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Leksell Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any AI-related effectiveness studies. The document is a 510(k) clearance letter from the FDA for a medical device called the "Leksell Stereotactic System," classifying it as substantially equivalent to a predicate device for specific indications for use.

Therefore, I cannot generate a response that includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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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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The Leksell Stereotactic System with disposable biopsy needle kit Indications for Use is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Elekta Leksell Stereotactic System. This document does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The letter serves as an FDA clearance, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements, but it does not include the detailed technical and clinical study information typically found in a 510(k) submission itself.

Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the actual 510(k) submission document (K031980) which would contain the study details.

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The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Elekta Leksell Stereotactic System, indicating that the device is substantially equivalent to a predicate device. It defines the indications for use but does not contain details of any performance studies, acceptance criteria, sample sizes, or ground truth establishment.

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The Leksell Stereotactic System is a system intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

The Leksell Stereotactic System is a stereotaxic instrument and accessories which functions on the center-of-the-arc principle. The basic components of the system are a cartcsian coordinate frame and a semi-circular arc. The system has been developed as a modular design with dedicated components and a range of optional accessories. Accessories are available for stereotactic micro-surgery and functional interventions, target localization, diagnostic and therapeutic procedures, and Gamma Knife surgery.

The provided text describes a 510(k) submission for the Elekta Leksell Stereotactic System, where the device is demonstrated to be substantially equivalent to predicate devices. The submission focuses on product characteristics and performance relative to existing, cleared devices, rather than a standalone clinical study with specific acceptance criteria in the manner of a novel AI/software medical device.

Therefore, much of the requested information (such as specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies often associated with AI/ML evaluations) is not present in this type of traditional medical device submission.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. The document states "Complete results of performance testing of the Leksell Stereotactic System have been included the 510(k) submission," but the specific details of the test set, including sample size or data provenance, are not provided in this summary. This generally pertains to engineering bench testing rather than clinical study data for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Available. For a stereotactic system, "ground truth" would typically refer to physical measurements or engineering precision rather than expert human interpretation of medical images to establish a diagnosis or finding. The document does not describe the use of human experts in this manner.

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

• Not Applicable/Not Available. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. The performance testing for this device would likely involve objective physical measurements and engineering specifications, where adjudication is not typically relevant.

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

• No. This is not an AI/software device. It is a physical stereotactic system. Therefore, an MRMC study and effects on human readers with/without AI assistance are not relevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its mechanical and functional design, often evaluated in a standalone bench-testing environment.

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

• Implied: For a stereotactic system, the "ground truth" would be established through precision engineering measurements and physical accuracy standards. This would involve comparing the system's calculated coordinates and physical targeting capabilities against known, independently verified reference points or specifications. However, the specific methodology is not detailed.

8. The sample size for the training set

• Not Applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. This device is not an AI/ML algorithm that requires a training set.

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