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PlusCare Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for use by qualified medical personnel only.

The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only. Temperature probes measure temperature through a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

This document is a 510(k) Premarket Notification from the FDA regarding a temperature probe. It is not a document describing the acceptance criteria and study proving an AI/Machine Learning device meets acceptance criteria.

The information provided describes a traditional medical device (a temperature probe) and demonstrates its substantial equivalence to a predicate device. This process primarily relies on comparing design, materials, technological characteristics, and performance specifications, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the specific questions you've asked, which are highly relevant to AI/ML device evaluations, are not applicable to the content of this document. For instance:

• No AI/ML device: There is no AI component, so there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" to establish for AI, no "MRMC studies," no "standalone algorithm performance," and no "training set."
• Traditional device equivalence: The study instead focuses on demonstrating that the new temperature probe is "exactly the same" as a previously cleared predicate device in terms of its intended use, design, operating principle, materials, measurement range, accuracy, and compliance with relevant safety and biocompatibility standards (e.g., IEC 60601-1, ISO 80601-2-56, ISO 10993 series).

To answer your prompt based solely on the provided text, the response would be:

This document describes the 510(k) clearance for a traditional medical device, the PlusCare Temperature Probe, not an AI/Machine Learning enabled device. Therefore, the information requested regarding acceptance criteria and studies demonstrating performance for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable to this submission.

The "acceptance criteria" for this device relate to its ability to meet established performance standards for clinical thermometers and demonstrate substantial equivalence to a legally marketed predicate device (Unimed Temperature Probe, K121427). The study conducted was a non-clinical test data assessment to ensure compliance with recognized standards for safety, biocompatibility, and performance, demonstrating that the subject device's specifications (e.g., accuracy, measurement range) are identical to those of the predicate device.

Here's what can be extracted from the document relating to its clearance, even though it's not an AI device:

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

For a traditional device like a temperature probe, acceptance criteria are typically specified in recognized standards and internal company specifications. The document highlights the key performance characteristics that were compared and found to be "Same" as the predicate device, implying these represent the performance thresholds met.

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

• Not applicable for "test set" in the context of AI evaluation. This document does not describe patient-based clinical "test sets" for performance evaluation in the way an AI device would.
• The "testing" involved non-clinical lab tests to ensure the device itself met physical, electrical, and biocompatibility standards. The document doesn't specify sample sizes for these internal engineering or bench tests for components, but rather focuses on the device's adherence to established standards.
• Data Provenance: The testing was presumably conducted by the manufacturer (JKH USA, LLC). No country of origin for specific test data is provided, but the submission is to the US FDA. The tests are "non-clinical" which implies laboratory or bench testing, not patient data trials.

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. There is no "ground truth" established by experts in the context of interpreting medical images or data, as this is a measurement device, not an interpretative AI device. The ground truth for temperature measurement is established by calibrated reference thermometers and physical principles.

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

• Not applicable. No adjudication method for medical expert interpretations is relevant here. Performance is based on direct measurement and compliance with engineering/biocompatibility standards.

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 relates to AI-assisted human performance, which is not relevant to a simple temperature probe.

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

• Not applicable. This describes an algorithm's performance without human interaction. This device is a sensor, not an algorithm.

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

• The "ground truth" for a temperature probe's accuracy is its ability to measure temperature precisely against traceable reference standards (e.g., highly accurate thermometers, known temperature baths).
• For safety and biocompatibility, the ground truth is compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above.

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The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors. It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality.

This document does not contain an AI/ML device study. Instead, it is a 510(k) premarket notification for Patient Monitoring Cables. The filing asserts substantial equivalence to predicate devices (K082959 and K142489) based on the fact that the subject device's cables are "exactly the same" and "identical" to the predicate devices.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device study is not applicable to this submission.

The document primarily discusses:

• Intended Use: Patient Monitoring Cables are used with ECG, EKG, SpO2, and BP monitoring devices to connect electrodes, catheters, and/or sensors to a monitoring device for general monitoring and/or diagnostic evaluation by healthcare professionals.
• Comparison to Predicate Devices: The submission states that the subject device is "exactly the same" as the predicate devices in terms of intended use, design/appearance, cable length, material, usage (reusable and disposable), sterility, and conformance to standards (IEC 60601-1, EC53, ISO 10993-5, -10).
• Non-clinical Test Data: The device meets recognized standards for safety (IEC 60601-1), performance (ANSI AAMI EC53), and biocompatibility (ISO 10993-1, -5, -10). Biocompatibility tests for cytotoxicity, sensitization, and skin irritation were conducted on the proposed device, showing no adverse effects.
• Clinical Test Data: No clinical testing was deemed necessary because the subject and predicate devices are stated to be "exactly the same."

