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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.

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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.

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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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Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower and upper back, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.

Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Conductive carbon film electrode" does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a standard FDA clearance letter confirming that the device is substantially equivalent to a predicate device and can be marketed. It details the device name, product code, regulation number, and indications for use. It also outlines general regulatory requirements.

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. This information would typically be found in the 510(k) submission itself, which is not fully included here.

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Conductive silicone rubber electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive silicone rubber electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.

Conductive Silicone Rubber Electrode

This document is an FDA clearance letter for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in the device's technical specifications, design validation reports, or clinical study summaries, which are not part of this FDA clearance notification.

Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the FDA has determined the "Conductive Silicone Rubber Electrode" device is substantially equivalent to legally marketed predicate devices.

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The DR-HO'S Back Pain Relief System Pro (Model: BPRS-1) is 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 nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

To temporarily increase local blood circulation in healthy muscles.

Heating Mode is to be used for temporary relief of minor aches and pains.

The DR-HO'S Back Pain Relief System Pro (Model: BPRS-II) is 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 nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

To temporarily increase local blood circulation in healthy muscles.

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This document is an FDA clearance letter for the DR-HO'S Back Pain Relief System Pro. It does not contain any information about the acceptance criteria or a study proving the device meets those criteria, as it is a device for pain relief using electrical stimulation and not an AI/imaging device.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily discusses the regulatory classification, indications for use, and general controls applicable to the device under the FDA's medical device regulations. It is not a clinical study report or a technical performance evaluation document.

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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.

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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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Metallic Fabric Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Metallic Fabric Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include wrist, elbow or arm, knee or leg and back band.

Metallic Fabric Electrodes (Model A:Leg Band with Electrodes, Model B:Back Belt with Electrodes, Model C:Arm Band with Electrodes, Model D:Knee and lower lee band with Electrodes, Model F:Triple Action Back Belt with Electrodes, Model G:Leg Rest with Electrodes - I, Model H:Leg Rest with Electrodes - II, Model I:Shirt with Electrodes) are cutaneous electrodes.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding "Metallic Fabric Electrodes." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.

The document primarily focuses on:

• The FDA's review and determination of substantial equivalence for the device.
• Regulatory information and requirements for the manufacturer.
• The indications for use for the Metallic Fabric Electrodes.

Therefore, I cannot fulfill your request based on the provided input.

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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.

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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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DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

DR-HO'S Electro Therapy Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%, And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.

Your request asks for information about the acceptance criteria and study proving a medical device meets these criteria, based on the provided text.

The provided text is a 510(k) summary for DR-HO'S Electro Therapy Conductive Gel. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical trial to prove de novo improved effectiveness or benefit. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the bench testing conducted to demonstrate safety and performance equivalence to established standards and predicate devices.

Here's the breakdown of the information you requested, based on the provided document:

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

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

• The document does not specify the sample sizes used for any of the individual bench tests (In vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Usability, Shelf Life).
• Data provenance (country of origin, retrospective/prospective) is not stated. These are laboratory bench tests and typically do not involve human subject data provenance in the same way clinical studies do. The tests were performed to specific ISO and ASTM standards.

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)

• This document describes performance based on bench testing against international standards (ISO, ASTM, IEC), not clinical studies requiring expert ground truth for interpretation of patient data. Therefore, there were no "experts used to establish the ground truth for the test set" in the context of clinical reads, nor are their qualifications mentioned, as this is not applicable here. The "ground truth" for these tests is the defined acceptance criteria within the standards themselves.

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

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where multiple readers interpret images or data and discrepancies need to be resolved. This document reports laboratory bench tests, not clinical studies with multiple readers. Therefore, no adjudication method is mentioned or applicable.

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 MRMC comparative effectiveness study was done. This is a 510(k) submission for a conductive gel, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence in terms of safety and basic performance characteristics (biocompatibility, shelf-life, electrical properties) with existing predicate devices, rather than proving a comparative effectiveness outcome with human readers or AI assistance.

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

• This device is a conductive gel. It is a physical product, not an algorithm or AI. Therefore, no standalone algorithm performance study was conducted. The "performance" refers to its physical and chemical properties and biocompatibility.

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

• For the bench tests, the "ground truth" is defined by the specific requirements and endpoints set forth in the referenced international standards (ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 62366-1, ASTM F1980-16). For example, for cytotoxicity, the "ground truth" is whether the extract caused cell death as measured by the standard's methodology. For impedance, it's a measurable electrical property.

8. The sample size for the training set

• This document describes bench testing and a 510(k) submission based on substantial equivalence, not an AI or machine learning model that would require a "training set." Therefore, no training set sample size is mentioned or applicable.

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

• As there is no training set for this type of device and submission, this question is not applicable.

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The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.

Not Found

I am sorry, but the provided text is a letter from the FDA to Guangzhou Xinbo Electronic Co., Ltd. regarding the 510(k) premarket notification for their Dr-Ho's Foot Pad Electrode. This document primarily focuses on regulatory approval, classification, and general controls.

The letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set details.

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.

Ask a specific question about this device