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The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

The subject device is similar to a traditional elevator, but features a manually inflatable balloon component at the distal end. The balloon is inflated/deflated with saline via a manual inflation syringe system with an integral pressure gauge.

The provided documents are a 510(k) premarket notification and subsequent administrative change letter for the "LB Medical Inflatable Tissue Elevator/Expander System." This device is a manual surgical instrument and, as such, the submission does not contain the typical acceptance criteria and study data associated with AI/ML-enabled devices or those requiring extensive clinical trials.

The documents indicate that clinical testing was not required to demonstrate substantial equivalence. The device was deemed substantially equivalent based on predicate devices and non-clinical bench testing.

Therefore, many of the requested categories of information for AI/ML devices or devices with rigorous clinical study requirements are not applicable to this submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

Study Details for Demonstrating Substantial Equivalence (Non-Clinical)

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

   • Sample Size: Not specified quantitatively in terms of "test set" for clinical performance, as clinical testing was not required. The "test set" for non-clinical bench testing and biocompatibility is not detailed in the provided summary.
   • Data Provenance: The studies were non-clinical (biocompatibility and bench testing). Specific country of origin is not detailed, but the submission is for the U.S. FDA. Retrospective/Prospective is not applicable to these types of non-clinical tests in the context of device approval.

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

   • Not applicable. Clinical ground truth from experts was not required given that clinical testing was not performed due to the nature and classification of the device and its predicate equivalence pathway.

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

   • Not applicable. Clinical adjudication was not relevant as clinical studies were not conducted.

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:

   • Not applicable. This device is a manual surgical instrument, not an AI/ML diagnostic or assistive device that would involve human readers.

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

   • Not applicable. This device is a manual surgical instrument, not an algorithm.

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

   • For non-clinical tests, the "ground truth" would be established by standardized testing methods and material science specifications (e.g., ISO standards for biocompatibility, engineering specifications for mechanical performance). No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) based on the provided documents.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable. This is not an AI/ML device requiring a training set.

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