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Compression Therapy Device (Model: LGT‐2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post‐mastectomy lymphedema).

Compression Therapy Device (Model: LGT‐2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT‐2210DS) is designed to be used in patients over 22 years old.

The LGT‐2210DS is a compression therapy device comprised of an intermittent pneumatic controller, sleeves with 6‐chamber, 4‐chamber combined and connectable hoses. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body, squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation.

The provided FDA 510(k) clearance letter is for a Compression Therapy Device (LGT-2210DS). This device is a physical therapy device and not an AI/ML medical device. Therefore, the document does not contain the information required to answer questions related to AI/ML device testing, such as acceptance criteria, performance metrics (sensitivity, specificity, AUROC), sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, or training set details.

The document primarily focuses on establishing substantial equivalence to a predicate device (Compressible Limb Therapy System MK300L) based on:

• Intended Use: Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema).
• Technological Characteristics: Intermittent pneumatic compression, compressor and valve system, sequential inflation.
• Safety and Performance Bench Testing: Service life, reliability, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), software V&V (specifically cybersecurity as the main software aspect noted), and biocompatibility (ISO 10993 series).

No AI/ML components are mentioned or implied in this 510(k) submission. The "Software Verification and Validation Testing" section explicitly states: "There is no wireless connection, Bluetooth, internet connection in the device, and Power socket is only for battery charging connection. The client information can be exported by entered Password with USB flash drive. Testing related to Cybersecurity was performed." This confirms the software involved is minimal and not AI-driven.

Therefore, I cannot provide a response to the prompt's specific requirements, as the provided document does not contain information about an AI/ML medical device.

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The device is intended 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 Pressure Therapy System is a powered inflatable tube massager. The device simulates manual kneading and stroking of tissues by sequential inflated cuffs, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It consists of a main unit, a 4-chamber leg cuff, and an air hose for connecting the unit to the cuff. Only one leg is treated during the treatment process. The cuff inflates and deflates sequentially to apply the pressure on the leg which is controlled by the main unit. Each cuff is equipped with a dedicated air hose. It is to be used by adults.

The FDA 510(k) clearance letter for the Intermittent Pressure Compression System (K242615) does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance (e.g., how effectively it relieves muscle aches or increases circulation). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (K243320) by meeting recognized safety and performance standards relevant to medical devices of its type.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical characteristics to those of the predicate device and highlights regulatory compliance. The acceptance criteria for clearance are primarily based on demonstrating that the subject device is as safe and effective as the predicate device by meeting recognized safety standards and showing that differences in technical characteristics do not raise new safety or efficacy concerns.

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

The document states, "testing was performed and results demonstrated that the Intermittent Pressure Compression System is as safe and effective as the predicate device." However, it does not specify any clinical test set sample size, data provenance, or details of a clinical study to prove efficacy in humans. The testing mentioned refers to compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series), not clinical trials.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. The clearance is based on substantial equivalence to a predicate device and compliance with device safety standards, not on a clinical ground truth established by experts for performance assessment in humans.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a clinical test set or an adjudication method for human performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is more common for diagnostic imaging devices involving human interpretation. The provided document concerns an intermittent pressure compression system, which is a therapeutic device, and does not mention any MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent in its mechanical and electrical operation, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is primarily established by:

• Substantial Equivalence: Comparison to a legally marketed predicate device (K243320) with known safety and efficacy.
• Compliance with Recognized Standards: Meeting international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). These standards serve as the "ground truth" for basic safety and essential performance.

There is no mention of clinical outcomes data, pathology, or expert consensus specific to the subject device's clinical efficacy in the provided document.

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. As above, this is not an AI/ML device.

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The Heat Exchange Equipment for Cryotherapy and Thermotherapy provides a combination of cold, heat, contrast, and compression therapies.

It is intended to treat post-surgical and trauma injuries to reduce edema, swelling and pain, for which cold and compression are indicated.

It is intended to treat post traumatic and post-surgical medical and/or surgical conditions, for which localized thermal therapy (hot or cold or contrast) are indicated.

