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LF900 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, venous insufficiencies, Lymphedema.

This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

The provided FDA 510(k) clearance letter and summary for the LF900 Powered Inflatable Tube Massager does not describe a study that proves the device meets acceptance criteria in the way typically expected for AI/ML or diagnostic devices. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.

Here's an breakdown based on your requested information, highlighting what is and is not present in the document:

Acceptance Criteria and Study for LF900 Powered Inflatable Tube Massager

This submission is for a Powered Inflatable Tube Massager, not an AI/ML or diagnostic device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a previously cleared predicate device, primarily through non-clinical performance and safety testing, rather than a clinical effectiveness study with ground truth establishment in the context of diagnostic accuracy.

The key change in the LF900 (K231437) from a previous version (K203019) is a change in maximum pressure from 180mmHg to 140mmHg and the addition of a sleeve type. The sponsor asserts equivalence to the LF400 (K150033), which also has a maximum pressure of 140mmHg.

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

Since this is not a diagnostic device, the acceptance criteria are not presented in terms of diagnostic metrics (e.g., sensitivity, specificity). Instead, they are related to safety, electromagnetic compatibility, and basic product performance after the pressure change.

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

• Sample Size: Not applicable. The "test set" for this device consists of non-clinical retests and gap tests of the device itself, not patient data.
• Data Provenance: The tests conducted are in-house tests ("Inhouse test] Product Performance Test report, RND-R-PRR-103-02(2022.06.13)"). This indicates the testing was performed by the manufacturer. Specific country of origin for the testing is not detailed beyond the manufacturer's location (Republic of Korea).

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

Not applicable. This device is not an AI/ML or diagnostic device requiring expert interpretation for ground truth. Its performance is assessed through objective engineering and safety standards.

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

Not applicable. Adjudication methods are used for subjective interpretations in diagnostic studies, which is not relevant here. Compliance with safety and performance standards is objective.

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 intermittent pneumatic compression system and does not involve AI or human "readers."

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

Not applicable. This device does not contain an algorithm in the sense of AI/ML. Its performance is assessed as a standalone electromechanical device. Clinical testing was not required to demonstrate substantial equivalence.

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

Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance would be the objective measurements obtained during electrical safety, electromagnetic compatibility, and product performance testing against specified engineering limits and standards.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set for this device.

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SP-1000/2000 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.

Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers which are sequentially inflated from the first air chamber to the fourth chamber. SP-1000 can adjust the pressure values of all chambers at once. The SP-2000 can adjust the pressure value for each channel. This device is composed of a power supply, a pump, a control unit, and a wearable unit. The power applied from the power supply is applied to the pump. And user can adjust the time through time control knob, during which time power is supplied to the air pump. When the set time is over, the pump will stop working. Air pump creates air pressure and transmits it to the Synchro motor. The air delivered to the synchro motor distributes the air to each channel of the sleeve. And there is a pressure control valve between the synchro motor, the user can adjust the pressure of each sleeve through the pressure control knob. The sleeve prevents blood from accumulating by repeatedly applying inflation/deflation to the wearing to the type of the sleeve, it can apply to the leg, lower body, and arm.

The provided text is a 510(k) Summary for the SP-1000 and SP-2000 devices. It states that clinical testing was NOT required to demonstrate substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria, as per the typical structure of an FDA clearance for AI/ML or diagnostic devices that require clinical validation, was not performed.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use: Both the proposed devices and the predicate device are indicated for "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."
• Comparison of Technological Characteristics: Similar operating principles (air inflation, 4 chambers), power sources, time settings, pressure ranges, and accessories (leg, arm, body sleeves).
• Non-Clinical Testing: Compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series) and usability.

Since no clinical study was conducted for this 510(k) clearance, I cannot provide details on:

1. Acceptance Criteria Table: No clinical acceptance criteria were defined or met through a clinical study.
2. Sample Size/Data Provenance: No test set or patient data was used for clinical evaluation.
3. Number of Experts/Qualifications: Not applicable as no ground truth was established from clinical data.
4. Adjudication Method: Not applicable.
5. MRMC Study/Effect Size: Not applicable.
6. Standalone Performance: Not applicable.
7. Type of Ground Truth: Not applicable.
8. Training Set Sample Size: Not applicable as the device is not an AI/ML product and did not involve a training set as understood in AI/ML validation.
9. Ground Truth for Training Set: Not applicable.

