Search Results

The Pain Therapy Device (Model: P.T.S-X):

TENS (Transcutaneous electrical nerve stimulation):

• For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
• For relief of pain associated with arthritis.
• For symptomatic relief and management of chronic intractable pain
  EMS (Electrical muscle stimulation):
• To stimulate healthy muscles in order to improve and facilitate muscle performance.
• To temporarily increase local blood circulation in healthy muscles.

NMES (Neuromuscular electrical stimulation):

• For relaxation of muscle spasm.
• Increase of blood flow circulation.
• Prevention or retardation of disuse muscle atrophy.
• Muscle re-education.
• Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Not Found

I am sorry, but the provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a medical device called "Pain Therapy Device (Model: P.T.S-X)".

This document specifies the regulatory classification of the device, its product codes, and the conditions for its use (TENS, EMS, NMES). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII):

TENS

• For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.

• For relief of pain associated with arthritis.

• For symptomatic relief and management of chronic intractable pain

EMS:

• To stimulate healthy muscles in order to improve and facilitate muscle performance.

• To temporarily increase local blood circulation in healthy muscles.

NMES:

• For relaxation of muscle spasm.

• Increase of blood flow circulation.

• Prevention or retardation of disuse muscle atrophy.

• Muscle re-education.

• Maintaining or increasing range of motion.

• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

• For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet, NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)", indicating that the device has been found substantially equivalent to legally marketed predicate devices.

The letter details:

• The device name and manufacturer.
• The FDA regulation number, name, and product codes.
• General controls provisions and additional requirements for the device.
• Contact information for FDA.
• The Indications for Use of the device, which include TENS, EMS, and NMES functions.

It does not include any technical specifications, performance metrics, clinical study results, or details on how substantial equivalence was demonstrated beyond the general statement of clearance. Therefore, I cannot generate the requested table or describe a study proving the device meets acceptance criteria based on this input.

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For Over-The-Counter Use:

TENS:

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leq, due to strain from exercise or normal household and work activities.

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS/NMES:

SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are used to stimulate healthy muscles in order to improve and facilitate muscle performance.

To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SM9075 (mode 25-48), SM9910 (mode 9-16), SM9067 (mode 10-18), SM9587W (mode 9-18) are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

TENS:

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are intended for the following use:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

PMS/NMES:

SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are intended for the following use:

• Temporary relaxation of muscle spasm

• Prevention or retardation of disuse atrophy

• Muscle re-education

• Maintaining or increasing range of motion

• Increase of local blood flow in the treatment area

• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Pain Therapy Device. This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in the 510(k) submission itself or in a separate study report, which is not included in the provided input.

Therefore, I cannot fulfill your request for the tables and study details based on the given text.

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The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I): TENS: - For relief of pain and management of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves. - For relief of pain associated with arthritis. - For symptomatic relief and management of chronic intractable pain EMS: - To stimulate healthy muscles in order to improve and facilitate muscle performance. - To temporarily increase local blood circulation in healthy muscles. NMES: - For relaxation of muscle spasm. - Increase of blood flow circulation. - Prevention or retardation of disuse muscle atrophy. - Muscle re-education. - Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Not Found

This document is a marketing clearance letter from the FDA for a Pain Therapy Device (models DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I).

It is NOT a report or study that details acceptance criteria and device performance. The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which means it clears the device for marketing. However, it does not provide details of specific performance testing, clinical study results, or the methodology (sample size, expert qualifications, etc.) used to establish performance.

Therefore, I cannot provide the requested information because the provided text does not contain:

1. A table of acceptance criteria and reported device performance: This document does not describe specific performance metrics or their acceptable thresholds.
2. Sample size used for the test set and data provenance: There is no mention of a test set, its size, or the origin of any data.
3. Number of experts used to establish ground truth and their qualifications: No information about expert involvement in establishing ground truth is present.
4. Adjudication method for the test set: No test set means no adjudication method is discussed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a study report, so no MRMC study details are provided.
6. Standalone (algorithm only) performance: This device is a physical electromedical device, not an AI algorithm.
7. Type of ground truth used: Not applicable as this is not a study of an AI or diagnostic device.
8. Sample size for the training set: Not applicable; this is a hardware device.
9. How ground truth for the training set was established: Not applicable.

