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Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.

Bio Compression Systems' Sequential Circulators are powered inflatable tube massagers which consist of a segmented pneumatic sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The sequential inflation of the garment simulates kneading and stroking of tissues with the hands, increasing circulation on the limb worn.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

The provided text is a 510(k) Pre-market Notification for a medical device (Sequential Circulators) and does not contain information about a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, which would include details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data for safety and electrical compatibility, and functional verification, rather than a clinical efficacy or diagnostic accuracy study.

Therefore, many of the requested categories cannot be filled from the provided text.

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

1. Table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in the format of diagnostic metrics (e.g., sensitivity, specificity, AUC) or a study proving those criteria are met. Instead, it lists technical standards and verification testing.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the device itself being tested against technical standards, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/diagnostic imaging device.

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.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance relates to compliance with engineering and safety standards, and functional specifications.

8. The sample size for the training set: Not applicable. This is not a machine learning/AI device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

The provided document is a 510(k) premarket notification for a medical device (Sequential Circulators) and does not describe a study that establishes acceptance criteria for a device based on expert performance or to prove a device meets acceptance criteria through a comparison with human readers or a standalone algorithm study.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, as required for 510(k) submissions to the FDA. The "acceptance criteria" discussed are primarily related to general performance, electrical safety, electromagnetic compatibility, and software verification/validation, rather than clinical performance based on ground truth established by experts.

Therefore, many of the requested points related to acceptance criteria and performance studies in the context of AI/ML or expert adjudication in a clinical setting cannot be directly extracted from this document.

However, I can provide the information that is present:

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

The document doesn't present "acceptance criteria" in a typical table format with quantitative performance metrics for a diagnostic or AI device (e.g., sensitivity, specificity). Instead, it lists various tests and validations performed to ensure the device performs as intended and is safe. The "reported device performance" is implied by the satisfactory completion of these tests, leading to the substantial equivalence determination.

Here's an interpretation based on the document's content:

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

The document does not specify sample sizes in terms of a "test set" for clinical evaluation in the way an AI/ML device submission would. The testing described (electrical safety, functional verification, comparative pressure) refers to engineering and bench testing of the devices themselves, not a dataset of patient cases.

• Sample Size: Not applicable in the context of clinical "test sets" for diagnostic performance. The sample size would refer to the number of device units tested.
• Data Provenance: Not applicable. The testing is described as being conducted on the subject device and reference devices, not on patient data.

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

This information is not applicable to this 510(k) submission. The device is a pneumatic compression device, not a diagnostic imaging device or an AI/ML algorithm requiring expert ground truth for clinical performance evaluation. The "ground truth" for this device's performance is its direct physical output (e.g., pressure, cycle time) verified through engineering tests against specifications.

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

Not applicable. There is no expert adjudication mentioned as this is not a diagnostic or AI/ML device relying on interpretation of clinical data.

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 not an AI-assisted device, and 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 AI algorithm.

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

For this device, the "ground truth" used for testing would be the engineering specifications and established standards for medical devices (e.g., pressure accuracy, cycle time, electrical safety parameters). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve training of an AI/ML model.

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

Not applicable. No training set for an AI/ML model.

Summary of the Study Proving Device Meets Acceptance Criteria (as described in the 510(k)):

The study to prove the device meets its "acceptance criteria" (understood here as performance specifications and safety standards) consisted of a series of bench testing, engineering verification, and validation activities. These included:

• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Adherence to recognized national and international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
• Predicate Device Routine Acceptance Tests Conducted on Subject Device: This implies the new device underwent the same internal quality control and performance tests as the predicate, including continuous and timed operation observation, pressure testing, and HiPot testing.
• Functional Verification and Validation Testing: Specific tests were conducted to verify and validate cycle time, treatment time, pressure setting endpoints, and overall functionality of all modes and settings.
• Comparative Pressure Testing: Specific tests were done to compare the pressure performance of the Subject Device and Predicate Device, particularly regarding individual chamber adjustment and pressure gradients. This was crucial for demonstrating substantial equivalence for critical performance parameters.
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for medical device software, confirming its functionality and safety (classified as "minor" level of concern).

