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Respiratory Muscle Trainer is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. Respiratory Muscle Trainer vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

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This document is a 510(k) clearance letter for a "Respiratory Muscle Trainer." It does not contain the information requested about acceptance criteria or a study proving device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements and general controls. It also includes the "Indications for Use" for the device, but this is distinct from performance criteria and study results.

Therefore, I cannot provide the requested information based on the provided text.

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The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

The Neurological Therapy Devices - Accessories -Conductive fiber(Model:Electrotherapy device Electrode for Knee, Electrotherapy device Electrode for Elbow, Electrotherapy device Electrotherapy device Electrode socks.Neurological physiotherapy devices-accessories), are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into Neurological Therapy Devices - Accessories garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves.

The Neurological Therapy Devices - Accessories-conductive silicone rubber(Model:Electrotherapy device Electrode belt for back of body, Electrotherapy device Electrode belt for Abdominal Muscle TrainerToning, Electrotherapy device Electrode belt for Body joints,Electrotherapy device Electrode belt for arm of body,Electrotherapy device Electrode belt for back of body,Electrotherapy device Electrode belt for shoulder of body,Neurological physiotherapy devices-accessories), is made of conductive silicone rubber coated in conductive garments material, has excellent conductive performance and good flexibility and plasticity, can adapt to the needs of different shapes and sizes of electrodes.

The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin.

The Neurological Therapy Devices - Accessories utilize conductive silicone rubber as a conduit for current transmission. When current passes through the garment electrodes, the conductive silicone rubber transmit the current to the surface of the body, thus enabling the transmission of current. The entire surface of the Neurological Therapy Devices - Accessories is very conductive having a resistance of less than 7 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these Neurological Therapy Devices - Accessories for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices).

The Neurological Therapy Devices - Accessories are non- sterile external devices which are designed for single patient, for multiple uses and are intended for Prescription Use and/or OTC use with FDA Cleared TENS and NMES class II devices.

The provided FDA 510(k) summary (K232995) describes the acceptance criteria and the study conducted to demonstrate that the Neurological Therapy Devices - Accessories meet these criteria.

Here's a breakdown of the requested information:

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)

• Sample Size for Test Set: The document explicitly states "No clinical testing was performed" (Section 8). Therefore, there isn't a "test set" in the context of human subjects or clinical data. The performance was evaluated through non-clinical bench testing. The sample sizes for the materials tested in biocompatibility and electrical performance bench tests are not specified in this summary.
• Data Provenance: The company is Shenzhen Roundwhale Technology Co., Ltd. in China. The testing would presumably have been conducted in China or by laboratories contracted by the company, adhering to international standards. The data is non-clinical (bench testing).

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 testing was performed, there was no "test set" requiring expert ground truth establishment in a clinical context. The performance was assessed against technical specifications and international standards in a laboratory setting.

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

Not applicable. There was no clinical test set requiring adjudication.

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 an accessory (an electrode) for electrotherapy devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is not an algorithm-only device. It is a physical accessory (electrode). The "standalone" performance refers to the device's electrical conductivity and biocompatibility, which were assessed via bench testing as described.

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

The "ground truth" for this device's performance is based on:

• International Standards: Specifically, ISO 10993 series for biocompatibility testing (ISO 10993-5, ISO 10993-10, ISO 10993-23).
• Technical Specifications: Defined electrical performance criteria (e.g., resistivity less than 7 ohms per inch).
• Comparison to Predicate Devices: Demonstrating similarity in design, materials, function, and performance to legally marketed devices.

8. The sample size for the training set

Not applicable. As this device is a physical cutaneous electrode and not an AI/machine learning model, there is no "training set."

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

Not applicable, as there is no training set for this device.

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

Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes.

Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381.

Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics:

• Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference.
• CR2032 Button batteries (DC3V) power supply, easy to use and safe.

The main differences among them are the followings but not affect its intended use:

• Appearance
• The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control.
• The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches.
• Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.

The provided text does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for an AI/ML medical device, as this is a 510(k) for a physical medical device (a powered muscle stimulator). The "acceptance criteria" are implied by the compliance with various international standards and the demonstration of substantial equivalence to predicate devices.