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The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its reusability.

This document describes the FDA's 510(k) clearance for a "Blood Pressure Cuff" by JKH USA, LLC. The key aspect of this clearance is the assertion that the subject device and the predicate devices are exactly the same. Therefore, the "study that proves the device meets the acceptance criteria" is primarily a claim of identity to previously cleared devices, rather than a new performance study.

Given this, I will tailor the response to reflect that the "study" is a comparison and assertion of sameness, rather than a novel clinical trial.

Here's the breakdown of the acceptance criteria and the "study" that supports it:

Acceptance Criteria and Reported Device Performance

• ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
• ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
• ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
• ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
  (These standards were also presumably met by the predicate devices, and the claim of identicality implies continued adherence.) |
  | Biocompatibility Established | Biocompatibility tests (cytotoxicity, sensitization, skin irritation) were conducted. Test results show no issue of cytotoxicity, sensitization, or skin irritation, given the skin contact duration of less than 30 days. |
  | No Material or Design Modifications from Predicate | "The subject and predicate devices are exactly the same, and there is no any difference between them." "The blood pressure cuffs are identical to the cleared version and are not modified." |
  | No Further Clinical Testing Necessary Due to Identity | "Since the blood pressure cuffs are identical, no further clinical testing is necessary." |

Details of the "Study" (Comparison and Assertion of Equivalence):

1. Sample sizes used for the test set and data provenance:
   This 510(k) submission relies on a claim of identicality to previously cleared predicate devices (K112544 and K120364, both "Unimed Blood Pressure Cuff" from UNIMED MEDICAL SUPPLIES INC). Therefore, there is no new clinical test set or patient data presented for this specific submission for the purpose of demonstrating performance. The "sample" is effectively the previously validated predicate device itself. No country of origin for a new test set is provided, and the data provenance is historical, based on the previous clearance of the predicate. This is a retrospective comparison based on design specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A) to this submission, as no new test set requiring expert ground truth establishment for a novel device performance study was conducted. The ground truth for the predicate devices would have been established at the time of their clearance through their respective validation studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A. No new test set requiring adjudication was performed.

4. 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 device is a passive blood pressure cuff, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This device is a physical medical accessory, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests (biocompatibility and standard compliance), the ground truth is established by laboratory test results conforming to the specified ISO standards (e.g., in vitro cytotoxicity, irritation, sensitization tests). For the device's overall performance, the "ground truth" for this submission is the established performance and safety of the predicate devices, which presumably met their own ground truth requirements through standard validations (e.g., accuracy against a reference standard for a blood pressure monitoring system, which the cuff is an accessory to, although the cuff itself simply maintains pressure).

7. The sample size for the training set:
   N/A. This is a passive medical device, not a machine learning model. No training set for an algorithm was used.

8. How the ground truth for the training set was established:
   N/A. No training set for an algorithm was used.

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SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.

As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.

The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin.

Four types of sensor housings are described in this submission:

• Reusable soft tip sensor comprised of an integrated silicone rubber tip.
• Reusable finger clip sensor with rigid halves and silicone pads
• Disposable non- adhesive sensor with sponge and velcro backing.
• Disposable adhesive sensors constructed of a medical tape laminate.

Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.

This document is a 510(k) summary for a pulse oximetry sensor (SpO2 Sensor), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and study design for an AI/ML device, such as sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.

The document states: "The subject and predicate devices are exactly the same. The sensors are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device." This indicates that the regulatory clearance is based on the device being identical to previously cleared devices, rather than on independent performance testing of a novel AI/ML algorithm.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or any of the other AI/ML specific information requested.

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The Massage Compression Boots are intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.

The subject device is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue by use of an inflatable garment. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device, supplied clean and non-sterile, utilizes the pneumatically controlled chambers 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 that is permanently attached to an inflatable sleeve of multiple air chambers. An ON/OFF button, a SET button, and a display of LEDs provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The sleeve component consists of multiple air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.

The provided text is a 510(k) summary for the JKH USA, LLC Massage Compression Boots. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a standalone study proving the device meets specific performance criteria.

