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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 Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.

The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.

The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.

The compression massage direction is from foot room and push up the thighs. 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 leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.

The provided text, a 510(k) Premarket Notification from the FDA, describes an "Air Compression Therapy Device, model: ST-502". This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K193354).

It does not contain information related to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML-driven medical device. The device described is a physical medical device (a powered inflatable tube massager) and the evaluation is for substantial equivalence to a predicate, not performance against specific AI/ML metrics.

Therefore, I cannot provide the requested information about acceptance criteria and a study report as it pertains to an AI/ML device per your prompt, because the provided input does not describe such a device or study.

If the prompt was intended to ask about the non-AI/ML device described in the document, here's what can be inferred about its "acceptance criteria" and "proof" based on the provided FDA submission:

Interpretation for the provided Non-AI/ML Device (Air Compression Therapy Device):

For this type of device, "acceptance criteria" would primarily revolve around demonstrating performance and safety characteristics similar to the predicate device, as well as adherence to recognized consensus standards. The "study that proves the device meets the acceptance criteria" would be the collection of non-clinical tests and comparisons performed.

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

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way an AI/ML study would specify metrics and results. Instead, it demonstrates substantial equivalence by comparing technical characteristics and compliance with standards. The "acceptance" is implied by demonstrating equivalence to a legally marketed device and meeting safety and performance standards.

Here's an inferred table based on the comparisons made:

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

• This is not applicable in the context of an AI/ML test set.
• For this physical device, the "test set" would implicitly refer to the physical units subjected to the non-clinical tests (e.g., electrical safety, EMC, biocompatibility). The document does not specify the number of units tested, which is typical for such submissions where testing is generally done on representative samples.
• Data provenance is not specified, but these are typically lab-based non-clinical tests.

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

• This is not applicable for this device as it's not an AI/ML device requiring expert ground truth for classification/detection.
• The "truth" for this device is based on objective measurements against engineering and safety standards (e.g., measuring pressure output, electrical leakage, electromagnetic emissions, and biological reactions in lab tests).

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

• Not applicable as there is no human-in-the-loop assessment or subjective interpretation being adjudicated. The tests are objective measurements against specified standard limits.

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 therapy device, not an AI/ML diagnostic or assistive tool. No human reader studies were conducted or are relevant.

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

• Not applicable. This is not an algorithm-only device. The core functionality is mechanical (pneumatic compression).

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

• For this device, the "ground truth" for its safety and performance is established through compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct physical/mechanical measurements (e.g., pressure output, timing accuracy, noise level). There is no "pathology" or "outcomes data" ground truth in the sense of a medical diagnostic AI.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.

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

• Not applicable. As there's no training set for an AI/ML model.

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The Air Compression Therapy Device 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 Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device, model HW6007

The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device (model HW6007). This document does not contain information about acceptance criteria, study details, or device performance metrics.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines regulatory requirements the manufacturer must comply with (registration, labeling, good manufacturing practices, etc.).
• Specifies the indications for use of the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on this document. These details are typically found in the 510(k) summary or the full submission, which are not included here.

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The Air Compression Therapy Device are 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 Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device. It confirms substantial equivalence to a predicate device and states the indications for use. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria for device performance, the study that proves it meets those criteria, or the methodology of such a study.

The letter focuses on regulatory clearance based on substantial equivalence, and while it references labeling and good manufacturing practices, it doesn't describe the clinical or performance studies you're asking about. Such information would typically be found in the manufacturer's 510(k) submission summary or other technical documentation, not in the FDA's clearance letter itself.

Therefore, I cannot provide the requested information from the given input.

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

Air Compression Therapy Device 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 3 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 reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

This document is a 510(k) premarket notification for an "Air Compression Therapy Device," which is a powered inflatable tube massager. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, focusing on non-clinical testing. This document does NOT describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, I cannot provide a response that directly addresses the prompt's request for information on acceptance criteria and study proving an AI device's performance, including details like:

• Sample size for the test set and data provenance: The document mentions "non-clinical tests" and "safety and performance tests" but does not detail a test set of patient data.
• Number of experts and qualifications for ground truth: Not applicable for non-clinical device testing.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Explicitly stated "No clinical test data was used to support the decision of substantial equivalence."
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable for non-clinical testing.
• Sample size for the training set: Not applicable as there is no AI/ML component.
• How ground truth for the training set was established: Not applicable.

