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The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.

The provided documents seem to be segments of a 510(k) submission for a medical device called "Leksell Stereotactic System® with Reusable Fixation Screws." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data for a new, standalone device or AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given text.

Here's an explanation of why and what information can be extracted:

Information NOT available in the provided text:

• Acceptance Criteria Table and Reported Device Performance: This type of document is a 510(k) summary, which typically focuses on demonstrating equivalence to an existing device rather than presenting raw performance data against specific, quantifiable acceptance criteria. There are no tables outlining performance metrics like accuracy, sensitivity, specificity, resolution, etc., or corresponding acceptance thresholds.
• Sample sizes (test set), data provenance: There is no mention of a specific test set, its size, or the origin of the data.
• Number and qualifications of experts for ground truth: No information is provided about experts used to establish a ground truth.
• Adjudication method for the test set: No adjudication method is mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned. The submission aims for substantial equivalence, not necessarily a comparison of reader performance with and without an AI.
• Standalone (algorithm only) performance: This device is a physical stereotactic system, not an AI algorithm, so standalone algorithm performance is not applicable or discussed.
• Type of ground truth used: Since no specific performance study is detailed, the type of ground truth used is not described.
• Sample size for the training set: Not applicable as it's a physical device, not a machine learning algorithm.
• How ground truth for the training set was established: Not applicable.

However, some relevant information can be extracted regarding the device and its regulatory context:

Device Description and Intended Use:

• Device Name: Leksell Stereotactic System® with Reusable Fixation Screws
• Intended Use: The system is intended for "localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiation therapy."
• Device Classification:
  • Common Name: Stereotaxic instrument
  • Product Code: HAW
  • Class: II
  • Regulation Number: 21 CFR 882.4560

Substantial Equivalence Claim:

• Predicate Device: Leksell Stereotactic System® (K031999)
• Claim: The functionality of the Leksell Stereotactic System® with Reusable Fixation Screws is "equivalent to its predicate device... in safety and effectiveness." The fundamental technical characteristics are stated to be "the same to those of the predicate device."

Regulatory Outcome:

• The FDA reviewed the 510(k) application (K080355) and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not require premarket approval (PMA).

In summary: The provided documents detail a 510(k) submission for a stereotactic system, focusing on its equivalence to a previously cleared device. It does not contain the specific performance study data and acceptance criteria typically associated with testing a new device or an AI algorithm against defined performance metrics.

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