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

The Heat Exchange Equipment for Cryotherapy and Thermotherapy (Z-ONE, ZT Cube and ZT Clinic) are AC-powered, software-controlled multi-modality devices, designed to impart localized heat exchange and compression therapies. The devices have been developed with the possibility of choosing between different programs: cold therapy, heat therapy and contrast therapy (alternating hot and cold). Moreover, they also possess an intermittent pneumatic compression activity, which is the effect of an alternance of compression and decompression. The compression activity is available in four different levels: minimum (15 mmHg), low-medium (40 mmHg), medium (60 mmHg) and maximum (80 mmHg). It is also possible for the professional user to select the duration of the pulsed compression. With heat treatment, only a low compression level, i.e. 15 mmHg can be selected.

The device allows for a maximum treatment time of 30 minutes for heat therapy, 90 minutes for cold therapy, and 90 minutes for contrast therapy.

The devices are designed to be compatible with a series of Thermal Wraps, that are available for different parts of the body: full leg, shoulder, thigh, knee, calf, elbow, wrist, ankle and hip.

The devices are designed to be used in rehabilitation facilities, outpatient clinics, and athletic training settings, by, or on the order of, licensed health care professionals.

The Heat Exchange Equipment for Cryotherapy and Thermotherapy is available in 3 different models:

• Z-ONE: portable unit with a comfortable handle for moving. This model is developed to deliver only cold therapy, with a temperature range between 41°F and 59°F (5°C - 15°C) and it allows the connection of up to two wraps at the same time and therefore the possibility to treat more patients using the same program simultaneously.

• ZT Cube: portable unit with a comfortable handle for moving. This model allows the delivery of cold therapy, heat therapy and contrast therapy (alternating hot and cold), with a temperature range of 34°F as minimum and 104°F as maximum (1°C - 40°C). Up to two wraps can be connected at the same time.

• ZT Clinic: unit designed and built for the complex needs of clinics and hospitals, as it can suit up to 4 thermal wraps simultaneously. This model can be used to deliver cold therapy, heat therapy and contrast therapy, alternating hot and cold. Temperature range is 34°F as minimum and 113°F as maximum (1°C - 45°C).

The devices are controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.

The provided text is an FDA 510(k) clearance letter for a medical device. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to a diagnostic algorithm's performance.

The document describes "performance bench tests" for the heat exchange equipment (temperature and pressure accuracy, wrap seam strength, leakage) and "skin temperature tests on healthy volunteers" and "durability tests of thermal wraps." These are engineering and safety performance tests for the physical device, not a study evaluating a diagnostic algorithm's accuracy against clinical ground truth.

Therefore, many of the requested fields related to a diagnostic study (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type, training set details) cannot be extracted from this document.

Below is a table summarizing the relevant information that can be extracted, along with an explanation for the missing information.

Acceptance Criteria and Device Performance Study for ZAMAR Medical Heat Exchange Equipment

As per the provided FDA 510(k) Clearance Letter (K242754), the device in question is a ZAMAR Medical heat exchange equipment for cryotherapy and thermotherapy, not an AI/diagnostic algorithm. Therefore, the acceptance criteria and study detailed in the document are related to the physical and functional performance of this therapeutic device, not the diagnostic performance of a software or AI.

The document does not describe a study that involves clinical outcomes or a diagnostic algorithm's performance. Instead, it describes engineering and safety verification tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size:
  • For "skin temperature tests": "healthy volunteers who provided informed consents" (specific number not provided).
  • For "durability of the thermal wraps": Tested over "200 repeated application cycles."
  • For other performance tests (temperature accuracy, pressure accuracy, wrap seam strength): Not specified, typically done on a representative sample of devices/components during manufacturing/design verification.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are engineering/bench tests and volunteer-based safety tests, not large-scale clinical data collection.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This document describes tests for a therapeutic device's physical performance and safety, not a diagnostic algorithm requiring expert-established ground truth for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable: As no diagnostic algorithm's performance is being evaluated against a ground truth, there is no need for an adjudication method for a test set in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. Since the device is a therapeutic heat exchange unit, an MRMC study was not performed or described.