Here's an interpretation of the "acceptance criteria" and "device performance" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the AI/ML-specific questions (2-9), the provided document does NOT discuss an AI/ML component or study of that nature.

The "Muscle Trainer" is a physical medical device (powered muscle stimulator) and the performance data section focuses on electrical safety, EMC, biocompatibility, and output waveform characteristics – typical for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.

Therefore, for questions 2 through 9, the answer is that the provided document does not contain this information as the device is not described as an AI/ML product.

Specifically:

• 2. Sample sized used for the test set and the data provenance: Not applicable. Performance testing is standard engineering/electrical testing, not a clinical study involving a "test set" of patient data for an algorithm.
• 3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML is not relevant here.
• 4. Adjudication method: Not 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: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

This document clearly outlines studies related to compliance with electrical safety standards, biocompatibility of materials, and validation of the device's electrical output parameters against established guidance and predicate devices, which are typical for traditional medical device clearance. It does not mention any AI or machine learning components.

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The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles. This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.

The provided text is a 510(k) Summary for the Pelvifine Pelvic Muscle Trainer. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence for regulatory approval.

However, this document does not contain information about clinical study acceptance criteria, device performance results from a clinical study, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The "Test Summary" section explicitly states that the device was evaluated by lab bench testing and usability testing, not clinical studies assessing its efficacy in treating urinary incontinence.

Therefore, I cannot fulfill your request for the comprehensive information about acceptance criteria and a study proving the device meets them, as the provided document does not contain this type of data.

The relevant section, "6. Test Summary," states:
"The Pelvifine Pelvic Muscle Trainer (Model: KM518) has been evaluated the safety and performance by lab bench testing and usability testing as following:

• Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
• Electromagnetic compatibility test according to IEC 60601-1-2 standard
• Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
• Usability test according to IEC 62366 standard
• Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
• The waveform test report has also been conducted to characterize the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning"

This clearly indicates a focus on technical and safety performance, not clinical efficacy. The substantial equivalence argument relies on the similarity of the new device's technical specifications and intended use to those of already approved predicate devices, rather than on proving its therapeutic effectiveness through a new clinical trial.

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The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.

The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.

The provided text is purely a 510(k) premarket notification summary and an FDA clearance letter. It describes the device and its intended use, but it does not contain any information about acceptance criteria, study methodologies, or performance results.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.

The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.

The provided text is a 510(k) Premarket Notification for the Athena Pelvic Muscle Trainer. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a standalone study with acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested details about a study and its results cannot be fully extracted.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

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

The document does not explicitly define "acceptance criteria" in the context of a performance study for the Athena Pelvic Muscle Trainer. Instead, it compares the device's technical specifications to those of legally marketed predicate devices to establish substantial equivalence.

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 describe a clinical performance study with a test set. This 510(k) is based on demonstrating substantial equivalence through comparison of technical specifications and intended use to predicate devices. No patient data or clinical study results for the Athena Pelvic Muscle Trainer are provided.

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 performance study involving a test set and ground truth establishment is described.

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

Not applicable, as no clinical performance study involving a test set 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 an electrical stimulator, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is an electrical stimulator, not an algorithm, and its performance is assessed against predicate devices' technical specifications, not by an algorithm's standalone performance.

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

Not applicable, as no clinical performance study with defined ground truth is described. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearance, to which the new device claims substantial equivalence.

8. The sample size for the training set

Not applicable, as no AI model or training set is mentioned for this device.

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

Not applicable, as no AI model or training set is mentioned for this device.

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The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.

The Breather (Inspiratory/Expiratory Muscle Trainer)

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance of "The Breather (Inspiratory/Expiratory Muscle Trainer)".

The document is a US FDA 510(k) clearance letter for the device, indicating that it has been found substantially equivalent to a predicate device. It specifies the regulatory class, product code, and a new intended use for the device (to assist in breathing coordination during nebulization treatments). However, it does not include any performance data, study results, or specific acceptance criteria for the device itself.

Therefore, I cannot provide the requested table and study details based on the given text.

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