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The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2401 is designed to provide muscle relaxation therapy by delivering heat and soothing massage to affected areas.

Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

The aircell leg massager is designed to provide temporary relief of minor muscle aches and pains and a temporary increase in blood circulation to the treated areas. The aircell leg massager stimulates kneading and stroking of tissues by using an inflatable garment.

Not Found

The FDA 510(k) Clearance Letter for the Ceragem Automatic Thermal Massager (CGM MB-2401) does not contain information regarding detailed acceptance criteria and a study that proves the device meets specific performance metrics beyond its stated indications for use.

The letter primarily focuses on the regulatory determination of substantial equivalence to predicate devices, allowing the manufacturer to market the device. It outlines the device's intended use and general regulatory requirements but does not include clinical study data, statistical performance metrics, or details about the validation process typically associated with detailed acceptance criteria of an AI/algorithm-driven device.

Therefore, the requested information cannot be extracted from the provided document.

Information NOT available in the provided document:

1. Table of acceptance criteria and the reported device performance: This information is not present. The letter does not specify quantitative performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not provided. There is no mention of a test set, its size, or where any data used for validation (if any) originated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment process is described.
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, and its effect size: Not applicable. The device is a physical therapy massager, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The FDA 510(k) clearance process for a Multi-Function Physical Therapy Table (like the Ceragem Automatic Thermal Massager) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering performance tests and adherence to recognized standards, rather than complex clinical effectiveness studies with explicit performance metrics like those for diagnostic AI tools. The provided document is a regulatory clearance letter, not a full submission document that would detail all validation studies.

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AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.

The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.

The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.

Manual operation systems:

• . Headpiece.
• . Extension of feet.
• Drops. .
• Dorso - lumbar release/breakaway
• Lateral Flexion. ●

Electrical operating systems:

• . Horizontal elevation.
• . Flexion of the lower limb sector.
• Extension or linear movement of the lower limb sector (distraction/traction).

This FDA 510(k) K241193 premarket notification describes the AGILIS - Multi-function Physical Therapy Table. The submission indicates that no clinical studies were performed for this device. Therefore, no information is available regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The submission focuses on demonstrating substantial equivalence to a predicate device (AIR-FLEX WITH AUTO-DISTRACTION, K063034) through non-clinical testing.

Here's a summary of the non-clinical testing for the AGILIS Multi-function Physical Therapy Table:

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

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

• No specific sample size for the test set is mentioned beyond a general statement of "operational control is carried out on 100% of the manufactured tables." This refers to manufacturing quality control rather than a specific test set for regulatory submission.
• The data provenance is not specified regarding country of origin or whether it was retrospective/prospective, as these were bench tests and internal operational controls.

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 studies with expert-established ground truth were performed.

4. Adjudication method for the test set

• Not applicable, as no clinical studies requiring adjudication were performed.

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 therapy table, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

• Not applicable. This is a physical therapy table, not a software algorithm.

7. The type of ground truth used

• For the non-clinical tests (electrical safety, EMC, performance), the "ground truth" implicitly refers to the requirements and specifications of the referenced international consensus standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for bench performance testing.

8. The sample size for the training set

• Not applicable, as no machine learning or AI component is mentioned requiring a training set.

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

• Not applicable.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302 is to provide muscle relaxation therapy by delivering heat and soothing massage.

Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

The Air Cell Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ceragem Automatic Thermal Massager). This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter is primarily concerned with:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, quality system regulations).
• Providing contact information for regulatory inquiries.
• Stating the intended use of the device.

Therefore, I cannot extract the information you requested regarding acceptance criteria and study details from the provided text.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1902 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Ceragem Automatic Thermal Massager (CGM-MB-1902)" does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance.

The letter is a standard FDA clearance document that states the device has been determined to be substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation details.
• General controls provisions (registration, listing, GMP, labeling, etc.).
• Applicable regulations (QS regulation, UDI Rule).
• Contact information for FDA.
• The "Indications for Use" for the device, which are limited to providing muscle relaxation therapy, temporary relief of minor muscle and joint pain/stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles.

There is no mention of:

• Any AI/ML component in the device.
• Specific performance metrics or acceptance criteria for such a component.
• Any study data (sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance) related to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided document does not contain this information. The device, as described, is a physical therapy device and not an AI/ML-driven diagnostic or therapeutic tool for which such detailed performance studies would be typically required for clearance.