The conclusion states: "The data included in this submission demonstrates that the Subject Device is substantially equivalent to the legally marketed Predicate Device and performs comparably to the Predicate Device that is currently marketed for the same intended use." This statement serves as the justification that the device meets the implied "acceptance criteria" for demonstrating substantial equivalence.

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VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home or hospital use to help prevent post-operative DVT in patients by stimulating blood flow as an aid in the prevention of DVT. The VascuEase IC-1200-WH (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The cycle times and pressure are preset at the factory and cannot be changed by the user. The user interface consists of an On/Off button and two-color LED indicating operational status of the unit. The device consists of a pump. inflatable garments, and interconnection tubing. The pump air compressor is capable of no more than 80 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHz. with a cycle of 15 seconds on and 45 seconds off, which is consistent with the majority of indications prescribed. The garment consists of a discrete inflatable chamber, attached to the pump via interconnection tubing and Velcro. The garment is applied externally over the affected limb(s); unilateral or bilateral treatment can be applied. The garments are supplied non-sterile and are intended for single patient use.

The provided text
describes the acceptance criteria and study proving a medical device, the VascuEase IC-1200-WH, meets these criteria for FDA 510(k) clearance. This is a Class II device, specifically a "Compressible Limb Sleeve," intended for the prophylaxis of Deep Vein Thrombosis (DVT) and other circulatory benefits.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VascuEase IC-1200-WH are based on its similarity and performance comparability to predicate devices. The document states that the device must meet "all performance specifications" and has undergone "functional testing," which "includes cycle timing and inflation pressure."

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

The document does not explicitly state a specific "test set" or its sample size in the context of a clinical study with patients. The performance data presented refers to internal product testing.

• Sample Size for Test Set: Not explicitly stated as a separate clinical "test set" with a specific patient count. The performance data relates to testing of the manufactured devices themselves. The document states, "Before being released every device is tested and must meet all performance specifications." This indicates an ongoing quality control process for each manufactured unit rather than a single pre-market clinical test set.
• Data Provenance: The data appears to be from internal testing by the manufacturer, Bio Compression Systems, Inc., within their typical manufacturing and quality control processes. There is no mention of country of origin for any clinical data (as there is no explicit clinical data presented). The testing described is intrinsic to the device's design and manufacturing rather than patient-derived.

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

Since the "test set" refers to internal performance testing of the device's operational parameters (pressure, cycle times, etc.) rather than a diagnostic or clinical efficacy study requiring human expert interpretation, the concept of "ground truth" established by external experts in this context is not applicable. The measurements taken (e.g., mmHgpressure, seconds for cycle times) are objective parameters.

4. Adjudication Method for the Test Set

As the "test set" pertains to objective performance metrics of the device (e.g., pressure, timing), and not a study requiring subjective interpretation or diagnosis, an adjudication method for establishing ground truth is not applicable. The device's performance is measured against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and functional performance parameters, not on comparative clinical efficacy or how human readers (or users) improve with AI assistance. The device is a physical therapeutic device, not an AI-assisted diagnostic tool.

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

This question is not applicable. The VascuEase IC-1200-WH is a physical medical device (pneumatic intermittent compression device), not an algorithm or software. Its performance is inherent to its mechanical and electronic function, which is tested directly. There is no AI component or algorithm that would operate "standalone."

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the engineering specifications and design requirements of the device and its predicate. The device's function (e.g., inflation pressure of 50 mmHg, inflation time of 15 seconds) are objective, pre-defined parameters. There is no "expert consensus," "pathology," or "outcomes data" directly used to establish the ground truth for these specific performance characteristics in the sense of a diagnostic or treatment outcome study.

8. The Sample Size for the Training Set

The document does not mention a "training set." This term is typically used for machine learning or AI models. Since the VascuEase IC-1200-WH is a physical medical device, not an AI algorithm, the concept of a training set is not applicable here.

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

As there is no "training set" for an AI or machine learning model, this question is not applicable to the VascuEase IC-1200-WH.

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The Bio Compression Systems Sequential Circulator SC-2004FC-OC with associated garments is a sequential, pneumatic compression device intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The device is intended for home or hospital use.

The Bio Compression Systems, Inc. SC-2004FC-OC Sequential Circulator is a pneumatic compression device ('pump') with associated compressible garment sleeves. The pump is manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes.