Therefore, many of the requested details about acceptance criteria, test set characteristics (sample size, provenance, expert consensus, adjudication), multi-reader multi-case studies, and ground truth for training/testing are not present in this type of regulatory submission. The FDA 510(k) pathway for Class II devices often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined performance metrics like sensitivity, specificity, and reader studies that are common for AI/ML-driven diagnostic devices.

However, I can extract the information that is available from the document:

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

The document doesn't present a table of acceptance criteria and reported device performance in the typical sense of quantitative metrics for a new, often AI/ML-driven, medical device's diagnostic or predictive capabilities. Instead, it compares the subject device to predicate devices on various technical specifications to demonstrate substantial equivalence.

Here's a summary of the comparisons, which serve as the "performance" relevant to a 510(k) for this type of device:

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

This document does not describe a clinical "test set" in the context of an AI/ML algorithm's performance evaluation. The substantial equivalence argument is based on non-clinical tests (bench tests for physical, electrical, and performance requirements, and software verification) and comparison to predicate devices, not patient data from a test set. Therefore, sample size and data provenance are not applicable in this context.

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 noted above, there was no clinical "test set" requiring expert-established ground truth for performance evaluation of a diagnostic or predictive algorithm.

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

Not applicable. No test set requiring adjudication was used.

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 type of study is not mentioned or required for this 510(k) submission for a non-diagnostic pneumatic compression device.

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

This is not an AI/ML diagnostic algorithm. The device itself is a "Powered Inflatable Tube Massager." Its "performance" is demonstrated by meeting general safety standards and comparison of its physical and functional characteristics to legally marketed predicate devices, not by a standalone performance study in the way an AI algorithm would be evaluated. The software verification was performed according to FDA guidance, but this refers to the robustness and functionality of the device's control software, not a standalone diagnostic performance.

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

Not applicable in the context of an AI/ML diagnostic or predictive model. The "ground truth" for this device's performance relies on its adherence to safety standards (e.g., electrical, mechanical) and the functional equivalence (e.g., pressure range, cycle time, intended use) to predicate devices already deemed safe and effective.

8. The sample size for the training set

Not applicable. There is no mention of an AI/ML training set as this is not an AI/ML device in the context of what would typically require such a set (e.g., for image analysis or disease prediction).

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

Not applicable.

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The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Not Found

This document is a 510(k) clearance letter from the FDA for a Disposable Medical Face Mask. It is not a document describing an AI/ML medical device or a clinical study for such a device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance, as the provided text does not contain any such details relevant to an AI/ML medical device.

The document discusses the regulatory clearance process for a simple medical device (a face mask) and confirms its substantial equivalence to
legally marketed predicate devices. It covers:

• The device name and applicant.
• The FDA regulation number, name, and product code.
• The regulatory class (Class II).
• General controls provisions of the Act (e.g., registration, listing, GMP, labeling).
• Indications for Use of the face mask.
• Type of Use (Over-The-Counter Use).

None of these sections contain information related to AI/ML device performance, acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC studies.

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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.

The subject device is a hand-held and battery-powered unit of TENS. It combines the electrical characteristics of TENS with the point stimulation delivered through the electrodes of a metal contact tip and a metal grounding contact on the device has only one TENS mode of the low frequency (2 Hz), and only one button (Power Button). When the Power Button is held down, the device will turn on and deliver the fixed stimulation output to the user's body skin; when the Power Button is released, the device will turn off and the stimulation output will stop. Therefore, the device is very simple and easy to use. The device is designed to generate small pulses of electrical current and delivers the pulses to the user's skin through the metal contact tip such that the underlying nerves and/or muscles are activated for pain relief.

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Medi-Direct TENS Pen." This document is primarily concerned with demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies that would be typical for more complex medical devices, especially those involving AI or nuanced diagnostic capabilities.

Therefore, the information requested about acceptance criteria, detailed study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) is not present in this document. This typically applies to devices that rely on complex algorithms, imaging analysis, or diagnostic accuracy, which is not the case for this TENS device.

Instead, the document details a comparison of technical specifications to predicate devices and adherence to voluntary electrical safety and electromagnetic compatibility standards.

Here's what can be extracted and inferred from the document regarding "acceptance" for this specific type of device, based on the principle of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

For this type of device, "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) against a clinical outcome. Instead, they are framed as meeting safety standards and having comparable technical characteristics and intended use to existing, cleared devices. The "reported device performance" is essentially the device's technical specifications and its compliance with standards.