The document is solely an FDA clearance letter based on substantial equivalence to existing devices, not a detailed technical or clinical performance report.

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The Pain Therapy Device (Model: P.T.S-III):

TENS:

• For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
• For relief of pain associated with arthritis.
• For symptomatic relief and management of chronic intractable pain

EMS:

• To stimulate healthy muscles in order to improve and facilitate muscle performance.
• To temporarily increase local blood circulation in healthy muscles.

NEMS:

• For relaxation of muscle spasm.
• Increase of blood flow circulation.
• Prevention or retardation of disuse muscle atrophy.
• Muscle re-education.
• Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Not Found

I'm sorry, but this document contains general regulatory information about a medical device (Pain Therapy Device, Model: P.T.S-III) and a 510(k) clearance letter from the FDA. It outlines the device's indications for use (TENS, EMS, NEMS functions) and general compliance requirements.

However, it does not contain any information about acceptance criteria for a study, nor does it describe a study that proves the device meets specific performance criteria. The document focuses on regulatory clearance for marketing, not on the detailed technical or clinical study results that typically accompany a device's performance validation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as the necessary information is not present in the provided text.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).

To temporarily increase local blood circulation in healthy muscles (Choose Mode A).

Pain Therapy Device is a household multifunctional device, it can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Pain Therapy Device has three operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin.

The electronic stimulatory main units have the operating elements of ON/OFF knob, Mode Selection key and Time Selection key which can be user-friendly controlled.

The device is equipped with accessories of electrode pads and an electrode wire. The electrode wire is used to connect the pads to the main unit. All the accessories can only be changed by local distributor. "Large Patch Electrode" and "Small Patch Electrode" are cleared in K090198.

"Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693.

The provided document is a 510(k) Summary for a Pain Therapy Device (K163611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on safety and performance through bench testing and comparison of technical specifications.

Therefore, it does not describe acceptance criteria for a study demonstrating device performance against specific targets, nor does it detail a clinical study with human subjects, ground truth establishment, or multi-reader multi-case analyses.

The document outlines the following information relevant to the device's validation:

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

The document does not present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) and the device's reported performance against those. Instead, it demonstrates compliance with recognized standards and substantial equivalence to predicate devices through technical specifications.

The "Test Summary" section (page 4) lists the following tests and their compliance:

The "Comparison to predicate device and conclusion" tables (pages 5-12) provide a detailed comparison of the subject device's technical specifications and intended uses against three predicate devices. The "Remark" column consistently states "SE" (Substantially Equivalent), indicating that the subject device's performance characteristics are considered equivalent to those of the legally marketed predicate devices, and that differences do not raise new issues of safety or effectiveness.

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

Not Applicable. The provided document does not describe a clinical study involving a test set, human subjects, or data provenance in the context of device performance. The testing was primarily bench testing to ensure compliance with standards and equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. As no clinical study or test involving human subjects with a "ground truth" was described, this information is not present. The "ground truth" for the technical comparisons is rooted in the specifications and regulatory clearances of the predicate devices and the relevant international standards.

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

Not Applicable. No clinical test set or adjudication method is described.

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 a Pain Therapy Device (Transcutaneous Electrical Nerve Stimulator, TENS/EMS). It is not an AI-powered diagnostic imaging device or similar system where "human readers" or "AI assistance" would apply. Therefore, no MRMC study was conducted or reported.

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

Not Applicable. This is a hardware medical device; the concept of "standalone algorithm performance" is not relevant in the context of this 510(k) submission. The "software verification and validation test" mentioned (page 4) refers to the embedded software within the device and its compliance with FDA guidance, not a standalone algorithm for diagnostic or interpretative purposes.

