and intended use being similar to predicate devices, rather than presenting a performance study against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set data or provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.

4. Adjudication method for the test set: Not applicable. No test set needing adjudication is mentioned.

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 electrical stimulator, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth data is presented.

8. The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

Summary of the K030507 Submission:

• Acceptance Criteria and Study: The submission does not define specific acceptance criteria or present a study to demonstrate performance against such criteria. Instead, it argues for substantial equivalence to predicate devices.
• Basis for Substantial Equivalence: The T.E.A.R. Tech3 is deemed substantially equivalent to the predicate devices (Surgi Stim K982388 and Jace Tri-Stim K931781) because it has the "same intended use and technological characteristics" and "no new questions of safety or effectiveness have been raised."
• Technological Characteristics: The device is a combination of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators.
• Indications for Use: The shared indications include relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, promotion of muscle re-education and range of motion, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The Interferential Stimulator has an additional indication for symptomatic relief and management of post-surgical, acute, or chronic pain.
• Target Population: Patients with chronic/acute pain syndrome, and/or recovering from orthopedic-related surgery.

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This device is a 'combination' device and has the same indications for use as two different types of predicate devices.

High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.

• Relaxation of muscle spasms ●
• Prevention or retardation of disuse atrophy .
• Increasing local blood circulation ●
• Muscle re-education .
• Maintaining or increasing range of motion ●
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●

Interferential Stimulators have one additional indication for use:

Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "Surgi Stim". It confirms that the device is substantially equivalent to predicate devices and can be marketed. However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study that proves the device meets specific performance criteria.

The letter focuses on the regulatory clearance process and states the "Indications For Use" for the Surgi Stim device which is a combination of High Volt Pulsed Galvanic Stimulators, Neuromuscular Electrical Stimulators, and Interferential Stimulators.

Therefore, I cannot answer your specific questions based on the provided text. The document does not describe a study or provide performance data.

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