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The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.

The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving device performance for an AI/CADe device. The document is a 510(k) premarket notification letter and summary for a cranial implant (Longeviti ClearFit Cranial Implant), which is a physical medical device, not an AI or CADe product.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (for an AI/CADe).
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information about MRMC comparative effectiveness studies or effect sizes for human readers.
6. Stand-alone performance data for an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "No new performance testing was required to determine substantial equivalence because the manufacturing and materials are identical to those described in K191210. The only additional testing for this submission was the addition of the acoustic property testing to support the labeling change." This indicates that the device's performance was not evaluated through the types of studies typically conducted for AI/CADe systems.

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The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.

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The provided text is a 510(k) clearance letter from the FDA for the Longeviti PMMA Static Cranial Implant, indicating substantial equivalence to a predicate device. It defines the device’s indications for use but does not contain any information regarding acceptance criteria, study details, or device performance metrics.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is typically found in the 510(k) submission summary or a separate clinical study report, which is not part of this document.

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The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.

The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm² and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.

The Longeviti ClearFit Cranial Implant is designed to correct bony voids and/or defects of the cranium. The provided document, a 510(k) Premarket Notification, primarily focuses on demonstrating substantial equivalence to a predicate device (Longeviti PMMA Static Cranial Implant, K170410) rather than a comprehensive study proving novel acceptance criteria.

Based on the information provided, the "acceptance criteria" are implied through various ISO and ASTM standard tests and the "study" is the battery of tests performed to fulfill these standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the listed tests (e.g., number of animals for biocompatibility tests, number of material samples for mechanical tests). It generally indicates that "These tests and their results contributed to the determination of Substantial Equivalence."

The data provenance is not specified. It is likely from laboratory testing conducted as part of the device development and regulatory submission process, rather than patient data. Therefore, it is prospective in the sense that the tests were conducted specifically for this submission. The country of origin for the data is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the provided document. The acceptance criteria and the "ground truth" (i.e., whether the device meets the standards) are established by the internationally recognized standards (ISO, ASTM, USP, AAMI, ANSI) themselves and assessed by qualified testing laboratories, not by a panel of clinical experts for a "test set" in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple experts to establish a consensus ground truth. The tests described here are laboratory and material characterization tests where the results are objectively measured against predefined standard specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through material properties, biocompatibility, and manufacturing process similarities to a predicate device, not on assessing the diagnostic or clinical effectiveness with human readers.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable here. The device is a physical cranial implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is the defined specifications and requirements within the referenced ISO, ASTM, USP, AAMI, and ANSI standards. For instance, for cytotoxicity, the ground truth is the cellular response deemed acceptable by ISO 10993-5. For tensile strength, the ground truth is the specified range or minimum value per ASTM D638-14 to ensure safety and performance.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The Longeviti ClearFit Cranial Implant is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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