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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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