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Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
   • Adhesive capsulitis,
   • Bursitis with slight calcification,
   • Myositis,
   • Soft tissue injuries, and
   • Shortened tendons due to past injuries and scar tissues.
4. Relief of pain, muscle spasms, and joint contractures resulting from:
   • Capsular tightness, and
   • Capsular scarring.
5. Localized increase in blood flow.
6. Increased range of motion of contracted joint using heat and stretch techniques.

As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.

It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.

The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.

This looks like a fascinating case study. Based on the provided FDA 510(k) clearance letter and summary, here's an analysis of the acceptance criteria and the study that proves the device meets them.

It's important to note that this document is for an Ultrasound Stimulator (Ultrasonic Diathermy), which delivers therapeutic ultrasound, not an AI/Software as a Medical Device (SaMD) that typically involves image analysis or diagnostic support. Therefore, many of the typical acceptance criteria and study designs related to diagnostic accuracy, MRMC studies, and nuanced ground truth establishment for AI models (as implied by the original request's detailed points) are not applicable to this type of physical therapy device.

The "acceptance criteria" here are primarily based on demonstrating substantial equivalence to predicate devices through engineering specifications, performance testing, and safety profiles, rather than clinical efficacy studies in the way an AI diagnostic tool would require.

Acceptance Criteria and Study Proving Device Meets Criteria

Given that the device is an Ultrasound Stimulator aiming for 510(k) clearance based on substantial equivalence, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) but rather in terms of demonstrating that its technical characteristics, performance, and safety are equivalent to legally marketed predicate devices. The "study" proving it meets these criteria is a comprehensive set of non-clinical, bench performance tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

For an Ultrasound Stimulator, the "acceptance criteria" are primarily a demonstration of equivalence to the predicate devices across various technical and functional parameters, and compliance with relevant safety standards. The "reported device performance" are the results of the non-clinical tests and direct comparisons to the predicate devices.

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Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.

The provided text is a 510(k) Summary for a medical device called "Cold Compression". This document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a study of its performance in a clinical or analytical setting.

Therefore, the input document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that "Clinical testing was not needed in support of this 510(k) application." (Section 8) and focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests for electrical safety and electromagnetic compatibility.

Instead, the document provides:

Non-Clinical Tests Performed:

• Tests: Non-clinical tests were performed to validate the design and assure conformance with voluntary design standards related to medical device electrical safety and electromagnetic compatibility.
• Standards:
  • IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
  • IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

Comparison Table (Table 1):
This table compares the subject device ("Cold Compression") with two predicate devices (K223541 and K183702) across various technical characteristics and specifications to establish substantial equivalence. While it doesn't present "acceptance criteria" in the traditional sense of a performance study, it details the characteristics where the device's performance parameters are deemed acceptable due to their similarity to a legally marketed device.

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The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

• Treatment of lymphedema
• Treatment of chronic venous insufficiency
• Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
• Reducing venous leg ulcer healing time
• Reducing edema due to venous stasis
• Enhancing venous return
  The device is intended for home, and hospital use.

As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.

The provided FDA 510(k) summary (K240011) describes the "Lymphedema Compression" device and its substantial equivalence to a predicate device, ManaFlow (K200353).

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

The provided document doesn't explicitly list "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the substantial equivalence relies on demonstrating that the subject device's characteristics and performance are identical to or similar to the predicate device. The primary "acceptance criterion" is functional and technical equivalence to the predicate.

Here's a table based on the comparison provided in the 510(k) summary:

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

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there was no clinical test set of patient data, no sample size of patients, and no data provenance relevant to clinical performance evaluation. The "test set" for the device's technical specifications consists of the individual components and the assembled device that underwent non-clinical bench testing.

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

Not applicable. Since no clinical testing was performed, there was no ground truth established by experts on patient cases. The evaluation of electrical safety, EMC, and physical/performance requirements relies on adherence to published voluntary standards and internal company specifications, not expert consensus on clinical outcomes.

4. Adjudication method for the test set

Not applicable. As no clinical testing or human reader study was conducted, there was no need for an adjudication method.

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 study was conducted. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical medical device (pneumatic compression) and does not involve an algorithm with standalone performance in the context of diagnostic interpretation. Its "performance" is based on mechanical and electrical parameters (e.g., pressure output, cycle time, safety features).

7. The type of ground truth used

The "ground truth" for this submission is adherence to recognized voluntary standards for medical device safety and performance (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the technical specifications and functional characteristics of the legally marketed predicate device. Bench tests validated that the subject device met its own design specifications, which were shown to be identical or very similar to the predicate.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. (See #8)

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Cold/Hot Compression combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

ColdHot Compression is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

The subject device is a prescriptive device, which combines cold/hot therapy and air compression. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

The subject device comes with the thermal-therapy wraps and the DVT wraps. The thermal-therapy wrap is nylon fabric on one side and velvet cloth on the other side; the DVT wrap is velvet on both sides. To avoid any potential adverse skin reactions such as redness, irritation, and cold/hot injury, the sock/clothing should be worn by the patient prior to use.

