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The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.

The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

This document is a 510(k) premarket notification for a medical device called the "WalterLorenz Surgical Assist Arm Scope Holder." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials. As such, the document explicitly states that "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the following information, typically found in studies proving device effectiveness, is not applicable to this 510(k) submission:

• A table of acceptance criteria and the reported device performance: This submission relies on substantial equivalence to predicate devices based on non-clinical performance data and similar indications for use, not on specific performance metrics against pre-defined acceptance criteria from a clinical study.
• Sample size used for the test set and the data provenance: Clinical testing was not performed; hence, there is no test set or related data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring ground truth establishment.
• Adjudication method for the test set: Not applicable as there was no test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical surgical assist arm, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there were no clinical studies generating such data.
• The sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable as this is a mechanical device, not an AI/ML algorithm.

However, the document does contain information about non-clinical performance data and acceptance criteria in a broader sense related to safety and effectiveness for substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical):

The submission states: "Non-clinical testing met all established acceptance criteria." While the specific acceptance criteria and detailed performance metrics are not explicitly presented in this summary document, the FDA's clearance implies that the sponsor provided sufficient non-clinical data to demonstrate that the device performs as intended and is as safe and effective as the predicate devices. The non-clinical tests would typically address aspects like:

• Mechanical Integrity/Durability: Ability to securely hold scopes and accessories, withstand repeated use, and resist forces encountered during surgical procedures.
• Compatibility: Ability to attach to the WalterLorenz Surgical Assist Arm and hold a range of scope diameters.
• Sterilization Effectiveness: Validation that the recommended sterilization method (steam sterilization) is effective for the reusable device.
• Material Biocompatibility: Assurance that the stainless steel material is suitable for medical devices and does not pose undue risks.

Key Information from the Document:

• Device Name: WalterLorenz Surgical Assist Arm Scope Holder
• Indications for Use: The device is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc.) and accessories during general diagnostic and therapeutic procedures, including neurologic procedures.
• Predicate Devices:
  • Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder
  • Secondary Predicate: K070509, Fisso Holding Arm
• Similarities to Predicate Devices (basis for substantial equivalence):
  • Similar indications for use.
  • Similar range of scope diameters accepted.
  • Identical sterility (provided non-sterile, to be steam sterilized by end-user).
  • Similar material (Stainless Steel).
• Non-Clinical Performance Data: "Non-clinical testing met all established acceptance criteria." (Specific details of these tests and criteria are not in this summary, but would have been submitted to the FDA).
• Clinical Performance Data: "Clinical testing was not necessary for the determination of substantial equivalence."
• Training Set (for AI/ML): Not applicable for this mechanical device.

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