6. Standalone Performance Study (Algorithm Only)

• No: The device is not a standalone diagnostic algorithm. The performance evaluation presented is for the physical medical device itself.

7. Type of Ground Truth Used

• Engineering/Performance Specifications and Safety Limits: For temperature, pressure, durability, and leakage, the "ground truth" is adherence to pre-defined engineering specifications and safety thresholds.
• Physiological Response (Safety): For skin temperature tests, "ground truth" would be the observed skin temperatures remaining within safe physiological limits.
• Not Clinical Ground Truth for Diagnosis: No clinical diagnosis or pathology reports were used as ground truth, as this is not a diagnostic device.

8. Sample Size for the Training Set

• Not Applicable: This device is a physical therapeutic unit, not an AI/machine learning algorithm that requires a training set.

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

• Not Applicable: As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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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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The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The Air compression massager is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for: Starting and stopping the massage treatment; Adjusting treatment related parameters such as treatment time and pressure level etc.; Selection of the chamber to boost the pressure. In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience. The product is provided non-sterile, and not to be sterilized by the user prior to use. All models in this submission are the same except for the color of controller and button shape.

The provided text describes a 510(k) premarket notification for an "Air compression massager." This document demonstrates the substantial equivalence of the new device to existing predicate devices, rather than proving that the device meets acceptance criteria through a specific study with clearly defined performance metrics, ground truth, and statistical analysis typically found for diagnostic or screening devices.

The document states: "No clinical test data was used to support the decision of substantial equivalence." This means there was no clinical study conducted to prove the device meets specific acceptance criteria related to its performance in a clinical setting (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).

Instead, the acceptance criteria and study described here are focused on non-clinical safety and performance aspects to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an attempt to extract and describe the information requested based on the provided text, acknowledging the limitations due to the device type and the nature of the 510(k) submission:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a massager and not a diagnostic device, the "acceptance criteria" and "performance" are framed around compliance with recognized safety and performance standards rather than typical diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

1. Table of Acceptance Criteria and Reported Device Performance

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

For this type of device and submission, the "test set" refers to the specific physical units or components of the device that underwent the non-clinical tests. The text does not specify the exact number of units tested.

• Sample Size: Not explicitly stated as a number of tested units beyond "a series of safety and performance tests were conducted on the subject device."
• Data Provenance: The document is a submission from "Sichuan Qianli-beoka Medical Technology Inc." in China. The testing would have been conducted by or for this manufacturer. The nature of these tests is laboratory-based, non-clinical. It is not retrospective or prospective in the sense of a patient-based clinical study.

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

• Number of Experts: Not applicable. For non-clinical performance and safety testing against engineering standards, "ground truth" is established by the specifications of the standards themselves and the measurement protocols. There are no human experts classifying outcomes in a test set as would be the case for an AI diagnostic device.
• Qualifications of Experts: Not applicable in the context of diagnostic interpretation. The testing would be conducted by qualified engineers and technicians at certified labs.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As non-clinical engineering and safety tests, outcomes are determined directly by measurement against defined thresholds in the standards, not by human or consensus adjudication of interpretations.

5. MRMC Comparative Effectiveness Study

• MRMC Study: No. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study is used for diagnostic devices to evaluate the impact of AI on human reader performance, which is not relevant for an air compression massager.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: Not applicable. This device is not an AI diagnostic algorithm; it is a physical medical device (massager). Its "performance" is measured by its mechanical and electrical characteristics meeting specified standards.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., IEC 60601-1, ISO 10993-1). This is essentially engineering and regulatory compliance, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is for a physical medical device, not an AI model that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, there is no ground truth to establish in this context.

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The Game Ready system is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulate kneading and stroking of tissues using an inflatable wrap. The Game Ready system is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, Large, Right (590432-04); Game Ready Shoulder Wrap, Medium, Left (590424-04); Game Ready Shoulder Wrap, Large, Left (590434-04); Game Ready Hip/Groin Wrap, Right (590602-04); Game Ready Hip/Groin Wrap, Left (590604-04); Game Ready Straight Knee Wrap (590100-04); Game Articulated Knee Wrap (590160-04); Game Ready Ankle Wrap, Large (590330-04); Game Ready Ankle Wrap, Extra Large (590340-04)

The provided text is an FDA 510(k) clearance letter for the Game Ready System, a powered inflatable tube massager. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines regulatory requirements for the manufacturer but does not include details on performance assessment studies or acceptance criteria that would typically be found in a clinical or validation study report.