The provided document is a 510(k) summary for the Bio Compression Systems Sequential Circulator SC-2004FC-OC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with defined acceptance criteria for a new, innovative device. Therefore, the information requested in the prompt, which is typical for studies validating AI/ML algorithms or novel medical devices, is largely not applicable or not present in this document.

However, I can extract what is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of a 510(k) for a pneumatic compression device with a minor modification.

Summary of Acceptance Criteria and Device Performance (within the context of this 510(k) submission):

The "acceptance criteria" in this context are primarily related to the functional specifications and safety of the device, ensuring the modified device performs comparably to the predicate and does not introduce new risks. The "study" for this type of device modification is typically internal engineering and performance testing.

Detailed Information as Requested (with caveats for this type of submission):

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

   • See the table above. The "acceptance criteria" here are defined by the required functional specifications and safety benchmarks for a pneumatic compression device, particularly in demonstrating equivalence to a predicate. The "reported device performance" indicates that the device met these criteria through internal testing.

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

   • Sample Size: Not specified. For this type of engineering and performance testing, it would typically be a fixed number of manufactured units from a production run, often a small sample or even just the modified prototype, to verify specifications.
   • Data Provenance: This would be internal engineering test data generated by Bio Compression Systems, Inc. The document does not specify country of origin or whether it's retrospective/prospective. As it's testing of a newly modified device, it would be prospective for the modification.

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

   • Not Applicable. This is an engineering modification to a physical device, not an AI/ML algorithm or diagnostic imaging device where expert consensus for ground truth is typically required. The "ground truth" for pressure, cycle times, and electrical safety is established by engineering standards, calibrated measurement equipment, and regulatory requirements (e.g., maximum pressure limits, electrical safety standards).

4. Adjudication method for the test set:

   • Not Applicable. See point 3. Testing of physical device specifications doesn't involve adjudication in the way clinical studies or expert review for AI algorithms do. Results are typically pass/fail against predetermined engineering specifications.

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 pneumatic compression device, not a diagnostic imaging system or an AI-enabled device requiring human interpretation. Therefore, MRMC studies are not relevant.

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

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

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

   • The "ground truth" for this device's performance testing is established by engineering specifications, calibrated measurement standards, and compliance with recognized voluntary standards (e.g., for electrical safety, pressure accuracy).

8. The sample size for the training set:

   • Not Applicable. This is a physical device modification, not an AI/ML system requiring a training set.

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

   • Not Applicable. See point 8.

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The Bio Compression Systems Sequential Circulator SC-2008-OC/Sequential Circulator SC-2004-OC with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The devices are intended for home or hospital use.

The Bio Compression Systems, Inc. SC-2004-OC Sequential Circulator and SC-2008-OC Sequential Circulator, are pneumatic compression devices ('pumps') with associated compressible garment sleeves. The pumps are manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes. The pumps can operate unilaterally and bilaterally as needed.

This document is a 510(k) premarket notification for the Sequential Circulator SC-2008-OC and SC-2004-OC. The purpose of this notification is to demonstrate that the new devices are substantially equivalent to previously legally marketed predicate devices.

Here's an analysis of the provided text in relation to the requested acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabulated format with specific pass/fail thresholds. Instead, it describes general performance specifications and testing that is conducted.

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

The document does not provide details on the sample size used for the performance testing. It states: "Before being released to market, every device is tested and must meet all performance specifications." This suggests that 100% of manufactured units undergo testing, which could be considered the "test set" in this context for manufacturing quality control, rather than a specific clinical or validation test set.

The provenance of the data is implied to be from the manufacturer's internal testing processes ("Bio Compression Systems, Inc."). No information is given regarding the country of origin of the data beyond the company's location in Moonachie, NJ, USA. The study appears to be an internal engineering validation and manufacturing quality control study, not a clinical trial; thus, it is a retrospective analysis of product performance against specifications.