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

• Sample Size: Not applicable. This document refers to non-clinical testing for electrical safety and electromagnetic compatibility, not a clinical "test set" in the sense of patient data for performance evaluation.
• Data Provenance: Not applicable for patient data. The non-clinical tests were performed on the device itself.

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

• Not applicable. Ground truth as typically understood (e.g., expert radiological reads, pathological confirmation) is not relevant for this device's premarket notification, which focuses on engineering specifications and safety compliance.

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 Transcutaneous Electrical Nerve Stimulator (TENS) Pen, a physical therapy device for pain relief. It does not involve AI, image reading, or human interpretation that would necessitate an MRMC study.

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

• Not applicable. No algorithm in the sense of a diagnostic or interpretative AI is involved. The device's "performance" is its electrical output and safety compliance.

7. The Type of Ground Truth Used:

• For this device, "ground truth" equates to engineering specifications, compliance with international voluntary standards (IEC 60601 series), and a comparison to the known, cleared characteristics of existing predicate devices. There is no clinical "ground truth" derived from patient outcomes or expert diagnoses mentioned.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI model or complex algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the same reason as above.

Summary of the Study Proving Acceptance for this Specific Device:

The "study" proving the device meets "acceptance criteria" (defined as substantial equivalence) is primarily non-clinical testing and a detailed comparison to established predicate devices.

• Non-Clinical Tests Performed (Section 8):

  • Validation of design and assurance of conformance with voluntary standards.
  • Standards Covered:
    • IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
    • IEC 60601-1-2: Electromagnetic Compatibility (EMC) requirements and tests.
    • IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
  • The document states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence."

• Substantial Equivalence Comparison (Section 6, Table 1):

  • A direct comparison of the "Medi-Direct TENS Pen" (subject device) to three predicate devices (K162517, K141260, K133789) across numerous parameters.
  • Key Parameters Compared: Intended Use, Prescription/OTC status, Power Source, Electrical Characteristics (leakage current, output channels, regulated current/voltage, waveform, shape, maximum output voltage/current, pulse duration, frequency, maximum phase charge, current density, power density), Software/Firmware, Safety Features (Overload/No-Load Trip, Automatic Shut-Off), User Controls, Indicators, Compliance with Standards, and Housing Materials.
  • Conclusion of Comparison: The document explicitly states: "the maximum output voltage and current of the subject device are within those ranges of the predicate device; the pulse duration, period, frequency, maximum phase charge, and maximum current density of the subject device are smaller or almost the same as those of the predicate device; the maximum average power density of the subject device is within the range of the predicate device. Therefore, the differences do not affect safety or effectiveness." And ultimately, "There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results to the predicate device."

In conclusion, for the Medi-Direct TENS Pen, "acceptance" for FDA clearance was demonstrated through engineering and electrical compliance testing against consensus standards and a feature-by-feature comparison to already cleared similar devices, rather than a clinical study evaluating diagnostic or treatment efficacy.

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Over-The-Counter Use:

TENS:

PL-029K.5BL, PL-029K.15, and PL-029T 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-029K.5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K15 is labeled for use only with its own compatible electrodes.

PMS:

PL-029K5BL, PL-029K15, and PL-029T are used 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.

PL-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:

The device of PL-029T is intended for temporary relief of minor aches and pains.

Prescription Use:

TENS:

PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

PMS:

PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:

• Temporary relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Maintaining or increasing range of motion
• Increase of local blood flow in the treatment area
• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

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). 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 ℃ 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/temperature and displaying/burning calories 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 provided text describes the JKH Stimulator Plus, a Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle Stimulation (PMS) unit, and heating device. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial.

Therefore, the requested information elements such as sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone performance studies are not available in this document. The document primarily relies on engineering and performance comparisons to a predicate device and compliance with voluntary standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of a clinical study or performance goal. Instead, it presents a comparison table between the subject device (JKH Stimulator Plus, K191151) and its predicate device (JKH Stimulator Plus, K182203), highlighting technical specifications. The "acceptance criteria" here are implicitly that the subject device's technical specifications are substantially equivalent to the predicate device and fall within safe and effective ranges for TENS/PMS devices.

