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.

Ask a specific question about this device

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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