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

No external experts are mentioned as being involved in establishing the "ground truth" for the performance specifications or test results. The performance data seems to be based on engineering measurements and comparisons to the established specifications of the predicate devices. The "ground truth" for basic device function (like pressure, cycle times) is typically based on validated measurement equipment and engineering standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

No adjudication method is described. This type of engineering validation study generally relies on objective measurements against pre-defined engineering specifications, rather than subjective interpretation requiring adjudication among multiple parties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No MRMC study was conducted or is mentioned. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI component, and the concept of human readers improving with AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical device (pneumatic compressor) and does not involve an algorithm with standalone performance in the context of AI/software. Its performance is its direct mechanical and electrical function.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and direct measurements. For example, pressure measurements, electrical leakage tests, and timing of inflation/deflation cycles against pre-defined, acceptable ranges. It's a technical ground truth rather than a clinical one like pathology, expert consensus on images, or outcomes data. The comparability to predicate devices also serves as a ground truth for "substantial equivalence."

8. The Sample Size for the Training Set

This question is not applicable. There is no AI or machine learning component, so there is no "training set."

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

This question is not applicable as there is no training set.

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The Bio Compression Systems' SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment for swelling of the extremities. The devices are intended for home or hospital use.

The devices consist of AC-powered pumps and inflatable garments connected by flexible tubing. The pumps consist of a compressor capable of a maximum pressure of 150 mmHg, a rotating disc valve driven by a motor and a digital pressure sensor, housed in durable plastic, Moving parts are not accessible to the user. The garments consist of four (SC-3004-DL and SC-3004FC-DL) or eight (SC-2008-DL and SC-3008-DL) discrete inflatable chambers, attached to the pump via tubing, and are applied externally over the affected limb or torso. Unilateral or bilateral limb treatment can be applied. Unique connector fittings on the tubing prevent accidental and incorrect pump/garment combinations or use with garments or sleeves from other manufacturers. The system provides gradient pressurization to the chambers, i.e., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, the pressure is released in all chambers simultaneously, and the cycle repeats. The SC-3004-DL provides a 90-second inflation/deflation cycle, while the SC-3008-DL, SC-2008-DL and SC-3004FC-DL models provide 50-second cycles. The SC-3004FC-DL model is "fast cycle" and use the faster (8-chamber device) motor to turn the valve, providing faster cycle times for the four-chamber models. Operating pressure is 30 to 120 mmHg. Pressure is pre-set at the factory to 60 mmHg (distal) with a decreasing distal-to-proximal gradient of 1 mmHg per chamber. The compressor is capable of no more than 150 mmHg pressure, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP and DOWN pressure button arrows. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off according to the pump pressure setting, and an LED panel displays the set pressure and displays "0" during the deflation cycle. In the SC-2008-DL device, the UP and DOWN pressure buttons allow the user to change the pressure in the distal chamber, and the decreasing 1 mmHg/chamber gradient is maintained throughout the remaining chambers. The SC-3004-DL. SC-3004FC-DL and SC-3008-DL models have the same feature but additionally provide a means to change the individual chamber pressures in the gradient. The software prevents reverse gradient adjustments. When the garments are inflated, they compress the limb and help to move lymph away from the extremities and/or torso so it can be eliminated by the body. Garments are available in sizes to accommodate varying limb lengths and girth, and custom garments can be provided. The SC-3004-DL and SC-3004FC-DL systems have four-chamber garments, and the SC-2008-DL and SC-3008-DL systems have eight-chamber garments. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. Instructions are provided for the patient to attach the garments and perform therapy at home after a physician has prescribed treatment and the patient has been oriented and educated on proper use of the device. The user interface consists of UP and DOWN pressure adjustment arrows (buttons). All controls and measurement functions are integrated into the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the valve, which turns and sends air to the output ports, filling each garment chamber sequentially. As the valve continues to rotate the air is released from all chambers at once and the garment deflates. The cycle repeats every 90 seconds for the SC-3004-DL or every 50 seconds for the SC-2008-DL, SC-3008-DL and 3004FC-DL. Treatment duration is prescribed by the physician, and typically is two one-hour sessions per day.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove efficacy through clinical trials. Therefore, much of the requested information regarding acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment, as typically associated with a clinical performance study for a novel device, is not present in this document.

However, I can extract the information that is available and clarify what is missing.