The subject device includes a main device and an optional DVT device, and has a limited shelf life of 3 years, based on the charge retention characteristics of the device's battery.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the typical sense.

Therefore, the information requested might not be fully available or explicitly stated in the provided text as it would be in a clinical study report.

Based on the provided text, here's what can be extracted and inferred:

1. Table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" here is primarily tied to demonstrating equivalence to the predicate device. The performance is assessed by comparing technical specifications.

Notes on Equivalence (as explained in the document):

• Note 1 (Cold Therapy): The subject device's cold therapy temperatures are within or similar to the range of the predicate/reference devices, and are adjustable by professionals. Differences are considered insignificant and do not raise new safety/effectiveness concerns.
• Note 2 (Heat Therapy): Similar to cold therapy, the heat therapy temperatures are within or similar to the predicate/reference devices and adjustable. Differences are insignificant.
• Note 3 (Edema Pressure): The subject device's lowest pressure is within the predicate's range and similar to the reference. The highest pressure is slightly higher but still adjustable by professionals. Differences are insignificant.
• Note 4 (DVT Pressure): The subject device's DVT pressures for calf and foot fall within or are slightly higher than the predicate/reference devices. Differences are insignificant.
• Note 5 (Cycle Length): The subject device's longest cycle length is similar to or longer than the predicate's, though shorter than the reference. Cycle length is adjustable. Differences are insignificant.
• Note 6 (Contrast Therapy Temp): The subject device's contrast therapy temperatures are either similar to the predicate or identical to the reference. No new safety/effectiveness issues.
• Note 7 (Contrast Cycle Length): The contrast therapy cycle length is slightly different from the predicate but identical to the reference. No new safety/effectiveness issues.
• Note 8 (Reservoir Fluid Capacity): The subject device's capacity is smaller than the predicate's but larger than the reference's. This difference does not raise new safety/effectiveness issues.

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

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there is no test set in the sense of patient data from a clinical study. The "testing" involved non-clinical bench tests and comparison of specifications to predicate devices. The data provenance is from internal JKH Health Co., Ltd. testing and comparison to publicly available predicate and reference device information.

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment for a patient-based diagnostic or therapeutic outcome.

4. Adjudication method 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 a physical medical device (Cold/Hot Compression unit), not an AI-powered diagnostic or assistive tool for human readers.

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.

7. The type of ground truth used

The "ground truth" for the non-clinical tests would be the measured physical parameters of the device (e.g., actual temperature output, actual pressure levels, cycle times) against the device's design specifications and the specifications of the predicate devices. For safety standards, the ground truth is adherence to the requirements of the standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design was likely based on engineering principles and comparison to existing devices.

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

Not applicable. No training set was used.

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Infrared Thermometer is intended temperature measurement at home or hospital for people of all ages without contact to human body.

Not Found

Here's an analysis of the provided text regarding the acceptance criteria and study for the JKH Health Co., Ltd. Infrared Thermometer:

Based on the provided FDA 510(k) clearance letter and Indications for Use, the document does not contain detailed information about the specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment that would typically be found in a clinical study report or detailed submission summary.

The document primarily focuses on the regulatory clearance process, confirming that the device (Infrared Thermometer, Models: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304) is substantially equivalent to legally marketed predicate devices. It states its intended use for non-contact temperature measurement for people of all ages at home or in a hospital setting.

Therefore, many of the requested details cannot be extracted from this particular document. I will highlight what can be inferred or is directly stated, and mark what is not present.

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

2. Sample sized used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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

• MRMC study: Not applicable. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results.
• Effect size of human improvement with AI: Not applicable.

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

• Standalone performance: Yes, this is an inference given the device's nature as an infrared thermometer. Its performance would be evaluated as a standalone device without human interpretation of its core function (temperature measurement). However, the specific details of this testing (e.g., how accuracy was validated against a reference standard) are not provided in this document.

7. The type of ground truth used

• Type of ground truth: Not explicitly stated. For a thermometer, the ground truth would typically be a highly accurate reference thermometer measurement (e.g., a laboratory-grade precision thermometer, or an invasive core body temperature measurement in a clinical setting for calibration/validation).

8. The sample size for the training set

• Sample size for training set: Not applicable and not specified. Infrared thermometers typically do not involve "training sets" in the machine learning sense. Their calibration and performance are based on physical principles and manufacturing processes, demonstrated through verification and validation testing.

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

• Ground truth for training set: Not applicable and not specified. See point 8.

Summary of what's provided for the JKH Health Co., Ltd. Infrared Thermometer:

• Device Name: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
• Regulation Number/Name: 21 CFR 880.2910, Clinical Electronic Thermometer
• Regulatory Class: Class II
• Product Code: FLL
• Intended Use: Temperature measurement at home or hospital for people of all ages without contact to the human body.
• Type of Use: Over-The-Counter Use
• Regulatory Status: Cleared via 510(k) (K211050) as substantially equivalent to predicate devices.