In summary, the FDA cleared the SP-1000/SP-2000 based on substantial equivalence to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and compliance with relevant non-clinical (electrical safety, EMC, usability) standards, without the need for a clinical study.

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A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.

This product is an Intermittent Pneumatic Compression system to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

The provided document is a 510(k) summary for the LX9max device, which is a powered inflatable tube massager. The document aims to demonstrate that the LX9max is substantially equivalent to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and a reference device (Rapid Reboot REGEN+).

Here's an analysis of the acceptance criteria and the study as requested:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics or thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has similar indications for use, technological characteristics, and safety and effectiveness profiles as the cleared predicate.

The table provided (Table 1: Comparison of Proposed Device to Predicate / Reference Devices) compares various characteristics:

The "reported device performance" for the LX9max is implicitly that it meets the safety and effectiveness standards of the predicate devices because its technological characteristics are similar, and any differences (pressure range, time range, sleeve type) do not raise new questions of safety or effectiveness. The justification for these minor differences is presented on page 7.

The document also states that the LX9max complies with several voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment (listed on page 8). These standards serve as technical acceptance criteria for safety.

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 Testing was not required to demonstrate the substantial equivalence of the LX9max to its predicate / reference device." (page 8).

Therefore, there

• was no clinical test set used for this submission to prove substantial equivalence.
• no observational data provenance (country, retrospective/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, as no clinical testing was performed for substantial equivalence.

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

Not applicable, as no clinical testing was performed for substantial equivalence.

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

Not applicable. This device is a physical therapy device (massager), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No clinical ground truth was established as no clinical testing was performed. The basis for substantial equivalence relies on comparison of technical characteristics and compliance with safety standards.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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LF900 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

The provided text describes a 510(k) premarket notification for a medical device called LF900, a powered inflatable tube massager. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

The text focuses on demonstrating substantial equivalence to a predicate device (POWER-Q1000 Premium) based on:

• Intended Use: Both devices are for treating conditions like lymphedema, edema, and venous insufficiencies.
• Technological Characteristics: Comparison of physical specifications like power source, time, pressure, and number of chambers. Small differences in these parameters are justified as not raising new safety or effectiveness concerns.
• Non-Clinical Testing: Compliance with electrical safety (IEC 60601 series) and device performance tests (pressure, time, sleeve durability).
• Clinical Testing: The document explicitly states, "Clinical testing was not required to demonstrate the substantial equivalence of the LF900 to its predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance, ground truth, expert adjudication, or MRMC studies. The device described in this FDA clearance is a physical medical device, not an AI/ML diagnostic or assistive tool.

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DVT-PRO is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-PRO is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency.

In this device, sleeves continuously inflated/deflated by the air pressure generated by the pump. This pressurization increases blood flow and prevent DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

The provided document describes the DVT-PRO device, a compressible limb sleeve intended to prevent Deep Vein Thrombosis (DVT). The submission is a 510(k) premarket notification (K203353), claiming substantial equivalence to a previously cleared device, DVT-PRO (K150980).

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format for performance metrics. Instead, it demonstrates substantial equivalence to a predicate device. The comparison focuses on technical characteristics and specifications. The "reported device performance" is essentially that the proposed device (DVT-PRO, K203353) performs equivalently to the predicate device (DVT-PRO, K150980) based on non-clinical testing.

Here's a table comparing the proposed device to the predicate device, highlighting critical specifications and differences:

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

The document indicates that "Non-clinical test (Product performance test)" was conducted to "prove that it is substantially equivalent to the equivalent device." However, specific details about the sample size (e.g., number of devices tested, number of test cycles) for this performance test are not provided.

The data provenance is from non-clinical testing performed by the manufacturer, DAESUNG MAREF CO., LTD., likely in Korea, South, given the manufacturer's address. The testing is in support of a 510(k) submission, confirming it is retrospective in the context of device development, but the specifics of when the tests were done are not explicitly stated, beyond the date of data preparation (February 22, 2021). The document states "A test was conducted that reflected the difference from the equivalent device, and after the change, it was confirmed that the product satisfies the existing performance."

