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The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles

• [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy

The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy

The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles

• [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy

The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy

The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The provided document is a 510(k) clearance letter from the FDA for a device called "Electrical Neuromuscular Stimulator, Cure Trio Models MC-310A, MC-310B," etc. This document states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It lists the indications for use for various models but does not delve into performance metrics, clinical study design, or results.

To answer your request thoroughly, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a substantial equivalence discussion document that typically accompanies 510(k) submissions.

Therefore, I cannot provide the requested information from the given text.

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The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence for female patients and to maintain urinary continence for female patients.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the KEFFORT (MC-100, MC-100A) device does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements and general information about the device's indications for use (rehabilitation of weak pelvic floor muscles for treating stress, urge, and mixed urinary incontinence in female patients, and maintaining urinary continence).

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance for any study.
3. Details on experts used to establish ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance. (Note: This device is an electrical stimulation device, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be applicable here).
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for a training set.
9. How ground truth for a training set was established.

These details about the device's performance against specific acceptance criteria and the underlying clinical or technical studies would typically be found in the 510(k) submission summary or a detailed clinical study report, which is not part of this FDA clearance letter.

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TENS:
1)The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
2) It is also intended to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:

1. The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

This FDA 510(k) clearance letter for the Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) does not contain any information regarding specific acceptance criteria, device performance, or any studies.

The document is primarily an administrative letter from the FDA to Oriental Inspiration Limited, notifying them of the substantial equivalence (SE) determination for their device. It outlines:

• Device Name: Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous electrical nerve stimulator for pain relief
• Regulatory Class: Class II
• Product Code: NUH, NGX, NYN
• Indications for Use:
  • TENS: Temporary relief of pain associated with sore and aching muscles, and symptomatic relief and management of chronic, intractable pain and pain associated with arthritis.
  • EMS: Stimulate healthy muscles to improve and facilitate muscle performance.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information because it is not present in the provided text. To answer your questions, one would need to review the actual 510(k) submission document or related performance data, which is not included here.

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HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The HEE HR Mini devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The HR Mini devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the HR Mini devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse.

The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

The provided document does not contain detailed information about specific acceptance criteria related to a clinical study for the Hee Hr Mini device's effectiveness in hair removal or reduction. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, safety, and regulatory compliance.

However, based on the Intended Use and the comparison table provided, we can infer the primary performance criteria the device is expected to meet, drawing parallels from its predicate devices which also claim "permanent reduction in hair regrowth."

Here's an analysis of the provided text in relation to your questions, noting where information is explicitly stated or can be inferred, and where it is not available.

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

The document does not explicitly state quantitative acceptance criteria for "permanent reduction in hair regrowth." However, the Intended Use for both the applicant device and its predicates defines this as:
"a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen."

The document states that the Hee Hr Mini passed all testing in support of the substantial equivalence determination, implying it met the expected performance for its intended use, which is aligned with the predicate devices. Since this is a 510(k) submission, the device is deemed "substantially equivalent" rather than proving superiority or achieving specific, novel clinical endpoints through a dedicated clinical trial for this submission.

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 provide details on a specific clinical test set for proving efficacy for this 510(k) submission. The performance data section focuses on "performance, software, electrical safety, EMC, biocompatibility and bench" testing, which are primarily technical and safety assessments, not an efficacy trial. It's common for 510(k) submissions to rely on substantial equivalence to predicate devices which have already established safety and efficacy, or on bench testing and limited human factor studies.

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

This information is not available in the provided text, as a clinical efficacy study with explicit ground truth establishment is not detailed for this 510(k) submission.

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

This information is not available in the provided text.

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

This is not applicable to the Hee Hr Mini device, which is an aesthetic light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.

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

This question is not directly applicable as the device is a hardware-based hair removal system, not an algorithm, per se. Its performance is inherent to its physical operation. The "Software Verification and Validation Testing" section mentions software, but this relates to the device's internal control and safety features, not a standalone diagnostic algorithm.

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

Given the lack of a detailed clinical efficacy study in this document, the type of ground truth used for efficacy (e.g., hair counts, photographic assessment by experts, patient self-assessment) for the Hee Hr Mini is not explicitly stated. For similar devices, ground truth for hair reduction efficacy is typically established through objective hair counts in a defined area, often by blinded assessors or using photographic analysis, over several months.

8. The sample size for the training set

The document does not mention a training set or provide details about any clinical trials or data used for training purposes, as this is not an AI/ML device in the context of typical "training sets."

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

As described in point 8, the concept of a "training set" in the context of AI/ML is not applicable here.

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BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.

This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.

The provided document is a 510(k) Summary for a medical device called BC-001+ Acne Purifier. This type of document is for premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on safety and technological equivalence rather than detailed clinical effectiveness studies with specific performance metrics like sensitivity, specificity, or reader studies for AI-powered devices.

Therefore, the information requested, particularly regarding acceptance criteria, reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This is because the device described is a light-emitting device for acne treatment, not an AI-powered diagnostic tool.

The "Performance Data" section (7. PERFORMANCE DATA) in the document refers to a series of tests to demonstrate the device's safety and general performance, not its diagnostic accuracy or effectiveness in comparison to a gold standard as would be done for an AI device.

Here's why each point you requested is not applicable or not found:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI-powered diagnostic device. The performance data listed (biocompatibility, electrical safety, software verification, usability) are safety and engineering performance criteria, not clinical outcome or diagnostic accuracy metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual device and its components undergoing engineering and safety tests, not a dataset for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic ground truth being established for an AI algorithm.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to whether it passes safety and engineering standards.
8. The sample size for the training set: Not applicable, as this device does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding "Performance Data" from the document:

The "PERFORMANCE DATA" section (Section 7) describes the following types of testing done for the BC-001+ Acne Purifier to support its substantial equivalence determination:

• Biocompatibility testing: Conducted according to ISO 10993-1. Tests included cytotoxicity, sensitization, and irritation.
• Electrical safety and electromagnetic compatibility (EMC) testing: Device complied with IEC 60601-1-11, IEC 60601-2-57, IEC 62471 standards for safety, EN 60601-1-2 for EMC, and IEC 62133 for battery safety.
• Software Verification and Validation Testing: Conducted as per FDA guidance for "Moderate" level of concern software.
• Usability Testing: Conducted according to FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design."

These tests confirm the device's safety and functional performance as a light therapy device, not its diagnostic accuracy.

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