However, I can extract the acceptance criteria and performance related to the mechanical and electrical safety and manufacturing aspects of this non-AI medical device based on the provided text.

Acceptance Criteria and Device Performance for Shenzhen Dongjilian Electronics Co., Ltd.'s Air Compression Therapy Device (K193354)

The provided submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety, performance, and adherence to recognized standards. It does not present clinical study data or involve AI/Machine Learning technologies for diagnostic or prognostic purposes, nor does it involve human readers or ground truth established by expert consensus on clinical cases.

The "acceptance criteria" in this context refer to the device conforming to safety and performance standards for its type.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of patient data or clinical cases because no clinical testing was performed. The tests conducted were non-clinical, focusing on the device's physical, electrical, software, and material properties. The data provenance is implied to be from Shenzhen Dongjilian Electronics Co., Ltd.'s internal testing, as it's part of their 510(k) submission. No information on country of origin of patient data (retrospective or prospective) is applicable.

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

Not applicable. Ground truth, in the context of this submission, refers to the device's conformance to recognized engineering and safety standards, not clinical diagnostic accuracy based on expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no information on human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical air compression therapy device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is its conformance to established international and national consensus standards for medical device safety, electromagnetic compatibility, usability, software, biocompatibility, and risk management, along with internal enterprise standards for performance. This is not a clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases).

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a "training set."

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

Not applicable, as there is no AI/ML model or training set.

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Compression Therapy Device (Model: LGT-2201DVT) is intended to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients.

LGT-2201DVT is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

Compression Therapy Device LGT-2201DVT a compression therapy device comprised of intermittent pneumatic controller, sleeves and connectable hose. 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. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly.

The provided documentation is a 510(k) premarket notification for a medical device called the "Compression Therapy Device (Model: LGT-2201DVT)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a study involving AI.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The information provided is primarily related to:

• Regulatory clearance: FDA's notification of substantial equivalence.
• Device identification: Trade name, regulation number, product code, etc.
• Intended use/indications for use.
• Comparison to a predicate device: Highlighting similarities and minor differences in specifications (size, weight, input power, battery, pressure range) and noting that these differences do not affect safety or effectiveness.
• Compliance with general safety and performance standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62133-2.

In summary, none of the requested information regarding acceptance criteria, study design for proving device performance (especially in the context of AI), sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is present in this document. This device is a physical, non-AI medical device, and its clearance process relied on demonstrating equivalence to an existing device through bench testing and standard compliance, not a clinical performance study with AI.

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Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm/ Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.

The provided text is a 510(k) Summary for the Compression Therapy Device Model LGT-2200SP. It asserts substantial equivalence to predicate devices and focuses on technical specifications and adherence to safety standards.

Here's an analysis of the provided text in relation to your request:

The document does not include detailed acceptance criteria or a study that rigorously proves the device meets those criteria in a clinical performance context. Instead, it focuses on demonstrating safety and effectiveness through compliance with recognized standards and comparison to predicate devices.

Let's break down your specific points based on the available information:

1. A table of acceptance criteria and the reported device performance:
   The document doesn't provide a typical "acceptance criteria" table for device performance in a clinical sense (e.g., accuracy, sensitivity, specificity). Instead, it compares the subject device's technical specifications and features to predicate devices, and asserts that differences do not raise new questions of safety or effectiveness.

   Here's a table summarizing the comparison of the device's technical specifications and features to the predicate devices, which act as a form of "acceptance" by demonstrating substantial equivalence:

