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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).

Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240 min

The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powderfree, ambidextrous, and orange-colored with a beaded cuff. The proposed device is offered in in the following sizes: Small, Medium, Large, Extra-Large, Extra Extra-Large.

The provided document is a 510(k) summary for the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl). This document details the performance of a medical device (gloves) against established standards rather than an AI/ML algorithm. Therefore, many of the requested categories for AI/ML studies are not applicable.

However, I can extract information related to the device's acceptance criteria and how its performance was tested.

Acceptance Criteria and Reported Device Performance

The device is evaluated against various ASTM standards. The relevant performance criteria and the reported device performance are presented in the table below:

Table 1: Acceptance Criteria and Reported Device Performance for Medline Powder-Free Orange Nitrile Patient Examination Gloves

Since this document is for a physical medical device (patient examination gloves) and not an AI/ML algorithm, the following sections are largely not applicable.

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

   • N/A. The testing refers to physical sampling of gloves for performance tests (e.g., integrity, strength, fentanyl permeation). Specific sample sizes for each test are not detailed in this summary, but these tests are typically conducted according to the methodology outlined in the cited ASTM and ISO standards. Data provenance (country of origin) is not specified, but the tests were performed in compliance with international and US standards. The testing is prospective (i.e., performed on the manufactured product to demonstrate compliance).

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)

   • N/A. Ground truth for device performance tests (e.g., material strength, hole detection, chemical permeation) is established by empirical measurements and objective criteria defined in the ASTM and ISO standards, not by expert consensus in the diagnostic sense.

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

   • N/A. This concept is for AI/ML algorithm evaluation where multiple readers might interpret data. Device performance testing relies on standardized test methods and objective measurements.

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

   • N/A. This study relates to a physical medical device, not an AI/ML system.

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

   • N/A. This study relates to a physical medical device, not an AI/ML system.

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

   • The "ground truth" for the device's performance is based on objective, empirical measurements against defined criteria in recognized standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6978-05, ISO 10993 series). For example, a glove passes the "Freedom from Holes" test if it meets the specified Acceptable Quality Limit (AQL), and fentanyl resistance is determined by measurable breakthrough time. Biocompatibility tests have specific endpoints (e.g., presence/absence of irritation, cytotoxicity).

8. The sample size for the training set

   • N/A. This device does not involve a training set as it is not an AI/ML algorithm.

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

   • N/A. This device does not involve a training set.

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For EMG mode:

• Relaxation muscle training and muscle re-education

For NMES (also known as STIM) mode:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
• Muscle Re-Education

For TENS mode:

• Symptomatic relief and management of chronic (long-term), intractable pain
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):

• Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
• Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)

For FES

• Helps to relearn voluntary motor functions of the extremities

The Medline DeNovo 4Pro Electrical Stimulation Device is a four-channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The proposed device is controlled by a MCU (Microcontroller Unit) that supports device functionality, display functionality. Bluetooth, and audio. The subject device is intended to be used for muscle stimulation for the purposes of urinary incontinence treatment, pain management, muscle strengthening and training, as well as muscle relaxation and re-education. The device is a TENS (Transcutaneous Electrical Nerve Stimulator), ETS (Electrical Muscle Stimulator) and NMES (Neuromuscular Electrical Stimulator also known as STIM) including FES (Functional Electrical Stimulation) with EMG biofeedback.

The Medline DeNovo 4Pro Electrical Stimulation Device features four channels for NMES (Neuromuscular Electrical Stimulator also known as STIM), with two that utilize Electromyography (EMG). Multiple stimulation protocols are pre-programed for three general categories of applications: muscle strengthening (i.e. biofeedback training), pain control, and neuromuscular re-education. Each category contains up to eight protocols to address the specific needs of the patient.

The Medline DeNovo 4Pro Electrical Stimulation Device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrodes applied on the skin or through a vaginal probe (for incontinence treatment protocols only). The parameters of the unit are controlled by the +/push buttons and touch screen (refer to Figure 1 and 2 below). The pre-programed protocols on the Medline DeNovo 4Pro Electrical Stimulation Device are all fully automatic and controlled by the device, and it is also capable of manual control in hand switch mode. The levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device can be used with or without linkage to a PC and includes a color, pressure sensitive touch-screen. This unit also comes with a wireless charger that is capable of charging during NMES (Neuromuscular Electrical Stimulator also known as STIM) via inductive charging. Batteries will not need to be regularly replaced, and charging will be made so much easier. The proposed device also has Bluetooth capabilities that will allow the device to connect to a computer for screen mirror imaging.

The provided text is a 510(k) Summary for the Medline DeNovo 4Pro Electrical Stimulation Device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.

The document primarily focuses on non-clinical testing (functional performance, electrical safety, EMC, software verification/validation, usability) to demonstrate that the device itself functions as intended and safely, rather than a clinical study assessing its diagnostic or prognostic performance with a test set, ground truth, and expert readers, which would be typical for many AI/ML-driven medical devices.

Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic/prognostic tasks cannot be extracted from this document because such a study is not described. The "Summary of Clinical Testing" explicitly states, "This section does not apply."

Here is a breakdown of what can be inferred from the provided text, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. The acceptance criteria implied are primarily related to safety, electrical performance, software functionality, and usability, as demonstrated by compliance with various IEC standards and internal verification/validation.
• Reported Device Performance: The document states that "The results of these tests demonstrate the overall safety of the subject device and ultimately support a substantial equivalence determination." This is a general statement of compliance, not a quantitative measure of performance against a specific clinical acceptance criterion.

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 as no clinical test set or data provenance for a performance study is described. The "test set" and "data" here refer to testing the device's electrical, mechanical, and software functions, not a cohort of patient data for a clinical outcome.

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 ground truth establishment process is described. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.

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

• Not applicable as no clinical test set requiring adjudication 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:

• No, an MRMC comparative effectiveness study was not done. The device described is an electrical stimulation device, not an AI/ML-driven diagnostic or image analysis tool that would typically involve human readers.

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

• Not applicable for a medical device of this type (electrical stimulator). This concept typically applies to AI/ML algorithms independently making a diagnosis or classification.

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

• For the non-clinical testing, the "ground truth" or reference was compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) and the device's own design specifications. There is no clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set:

• Not applicable as no AI/ML training set is described. The "training set" related to this device would be the engineering development and verification process, not a data set for model training.

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

• Not applicable as no AI/ML training set is described.

In summary, the provided document is a regulatory submission for a physical electrical stimulation device, not an AI/ML-driven medical device requiring the type of clinical performance study details you are asking for. The "study that proves the device meets the acceptance criteria" in this context refers to functional, electrical, software, and usability testing to ensure safety and performance of the device hardware and embedded software against engineering specifications and regulatory standards, not a clinical trial evaluating its diagnostic or treatment efficacy using patient data and expert interpretations.

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