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The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

Wrap Accessory Electrodes with GMX-ABSBELT01、GMX-ABSBELT02、GMX-WRIST01、 GMX-ELBOW01、GMX-LEG 01、GMX-ANKLE01、GMX-KNEE01、GMX-FOOT PAD 01、 GMX-GLOVES 01、SHOULDER01、GMX-NCK01, are intended to be used with legally Marketed transcutaneous electrical nerve stimulators or powered muscle stimulators which could be used in place of traditional cutaneous electrode patches. The different series of model means different placement of the Wrap Accessory Electrodes. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the "Wrap Accessory Electrodes" to legally marketed predicate devices. This type of submission relies on demonstrating that a new device is as safe and effective as an already cleared device, rather than proving absolute safety and effectiveness through extensive clinical trials.

As such, the document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets such criteria. The device in question is a passive accessory (electrodes) used with electrical stimulating devices, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document.

However, based on the provided text, we can extract information regarding the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the "study" (non-clinical testing) from the document's perspective:

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

The document doesn't present a formal table of "acceptance criteria" for performance in the typical sense of AI/ML metrics (e.g., sensitivity, specificity, AUC). Instead, it shows a comparison to predicate devices and lists various electrical performance parameters. The "acceptance criteria" are implied to be that the proposed device performs similarly to or within acceptable ranges of the predicate devices for safety and basic electrical functionality.

• 500Ω: TENS 1:112, TENS 2: 114, STIM1:116, STIM2:116, STIM3:76, STIM4: 70 V
• 2kΩ: TENS 1: 250, TENS 2: 240, STIM1: 250, STIM2: 250, STIM3: 158, STIM4: 146 V
• 10kΩ: TENS 1: 300, TENS 2: 286, STIM1: 310, STIM2: 308, STIM3: 278, STIM4: 276 V
  Maximum Output Current:
• 500Ω: TENS 1: 224, TENS 2: 228, STIM1: 232, STIM2: 232, STIM3: 152, STIM4: 140 mA
• 2kΩ: TENS 1:125, TENS 2: 120, STIM1: 125, STIM2: 125, STIM3:79, STIM4: 73 mA
• 10kΩ: TENS 1: 30, TENS 2: 28.6, STIM1: 31, STIM2:30.8, STIM3: 27.8, STIM4: 27.6 mA
  Pulse period: 20~200 mSec
  Frequency:
• TENS 1: 33, TENS 2: 5, STIM1:37, STIM2:25, STIM3: 5, STIM4: 50 Hz
  Maximum Phase Charge (500Ω):
• TENS 1: 11, TENS 2: 11, STIM1: 11.4, STIM2: 10.6, STIM3: 22.8, STIM4: 20.4 µC
  Maximum Charge Density (500Ω):
• TENS 1: 0.024, TENS 2: 0.01, STIM1:0.027, STIM2: 0.021, STIM3: 0.021, STIM4: 0.059 mA/cm²
  Maximum Average Power Density (500Ω):
• TENS 1: 1.33, TENS 2: 0.554, STIM1: 1.54, STIM2: 1.13, STIM3: 0.793, STIM4: 2.01 mW/cm² |
  | - Compliance with basic safety and essential performance standards | IEC 60601-1-11:2020, IEC 60601-2-10:2012 +A1:2016+A2:2023, IEC 60601-1-6:2010+A1:2013+A2:2020. |
  | - Hot spot test | Conducted (results not detailed but stated to meet predefined acceptance criteria). |
  | - Maximum/Minimum resistance value | Conducted (results not detailed but stated to meet predefined acceptance criteria). |

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

• Sample Size: Not explicitly stated as a "sample size" in the context of a clinical test set. The testing refers to individual units of the Wrap Accessory Electrodes for non-clinical performance and safety evaluations. The document implies a sufficient number of devices were tested to draw conclusions on performance and safety compliance.
• Data Provenance: The testing was conducted by Gymmax Technology Shenzhen Co., Ltd., which is based in China. The data would be from laboratory testing of the physical devices. This is not a retrospective or prospective human data study in the medical sense.

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

Not applicable. This is not a study assessing diagnostic performance where expert ground truth is required. The "ground truth" for these tests are objective measurements against established engineering and medical device standards (e.g., ISO, IEC).

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

Not applicable. No human adjudication is mentioned or required for these types of engineering and safety tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/ML device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a passive accessory device, not an algorithm.

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

The "ground truth" here is compliance with recognized international and national standards for medical devices, specifically for electrical safety, biocompatibility, and intended performance of cutaneous electrodes. This is established through objective physical and electrical measurements, and laboratory biological tests, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable.

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The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.

The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Wrap Accessory Electrodes." It primarily addresses the regulatory approval process and includes a description of the device's intended use.

However, the document does NOT contain any information about acceptance criteria, device performance data (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot answer your request using the provided text. The information required to describe the acceptance criteria and the study that proves the device meets them is not present in this document.

Ask a specific question about this device

Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory 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 the hands (gloves) and feet (socks).It is intended for adult patients.

Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory 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.

The provided text is a 510(k) premarket notification letter from the FDA regarding "Wrap accessory electrodes." This document is a regulatory clearance for a medical device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI/ML-based medical device performance study.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This determination of substantial equivalence for a Class II medical device like electrodes is primarily based on performance testing and comparison to existing devices, not on the type of clinical performance study (like an MRMC study or standalone AI performance study) typically performed for AI/ML-based diagnostic devices.

Therefore, I cannot fulfill your request using the provided text. The questions you've asked are relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are established, and clinical studies are conducted to demonstrate their effectiveness, often involving human readers and ground truth data.

To answer your questions, I would need a document that describes the clinical performance assessment of an AI/ML device, including study design, results, and ground truth establishment.

Ask a specific question about this device