What is NOT provided in this FDA 510(k) clearance letter (and would typically be found in a detailed test report or submission summary):

• Specific numerical acceptance criteria for accuracy, precision, or other performance characteristics.
• Detailed results of the device's performance against these criteria.
• Information about the clinical or laboratory studies conducted (e.g., number of subjects, age groups, measurement sites, comparison methods, statistical analysis).
• Any information regarding training data, ground truth establishment, or expert involvement, as these are more pertinent to AI/ML-driven devices.

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The Compression Therapy Device is intended to be an easy to use portable by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation;
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
• · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Compression Therapy Device

Based on the provided text, the document is an FDA 510(k) clearance letter for a "Compression Therapy Device." This letter does not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be required to answer your request.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It discusses regulatory compliance, labeling, and other administrative aspects. It does not provide a technical report of device performance or the study design and results validating its functionality against specific acceptance criteria.

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

To answer your request, you would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a comprehensive technical submission to the FDA.

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TENS:
PL-029K29, PL-029K30, and PL-029Q are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen. legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). the device may also provide heat for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/light if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.

The provided text is a 510(k) Summary for the StimPlus Patch, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) with heating function. The document focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study involving human patients.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to clinical performance) cannot be extracted from this document because the submission method relies on demonstrating substantial equivalence to pre-existing, cleared devices rather than a de novo clinical performance study.

However, I can extract the information related to the non-clinical tests and the comparison of the device's technical specifications to those of its predicates, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.

Here's the breakdown of what can and cannot be answered based on the provided text:

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

The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This is achieved by showing that the subject device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. The core of this is the comparison table of technical parameters.

Table: Comparison of Subject Device (StimPlus Patch) to Predicate Devices

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TENS (Modes 1, 2, 4, 5, 6, 8)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (also called EMS, Modes 1, 3, 7)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating Mode Temporary relief of minor aches and pains.

Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 °C.

The device could be easily operated through its buttons to manually realize its functions, such as turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.

The electrodes cleared include the electrode pads and electrode garments, which could be packaged separately and/or together with the subject device.

This document is a 510(k) summary for an Electronic Pulse Stimulator (device K162517). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices (K153520 and K070299). Since this is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) device, the acceptance criteria and study information will focus on its electrical and heating parameters rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a predetermined numerical threshold for a clinical outcome (e.g., "sensitivity must be >90%"). Instead, it demonstrates "substantial equivalence" based on various technical specifications and intended use. The "reported device performance" is essentially a comparison of these technical specifications between the subject device and the predicate devices.

The table below summarizes the comparison from Table 1 in the document for the subject device (PL-029K13, as it includes the heating mode) and its primary predicate (PL-029K6, K153520) for electrical stimulation, and the heating predicate (ezFit Digital Heating TENS, K070299) for the heating function. The ranges and specific values are presented as performance data.

For non-clinical tests, the "acceptance criteria" were compliance with specific voluntary standards:

• IEC 60601-1 (medical electrical equipment safety and essential performance)
• IEC 60601-1-2 (electromagnetic compatibility)
• IEC 60601-2-10 (particular requirements for nerve and muscle stimulators)
• FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.

The reported device performance for these non-clinical tests is that the device "conformed" and "met the requirement of safety" for the standards and guidance, respectively.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device..."

Therefore, there is no clinical test set, human subject data, or data provenance (country of origin, retrospective/prospective) described in this 510(k) summary for the purpose of demonstrating substantial equivalence. The evaluation relies on technical comparisons to predicate devices and adherence to engineering and safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As no clinical test set was used, there was no ground truth established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would be the specifications and requirements of the regulatory standards themselves, which are established by expert committees in their respective fields (e.g., electrical engineering, medical device safety).

4. Adjudication Method for the Test Set

Since no clinical test set with human subject outcomes was used for demonstrating substantial equivalence, no adjudication method (like 2+1 or 3+1 consensus) was applied.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which is not applicable to an Electronic Pulse Stimulator submission focused on electrical and heating parameters and substantial equivalence to existing devices.

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

No, a standalone performance study in the context of an AI/ML algorithm was not done. The "performance" in this submission refers to the technical specifications of the device (e.g., output voltage, current, temperature) and its compliance with safety standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the technical specifications, the "ground truth" is established by engineering measurements against reference standards (e.g., voltmeters, ammeters, thermometers calibrated to international standards) to verify the device's output. For compliance with voluntary standards (IEC 60601-1, -1-2, -2-10), the "ground truth" is the requirements outlined in those international standards. For software, it's compliance with FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Since this is not an AI/ML device, there is no training set sample size described. The device's operation is based on fixed electrical circuits and heating elements, not learned models.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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TENS (Modes 1, 2, 4, 5, 6)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 1 and 3)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

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The provided text is a 510(k) premarket notification letter from the FDA regarding an "Electronic Pulse Stimulator." It confirms substantial equivalence to predicate devices for specific Indications for Use. However, this document does not contain any information regarding acceptance criteria, device performance, study details, 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 based on the provided text. The document is primarily a notification of regulatory clearance, not a summary of performance studies.

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