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The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-Temporary relief of minor joint pain associated with arthritis.
-The temporary increase in local circulation where applied.
-Relaxation of muscle.
The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.

The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.

The given document is a 510(k) premarket notification for a medical device (N7-S Multi-Function Physical Therapy Table) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to predicate devices (CGM MB-1701 & CGM MB-1702, and N5-1) based on indications for use, technological characteristics, and performance testing for safety and basic functionality (e.g., temperature range, pressure performance of air cell massager).

The sections that might contain information about studies are "Performance Test" and "Clinical Test Summary" (page 14). However, these sections state:

• Performance Test: "A comprehensive performance test was conducted on the subject device, including a pressure performance test of the Air Cell Massager, to substantiate its equivalence to the predicate device A(K220572)." It lists items evaluated such as temperature range, extra overheating protection, temperature sensor function, heating part, skin surface temperature, and pressure performance of the Air cell massager. It concludes that "the subject device met all applicable performance requirements and was substantial equivalent with predicate devices."
• Clinical Test Summary: "No clinical studies are considered necessary and performed."

Therefore, the provided document does not describe: AI/ML acceptance criteria, a study proving an AI/ML device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or how ground truth for training data was established.

The device, N7-S, appears to be a physical therapy table with heat and massage functions, including an air massager. It is not an AI/ML-driven device based on the provided text, and thus, the detailed questions about AI/ML performance metrics are not applicable to this submission.

Without information on AI/ML components or their performance evaluations, I cannot fill out the requested table or provide details on the study's AI/ML specific aspects.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
-Temporary relief of minor muscle and joint pain stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied

• Relaxation of muscles
  The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.

The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 4 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure cognized to the sensor, cycling airflow into and out of sleeves to compress body.

The provided text is related to a 510(k) premarket notification for a medical device (Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702). It discusses the device's indications for use, description, and a comparison to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies. The document specifically states "The subject device has undergone safety and performance tests, and the results conformed with the test requests," and lists several non-clinical tests (Skin Temperature Study, Usability Study, EMC and electrical safety testing, software validation, and Biocompatibility studies). These are general tests demonstrating safety and compatibility, not a study designed to evaluate performance against specific clinical acceptance criteria as typically seen for AI/ML devices.

Therefore, I cannot provide the requested information from the given text. The text does not detail a study proving the device meets specific performance acceptance criteria for clinical efficacy or accuracy in the way the prompt implies (e.g., for an AI/ML algorithm). The listed tests primarily focus on electrical safety, EMC, biocompatibility, software functionality, and user manual usability, which are safety and basic functional performance aspects, not clinical performance against acceptance criteria.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

The Ceragem Automatic Thermal Massager which offers two models, CGM MB-1701 & CGM MB-1702 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from up and down movement of the internal motor, and heat from the internal and external projectors.

The main components of the subject device are a main table mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main table has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and up/down and vertically along the spinal line. The main table mat has a heating pad for thermal effect.

The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.

The only difference between the model CGM MB-1701 and the CGM MB-1702 is that the CGM MB-1701 has an air massage module for calf on the supporting mat. The supporting mat of the both models has a heating pad.

This document is a 510(k) Premarket Notification from Ceragem Co, Ltd. to the FDA for their Automatic Thermal Massagers, Models CGM-MB-1701 & CGM-MB-1702. The purpose of this notification is to demonstrate that their new devices are substantially equivalent to a legally marketed predicate device (Automatic Thermal Massager, Model CGM MB-1101, K140592) and thus do not require a Premarket Approval (PMA).

The information provided focuses on demonstrating substantial equivalence based on indications for use, principle of operation, technological characteristics, and performance specifications. However, the document does not describe a study that involves an AI/algorithm to meet acceptance criteria in the way envisioned by your request.

Specifically, the "Performance Tests (Non-clinical)" section (Page 6) details several tests conducted, but none of them are related to AI/algorithm performance. The tests are:

• Skin temperature study: To verify heat delivery.
• Usability study: To validate lay user operation with the manual.
• EMC and electrical safety testing: To meet standards like ANSI AAMI ES60601-1, IEC 60601-1-2, etc.
• Biocompatibility tests: Cytotoxicity, skin irritation, and sensitization for new materials.
• Firmware validation tests: To verify the software works as intended.