General Acceptance Criteria (Implicitly Met by Substantial Equivalence and Standards Compliance):

• Safety: Demonstrated by compliance with voluntary standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and the lack of new safety issues compared to the predicate device.
• Effectiveness: Demonstrated by substantial equivalence to a legally marketed predicate device for the stated indications for use (pain relief, muscle performance, blood circulation, temporary relaxation of muscle spasm, prevention of disuse atrophy, muscle re-education, range of motion, prevention of post-surgical venous thrombosis). The document highlights that the output parameters are "therapeutically effective with either device."
• Performance: Technical specifications (voltage, current, pulse width, frequency, etc.) are within ranges considered appropriate for TENS/PMS devices and comparable to the predicate.
• Biocompatibility: Electrodes and materials are compliant with ISO 10993 standards.
• Software Validation: Software verification was carried out according to FDA guidance.

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

• Not Applicable. This is a 510(k) submission based on substantial equivalence. No clinical test set data from actual patients is presented as part of the evidence. The "tests" mentioned are non-clinical engineering and standard compliance tests.

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

• Not Applicable. No ground truth for clinical performance was established in this context. The evaluation is based on engineering specifications and comparison to a predicate device.

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

• 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. This is not an AI-assisted device, nor is it a diagnostic device where MRMC studies are typically performed.

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 (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. For this submission, the "ground truth" for proving safety and effectiveness is tied to compliance with recognized standards and the demonstration of substantial equivalence to a predicate device that has already been cleared.

8. The sample size for the training set:

• Not Applicable. No training set data for an AI/algorithm is mentioned.

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

• Not Applicable. No training set data for an AI/algorithm is mentioned.

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Over-The-Counter Use:

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

PL-029K12 and PL-029K13 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-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

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

PL-029K12 and PL-029K13 are used 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.

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis
• Temporary relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Maintaining or increasing range of motion
• Increase of local blood flow in the treatment area
• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

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 of ON/OFF button, intensity increase button, 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). 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 ℃ 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/temperature and displaying/burning calories 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 provided text is a 510(k) Summary for the JKH Stimulator Plus (K182203), which is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) unit with heating capabilities. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against pre-defined acceptance criteria through a specific study.

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets them (as per the prompt's request for a table of acceptance criteria, sample size, expert involvement, etc.) is not explicitly present in this type of FDA submission document.

Here's a breakdown of why this information is missing and what is provided instead:

• No specific acceptance criteria table for performance: 510(k) submissions for substantial equivalence typically don't include a detailed table of acceptance criteria for clinical performance endpoints like accuracy, sensitivity, or specificity. Instead, they demonstrate that the new device's technical characteristics and intended use are similar enough to already legally marketed predicate devices such that it raises no new questions of safety or effectiveness.
• No dedicated "study" proving performance against acceptance criteria: The document refers to "Non-Clinical Tests Performed" (Section 8) but these are primarily bench tests and biocompatibility tests (e.g., IEC 60601 series, ISO 10993 series) to ensure electrical safety, electromagnetic compatibility, and safe material use, not a clinical trial or performance study against specific acceptance metrics for pain relief or muscle stimulation effectiveness.
• No information on sample size (clinical), expert involvement, adjudication, MRMC studies, or specific ground truth methodologies for performance: These elements are characteristic of clinical performance studies, which are generally not a requirement for 510(k) substantial equivalence for devices like TENS units unless new questions of safety or effectiveness are raised.

Based on the provided text, I can infer and extract information relevant to the prompt's structure, but it's crucial to understand that it's from the perspective of substantial equivalence rather than meeting specific performance acceptance criteria from a pre-defined study.

Attempted Interpretation of Acceptance Criteria and "Study" Information based on K182203:

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

Since this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the comparison to a predicate device. The "reported device performance" is framed in terms of technical specifications being within ranges demonstrated by legally marketed devices, indicating no new safety or effectiveness concerns.

PMS (Modes 1, 3, 7): Stimulate healthy muscles to improve/facilitate muscle performance, improve muscle tone/firmness, strengthen muscles (arms, abdomen, legs, buttocks), temporarily increase local blood circulation in lower extremities.