   Elements of Comparison	Subject Device (LGT-2200SP)	Predicate Device (Primary: NormaTec Pulse/Pro)	Predicate Device (II: Rapid Reboot System)	Predicate Device (III: Senyang Pt 1002)	Verdict (Equivalence Claim)
   Classification Name	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Substantially Equivalent (SE)
   Regulation Class	2	2	2	2	SE
   Regulation Number	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	SE
   OTC & Rx	OTC	OTC	OTC	Rx	Minor different (Noted in Remarks below)
   Indications for Use	Temporary relief of minor muscle aches and pains, temporary increase in circulation. Simulates kneading/stroking.	Temporary relief of minor muscle aches/pains, temporary increase in circulation.	Temporary relief of minor muscle aches/pains, temporary increase in circulation in healthy people. Simulates kneading/stroking.	Treating primary lymphedema, edema, venous insufficiencies, lymphedema (Rx use).	Minor different (Noted in Remarks below)
   Power Source	AC100-240V, Battery 11.1V, 6500mAh	12 VDC via IEC 60601-1 PSU, Optional rechargeable battery	110 V, 60Hz	110 V, 60Hz	Minor different (Noted in Remarks below)
   Power Consumption	90VA	14W	30W	30W	Minor different (Noted in Remarks below)
   Dimensions (WHD)	270148129mm	4"*5" *9"	10" x 6.5" x 5"	260170130mm	Minor different (Noted in Remarks below)
   Weight	2.0 Kg (4.4 pounds)	3.6 pounds	5.8 pounds	5.8 pounds	Minor different (Noted in Remarks below)
   Housing Materials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	SE
   Number of Chambers	4-chamber	5 or less	4 Chambers	4 Chambers	SE
   Sleeve Materials	Polyether Nylon Fabric	200 denier nylon with polyurethane laminate/extrusion	Nylon with a Polyurethane laminate	Thermoplastic Urethane	Minor different (Noted in Remarks below)
   Mode of Compression	Sequential	Sequential	Sequential	Sequential	SE
   Device Pressure Range	30-150mmHg	30-110 mmHg	0-200 mmHg	0-250mmHg	Minor different (Noted in Remarks below)
   Treatment Time	1min-99min, default 30min, step of 5min	Stays on until user turns off or 10mins to continuous	10, 20, or 30 minute, with option to add 10 minutes	0 - 30mins	Minor different (Noted in Remarks below)
   Work Mode	6 modes (SEQUENTIAL, SQUEEZE, FLUSH, FLOW, RELEASE, WAVE)	Sequential, Zone pulses (2 modes)	Model A, Model B (2 modes)	Model A, Model B (2 modes)	Minor different (Noted in Remarks below)
   Patient Contact	Non-conductive appliances	Non-conductive appliances	(Image of Predicate II)	(Image of Predicate III)	SE
   Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	SE
   Technology	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	SE
   FDA-Recognized Standards	ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, ISO 10993-5, ISO 10993-10	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1:2014, IEC 60601-1-2:2014, EN ISO 10993-5:2009, EN ISO 10993-10:2010	IEC 60601-1, IEC 60601-1-2, ISO10993-5, ISO10993-10	Minor different (Noted in Remarks below)

   Remarks on "Minor different" Verdicts:

   • Indications for Use: The document states, "Although there is a little difference about the indication for use, the meanings are the same. This difference does not affect the safety and effectiveness." (Note 1)
   • Power Source, Consumption, Dimensions, Weight: "Although the subject device design and specification parameter between the predicate are different, they are both complied with ANSI/AAMI ES60601-1. So the minor differences on such parameters do not affect the safety and effectiveness." (Note 2)
   • Sleeve Materials, Sleeves (dimensions/types): "Although the device provides four kind sleeves which have minor difference about size and appearance, the sleeve chamber number are the same and the applicable body areas are included in the predicate... the biocompatibility of sleeves is also complied with ISO 1099-5 and ISO 10993-10. Therefore, the difference would not raise adversely impact on safety and effectiveness." (Note 3)
   • Device Pressure Range: "Although the pressure range of subject devices, the range is smaller and contained by the predicate device (1), so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 4). (There seems to be an error in the text where it ambiguously says "range is smaller and contained by the predicate device (1)" when for PD(II) and PD(III) the subject device's range is within a larger range.)
   • Treatment Time: "Although the treatment time range of subject device is to 99mins, which seems to be longer than the predicated with is suitable for daily use. And the treatment time is optionally set by user with 5mins step, which is more exact to the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 5). (There seems to be an error in the text where it mentions "difference of pressure range" instead of treatment time range).
   • Work Mode: "Although the subject device provides six kinds of work mode, the SEQUENTIAL and FLUSH mode are the same with the other work modes of subject device just have different about the different chambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 6).
   • FDA-Recognized Standards: "The subject device references more sufficient safety standards than the 'safety of the safety' of the device is verified via tests." (Note 7 - this implies the subject device meets or exceeds the standards referenced by predicates, further supporting SE).

