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The Air Compression Leg Massager is used to temporarily relieve mild muscle pains and discomfort, and temporarily increase blood circulation to the treatment areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager 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 with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The models include UM605, UM606, UM607, UM608，UM609，UM610, UM611, UM617. All of them have same Indications for use, technological characteristics and similar device appearance. And they have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences for them are software function, operation method for mode adjustment and the shape of compatible inflatable garment. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of the main body. The main body and the inflatable garment are not detachable. Function buttons and light emitting diode (LED) indicators on the main body make up the user interface. Each inflatable garment is connected to the main body by air hoses and encase a 2-chamber air bladder inside. Calves can be wrapped and massaged separately by the two chambers. The main unit is directly installed on the inflatable garment through tubes and fixing buckles, and there is no need for users to install it again. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. In operation, the user turns the power on via the Power button. Then the main body controls the inflating and deflating of the air bladders according to preset program.

The provided FDA clearance letter for the Air Compression Leg Massager (UM605, UM606, UM607, UM608, UM609, UM610, UM611, UM617) does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Instead, this document is a 510(k) summary for a physical, non-AI medical device (Air Compression Leg Massager). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the Substantial Equivalence (SE) determination based on comparison to a predicate device and compliance with recognized performance and safety standards, rather than an AI model's performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot extract the information required for your specific prompt which is tailored for AI/ML device studies. The information you are seeking (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or present in this type of FDA clearance for a non-AI physical device.

Here's how the provided information relates to a non-AI device clearance:

• Acceptance Criteria & Reported Performance: The "acceptance criteria" for this device are primarily satisfying the safety and performance requirements of the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2) and biocompatibility standards (ISO 10993-5, ISO 10993-10, ISO 10993-23). The "reported device performance" is that the device "conforms" to these guidances and standards, and the manufacturer has demonstrated "substantial equivalence" to a predicate device.

  Acceptance Criteria (from Standards/Predicate Comparison)	Reported Device Performance
  Power Source Safety: Compliance with IEC 60601-1 & IEC 62133-2 for internal rechargeable Lithium Battery	"Battery both of them are complied with the 60601-1 standard." "This difference will not affect the safety and effectiveness." (referring to difference from predicate)
  Physical Parameters (Dimensions, Weight, Appearance) Impact on Safety/Effectiveness	"The physical parameters (dimensions, appearance,) have minor differences with predicate device. They will not affect the safety and effectiveness of the subject device."
  Application Area: Covered by predicate device's application	"The application area of subject device is covered in predicate device. It will not affect the safety and effectiveness of the subject device."
  Timer Settings: Functionality for varied treatment times	"The proposed device just offers three timing settings (15min, 30min, 45min), which are more convenient for patients to use, while the predicate only has one time setting." Implied compliance with safety.
  Working Mode Equivalence: Similarity of compression modes	"The subject device has only one working mode, and it is substantially equivalent to the second working mode 2 of the predicate device."
  Noise Level: No exceedance of acceptable noise limits	"＜55dB" (compared to predicate's ≤ 65 dB). "The acceptance criteria of subject device is included in predicate device. It will not raise any safety and effectiveness issue of the subject device."
  Operating Conditions: Device safely operates within specified environment	"The operating condition and the transportation &storage environment of subject device has passed the safety test, and the Instructions for Use provides the operating condition, so the difference in operating condition between subject device and predicate device will not affect the safety and effectiveness of subject device."
  Electrical Safety & EMC: Compliance with IEC 60601-1, 60601-1-2, 60601-1-11	Explicitly stated: "IEC 60601-1", "IEC 60601-1-2", "IEC 60601-1-11", "IEC 62133-2"
  Biocompatibility: Absence of adverse biological reactions	"The biocompatibility evaluation for the device was conducted in accordance with... ISO 10993-1," including "Cytotoxicity," "Sensitization," "Irritation."
  General Safety and Effectiveness: Non-inferiority to predicate	"The subject device... is substantially equivalent to the predicate device (K222991)."

The requested information points (2-9) are specific to the evaluation of AI/ML models in medical devices. Since this is a traditional, non-AI device, these sections are not applicable and are not present in the provided document.

To reiterate:

• No AI/ML Performance Study Conducted: This clearance is for a physical device, not an AI/ML algorithm.
• No Test Set/Training Set: These concepts are not applicable to the clearance of this type of device.
• No Experts for Ground Truth: Ground truth (e.g., for disease detection) is not established for this device as it does not perform diagnostic or screening functions.
• No MRMC Study: This is a human-use device, but it does not involve human readers interpreting images with or without AI assistance.
• No Standalone Algorithm Performance: The device itself is the product, not an algorithm.
• No Clinical Tests: As stated directly: "No Clinical Test conducted."

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Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.

Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.

Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.