Analysis of the Provided Document:

The document describes several Bio Compression Systems' Sequential Circulator devices (SC-3008-DL, SC-3004-DL, SC-3004FC-DL, and SC-2008-DL) and compares them to a predicate device (SC-3008 Sequential Circulator, K043423). The core of the FDA submission is to demonstrate "substantial equivalence" based on similar technological characteristics and performance specifications, not the establishment and proof against new clinical acceptance criteria through a dedicated study.

1. Table of acceptance criteria and the reported device performance:

The document states that "Before being released every device is tested and must meet all performance specifications." It lists the types of functional testing performed:

Note: The document does not provide specific numerical acceptance limits (e.g., "electrical leakage must be

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When used with GID-3045-T Calf/Thigh or GID-3045-K Calf garments:

• Intended for prophylaxis of deep vein thrombosis
  When used with GI-3045-F Foot Garments
• Intended for prophylaxis of deep vein thrombosis
• Enhancement of venous and arterial circulation
• Prevention of venous stasis ulcers
• Reduction of acute or chronic edema
• Reduction of lower limb pain due to surgery or trauma
• Reduction of compartment pressures

The IC-1545-DL Multi-Flo DVT Combo (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The applicant device is a digitally-controlled version of the predicate device, with identical specifications. There is no change in fundamental technology and no change in intended use from the predicate device, K610857. The digital modification provides identical call/thigh (KT) and foot (F) timing and pressure options as the predicate and it has the same intended use as the predicate, including prophylaxis of deep vein thrombosis (DVT) and enhancing venous and arterial circulation. Tubing connector design variations prevent interchangeability of garments between the models. The user interface consists of a soft keypad where the predicate has a rocker on/off switch and a pressure adjustment knob. The analogue pressure gauge and regulator have been removed, making the applicant unit 27% smaller and 47% lighter than the predicate, and both are designed to hang on bedrails for easy access to bed-ridden patients. The device consists of a pump, inflatable garments, and interconnection tubing. The pump compressor is capable of no more than 150 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHg, with a cycle of 15 seconds on and 45 seconds off (KT option). This is consistent with the majority of indications prescribed. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump sends air to the output ports, filling the garments with air. A digital pressure sensor maintains the pressure by turning the compression pump on and off. After 45 seconds, the timer stops the pump and opens a valve to deflate the garnents and 15 seconds later the cycle repeats. In order to achieve its intended use, the device is attached via interconnecting tubing to sleeves (garments) applied externally and bilaterally over the lower extremities. The garments contain discrete, interconnected and segmented inflatable chambers. The pump provides intermittent, rapid impulse pressurization to the chambers. The pressure can be adjusted up or down in increments of I mmHg with up and down soft key arrows, and an alarm is provided for low/no pressure. When the garnents are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. The device runs continuously until turned off. An LED display shows the pressure setting during the inflation cycle and "0" during the deflation cycle. Pressure setting can be changed by the user, while timing cycles can be changed with special instructions provided to the distributor. An alarm will alert the user if inflation pressures do not exceed 30 mmHg. All garments are supplied non-sterile and for single patient use. DVT prophylaxis garments are available in a total of three anatomical configurations as indicated to the calves or the calves and the thighs (KT) and the feet (F).

This document describes the IC-1545-DL Multi-Flo DVT Combo Intermittent Pneumatic Compression Device, a device intended for prophylaxis of deep vein thrombosis and enhancement of venous and arterial circulation, among other uses. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Model Multi-Flo IC-1545-KT/F Intermittent Circulator).

Acceptance Criteria and Device Performance

The device's performance is accepted based on functional testing and comparison to the predicate device. The key acceptance criteria revolve around maintaining similar performance specifications and inflation cycle profiles to the predicate device, despite changes in the user interface (digital vs. analog).

The overall acceptance criteria appear to be that the applicant device (IC-1545-DL Multi-Flo DVT Combo) demonstrates equivalent inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) compared to the predicate device (Model Multi-Flo IC-1545-KT/F). The device also underwent aesthetic and electrical leakage testing.

Study Information

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness.