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: "Clinical performance is not deemed necessary." (Section 7. Summary for clinical test). Therefore, there is no test set, sample size, or data provenance regarding clinical performance. The evaluation was based on bench testing and comparison to predicates.

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):
   As no clinical test set was used, there were no experts establishing ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As no clinical test set was used, there was no adjudication method.

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:
   This device is a physical therapy device (compression therapy device), not an AI imaging or diagnostic algorithm. Thus, an MRMC study and AI assistance effectiveness are not applicable and were not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This is a physical therapy device. The concept of "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   As no clinical studies were performed, there was no clinical ground truth established (such as expert consensus, pathology, or outcomes data). The "ground truth" for demonstrating substantial equivalence was adherence to recognized safety standards and functional comparison to legally marketed predicate devices.

8. The sample size for the training set:
   As no machine learning or AI component is mentioned, there is no training set, and therefore no associated sample size.

9. How the ground truth for the training set was established:
   As there is no training set for an AI/ML model, this question is not applicable.

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Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.

The Model 601 Compression Therapy Device utilizes a software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model 601 device, each garment contains up to 4 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.

This 510(k) submission for the Mego Afek PHLEBOPRESS DVT MODEL 601A Compressible Limb Sleeve Device does not contain the kind of detailed information typically found in a study proving a device meets specific acceptance criteria that usually involves rigorous performance metrics and statistical analysis.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. It relies on a comparison of features, intended use, and existing safety and performance standards.

Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not provided in the given text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. This document refers to "various performance tests and software validation tests," but does not provide details on the number of subjects or test units involved.
• Data Provenance: Not specified. The testing was conducted by Mego Afek Ltd. in Israel, but no details about the origin of any clinical data (if collected) are provided. It appears to be product validation testing, not a clinical study involving human patients to prove efficacy against acceptance criteria.

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

• Not Applicable. The document describes device-level performance and software validation tests, not a clinical study requiring expert-established ground truth for disease detection or diagnosis.

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no clinical test set with human data requiring expert review for ground truth, no adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• Not Applicable. This device is a physical compression therapy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device. While it has software controls, the "standalone performance" concept as applied to AI algorithms is not relevant here. The device's performance is inherently "standalone" in that it operates independently of human interpretation of its outputs for diagnosis.

7. The Type of Ground Truth Used:

• For the described "performance tests and software validation tests," the "ground truth" would be the engineering specifications and design requirements of the device (e.g., target pressure levels, cycle times, software logic correctness). There is no "ground truth" in the sense of clinical outcomes or disease states for a diagnostic AI.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The software validation tests ensure its programmed functions work correctly, not that it "learns" from data.

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

• Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary of the Study/Evidence Provided:

The provided document describes a technical validation and substantial equivalence argument, rather than a clinical study with detailed performance metrics against specific acceptance criteria.

The "study" cited is:

• "extensive safety, performance testing, and validation before release."
• "various performance tests and software validation tests, designed to ensure that the device met all its functional specifications."
• Tests were performed to ensure compliance with "industry and safety standards."

The conclusions drawn are based on:

• This internal performance testing.
• A direct comparison of its features, intended use, and operating parameters (inflation/deflation pressures and sequences, operating modes) to currently legally marketed predicate devices (Mego Afek's PhleboPress Model 701A, Huntleigh Healthcare's Flowtron Excel Model AC550, and Flowtron Universal Model AC600).

The approval is based on the FDA's finding of substantial equivalence to these predicate devices in terms of safety and efficacy. Specific quantitative acceptance criteria or clinical outcome data from trials are not detailed in this 510(k) summary.

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Treatment of Venous disorders and Dysfunction of the "Muscle Pump"

PBS (Petit Basic System) Model 701 A Compression Therapy Device

This document does not contain the information required to answer your request. It is a 510(k) premarket notification letter from the FDA to Mego Afek Ltd. regarding their PBS Model 701A Compression Therapy Device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details of any study (sample sizes, data provenance, ground truth establishment, expert information, adjudication methods) used to prove the device meets acceptance criteria.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document primarily states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby permitting the device to proceed to market. It outlines regulatory requirements that the manufacturer must comply with.

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