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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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