The "firmware validation tests" are the closest to "algorithm" but they are for the device's operational firmware, not an AI or diagnostic algorithm assisting human readers as your prompt implies. The acceptance criteria for these tests are not detailed beyond "the test results of all the tests supported that it is substantially equivalent to the predicate device."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving an AI/algorithm meets those criteria because the provided text does not contain such a study. The document is for a physical medical device (thermal massager) and its assessment for market clearance, not an AI-powered diagnostic or assistive tool.

To answer your specific points, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of an AI/algorithm. The document discusses "performance specifications" for the physical device, such as temperature range, intensity levels (1-9 vs 1-6), and massage modes (more options in the subject device), and states that a skin temperature study was performed to maintain 40-45°C. This is not for an AI.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/algorithm study. Sample sizes for the non-clinical performance tests (e.g., skin temperature, usability) are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert reads, pathology reports) is not mentioned.
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: No, this type of study was not done as the device is a physical massager, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/algorithm. For the device, the "ground truth" for its performance seems to be physical measurements (e.g., skin temperature, electrical safety parameters) and comparison to the predicate device's established performance ranges.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and its associated summary pertain to a physical therapeutic device (a thermal massager) and its substantial equivalence to a predicate device. It evaluates the fundamental safety and functional performance of the hardware, not an AI component. Therefore, the questions related to AI/algorithm performance and study design cannot be answered from this document.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors. The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.

The provided text is a 510(k) summary for the Ceragem Automatic Thermal Massager, Model CGM-MB-1901. This type of document is for medical devices that are deemed substantially equivalent to a legally marketed predicate device. It focuses on demonstrating that the new device is as safe and effective as the predicate, rather than proving efficacy from scratch with extensive clinical trials like a PMA would require.

Therefore, the information regarding acceptance criteria and studies proving the device meets those criteria in the context of efficacy, particularly for AI/Machine Learning devices, is not present in this document. This document details engineering and safety/performance testing relevant to mechanical and thermal devices, not AI performance. Specifically:

• Acceptance Criteria for AI/ML Performance: Not applicable/not defined as this isn't an AI/ML device.
• Study Proving Device Meets Acceptance Criteria: The studies described ("skin temperature study," "usability study," "EMC and electrical safety testing," "cytotoxicity test," "skin irritation & sensitization tests," and "firmware validation tests") are all related to the physical, electrical, and material safety and performance of a thermal massager, not the accuracy or performance of an AI algorithm.

Let's break down what is available in the document related to testing, even though it doesn't fit the typical "acceptance criteria for an AI device" framework:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a thermal massager):

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

• The document does not specify sample sizes for these performance and safety tests (e.g., number of subjects in the skin temperature or usability study, number of material samples for biocompatibility).
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/in-house testing) with a potential small human component for skin temperature and usability. They are not referred to as retrospective or prospective clinical studies in the typical sense.

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

• Not applicable/not specified. The studies described are engineering, safety, and basic human factor (usability) tests, not diagnostic accuracy studies requiring expert readers to establish ground truth.

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

• Not applicable. This is not a study requiring reader adjudication for diagnostic accuracy.

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

• No, an MRMC study was not done. This device is not an AI/ML diagnostic or assistive device.

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

• No, this is not an AI/ML device. "Standalone performance" is not relevant here.

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

• Ground truth in the typical AI/ML sense (e.g., confirmed disease status) is not relevant. The "ground truth" for the tests performed would be:
  • Skin Temperature: Measured temperature readings.
  • Usability: Observation of user interaction and completion of tasks using the manual.
  • Electrical Safety/EMC: Compliance with standard thresholds and test procedures.
  • Biocompatibility: Laboratory results showing absence of toxic or irritating reactions.
  • Firmware: Expected functional outputs/behaviors.

8. The sample size for the training set:

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

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

• Not applicable.

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The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;

-Temporary relief of minor muscle and joint pain, and stiffness.

• Temporary relief of minor joint pain associated with arthritis.

• The temporary increase in local circulation where applied.

• Relaxation of muscle.

The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:

• (1) Main assembly
• (2) 5-Ball Projector
• (3) Remote Control
• (4) Accessories

Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.

This document is a 510(k) Premarket Notification from Nuga Medical Co., Ltd. for their device, the N5-1. The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy in the way an AI/software device typically would.

