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The V12 PRO 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. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.

V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord.

The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.

The provided text describes the V12 PRO device and its FDA 510(k) clearance application. It focuses on demonstrating substantial equivalence to a predicate device (Ballancer 505 System) rather than providing detailed acceptance criteria and a study dedicated to proving those criteria for the V12 PRO as a standalone device.

However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the conducted performance tests. The study's main goal was to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with N/A where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The primary "study" described is a non-clinical performance evaluation and comparison to a predicate device conducted to demonstrate substantial equivalence for regulatory clearance (K210913).

Specific Information:

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

   • Test Set Sample Size: The document does not specify a "test set" in terms of subject or patient count for clinical performance. The testing described focuses on device characteristics, not patient outcomes. The "Pressure Distribution Comparison Test" was performed on the device itself and the predicate.
   • Data Provenance: The tests (biocompatibility, electrical safety, EMC, software V&V, pressure distribution) were conducted on the V12 PRO device and compared against the Ballancer 505 System (predicate device). No information on patient data (country of origin, retrospective/prospective) is provided as this was a non-clinical submission.

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

   • N/A. This was a non-clinical submission focusing on technical performance and equivalence. No human expert "ground truth" was established for a test set of clinical images or patient outcomes. The "ground truth" for the technical tests would be the established industry standards (IEC, ISO) and the characteristics of the predicate device.

3. Adjudication method for the test set:

   • N/A. Not applicable as there was no expert adjudication of clinical data or images.

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. This device (V12 PRO) is a powered inflatable tube massager, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not performed.

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

   • N/A. This device does not have an "algorithm only" performance in the sense of an AI diagnostic. The device's performance is inherently "standalone" in its mechanical and software operation, but it requires human application and setting adjustments. The software verification and validation are essentially demonstrating its "standalone" functionality.

6. The type of ground truth used:

   • Technical Specifications/Industry Standards: For biocompatibility, electrical safety, EMC, and software, the "ground truth" was compliance with established international standards (ISO, IEC, FDA guidance).
   • Predicate Device Characteristics: For the Pressure Distribution Comparison Test, the "ground truth" was the comparable performance (pressure curve) of the legally marketed predicate device, the Ballancer 505 System.

7. The sample size for the training set:

   • N/A. This document does not describe the development of a machine learning or artificial intelligence algorithm that would require a distinct training set. The "software" mentioned refers to the device's operational control software, which undergoes traditional software verification and validation, not machine learning model training.

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

   • N/A. See point 7.

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Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

SLK Varilymph 12 Pro Compression Therapy Device utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus, treat the symptoms of a variety of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main control contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and a rotating dis controlling air outflow. The regulated compressed air is transferred via an air distributor through a series of hoses to a sleeve garment. Each garment contains 12 pressure cells. The sleeve fits on the affected limb and can easily adjusted to any limb size within the sleeve tolerance. The devices are powered from a system supply voltage (230V / 110V).

The SLK VariLymph 12 Pro (SLK V12 Pro) consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance; and a power cord.

The user interface on the SLK VariLymph 12 Pro is a Membrane Keypad with dome switches. The settings are shown on a 3,2" LCD Screen.

The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

The SLK VariLymph 12 Pro is a compressible limb sleeve device. The provided text indicates that its predicate device is the LYMPHA PRESS OPTIMAL MODEL 1201AP COMPRESSIBLE LIMB SLEEVE DEVICE (K082149). The justification for substantial equivalence relies on non-clinical performance data and a comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics. Instead, it describes various tests and concludes that the device performs similarly to the predicate. The overall acceptance criterion is demonstrating substantial equivalence in safety and efficacy to the predicate device.

Here's a summary of the performance claims based on the non-clinical data:

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

The document describes non-clinical performance data and a comparison to a predicate device. There is no mention of a "test set" in the context of patient data or clinical trials for the SLK VariLymph 12 Pro. The primary "test" to show equivalence was a "Pressure distribution Comparison Test."

• Sample Size for Pressure Distribution Test: Not explicitly stated as a number of devices or measurements. It refers to "the test" and "pressure curves," implying a comparison of the pressure output of the SLK VariLymph 12 Pro against the Lympha Press Optimal predicate device.
• Data Provenance: The "Expert Report by Berlin Cert GmbH" suggests the testing was conducted by an external German certification body. The document does not specify a country of origin for any "data" beyond this. The data is based on device performance, not patient data, so "retrospective or prospective" is not applicable in the typical clinical sense.

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

• Number of Experts: One "Expert Report by Berlin Cert GmbH" is mentioned. It's unclear if this refers to a single expert or a team/committee from Berlin Cert GmbH.
• Qualifications of Experts: Not explicitly stated beyond being an "Expert Report by Berlin Cert GmbH." Berlin Cert GmbH is a recognized certification body, implying their expertise in medical device testing and conformity assessment.

4. Adjudication Method for the Test Set:

Not applicable. The "Pressure distribution Comparison Test" involved comparing technical pressure curves, not expert adjudication of clinical outcomes or images.

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 compressible limb sleeve, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

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

Not applicable. The device is a physical therapeutic device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance comparison was the performance characteristics (specifically pressure distribution) of the legally marketed predicate device (Lympha Press Optimal Model 1201AP). The SLK VariLymph 12 Pro's pressure curves were compared to those of the predicate.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of an algorithm or AI model requiring a training set.

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

Not applicable. No training set was used.

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