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The BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.

Transcutaneous Electrical Nerve Stimulator For Pain Relief

This is a 510(k) premarket notification for a Class II medical device, specifically a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The provided document is an FDA letter of clearance and the "Indications for Use" section. This type of document typically does not contain the detailed study information regarding acceptance criteria and performance data as it is a summary of the FDA's decision, not the full submission.

Therefore, based only on the provided text, I cannot answer the questions about acceptance criteria and study details. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device's performance was compared to a predicate device, but the specifics of that comparison, including acceptance criteria and study details, are not present in this document.

To answer your questions, I would need to review the full 510(k) submission, which is not provided here.

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T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

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I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification approval letter for the "Pain Buddy" Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, stating that the device is substantially equivalent to a legally marketed predicate device.

The document includes:

• Trade/Device Name: Pain Buddy
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous electrical nerve stimulator for pain relief
• Regulatory Class: II
• Product Code: NUII
• K Number: K102051
• Indications for Use: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device is for Over-The-Counter Use.

However, it does not contain the specific details requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is primarily an FDA approval letter for substantial equivalence, not a detailed study report.

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Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

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This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test sets or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established.

Therefore, I cannot provide the requested table and details as the input document does not contain this type of information. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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(TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems. Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: relaxation of muscle spasm; muscle reeducation; prevention of disuse atrophy; maintaining and increasing the range of motion; and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of disuse atrophy, relaxation of muscle spasm, muscle reeducation, maintaining and increasing the range of motion, and as immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7

This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria in the format requested.

The document states that the device, a "Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7," has been determined to be "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the device is as safe and effective as a legally marketed device that does not require premarket approval.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Device Performance Table: The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present performance data for the device against such criteria. Substantial equivalence is a regulatory standard, not a performance metric defined by specific statistical outcomes.
2. Sample Size and Data Provenance for Test Set: This information is not part of a 510(k) clearance letter. The substantial equivalence determination is based on a comparison to predicate devices, which may or may not involve a new clinical study. If a study was performed, its details are not included here.
3. Number and Qualifications of Experts: Not applicable or provided. The determination is made by FDA reviewers based on the submission from the manufacturer, not a consensus of external experts establishing a ground truth for a test set.
4. Adjudication Method: Not applicable or provided.
5. MRMC Comparative Effectiveness Study: Not mentioned or implied. A 510(k) clearance typically does not require a comparative effectiveness study showing human reader improvement with AI assistance, as this is not an AI device.
6. Standalone Performance Study: The document does not detail any standalone performance study. The focus is on substantial equivalence to existing devices.
7. Type of Ground Truth: Not applicable or provided in the context of a performance study.
8. Training Set Sample Size: Not applicable. This device is not an AI/ML device that requires training.
9. Ground Truth for Training Set Establishment: Not applicable.

In summary, this document is an FDA clearance letter for a device, confirming its substantial equivalence to other devices already on the market. It does not provide the detailed study information (acceptance criteria, performance data, clinical study specifics) typically associated with a clinical trial or performance evaluation designed to establish new performance claims.

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Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1

The provided text is a 510(k) summary for a medical device (Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1). This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed information you asked for, such as:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document states that the device was found substantially equivalent to legally marketed predicate devices, meaning it met the requirements through comparison with existing approved devices, rather than through a direct study demonstrating its performance against predefined acceptance criteria in the way you've described.

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Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or intractable pain and as an adjunct in the management of post-surgical and post-traumatic acute pain.

Interferential Stimulator Model BMLS02-6

This is an FDA 510(k) clearance letter for an Interferential Stimulator, Model BMLS02-6. This type of document does not contain the detailed study information or acceptance criteria you are requesting.

FDA clearance letters typically:

• State that the device has been found substantially equivalent to a predicate device.
• List the device name, regulation number, and product code.
• Specify the indications for use.
• Refer to general controls and applicable regulations.

They do not include:

• Specific acceptance criteria for performance.
• Results of studies proving the device meets those criteria (e.g., performance tables, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).
• Details about training sets or how their ground truth was established.

To find the information you are looking for, you would typically need to consult the full 510(k) summary, clinical study reports, or other design control documents submitted to the FDA, which are generally not part of the publicly released clearance letter.

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External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.

The provided text describes a 510(k) premarket notification for a neuromuscular stimulator (BMLS03-3) and does not contain detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for performance claims of AI/ML or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

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

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

The document does not explicitly define acceptance criteria as a set of quantified performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) for clinical or diagnostic outcomes.

The "acceptance criteria" here implicitly revolve around demonstrating functional equivalence based on device specifications to the predicate devices.

Acceptance Criteria (Implied from Substantial Equivalence Claim):

• Output Pulse Strength Equivalence: The BMLS03-3's output pulse strength must be equivalent to that of the BMLS03-1 predicate device.
• Other Device Parameters: The BMLS03-3 must be identical to the BMLS02-5 predicate device in all other aspects (e.g., waveform, pulse rate, pulse width, intensity range, modes, display).

Reported Device Performance (from "Comparison to Predicate Device"):

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

• Sample Size for Test Set: Not applicable. No clinical "test set" in the context of patient data was used. The testing was limited to "bench testing" of the physical device.
• Data Provenance: Not applicable, as no human data was used for testing. The "bench testing" would involve laboratory measurements.

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

• Not applicable. There was no ground truth for a test set established by experts, as no clinical or diagnostic performance was being evaluated. The equivalence was determined through engineering bench tests.

4. Adjudication method for the test set

• Not applicable. No adjudication method was used, as there was no test set requiring expert review or consensus.

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 a medical device (neuromuscular stimulator), not an AI/ML or diagnostic imaging device. Therefore, MRMC studies and "human readers" are not relevant to this submission.

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

• Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluated the device's physical output characteristics.

7. The type of ground truth used

• The "ground truth" for the equivalence claim was based on measurements from bench testing comparing the physical output characteristics (specifically pulse strength) of the BMLS03-3 directly against the BMLS03-1 predicate device, and other parameters against the BMLS02-5 predicate device. It's not a clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set

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

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

• Not applicable. (See #8)

Summary of the Study:

The "study" to prove the device meets acceptance criteria was non-clinical bench testing.

• Methodology: The BMLS03-3 was directly compared to two predicate devices:
  • BMLS02-5: The BMLS03-3 was found to be "identical in every way" except for output pulse strength.
  • BMLS03-1: The output pulse strength of the BMLS03-3 was determined to be "equivalent" through bench testing.
• Purpose: To demonstrate that the new device (BMLS03-3) is substantially equivalent to legally marketed predicate devices, thereby allowing it to be cleared for market without requiring new clinical trials.
• Conclusion: Based on the bench testing, the FDA determined the device to be substantially equivalent to the predicate devices for the stated indications for use. No clinical trials were deemed necessary, as explicitly stated in the document ("Clinical Testing: Not applicable.").

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Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.

Interferential Stimulator Model BMLS03-6

The provided text is a 510(k) clearance letter for an Interferential Stimulator, Model BMLS03-6. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table and study description based on the provided text. The document is solely a regulatory clearance letter, not a technical report or study summary.

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High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

High Volt Pulsed Current Stimulator For Muscle Reeducation - Class II Model BMLS02-7

This document is a 510(k) clearance letter from the FDA for a High Voltage Pulsed Stimulator. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes as requested in your prompt.

The letter solely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and other applicable regulations.

Therefore, I cannot provide the requested information based on this document.

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Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

(TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS03-5

I'm sorry, but this document is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.

This document does not contain information about:

• Acceptance criteria or reported device performance.
• Any specific study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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