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

Not applicable. This is a non-clinical performance test for a mechanical device comparing its specifications to a predicate device. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations. The "ground truth" for the performance test appears to be the expected performance range or specification as defined by the manufacturer and relevant standards (e.g., pressure output accuracy).

4. Adjudication method for the test set

Not applicable. As noted above, this involves non-clinical performance testing against specifications, not expert adjudication of clinical outcomes or interpretations.

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. The DVT-PRO is a physical medical device (compressible limb sleeve) and not an AI/software device that involves human readers or AI assistance in interpretation. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. The DVT-PRO is a physical device and does not involve standalone algorithm performance in the way an AI diagnostic tool would.

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

The "ground truth" for the non-clinical performance testing of the DVT-PRO device consists of engineering specifications and relevant performance standards. The device's performance was compared against these established technical benchmarks and the specifications of the predicate device (K150980). For example, pressure output was verified against defined ranges (e.g., LEG: 20-65mmHg ±15mmHg).

8. The sample size for the training set

Not applicable. This device does not use an algorithm that requires a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE.

Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

The provided document is a 510(k) Pre-Market Notification for the DVT-4000S device. It does not contain a study demonstrating acceptance criteria for the device's performance in terms of its intended use (preventing DVT/PE by increasing venous blood flow).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.

Therefore, many of the requested details about acceptance criteria, device performance against those criteria, sample sizes, expert involvement, and ground truth establishment are not present in this document.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria for DVT/PE prevention or venous blood flow increase, nor does it report performance metrics against such criteria. The "specifications" listed are more about the device's operational parameters rather than clinical outcomes.

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

• Clinical Test Set: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-4000S to its predicate device." Therefore, there is no clinical test set mentioned, and thus no sample size or data provenance for such a test.
• Non-Clinical Test Set: For electrical safety, EMC, and biocompatibility, the sample size is not specified, but these are typically tested on a representative number of devices (e.g., a small batch) during product development and regulatory submission. The provenance would be from laboratory testing performed by the manufacturer or a certified testing facility.

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

Not applicable, as no clinical test set requiring ground truth establishment by experts was conducted or reported.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication was conducted or reported.

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 mechanical compression device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a mechanical compression device, not an algorithm.

7. The type of ground truth used:

Not applicable, as no clinical test involving ground truth for disease detection/prevention was performed. The ground truth for electrical safety or biocompatibility would be defined by the standards themselves (e.g., does it conduct electricity safely, does it cause cell death).

8. The sample size for the training set:

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

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

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

Summary of Study (as presented in the document):

The "study" presented is a substantial equivalence comparison to a legally marketed predicate device (DVT-2600). The manufacturer asserts that the DVT-4000S is substantially equivalent to the DVT-2600 based on:

• Identical Indications for Use: Both devices are intended to prevent DVT/PE by increasing venous blood flow.
• Similar Technological Characteristics: The operating principle (sequential inflation of air chambers) is the same. Key specifications like pressure range and number of chambers are identical.
• Minor Differences Justified: The differences (power consumption and inclusion of a battery in DVT-4000S) were deemed not to raise new questions of safety or effectiveness. Performance tests confirmed that the device functions equivalently when using AC power or battery.
• Compliance with Voluntary Standards: The DVT-4000S complies with recognized standards for electrical safety (IEC 60601-1:2012), electromagnetic compatibility (IEC 60601-1-2:2014), and biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).

The basis for market clearance, in this case, is not a clinical study demonstrating performance against specific clinical acceptance criteria, but rather a demonstration of substantial equivalence to an already cleared device and compliance with relevant safety and performance standards.

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A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

The provided text is a 510(k) premarket notification for the DVT-2600 device, a compressible limb sleeve intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the information required for a detailed description of acceptance criteria and a study proving those criteria are met is not available in the provided text.