Therefore, I cannot extract the requested information from the provided input.

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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Air Pressure Therapy System."

This document does not contain any information about:

• Acceptance criteria
• Device performance results
• Details of a study (e.g., sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by so doing, aids in the stimulation of blood flow in the legs.

The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.

The ElastiMed SACS PRO is a lightweight, portable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression.

The SACS PRO device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in Clinics, hospital, athlete training, and home environments.

The provided text is a 510(k) Premarket Notification for the SACS PRO device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria for software or algorithm performance. The "Performance Data" section addresses non-clinical validation of physical and electrical safety, software validation, and durability, but does not include a study design or results demonstrating the stated indications for use (e.g., temporary relief of minor muscle aches, temporary increase in circulation).

Therefore, I cannot extract specific information regarding acceptance criteria, test set sample sizes, expert ground truth establishment, or human reader effectiveness from this document as it is not a study report for the device's therapeutic efficacy or an AI/ML algorithm's diagnostic performance.

However, I can extract information related to the software validation process described in the document, which implicitly means the software met its specified requirements.

Here's a breakdown of what can be extracted and what cannot:

Information Present in the Document:

• Software Validation: "Software validation was conducted per FDA's Content of Premarket Submissions for Device Software Functions (June 14, 2023) and ANSI AAMI IEC 62304:2006/A1:2016 [Including Amendment 1 (2016)]."
• Device Performance Attributes (General Statement): "...have shown that the SACS PRO device has performance characteristics consistent with the predefined requirements for the devices' intended and indications for use."
• Data Provenance (Implied): The non-clinical testing was conducted for the secondary predicate device (ElastiMed SACS, K232300), which is "entirely identical in design and physical form" to the subject device (SACS PRO). The document states, "all performance data as provided for the approval of the secondary predicate device are applicable for the subject device." This suggests the data is from prior validation, likely retrospective in relation to this 510(k) submission for the SACS PRO. The country of origin of the data is not specified, but the applicant (ElastiMed Ltd.) is based in Israel.
• Sample Size for Training Set: Not applicable/not provided. This device is not described as having a machine learning component that would require a "training set" in the typical sense of AI/ML. The "software validation" refers to traditional software engineering validation, not AI model training.
• How Ground Truth for Training Set was Established: Not applicable/not provided for the same reason as above.
• Type of Ground Truth Used: Not applicable/not provided related to human physiology or clinical outcomes. The "ground truth" for the software validation would be its adherence to specified functional and safety requirements, tested against the design specifications.

Information NOT Present in the Document:

• A table of specific "acceptance criteria" and "reported device performance" for its therapeutic indications. The table provided is for "Testing" (types of tests conducted), not performance metrics for muscle ache relief or circulation increase.
• Specific "sample sizes" for a clinical or performance test set related to the device's therapeutic efficacy. The non-clinical tests mentioned (electrical safety, EMC, mechanical, functional, durability) would have their own sample sizes (e.g., number of devices tested), but these are not detailed in this summary.
• "Number of experts used to establish the ground truth" or their qualifications. This would be relevant for devices that rely on expert interpretation (e.g., imaging devices), which this is not.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human readers improved with AI assistance. This is not an AI-assisted diagnostic or therapeutic device.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data) for clinical efficacy.

Given the nature of the device (Powered Inflatable Tube Massager) and the document provided, the "acceptance criteria" and "study" are focused on safety and functional performance as a medical device, rather than the performance of an AI/ML algorithm or a comparative clinical efficacy study.

Here's the closest one can get to answering your request based only on the provided text, focusing on the software validation aspect.