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

Not Applicable. For a device of this type, demonstrating "substantial equivalence" relies on technical specifications, safety testing (electrical, EMC, biocompatibility, usability), and comparison of intended use to legally marketed predicate devices. The "ground truth" for this regulatory submission is compliance with established standards and the characteristics of the predicate devices. There is no mention of clinical outcomes data in the sense of a dedicated clinical trial to establish efficacy against a "ground truth" condition.

8. The sample size for the training set:

Not Applicable. The document does not describe the development or training of an AI algorithm, therefore, no training set or its sample size is mentioned.

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

Not Applicable. As there is no training set for an AI algorithm, this information is not provided.

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The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for:

• · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
• · Symptomatic relief of acute pain
• · Symptomatic relief of post-operative pain

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain. Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:

• . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
• . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
• . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
• . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
  The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.

This is a 510(k) premarket notification for the BiowaveHOME Neuromodulation Pain Therapy System. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria as you would typically find in a PMA or De Novo submission.

Therefore, the provided document does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the way you would expect for a novel device.

Here's why and what information can be extracted:

• No new performance study: The document explicitly states that this is a "Special 510(k)" and that the "purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewave Neuromodulation Pain Therapy Device (K072123)." It emphasizes that the modified BiowaveHOME device "has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123." This means Biowave Corporation is leveraging the prior clearance of the predicate device (K072123) and argues that the modifications are minor and do not significantly alter the device's fundamental safety or effectiveness.
• Basis for Substantial Equivalence: The submission focuses on comparing the BiowaveHOME with its predicate (Homewave Neuromodulation Pain Therapy Device, K072123) and other related predicate devices (Deepwave (BiowavePRO), K053389; Deepwave Percutaneous (BiowavePENS), K053389) on design, function, intended use, and indications. The argument is that since the modified device is so similar to an already cleared device, it is "substantially equivalent" and does not require new efficacy studies.

Therefore, many of your requested items about a performance study, acceptance criteria, sample sizes, experts, ground truth, and MRMC studies, are not applicable or not present in this type of submission.

However, I can provide the available information:

• Device Name: BiowaveHOME Neuromodulation Pain Therapy System
• Product Code: GZJ (Transcutaneous electrical nerve stimulator for pain relief)
• Indications for Use:
  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
  • Symptomatic relief of acute pain
  • Symptomatic relief of post-operative pain

Here's a breakdown of what can and cannot be answered based on the provided text:

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

   • Not applicable/Not provided. This submission does not define new acceptance criteria for a clinical performance study because it's based on substantial equivalence to a predicate device. Performance is assumed to be equivalent to the predicate.

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

   • Not applicable/Not provided. No new clinical "test set" was used for performance validation in this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. No independent expert review of a test set for ground truth was conducted for this 510(k).

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

   • Not applicable/Not provided. No test set adjudication method is mentioned as no new clinical study was conducted.

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/Not provided. This device is a pain therapy system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not provided. This is a hardware neuromodulation device, not an algorithm.

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

   • Not applicable/Not provided. No new ground truth assessment for clinical performance was performed for this 510(k). The "ground truth" for its effectiveness is implicitly tied to the prior clearance of its predicate device, based on the studies that supported that predicate.

8. The sample size for the training set:

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

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

   • Not applicable/Not provided. As above, no training set is relevant here.

In summary, this document is an FDA 510(k) clearance letter and its associated summary for a device that is essentially a modified version of an already cleared device. It relies on demonstrating substantial equivalence rather than presenting new clinical study data with specific acceptance criteria.

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The Homewave Neuromodulation Pain Therapy Device is indicated for:

• . Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain
• Symptomatic relief of acute pain .
• Symptomatic relief of post-operative pain .

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices.

Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows:

• Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave)
• . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use.
• . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave.

The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.

This K072123 document is a Special 510(k) summary for the Biowave Homewave Neuromodulation Pain Therapy Device. It describes minor modifications made to a previously cleared device (Deepwave Neuromodulation Pain Therapy Device, K052289) and asserts substantial equivalence to predicate devices.