Here's an explanation based on the available text:

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

   • The document does not provide a table of specific performance acceptance criteria (e.g., minimum pressure levels, pulsation rates, blood flow increase percentages, etc.) that the DVT-2600 device was tested against.
   • Instead, it compares the technological characteristics of the DVT-2600 to a predicate device (also named DVT-2600, K112677 from DAESUNG MAREF CO., LTD.) to establish substantial equivalence. The performance listed relates to general specifications like pressure ranges and number of chambers, which are compared to the predicate device, not against predefined acceptance criteria from a study.

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 testing was not required to demonstrate the substantial equivalence of the DVT-2600 to its predicate device." This means there was no clinical "test set" in the context of a performance study to prove new acceptance criteria.
   • The non-clinical tests mentioned (electrical safety, EMC, biocompatibility) are general compliance tests for standards, not performance studies against specific clinical acceptance criteria.

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 set for performance evaluation was conducted.

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

   • Not applicable, as no clinical test set for performance evaluation was conducted.

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. The DVT-2600 is a physical medical device (compressible limb sleeve), not an AI-powered diagnostic or assistive tool.

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

   • Not applicable, as it's not an algorithm-based device.

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

   • Not applicable, as no clinical performance study was conducted to establish ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device based on similar technological characteristics and non-clinical safety/EMC standards compliance.

8. The sample size for the training set:

   • Not applicable, as no machine learning or AI model was developed for this device that would require a training set.

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

   • Not applicable for the same reason as above.

Summary from the provided text:

The DVT-2600 received 510(k) clearance based on "substantial equivalence" to a predicate device (K112677, also named The Venous Assist System DVT-2600 from DAESUNG MAREF CO., LTD.).

• Acceptance Criteria & Performance: The document provides a comparison of specifications between the proposed device and the predicate device, claiming they are largely identical except for the inclusion of a battery in the proposed device. The "performance" assessment is based on this comparative technical specification rather than a dedicated study with defined acceptance criteria.
  • Proposed Device (DVT-2600):
    • Power Source: 100-240VAC, 50/60Hz
    • Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
    • Number of chambers: 3
    • Battery: 3200mAh, 3350mAh
  • Predicate Device (DVT-2600 / The Venous Assist System):
    • Power Source: 100-240VAC, 50/60Hz
    • Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
    • Number of chambers: 3
    • Battery: -
  • Justification for Substantial Equivalence: The battery difference was deemed not to affect performance, confirmed by a product performance test report (though the report itself is not included in the provided text).
• Study Data: No clinical performance study data against specific "acceptance criteria" is provided or stated to have been conducted. The submission relies on non-clinical tests for electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility for the sleeves (ISO 10993-5, ISO 10993-10). These are compliance tests to standards, not performance studies against medical efficacy acceptance criteria.
• Ground Truth: The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the legally marketed predicate device, to which the new device is substantially equivalent.
• Sample Size: Not applicable for performance studies.
• Experts: Not applicable for performance studies.
• Adjudication/MRMC/Standalone AI: Not applicable as the device type does not involve these methodologies.

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Lympha-Flow(LF1200) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Lympha-Flow(LF1200) is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. Lympha-Flow(LF1200) comprises of 12-step sleeves and accelerates the circulation of body fluid by evenly distributing the pressure to limbs.

This looks like a 510(k) summary for a medical device called Lympha-Flow (LF1200), an intermittent pneumatic compression system. The document focuses on demonstrating substantial equivalence to a predicate device (LX7, K102320), rather than a standalone clinical study to prove effectiveness against explicitly stated acceptance criteria.

However, I can extract information related to performance testing and substantial equivalence, which serves a similar purpose in the regulatory context.

Acceptance Criteria and Reported Device Performance

The document doesn't present explicit "acceptance criteria" in the format of a clinical study goal (e.g., "achieve 90% sensitivity"). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a legally marketed predicate device. The "reported device performance" is primarily the successful completion of these tests and the determination of substantial equivalence.

Here's a table based on the provided text, outlining the performance data submitted:

Study Details (Based on available information)

2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" with a specific sample size. The testing described (biocompatibility, electrical safety, EMC, software V&V) is typically performed on a limited number of device units or components, not a patient sample. This is not a study with data provenance in terms of country of origin or retrospective/prospective patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. For technical standard compliance (IEC, ISO, EMC), "ground truth" is established by the successful execution of tests according to the standard's methodology and acceptance criteria. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device. There is no mention of external experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:
Not applicable. No clinical test set with human subject data requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for diagnostic imaging devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is a therapy device (pneumatic massager), not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" as typically understood in AI/ML medical devices is not directly applicable. The device's performance is standalone in the sense that its mechanical and electrical functions are tested independently and against standards.