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

   • Test Set Sample Size: Not applicable in the context of a clinical performance study with a distinct "test set" as typically understood. The closest equivalent is the functional testing performed on every device before release. The document states, "Before being released every device is tested and must meet all performance specifications." This suggests a 100% inspection/testing of manufactured units.
   • Data Provenance: The functional testing is conducted internally by the manufacturer (Bio Compression Systems, Inc.). No external clinical data or country of origin for a "test set" is provided as this is not a clinical study.

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

   • Not applicable. The "ground truth" for the functional testing is the device's technical specifications and the performance of the predicate device. This is established by engineering and manufacturing standards, not medical experts.

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

   • Not applicable. Adjudication methods are typically used in clinical studies for interpretation of results by multiple experts. The functional testing described is objective and quantitative, based on predefined technical specifications.

4. 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 MRMC comparative effectiveness study was done, as this is a physical medical device (intermittent pneumatic compression device), not an imaging or AI-assisted diagnostic tool involving human reader interpretation.

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

   • Not applicable, as this is not an algorithm or AI device.

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

   • The "ground truth" for demonstrating substantial equivalence and meeting performance specifications relies on:
     • Engineering Specifications: Defined parameters for pressure, timing, etc.
     • Predicate Device Performance: The established operating characteristics and clinical efficacy of the predicate device (K610857). The applicant device is designed to operate within these "clinically-established parameters."

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable, as there is no training set.

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The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: • amputations (minor) • angioplasty/stent failure • arteriopathic wounds . graft failure . intermittent claudication . ischemia . night pain . rest pain . small vessel disease ● ulcers.

The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (IC-BAP-DL, applicant device) is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The device consists of an AC-powered pump, inflatable garments, and interconnection tubing. In operation, the device is attached via the interconnection tubing to sleeves or garments containing discrete inflatable chambers, which are applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations or use with garments or sleeves from other manufacturers. The pump design provides intermittent, rapid impulse pressurization to the chambers. Inflation and deflation cvcles are requlated by a two-section valve, turned by the valve motor at three rpm. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off using information from the pressure sensor. When the garments are inflated. they compress the blood vessels in the foot and calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. Pressure is pre-set at the factory to 120 mmHg, and the compressor is capable of no more pressure than 150 mmHq, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP/DOWN soft key arrows. An LED panel displays the set pressure and display "0" during the deflation cycle. Foot/calf garments are connected and are available in a range of sizes. The garments contain discrete, interconnected and segmented inflatable chambers, providing a single inflation chamber for the foot and two inflation chambers for the calf. Garments are supplied nonsterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. The device is intended for home use. and instructions are provided for the patient to attach the garments and perform therapy after physician prescription and patient orientation and education. The user interface consists of a soft keypad and UP/DOWN pressure adjustment soft kev arrows. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the 2-section valve, which turns and sends air to the two bilateral output ports, filling first the foot and then the calf garments. As the valve continues to rotate the air is released from all chambers at once and the garments deflate. The cvcle repeats three times per minute and default treatment time is one hour, controlled by an internal timer on the PCB.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data that the device is tested against before release. However, it does not explicitly state quantitative acceptance criteria for each parameter other than the displayed pressure accuracy. Instead, it emphasizes comparable inflation cycle profiles to the predicate device.

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "Before being released every device is tested and must meet all performance specifications." This implies that the sample size for the test set is n=1 (each individual device manufactured).

The data provenance is prospective manufacturing quality control testing. The country of origin for the data is not specified, but given the US regulatory context, it would likely be where the devices are manufactured or tested.

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

This information is not applicable in this context. The "ground truth" here is based on the device's technical specifications and engineering measurements, not clinical expert consensus. The testing described is functional testing against engineering requirements.

4. Adjudication Method for the Test Set:

This information is not applicable. The functional testing described is a direct measurement against defined specifications, not a subjective interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned or performed. The study focuses purely on the device's functional equivalence to its predicate, not its clinical effectiveness against human readers or other treatments.

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

Yes, a standalone performance evaluation was conducted. The "Performance Data" section describes "functional testing" performed on "every device" before release, which includes objective measurements like electrical leakage, pressure adjustment, inflation pressure, air pressure display accuracy, and inflation/deflation cycle times. This is a standalone evaluation of the device's physical and functional characteristics.

