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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 < X mA") or numerical results for the reported device performance (e.g., "electrical leakage was Y mA"). It simply states that the device "must meet all performance specifications" and "the results demonstrate inflation cycle profiles."

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

• Sample Size: Not specified. The document states "Before being released every device is tested," implying 100% testing of manufactured units, but not for a specific "test set" in the context of a validation study for regulatory submission.
• Data Provenance: Not specified, but generally refers to in-house manufacturing quality control testing. It is retrospective in the sense that completed devices are tested. Country of origin is the US, as Bio Compression Systems, Inc. is located in Moonachie, New Jersey.

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

• Not Applicable. This information is relevant for studies involving subjective assessments or diagnoses (e.g., image interpretation). The reported "performance data" refers to objective engineering and functional tests of the device's mechanical and electrical operation, not its clinical efficacy or diagnostic accuracy, which would require expert-established ground truth.

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

• Not Applicable. As described above, the "performance data" relates to objective device function testing, not subjective assessment requiring adjudication.

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

• No. This is not an AI device or a diagnostic imaging device. Therefore, an MRMC study is not relevant and was not performed.

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

• No. This is not an algorithm-based device. The device is a pneumatic compression pump.

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

• For the functional performance testing, the "ground truth" would be established engineering specifications, standards, and calibrated measurement equipment. For example, a pressure gauge reading would be compared against a known standard.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set.

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

• Not Applicable. As above, no training set for an algorithm was used.

In Summary:

The provided document details a 510(k) submission for pneumatic compression devices. The "performance data" discussed refers to internal quality control and verification of engineering specifications, not a clinical trial to establish new efficacy acceptance criteria or clinical ground truth. The submission's goal is to demonstrate that the new digital models are substantially equivalent to a previously cleared analog predicate device, primarily through comparison of design, intended use, and functional operation, rather than new extensive clinical studies.

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