7. The Type of Ground Truth Used:
The "ground truth" here is the adherence to recognized international and national standards for medical devices (ISO, IEC, AAMI, FDA guidance) and the established safety and efficacy profile of the predicate device (LX7(V7), K102320).

8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-based device that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8).

Summary of Device and Study Type:
The Lympha-Flow (LF1200) is an intermittent pneumatic compression system. The study presented here is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device, LX7). This involves comparing the new device's technological characteristics, indications for use, and performance data (biocompatibility, electrical safety, EMC, software V&V) to those of the predicate device and relevant standards. It is not a clinical trial to establish de novo safety and effectiveness or to demonstrate improvement over human performance. The "acceptance criteria" are implicitly met through compliance with recognized standards and a successful demonstration of substantial equivalence.

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DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

DVT-4000 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant.

The provided document is a 510(k) premarket notification for a medical device called DVT-4000, an intermittent pneumatic compression (IPC) system. It focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven system.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove a device meets acceptance criteria for an AI/algorithm. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Details on sample size, data provenance, expert ground truth establishment, or adjudication methods for an AI/algorithm test set.
• Information about MRMC studies.
• Data on standalone algorithm performance.
• Type of ground truth used for AI/algorithm.
• Training set details for AI/algorithm.

The "Performance Data" section (Page 13) refers to standard safety, EMC, biocompatibility, and software verification/validation testing, which are typical for traditional medical devices and not specific to the performance validation of an AI/algorithm. The software is noted as "moderate" level of concern, indicating it's likely responsible for controlling the mechanical operation of the IPC system, not for AI-driven diagnostic or treatment decisions.

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DVT-Pro is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-Pro is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

DVT-Pro device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.

The provided document is a 510(k) Summary for a medical device called "DVT-Pro," a compressible limb sleeve system used to prevent Deep Vein Thrombosis (DVT). The document outlines the device's characteristics and compares it to a predicate device (DVT-2600) to demonstrate substantial equivalence, but it does not contain information on acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or reader studies). The "performance data" section primarily refers to safety and software validation testing, not clinical performance for its stated indications.

Therefore, I cannot provide the detailed information requested in the prompt, especially points related to:

• A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like accuracy, sensitivity, specificity).
• Sample size used for the test set or training set for clinical performance evaluation.
• Data provenance, number of experts, adjudication methods, or ground truth types for clinical performance.
• MRMC comparative effectiveness study or standalone performance.

The document focuses on demonstrating that the DVT-Pro device is substantially equivalent to an existing device (DVT-2600) based on:

• Intended Use: Both devices are for "Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency." The DVT-Pro explicitly states it's for DVT prevention by improving blood velocity.
• Technological Characteristics Comparison (See the table on page 8-9): This table highlights similarities in mechanical and electrical specifications, such as mode of compression (sequential), pressure ranges (with slight differences in maximums for leg/foot), and general design.
• Safety and Software Validation:
  • Biocompatibility testing: ISO10993-5, ISO10993-10 were performed.
  • Electrical safety and performance testing: Conducted according to IEC 60601-1:2005 + CORR.1(2006) + CORR(2007).
  • EMC testing: Conducted according to IEC 60601-1-2:2007.
  • Software Verification and Validation Testing: Documented as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was classified as "minor" level of concern. All test results were satisfactory.

Key Missing Information (as per your prompt):

The document does not detail any clinical performance study (e.g., to measure the device's effectiveness in preventing DVT) with specific acceptance criteria like accuracy, sensitivity, or specificity. The "performance data" discussed is related to engineering and software validation for safety and proper functioning, not clinical outcomes directly demonstrating DVT prevention efficacy against a defined ground truth.

Therefore, I cannot populate the table or answer the specific questions regarding clinical performance studies, test set/training set sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.

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