The provided text does not contain detailed information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria. The document is a 510(k) summary for an Air Compression Leg Massager, primarily focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results for the subject device.

The "Performance Data" section (VIII) lists several non-clinical tests performed to support the substantial equivalence determination, but these are primarily related to safety, electromagnetic compatibility, battery safety, and software validation, not the direct clinical performance of improving circulation or relieving aches and pains.

Therefore, many of the requested details cannot be extracted from this document. However, I can summarize what is present:

What is present in the document:

• Non-clinical tests performed: Biocompatibility, Electrical Safety and EMC, Battery Safety, and Software Verification and Validation.
• Result of these tests: They "passed" or "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
• Overall Conclusion: The device is considered "as safe, as effective, and performs as well as the primary predicate device and secondary predicate device" based on this analysis and non-clinical tests.

What is NOT present in the document (and thus cannot be filled in):

• A table of acceptance criteria and reported device performance for clinical effectiveness (e.g., specific metrics for pain relief or circulation increase).
• Sample size used for a performance test set.
• Data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
• Number of experts used or their qualifications for establishing ground truth (as no clinical performance study is detailed).
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used for clinical performance.
• The sample size for the training set (as it's a physical device, not an AI/ML algorithm that requires a training set in the described sense).
• How the ground truth for the training set was established.

Based on the available information, here's a summary of the compliance for the listed non-clinical tests:

Study that proves the device meets the acceptance criteria:

The document states that the substantial equivalence determination is supported by these non-clinical performance data. It does not describe a clinical study measuring the device's efficacy in achieving "temporary relief of minor muscle aches and pains" or "temporary increase in circulation," as the FDA often relies on technological similarity to a predicate device for this type of claim, assuming the predicate's effectiveness. The listed tests are primarily aimed at ensuring the device's safety and fundamental operational integrity as an inflatable tube massager.

Therefore, for the clinical performance claims (pain relief, circulation increase), the "study" is implicitly the demonstration of substantial equivalence to already cleared predicate devices that have established these claims, rather than a de novo clinical trial with specific clinical acceptance criteria for the subject device.

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Air compression Leg Massager is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an "Air compression Leg Massager." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample size for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of a performance study. K240373 refers to a Class II device (Powered Inflatable Tube Massager) which typically undergoes a different type of review process than novel AI/ML-driven diagnostic devices that would require such extensive performance data.

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The air compression leg massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using an inflatable garment.

Not Found

This document is an FDA clearance letter for a medical device called an "Air compression leg massager" (K240981).

Based on the provided text, the document does not contain information about acceptance criteria or supporting studies related to device performance.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the Act. It outlines regulatory requirements, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It also mentions other applicable regulations like the Quality System (QS) regulation.

Therefore, I cannot provide the requested information about acceptance criteria and study details because it is not present in the provided FDA clearance letter.

The letter focuses on the regulatory clearance process, not on the specific performance data or study results of the device.

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Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager (Model: EMK-701) is a portable and rechargeable device. lt is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Handheld Controller. Function buttons and light emitting diode (LED) indicators on the Handheld Controller make up the user interface. There are 3 ports at the bottom of Handheld Controller for connecting the alternating current (AC) adapter plug and two air hoses.

Each leg wrap has an air hose for connection to Handheld Controller, and both encase a 2chamber air bladder inside. Feet and calves can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.

The provided text is a 510(k) summary for the "Air Compression Leg Massager (model: EMK-701)," which is a medical device for temporary relief of muscle aches and improved circulation. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of technical specifications and performance testing. It does not describe a study that involves statistical acceptance criteria, human readers, or a clinical effectiveness study.

Based on the information provided, here's a breakdown of what is and isn't available:

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

The document includes a "Test Summary" section that lists several international standards to which the device was evaluated for its safety and performance. However, it does not provide specific acceptance criteria values (e.g., "Pass/Fail" thresholds) or quantitative reported device performance results against those criteria. It merely states that the device "has been evaluated for its safety and performance by lab bench testing as following:" and then lists the standards.

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

The document explicitly states: "No Clinical Test conducted." Therefore, there is no test set in the sense of patient data for a clinical study. The evaluations conducted were "lab bench testing" which typically refers to laboratory experiments on the device hardware and software, not human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable, as no clinical test was conducted and no "ground truth" based on expert consensus was established for a test set.

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

Not applicable, as no clinical test was conducted and no "ground truth" based on expert consensus was established for a test set.

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

Not applicable. This device is an "Air Compression Leg Massager," not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance in the way an MRMC study would measure.

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

Not applicable, as this is a physical therapy device and not an AI algorithm.

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

Not applicable, as no clinical test involving patient data was conducted. The ground truth for the lab bench tests would be the specifications and requirements defined by the listed international standards themselves (e.g., "EMC emissions must be below X level," "biocompatibility tests must show no cytotoxicity").

