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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 FD EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:

• Prevention or retardation of muscle disuse atrophy; -
• Relaxation of muscle spasm; .
• Muscle reeducation; ・
• Maintaining and increasing the range of motion; -
• Increasing local blood circulation; -
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .

The FD EMS is a handheld battery powered EMS device, which is used for muscle stimulation. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the skin of patient. Consequently, the electrical pulses would then pass through the skin to nerves of the muscle and cause the muscle to expand and contract. FD EMS has two output channels and seven stimulation programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 15 steps.

The provided text is a 510(k) summary for the FD EMS device, which is a powered muscle stimulator. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies to prove device performance against acceptance criteria in the manner requested.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes or specific quantitative metrics. The basis for clearance is substantial equivalence to a predicate device, BMLS03-1 (K031427), not new performance data against pre-defined clinical acceptance criteria.

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

No clinical test set or data provenance is mentioned because "Clinical Testing 10.8: Not Applicable as there are no new or innovative aspects that have been introduced." The submission relies on non-clinical testing for compliance with voluntary standards and software verification.

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

Not applicable, as no clinical test set was used to establish ground truth because no clinical testing was performed for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

Not applicable. No MRMC study was conducted or mentioned. The submission states that clinical testing is not applicable.

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

Not applicable. This device is a physical muscle stimulator, not an AI/algorithm-based diagnostic or therapeutic device that would typically involve "standalone" performance evaluation in the context of an algorithm.

7. Type of Ground Truth Used:

Not applicable. No clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence relied on engineering specifications, adherence to voluntary standards (EN 60601-1 and EN 60601-1-1), software verification, and comparison of intended use and technological characteristics to the predicate device.

8. Sample Size for the Training Set:

Not applicable. No training set is mentioned as part of this 510(k) submission, as it's not for an AI/machine learning device.

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

Not applicable. No training set and therefore no ground truth for a training set was established.

Summary of what the document does provide:

• Non-clinical Testing: Compliance to EN 60601-1 and EN 60601-1-1 requirements, and software verification according to FDA software guidance. These are considered sufficient to demonstrate safety and effectiveness for a device of this type when substantially equivalent to a predicate.
• Technological Comparison: The FD EMS has similar basic technological characteristics, is battery-powered, has adjustable output amplitudes, and is a two-channel device, just like the predicate (BMLS03-1, K031427).
• Key Technological Difference: The FD EMS possesses an "open-circuit detection feature" to check continuity and avoid output increment in the absence of a load, which is presented as an added safety feature, not a new innovative aspect requiring clinical validation.
• Intended Use: Identical indications for use as expected for a powered muscle stimulator to treat conditions like muscle disuse atrophy, muscle spasm, etc.

In conclusion, the 510(k) summary for the FD EMS explicitly states that clinical testing was "Not Applicable" because there were no new or innovative aspects introduced. Therefore, the detailed information requested regarding clinical acceptance criteria, sample sizes, expert ground truth, and study designs is not present in this document. The device's clearance is based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing and comparison of technical characteristics and intended use.

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The FD TENS 2030 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.

The FD TENS 2030 is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

FD TENS 2030 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.

Here's an analysis of the provided text regarding the FD TENS 2030 device and its acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is a TENS unit, and its performance is assessed through non-clinical testing for compliance with voluntary standards. There are no explicit "acceptance criteria" presented in terms of specific performance metrics for the device itself (e.g., pain reduction percentage, battery life). Instead, the acceptance is based on meeting safety and technical standards and demonstrating substantial equivalence to a predicate device.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "10.8 Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced."

This indicates that no clinical testing with a test set was performed for this device. Therefore, there is no information on:

• Sample size used for the test set
• Data provenance (country of origin, retrospective/prospective)

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

Since no clinical testing (and thus no test set to establish ground truth) was performed, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical testing with a test set was performed, an adjudication method for a test set is not applicable and not provided in the document.

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

No MRMC study was performed. The document states "Clinical Testing: Not Applicable." Therefore, there is no information on the effect size of human readers improving with or without AI assistance. (Note: This device is a physical TENS unit, not an AI-powered diagnostic or assistive tool, so an MRMC study in the context of AI would not typically apply).

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was performed. The device is a physical TENS unit. The text only mentions "software verification has been carried out according to the FDA software guidance," which refers to the internal software quality and not an algorithmic performance study for a clinical task.

7. Type of Ground Truth Used

No clinical ground truth (expert consensus, pathology, outcomes data) was used because clinical testing was "Not Applicable." The acceptance of the device is based on engineering and safety standards compliance and substantial equivalence to a predicate device.

8. Sample Size for the Training Set

No clinical training set was used, as clinical testing was "Not Applicable."

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

No clinical training set was used, and therefore, no ground truth for a training set was established. The "ground truth" for the device's acceptance is based on its adherence to established electrical safety and medical device standards.