Based on the provided document, there are no specific acceptance criteria or a study described that directly proves the device meets specific performance criteria through a clinical trial or performance study.

The document focuses on demonstrating substantial equivalence based on design and functional similarities to previously cleared predicate devices, rather than presenting new performance data against specific acceptance criteria. This is typical for a Special 510(k) for minor modifications.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No such table is present as no new performance study was conducted or presented to satisfy specific criteria.
• Sample size used for the test set and the data provenance: No test set or associated data is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used to establish ground truth.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 nerve stimulator, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Basis for Substantial Equivalence (as per the document):

The Homewave Neuromodulation Pain Therapy Device is a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and Deepwave PENS Neuromodulation Pain Therapy Device (K061166).

Key modifications in the Homewave device include:

• Smaller lithium-ion polymer rechargeable battery (approx. 3 hours vs. 8 hours for Deepwave).
• Custom connector with an electronic integrated circuit ("chip") that limits electrode use to 5 twenty-minute treatments or 100 minutes total.
• Fixed treatment time of 20 minutes (vs. adjustable 5-60 minutes for Deepwave).

The basis for substantial equivalence is stated as:
"Biowave Corporation's Homewave and Deepwave devices are similar in design and function. Both devices offer a dual sinusoidal signal with a frequency difference of 122 Hz. Both the proposed and predicate devices are software controlled TENS units that provide the user with pain reduction. The conclusion of this technical comparison is that Biowave's Homewave Device is substantially equivalent to the predicate devices for the indications specified."

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The Deepwave Neuromodulation Pain Therapy Device is indicated for:

• Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
• Symptomatic relief of post-traumatic acute pain .
• Symptomatic relief of post-operative pain .

The Biowave Corporation Neuromodulation Pain Therapy Device is a battery-powered device intended to provide clinicians with the flexibility to prescribe powered muscle stimulation and TENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller electrode pad ("Pain Site Pad") placed directly over the source of the pain (the treatment site).

The provided text for K052289, "Deepwave Neuromodulation Pain Therapy Device," is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone (algorithm only) performance study.
• How ground truth was established for either test or training sets.

Instead, the submission focuses on comparing the proposed device's indications for use, design, and function to a predicate device to establish substantial equivalence. The key information provided is:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in a table. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or substantially equivalent indications for use and similar technological characteristics.
• Reported Device Performance: No specific performance metrics or clinical study results with numerical values are reported to demonstrate efficacy against pre-defined acceptance criteria. The claim of performance is implicitly that it performs equivalently to the predicate device for pain relief.

2. Sample Size and Data Provenance for Test Set: Not applicable. The document does not describe a clinical study with a test set in the conventional sense of a diagnostic or predictive device.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not mentioned as such. The basis for efficacy is the established use of similar technology in the predicate device for pain relief.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable.

6. Standalone Performance Study: Not mentioned or applicable.

7. Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy studies. The "ground truth" for the device's intended use (symptomatic relief of pain) is based on the therapeutic effect of electrical stimulation, which is a well-established mechanism for pain management. The submission relies on the established safety and efficacy of the predicate device.

8. Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for the Training Set Was Established: Not applicable.

Summary of Device Comparison (Basis for Substantial Equivalence):

The document states that the Deepwave Neuromodulation Pain Therapy Device's indications for use are identical to those of the predicate device (Chattanooga Group Forte Model CPS 200 Stimulator Device, K982828).

• Identical Indications:

  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
  • Symptomatic relief of post-traumatic acute pain.
  • Symptomatic relief of post-operative pain.

• Similar Design and Function: Both devices offer a biphasic waveform, sine waves, and a beat frequency in the range of 100-200 Hz. Both are software-driven TENS units that provide a treatment program for pain reduction.

Conclusion: The submission concludes that the Biowave Deepwave Device is substantially equivalent to the predicate devices for the specified indications based on the identical indications for use and similar technological characteristics. This type of 510(k) submission primarily relies on comparisons to legally marketed devices, rather than new extensive clinical trials, to demonstrate safety and effectiveness.

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