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

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

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

In summary:

The provided document is a regulatory submission for a medical device that relies on establishing substantial equivalence to predicate devices through technical comparisons and compliance with recognized safety and performance standards via lab bench testing. It does not involve clinical studies, AI algorithms, human readers, or the typical "acceptance criteria" and "study" framework associated with evaluating software-as-a-medical-device or AI-driven diagnostics. The "study" mentioned for demonstrating compliance refers to the series of lab tests against international standards, rather than a clinical trial with patient data and expert ground truth.

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The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager (Model: LY-670D)

This document is a 510(k) clearance letter from the FDA for a medical device called "Air Compression Leg Massager (Model: LY-670D)". It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided describes the regulatory classification and indications for use of the device. However, it does not contain any details about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies with specific statistical acceptance criteria for novel claims. For devices like this, the "study" demonstrating substantial equivalence likely involved a comparison of design, materials, performance specifications (e.g., pressure, cycle times), and intended use to an already cleared device.

Therefore,Based on the provided document, I cannot answer your request as the information about acceptance criteria and a study proving the device meets these criteria is not present in the FDA 510(k) clearance letter.

The 510(k) process for a device like an Air Compression Leg Massager typically relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria as would be seen for a novel diagnostic AI algorithm, for example.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the "proof" the device meets requirements is its similarity to a legally marketed device that the FDA has already deemed safe and effective for similar indications. The specific details you are asking for (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are typically found in submissions for more complex or novel devices, especially those involving AI/ML components for diagnostic or prognostic purposes, or those undergoing a De Novo classification.

The provided text only covers the regulatory clearance and the device's intended use (temporary relief of minor muscle aches and temporary increase in circulation).

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Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.

The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health. The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following: . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power. The subject device is comprised of the following components: - Control Unit - AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for converting line power to DC power - Connector Air Hose (connects Control Unit to the inflatable air compression boots) - Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.

This document describes the premarket notification (510(k)) for the Air Compression Leg Massager (model: FE-7204B). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for efficacy. The "acceptance criteria" discussed here are related to regulatory compliance and safety/performance standards, not clinical performance metrics.

Here is an analysis based on the provided text, structured according to your request:

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

The document does not specify quantitative "acceptance criteria" in terms of clinical performance (e.g., a specific reduction in muscle aches or circulation increase percentage). Instead, acceptance is implied by adherence to recognized non-clinical standards and the demonstration of substantial equivalence to a predicate device. The "reported device performance" is largely described through its characteristics and comparison to the predicate.

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

The document explicitly states: "Summary for clinical test: Clinical performance is not deemed necessary." Therefore, there was no clinical test set with human subjects used to prove the device meets performance criteria. The "tests" mentioned are non-clinical, conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study requiring expert-established ground truth was performed for this 510(k) submission. The ground truth for the non-clinical tests (e.g., electrical safety, EMC) is derived from the objective standards themselves.

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

Not applicable, as no clinical study requiring adjudication of human subject data was 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 an air compression massager, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). The device's performance against these standards constitutes the "truth" for regulatory compliance in this context.

8. The sample size for the 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

Not applicable.

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Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Air compression leg massager HY-1117A is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center 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. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

The provided document is a 510(k) Pre-market Notification for a medical device called "Air compression leg massager HY-1117A". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study for a novel device. Therefore, the document does not describe:

• Specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy).
• A "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or algorithm performance study.
• Sample sizes for test or training sets for an AI/algorithm.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth for an AI/algorithm.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating that the subject device is similar enough to a predicate device (Air Compression Therapy Device, K193354) by comparing their indications for use, technological characteristics, and conformance to recognized safety standards. The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable", indicating that no such studies were conducted for this submission.

The "acceptance criteria" in this context refer to meeting recognized safety and performance standards for a device of its class, and demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is provided, framed in the context of your request to the extent possible:

1. A table of (implied) acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in a typical quantitative performance metric table. Instead, it compares the subject device's characteristics against those of a predicate device to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it is "substantially equivalent" to the predicate.

Study that proves the device meets the acceptance criteria:

The "study" to demonstrate acceptability in this 510(k) submission is a comparison to a predicate device (K193354) and conformance to recognized consensus standards. The document explicitly states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This means no new clinical trials or animal studies were conducted. The device's safety and effectiveness are supported by its substantial equivalence to the predicate device and demonstration of meeting fundamental electrical safety, electromagnetic compatibility, home healthcare environment requirements, and biocompatibility standards.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical or algorithmic performance test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical massager, not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/algorithm context. The "ground truth" for this submission is that the predicate device is legally marketed and generally considered safe and effective for its intended use, and the subject device shares sufficient characteristics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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