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The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP (L) and Cranial Loop (XL), are longterm implantable devices indicated for post-craniotomy bone flap fixation.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

The Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. They can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4mm to 24 mm.

The request cannot be fulfilled as no information regarding acceptance criteria, study details, sample sizes, expert involvement, or specific ground truth methods is provided for an AI/CADe device. The provided text is a 510(k) clearance letter for a cranial bone fixation system, which is a physical implant, not a software or AI device. The document explicitly states "No clinical testing was performed to support this submission." and focuses on "Biomechanical and functional testing" for a physical device.

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The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.

The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.

Two different sizes are presented:

• . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
• . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.

The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.

The provided document is a 510(k) premarket notification for a medical device called "Cranial COVER". This type of document is and does not feature studies in the traditional sense you're asking about (e.g., studies for AI algorithms). The document instead reports on mechanical and performance testing to demonstrate substantial equivalence to predicate devices, which is a common regulatory pathway for medical devices.

Therefore, many of the requested categories for AI/clinical studies are not applicable to this document. I will extract the information that is present regarding the device's acceptance criteria and the engineering tests performed.

No information is available regarding:

• Sample sizes used for test set or data provenance in the context of an AI study.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Standalone (algorithm only) performance.
• Sample size for a training set.
• How ground truth for a training set was established.

Acceptance Criteria and Device Performance (Mechanical and Performance Testing)

The "Cranial COVER" is a physical medical device (burr hole cover), not an AI algorithm. Therefore, the "acceptance criteria" discussed are design specifications and performance metrics related to mechanical function, biomechanics, and biocompatibility, as opposed to diagnostic performance metrics like sensitivity, specificity, or AUC.

Here's a table summarizing the acceptance criteria (stated as "Goal" or implied by standard adherence) and the reported device performance from the "Discussion of mechanical and performance testing" section:

Additional Applicable Information from the Document:

The document states:

• No clinical testing was deemed necessary to support substantial equivalence to predicate devices.
• Biocompatibility: The implantable parts are made of PEEK, which is "well established as an implantable thermoplastic material." The non-implantable parts are made of "biocompatible polymers." This is a qualitative assessment of material suitability.
• Sterility: The sterilization method is identical to the predicate device, Cranial LOOP XL, and the results are comparable. This implies meeting ISO 11137-1/2, ISO 11737-1/2 standards for sterilization.
• Standards Applied: The device adheres to several ISO standards related to sterilization (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2006, ISO 11737-2:2009) and biological evaluation of medical devices (ISO 10993-1:2009). Adherence to these standards serves as a form of acceptance criteria.

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The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL, are long-term implantable devices indicated for post-craniotomy bone flap fixation.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP L (FC050100) are for use within the calvarial gap while the Cranial LOOP XL (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

The Cranial LOOP. Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. This submission includes a line extension for the Cranial LOOP L and Cranial LOOP XL which have new device dimensions and design features that reduce lateral movement after implantation.

Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. It can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4 mm to 24 mm.

The provided text describes the regulatory clearance of a medical device, the "Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System." However, the supplied document does not describe a study involving an AI or algorithm-based device that requires acceptance criteria, a test set, expert ground truth, MRMC studies, or training sets as requested in the prompt.

The document pertains to a physical medical device (a burr hole cover) and details its mechanical, functional, and biomechanical testing to demonstrate substantial equivalence to a predicate device for regulatory clearance. It clearly states: "Clinical data was not required in support of this submission."

Therefore, I cannot provide the information requested in the prompt's numbered list because the provided text does not contain any data related to an AI or algorithm-based device study.

The document mainly covers:

• Device Description: What the Cranial LOOP system is.
• Predicate Device: Its comparison to a previously cleared device (K101235).
• Nonclinical Testing: Various physical tests performed on the device to assess its functionality and performance (e.g., breaking strength, cadaveric tests, biomechanical strength, accelerated aging, dimensional tests, packaging integrity).
• Substantial Equivalence Discussion: How the new device is similar to the predicate device in terms of intended use, operating principle, design, materials, manufacturing, and sterilization processes.

To directly answer the prompt based on the absence of the requested information in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not presented in a formal table with specific numerical acceptance criteria and reported performance values for an AI/algorithm. The document lists "Tests" (e.g., Functional verification, Cadaveric test, Biomechanical tests) but does not provide quantitative acceptance criteria or detailed numerical results for each test. Instead, it refers to the outcome generally as "Mechanical and various performance testing confirms the Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate device."
2. Sample sizes used for the test set and the data provenance: Not applicable to an AI test set. For the physical device testing:
   • Functional verification: Implied that individual units were tested, but specific sample sizes are not explicitly stated (e.g., "A load was applied").
   • Cadaveric test: "Three different craniotomies were tested." (Provenance: not specified, presumably in a lab setting).
   • Accelerated aging test: "5 samples" for 'Blister seal strength', 'Leak integrity', 'Sterility', 'Tensile strength'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and performance testing against defined specifications, not expert consensus on data like images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" refers to engineering specifications, physical properties, and performance against those specifications (e.g., "breaking strength," "adaptation to different cranium curvatures," "strength to bone flap compression"), assessed through standardized, non-clinical mechanical and biological testing.
8. The sample size for the training set: Not applicable. There is no training set for a physical implantable device.
9. How the ground truth for the training set was established: Not applicable.

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The Cranial LOOP Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.

The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use.

The provided text describes a 510(k) premarket notification for the "Cranial LOOP Cranial Bone Fixation System". It outlines the device's intended use, technological comparison to predicate devices, and a general statement about performance testing. However, it does not contain the specific details required to complete your request, particularly regarding acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document states: "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices." This is a summary statement, not the detailed study information you're asking for.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth determination based solely on the provided text.

The closest I can get to addressing your points, based on the limited information, is:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not explicitly stated in the provided text. The document broadly implies that the device must "perform as intended" and be "substantially equivalent to the predicate devices."
   • Reported Device Performance: Not explicitly quantified in the provided text. The document states that "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices."

The remaining points (2-9) require detailed study information that is not present in the provided 510(k) summary document. This document focuses on the regulatory submission, intended use, and substantial equivalence claim, rather than the raw data or detailed methodology of the performance studies.

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