7. Type of Ground Truth Used:

The ground truth used for the device's performance evaluation is based on engineering specifications and pre-defined performance parameters for the device itself and its predicate. This includes measurements against expected pressure levels, timing, and electrical safety standards.

8. Sample Size for the Training Set:

This information is not applicable. The device described is a mechanical/electronic medical device with a pre-defined and tested operational logic, not a machine learning or AI-based system that requires a "training set" in the conventional sense. Its "training" is in its design and manufacturing process.

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

This information is not applicable for the reasons stated above.

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The 2004-0C and 2008-0C Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The devices are intended for home use by people who are in good health.

The device consists of an air compressor with manually adjustable pressure settings (i.e., the user manually adjusts the pressure, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing four (2004-OC) or eight (2008-OC) discrete, segmented inflatable chambers externally applied to the limb. The pump consists of a compressor capable of a maximum pressure of 150 mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). An in-line check valve limits the output pressure to 80 mmHg, and a calibrated dial gauge displays pressure in the range of 0-125 mmHq. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the distal chambers have a default value set at the factory (60 mmHg distal), and can be adjusted by the user to distal pressures between 30 mmHg and 80 mmHg. Pressures decrease by 5 mmHg in each proximally sequential chamber. Garments are available in sizes to accommodate varying limb lengths. An adapter is available to support bilateral treatment.

The provided text describes a 510(k) submission for the 2004-OC and 2008-OC Massage Systems. It details the device, its intended use, and a comparison to a predicate device, but it does not include a formal study demonstrating the device meets specific quantitative acceptance criteria.

Instead, the document states: "Before being released, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, inflation pressure in each segment, pressure adjustment, pressure gradient across the segments, air pressure gauge accuracy, and inflation/deflation cycle times."

This implies that internal quality control and performance verification are conducted for each device, but a structured clinical or performance study with defined acceptance criteria and statistical analysis, as typically required for demonstrating efficacy or substantial equivalence in certain medical devices, is not explicitly provided or referenced in the summary.

Therefore, many of the requested sections (2-9) cannot be filled with the provided information.

Here's a breakdown of what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document speaks to "every device is tested" for internal performance specifications before release, suggesting a 100% inspection or quality control process. It does not describe a distinct "test set" for a larger, formal validation study. Therefore, no information on sample size or data provenance (country of origin, retrospective/prospective) related to a specific validation study is available.

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

Not applicable. No formal ground truth establishment by external experts for a test set is described.

4. Adjudication method for the test set

Not applicable. No formal adjudication method for a test set is described.

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 massage system, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithmic device in the context of standalone performance evaluation for diagnostic or assistive tasks.

7. The type of ground truth used

For the internal performance specifications, the "ground truth" would be the engineering design specifications and calibrated measurement tools for parameters like pressure, cycle times, and electrical safety. It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic device study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

• Amputations (minor)
• Angioplasty / stent failure
• Arteriopathic wounds
• Graft failure
• Intermittent claudication
• Ischemia
• Night pain
• Rest pain
• Small vessel disease
• Ulcers

The BioArterial Plus Arterial Blood Flow Enhancement System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.

Here's an analysis of the acceptance criteria and supporting study for the "BioArterial Plus Arterial Blood Flow Enhancement System" based on the provided text:

Acceptance Criteria and Device Performance

Study Details from the Provided Document:

1. Sample size used for the test set and the data provenance:
   The document does not specify a sample size or data provenance for human subject testing. The "Performance Data" section only mentions "bench testing."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring expert ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring adjudication.
4. 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 information is not applicable. The device is an "Arterial Blood Flow Enhancement System" and not an AI-powered diagnostic or interpretive device that would involve human readers or MRMC studies.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is a physical medical device (pump and garments) for enhancing blood flow, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the bench testing, the "ground truth" used was the specifications and performance profiles of the predicate devices. The testing aimed to show similarity to these established devices rather than a biological or clinical ground truth in the traditional sense.
7. The sample size for the training set:
   This information is not applicable as there is no mention of a "training set" for an algorithm or AI model within this 510(k) submission. The performance assessment was based on bench testing of the physical device.
8. How the ground truth for the training set was established:
   This information is not applicable for the reasons stated above (no training set for an algorithm).

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