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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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BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the "Bircoll Balloon Dissector." The documents are FDA 510(k) letters for an administrative change and the original clearance, which primarily discuss regulatory classification, substantial equivalence, and general controls. They do not include the specific technical details of the device's performance or the studies conducted to establish its effectiveness.

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The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue. This device is a temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical Balloon Dissector/Expander is a single use, disposable device provided sterile to the physician. The major components of the device are a balloon dissector and an injection port/connector.

This document is a 510(k) summary for the Spacemaker® Surgical Balloon Dissector/Expander, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner you're requesting for an AI/ML device.

Here's why and what information is provided:

This device is a Class I manually operated surgical instrument for general use, which was cleared in 1997. At that time, and for this type of device, the regulatory pathway (510(k)) primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through extensive clinical studies as would be required for higher-risk or AI/ML devices today.

The document states:

• "Testing in Support of Substantial Equivalence: Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."

This indicates that some design-related tests were performed (likely mechanical or material tests according to ASTM standards), but these are not performance studies in the context of diagnostic accuracy, which is what your questions imply for AI/ML.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The clearance was based on substantial equivalence to existing devices.
2. Sample size used for the test set and the data provenance: Not applicable in the context of an "AI/ML" test set. The "tests" mentioned were likely engineering/device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device designed for diagnostic interpretation.
6. If a standalone performance study was done: "Specific ASTM tests" were done to evaluate design differences, but not a standalone clinical performance study as would be expected for an AI/ML diagnostic tool. The clearance is based on equivalence.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).

Summary of available relevant information from the document:

• Device Name: Spacemaker® Surgical Balloon Dissector/Expander
• Regulatory Pathway: 510(k) (Substantial Equivalence)
• Principle of Operation: Handheld, manually manipulated surgical balloon device which dissects tissue planes and expands overlying tissue.
• Tests Performed: "Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."
• Basis for Clearance: Substantial equivalence to predicate devices (K951878 Spacemaker® and Spacemaker® II, K904265 Inamed Ruiz-Cohen Intraoperative Expander, K862203 McGhan Magna-Site™ Tissue Expander, K843704 McGhan Tissue Expander).

The document is a regulatory clearance for a physical surgical tool from 1997, preceding the widespread use of AI/ML in medical devices and the associated regulatory requirements for performance metrics and studies.

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