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The INF 4160 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.

The INF 4160 is a rechargeable battery operated Interferential Current Therapy Device. Its internal circuitry can generate symmetrical sinusoidal waveforms. The associated outputs are delivered through lead cables to electrodes placed on the user/patient skin. The output passes through the skin and activates the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

The provided text describes a 510(k) summary for the device INF 4160, an Interferential Stimulator. However, it explicitly states that no clinical testing was performed for this device as it did not introduce new or innovative aspects.

Therefore, the requested information regarding acceptance criteria derived from a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for test and training sets cannot be extracted from this document, as such a study was not conducted.

Here's a breakdown of what can be inferred from the document regarding the lack of such a study:

• Acceptance Criteria and Reported Device Performance: This information is not provided as no clinical study was performed.
• Sample Size (test set) and Data Provenance: Not applicable, as no clinical study was performed.
• Number of Experts and Qualifications: Not applicable, as no clinical study was performed requiring expert review.
• Adjudication Method: Not applicable, as no clinical study was performed.
• MRMC Comparative Effectiveness Study: "Not Applicable as there are no new or innovative aspects that have been introduced." This directly indicates that a multi-reader multi-case comparative effectiveness study was not done.
• Standalone Performance: Not applicable, as no clinical study was performed.
• Type of Ground Truth: Not applicable, as no clinical study was performed.
• Sample Size (training set): Not applicable, as no clinical study was performed for the device itself that would involve a training set.
• How ground truth for training set was established: Not applicable, as no clinical study was performed.

The document indicates that the device's substantial equivalence to the predicate device (IF-4000, K952683) was established based on:

• Similar intended use.
• Similar technical characteristics.
• Compliance with applicable voluntary standards (ANSI/AAMI NS4-1986 and EN 60601-1-2).
• Software verification carried out according to FDA software guidance.
• The primary difference, a rechargeable battery pack, was determined not to affect safety and effectiveness.

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The L-TENS 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.

The L-TENS is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.

This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "L-TENS". This type of device, used for pain relief, is typically cleared based on substantial equivalence to a predicate device rather than extensive clinical studies with specific acceptance criteria that demonstrate performance against a 'ground truth' in the way AI/ML devices often are.

Therefore, the requested information elements related to acceptance criteria, ground truth, expert adjudication, multi-reader multi-case studies, and standalone performance for AI/ML devices are not applicable to this 510(k) submission.

Here's a breakdown of why and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. For a TENS device seeking 510(k) clearance, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (FDTENS 2010, K994266) regarding its intended use and fundamental technological characteristics, along with compliance to relevant non-clinical standards. The device is not making claims that require specific performance metrics (like sensitivity, specificity, or AUC) against a clinical ground truth for a diagnostic or AI/ML algorithm.

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

• Not Applicable. There was no "test set" in the context of clinical data for performance evaluation as would be done for an AI/ML device. The clearance is based on technological comparison and compliance with non-clinical standards.

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

• Not Applicable. No ground truth was established for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/ML device, and 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 not an AI/ML device.

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

• Not Applicable. The device did not rely on a clinical "ground truth" for its 510(k) clearance, but rather on demonstrating equivalence to an existing device and meeting safety standards through non-clinical testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there was no "training set."

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

• Not Applicable. There was no training set or associated ground truth.

Summary of available information from the document:

• Device Name: L-TENS
• Predicate Device: FDTENS 2010 (K994266)
• Intended Use: 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.
• Technological Comparison: Substantially equivalent to the predicate. Both are battery-powered with adjustable output. The L-TENS has one channel (predicate has dual) and an added "open-circuit detection feature" to prevent output increment in the absence of load. Both comply with "shrouded patient cable connectors" rule.
• Non-clinical Testing:
  • Compliance to voluntary standards: ANSVAAMI NS4-1986, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
  • Software verification carried out according to FDA software guidance.
• Clinical Testing: "Not Applicable as there are no new or innovative aspects that have been introduced."
• Conclusion: The device is substantially equivalent to the predicate and poses no new questions of safety and effectiveness.

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TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain > chronic, acute or post-operative pain.

Not Found

This document is a 510(k) clearance letter for the Medisana Digital TENS device, not a study report or technical specification detailing acceptance criteria and performance data. Therefore, the information requested in the prompt cannot be extracted from the provided text.

The document confirms that the device is substantially equivalent to legally marketed predicate devices for the indications specified (treatment of chronic, acute, or post-operative pain using Transcutaneous Electrical Nerve Stimulation), allowing it to be marketed. It does not contain details about specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.

Not Found

This is a 510(k) clearance letter for the FDTENS 2010 device, a Transcutaneous Electrical Nerve Stimulation (TENS) unit. The document states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for the FDTENS 2010.

Therefore, I cannot populate the requested table or answer the specific questions about the study design or results. The document is solely a regulatory clearance letter, not a performance report or study summary.

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