Therefore, many of the details requested in your prompt (such as acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not provided in this regulatory document. This submission focuses on comparing the N5-1's design, technological characteristics, and intended use to a previously cleared predicate device to show that it does not raise new questions of safety or effectiveness.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document is for a physical therapy device, not an AI/software device that processes data for diagnosis or treatment decisions. Therefore, there is no "test set" in the context of data for an algorithm.
• The safety and performance are evaluated through engineering tests (electrical safety, EMC) and comparison to a predicate device. Clinical studies were explicitly stated as not being necessary or performed.

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

• Not applicable. There is no "test set" in the context of an algorithm's performance requiring ground truth established by experts.

4. Adjudication method 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:

• No. This is not an AI-assisted diagnostic or therapeutic device that requires human readers.

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

• No. This is a physical therapy device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of an AI/software device's performance. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., AAMI ES60601-1, IEC 60601-1-2) and demonstrating substantial equivalence to a legally marketed predicate device with the same intended use and similar technological characteristics.

8. The sample size for the training set:

• Not applicable. There is no AI training set.

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

• Not applicable. There is no AI training set.

Summary of the Study:

The document describes a non-clinical study primarily focused on demonstrating substantial equivalence to a predicate device (K111329, NM-7000) for regulatory clearance. This is done by comparing:

• Intended Use: The N5-1's intended use is identical to the predicate device.
• Technological Characteristics: The N5-1 is shown to have similar design, function, and technical characteristics (e.g., emission source, temperature range, safe working load) to the predicate device. Minor differences are identified and argued not to raise new safety or effectiveness concerns.
• Performance via Standards Compliance: Electrical safety and electromagnetic compatibility (EMC) were tested against recognized standards (AAMI ES60601-1 and IEC 60601-1-2, respectively). The device "complies" with these standards.
• Software Validation: The device's software (classified as "MODERATE level of concern") was designed, developed, verified, and validated according to a software development process and FDA guidance.
• Biocompatibility: No biocompatibility testing was performed as the device does not have direct patient contact.

Conclusion: Based on this comparison and compliance with engineering standards, NUGA MEDICAL Co., Ltd. concludes that the N5-1 is substantially equivalent to the predicate device. No clinical studies were deemed necessary or performed for this submission.

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The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.

Here's a breakdown of the acceptance criteria and study information for the Ceragem Automatic Thermal Massager, Model CGM-MB-1101, based on the provided FDA 510(k) summary:

This device does not involve AI/ML technology, so many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable and will be marked as such. The study described is primarily a comparison to a predicate device and adherence to industry standards, rather than clinical performance trials with specific disease outcomes.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are mainly demonstrated through substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" in this context refers to the device's functional specifications being within acceptable limits and similar to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Table of Acceptance Criteria and Reported Device Performance

(See table above)

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

• Sample Size (Test Set): Not applicable in the context of clinical performance data for efficacy. The "test set" here refers to the device itself being tested for compliance with technical standards and compared against its predicate's specifications. No patient outcome data or imaging data is presented to require a test set sample size.
• Data Provenance: The data primarily originates from the manufacturer's engineering specifications, technical testing reports, and a comparison against the previously cleared predicate device (K040031) by the same manufacturer. It is a retrospective analysis of the device's design and technical specifications relative to a predicate, combined with physical testing for safety standards.

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

• Not applicable. This is not an AI/ML device that generates diagnoses or interpretations. "Ground truth" in this context would refer to the established engineering standards and the specifications of the predicate device, which are objectively measurable and defined by regulatory bodies and the manufacturer. Experts involved would be engineers and regulatory specialists, but their role is not to establish a "ground truth" for a diagnostic output.

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

• Not applicable. This pertains to diagnostic outcomes and expert consensus, which does not apply to this type of device submission. The "adjudication" is essentially the FDA's review of the manufacturer's claims of substantial equivalence and compliance with 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 is a non-AI therapeutic device.

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

• Not applicable. This is a non-AI therapeutic device.

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

• The "ground truth" implicitly used is the established safety and performance standards for similar electromechanical thermal massage devices (e.g., UL, IEC, ISO standards) and the specifications and regulatory clearance of the predicate device (K040031). There is no diagnostic "ground truth" involved.

8. The sample size for the training set

• Not applicable. This is a non-AI device; there is no training set.

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

• Not applicable. This is a non-AI device; there is no training set or associated ground truth.

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