Heating (PL-029K13): Temporary relief of minor aches and pains. (All match predicates). |
| Safety Standards | Compliance with recognized electrical safety, EMC, and biological evaluation standards. | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, and FDA Guidance for software. |
| Maximum Skin Temp. | For heating function, must be within safe limits (matches predicate's max temp.). | 43 °C (PL-029K13 only), matches K162517 predicate. |
| Electrical Output | Electrical parameters (Max. Output Voltage, Max. Output Current, Pulse Width, Frequency, Max Phase Charge, Max Current Density, Max Avg. Power Density) must be within the range of cleared predicate devices, such that they do not raise new safety or effectiveness concerns. | Values provided for both PL-029K12 and PL-029K13 across 500Ω, 2KΩ, and 10KΩ loads. These values are identical to the K162517 predicate and are stated to be within the range of other FDA-cleared transcutaneous electrical nerve stimulators, and differences from some predicates do not raise new safety/effectiveness questions. |
| Electrode Compatibility | Labels must ensure safe and proper use of compatible electrodes. | Labeled for use only with its own compatible electrodes. Concerns for safe and proper use fully addressed through labeling. Electrodes are the same as or biocompatible with those cleared for predicates. |
| Device Operation | Manual and optional wireless control should facilitate user operation without raising safety concerns. | Easily operated through buttons (ON/OFF, intensity, heat, display/burning calories). Optional wireless control via remote or Bluetooth APP. |

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

• Sample Size for Test Set: Not applicable in the context of clinical performance for this 510(k). The "test set" here refers to the actual device units subjected to engineering bench tests and biocompatibility tests. The document does not specify the number of units tested.
• Data Provenance: The tests performed are non-clinical (bench testing, biocompatibility) of the manufactured device. These tests are presumably conducted by the manufacturer or contracted labs. The origin isn't stated in terms of country or retrospective/prospective as it relates to clinical data, but rather reflects standard engineering and safety evaluations for device manufacturing.

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

• Experts for Ground Truth: Not applicable. For demonstrating substantial equivalence, "ground truth" (clinical diagnosis) is not established by experts for a specific test set. Rather, the device's technical specifications are compared to those of established, legally marketed predicate devices. The expertise involved would be internal engineering and regulatory expert(s) at JKH USA, LLC, and the FDA reviewers themselves, evaluating the submission for regulatory compliance and equivalence.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) submission.

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: No. This device is a TENS/PMS unit, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

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

• Standalone Performance: Not applicable. This device does not have an AI algorithm. It is a direct electrical stimulation device.

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

• Type of Ground Truth: Not applicable in the clinical sense. For a 510(k) demonstrating substantial equivalence for a TENS/PMS device, the "ground truth" for regulatory approval lies in conforming to recognized safety and performance standards (bench testing) and demonstrating that its technological characteristics and intended uses are the same as or similar enough to already legally marketed predicate devices that it does not raise new questions of safety or effectiveness. The effectiveness of the class of device is established through prior predicate device clearances.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

Summary of what the document does provide regarding "proof":

The "proof" in this 510(k) summary is based on technical comparison and compliance with voluntary standards, not clinical performance studies against specific acceptance criteria.

• Technical Comparison (Section 6 & 7): The core of the substantial equivalence argument is presented in "Table 1. Comparison between the subject device and the predicate device" and the subsequent "Summary of Substantial Equivalence" (Section 7). This table systematically compares the JKH Stimulator Plus (K182203) to multiple predicate devices (K162517, K031017, K140333, K153704) across various features including:

  • Intended Use (for both OTC and Prescription uses)
  • Power Source
  • Compliance with Voluntary Standards (electrical safety, EMC, biocompatibility)
  • Functions and Design (Electrical stimulation and heat)
  • Maximum skin temperature (for heating mode)
  • Electrical Output Parameters (Maximum output voltage, current, pulse width, frequency, phase charge, current density, average power density at various loads).

• Conclusion of Equivalence (Section 7): The document argues that:

  • The subject device (JKH Stimulator Plus) is identical to one of the predicates (K162517) from the same manufacturer for core electrical stimulation and heating features.
  • Any differences in technical specifications (e.g., specific pulse width or frequency ranges, output parameters) compared to the other predicate devices are within accepted ranges for TENS/PMS devices and do not raise new questions of safety or effectiveness. This is supported by explanations such as "neither device gives the user control over frequency," "both devices are using standard TENS stimulation frequencies," and the output parameters are "therapeutically effective with either device."

• Non-Clinical Testing (Section 8): JKH USA, LLC performed bench tests to ensure the device's design conforms to recognized consensus standards for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Software verification was also conducted per FDA guidance. These tests serve as "proof" that the device is built safely and functions as intended within engineering parameters.

In essence, the "study" proving the device met "acceptance criteria" here is the aggregated body of evidence presented in the 510(k) to demonstrate substantial equivalence to existing, legally marketed devices, rather than a de novo clinical trial with specific performance endpoints.

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