Device: SACS PRO (Powered Inflatable Tube Massager)

Study Details (as inferable from the document):

1. Sample Size used for the test set and the data provenance:
   • Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of units for electrical safety, durability, mechanical).
   • Data Provenance: The data is retrospective relative to this specific 510(k) submission for the SACS PRO, as it was conducted for the "identical secondary predicate device" (ElastiMed SACS, K232300). The country of origin of the data is not specified, but the manufacturer is based in Israel.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of device and the validation described do not typically involve human experts establishing "ground truth" for performance. Ground truth for safety and performance testing would refer to engineering specifications and regulatory standards.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an imaging device or an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "software validation" performed is essentially a standalone (algorithm/software only) validation against its requirements and relevant standards.
6. The type of ground truth used: For software and non-clinical performance, the ground truth is defined by:
   • Compliance with specific engineering design specifications of the device.
   • Compliance with international and national standards (e.g., IEC 60601-1-2, ES60601-1, IEC 62304) and FDA guidance documents.
   • Predefined pass/fail criteria based on the device's functions, indications, and essential performance.
7. The sample size for the training set: Not applicable. This device's software is validated through traditional software engineering methods, not by training a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Leg Massager (Models:RP-ALM070H, RP-ALM071H) 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.

Leg Massager (Models:RP-ALM070H, RP-ALM071H) 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.

Leg Massager (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

Here's an analysis of the provided FDA 510(k) summary, specifically addressing acceptance criteria and study information related to the device.

Key Observation: The document describes a traditional medical device (Leg Massager) and an application for substantial equivalence based on a comparison to predicate devices, not an AI/ML-powered device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence through technical specifications, indications for use, and adherence to recognized standards, rather than clinical performance based on AI/ML algorithms.

Acceptance Criteria and Device Performance (Not Applicable - Traditional Device)

Since this is a traditional medical device submission for a Leg Massager (Models: RP-ALM070H, RP-ALM071H) and not an AI/ML-powered device, the concept of "acceptance criteria" and "reported device performance" in the context of an algorithm's diagnostic accuracy is not directly applicable.

Instead, the submission demonstrates substantial equivalence by showing that the device meets the same indications for use and has similar technological characteristics to existing legally marketed predicate devices, and that it complies with recognized safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Summary of Study:

The study presented in this 510(k) submission is a comparison study to demonstrate substantial equivalence to legally marketed predicate devices. It is not a clinical trial evaluating the device's efficacy or an AI/ML performance study. The "study" involves a detailed comparison of the subject device's (Leg Massager Models: RP-ALM070H, RP-ALM071H) indications for use, technological characteristics, safety features, performance specifications, and adherence to recognized electrical and biocompatibility standards against two predicate devices:

1. Shenzhen Dongjilian Electronics Co., Ltd. - Air Compression Therapy Device (K193354)
2. Medella Health Limited - FLOWpresso (K223729)

The core methodology is a side-by-side comparison table (Table 6A and 6B) detailing each characteristic and providing a "Differences Discussion" to justify why any minor differences do not raise new questions of safety or effectiveness.

Detailed breakdown of requested information:

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

• Not applicable. This is not an AI/ML performance study with a test set of data. The submission relies on a comparison of technical specifications and adherence to standards.

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. Ground truth establishment by experts is relevant for diagnostic accuracy studies, typically involving AI/ML. This submission is for a physical medical device.

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

• Not applicable. No test set or expert adjudication is involved in this type of 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

• Not applicable. This is a physical device, not an AI/ML-powered diagnostic aid involving human readers.

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

• Not applicable. There is no algorithm for standalone performance in this device.

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

• Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their FDA clearance and compliance with recognized consensus standards (e.g., IEC 60601-1, ISO 10993).

8. The sample size for the training set

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

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

• Not applicable. As no training set is used, no ground truth for it was established.

Conclusion from the document:
The FDA's decision to clear the device (K232965) indicates that based on the provided comparison and adherence to standards, the Leg Massager (Models: RP-ALM070H, RP-ALM071H) is considered substantially equivalent to the predicate devices and is deemed as safe, effective, and performs as well. The acceptance is based on alignment of functional characteristics, intended use, and compliance with general safety and performance standards.

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