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The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implant. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria for a study demonstrating device performance, nor details of a study that proves the device meets such criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Information regarding the training set's size or how its ground truth was established.

The document primarily focuses on the regulatory aspects of the device, establishing substantial equivalence to a predicate device, and outlining general controls and FDA regulations. It mentions that there are "no technological differences to the material (PMMA) and no differences to the materials of manufacturing. There are no differences to the packaging or sterilization process" compared to its predicate device (Longeviti ClearFit OTS Cranial Implant, K212058). This suggests that the substantial equivalence determination is based on the similarity of the device to previously cleared devices, rather than new performance data from a specific study demonstrating new acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The text does not contain that information.

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The Longeviti ClearFit™ OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that a specific new device (such as an AI/ML powered device) meets acceptance criteria for classification tasks (e.g., detecting disease, segmenting organs).

Therefore, the document does not contain the information needed to answer questions 1-9 in the requested format, as those questions typically apply to studies evaluating the performance of AI/ML algorithms, especially in diagnostic or clinical decision support contexts.

The document discusses:

• Device Description: Off-the-shelf polymethyl methacrylate (PMMA) cranial implants.
• Intended Use: Correct and/or restore bony voids and/or defects of the cranium.
• Comparison to Predicate: The key difference highlighted is that the subject device is a fixed-size implant, while the predicate is a patient-specific implant. However, the document emphasizes that they use the same materials and manufacturing processes.
• Performance Testing: References several ASTM standards for tensile, flexural, and impact properties of plastics, stating that these tests were "passed" and are applicable due to similar materials and manufacturing.

It does not describe:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" in the sense of a clinical trial or algorithm performance evaluation using a test set of data with ground truth.
• Sample sizes for AI training or test sets.
• Expert involvement for ground truth establishment or MRMC studies.
• Any AI/ML components.

Therefore, it is impossible to populate the requested table and answer the study-related questions based on the provided text, as this document pertains to a physical medical device (cranial implant) and not an AI/ML powered device.

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Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.

Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).

The provided documents do not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of AI/ML-based medical devices or diagnostic tools.

The document is a 510(k) premarket notification for the Longeviti PorousFit implant, which is a physical medical device (an implant for craniofacial reconstruction). The FDA letter and the 510(k) summary pertain to demonstrating substantial equivalence to a predicate device, not to demonstrating performance against specific accuracy metrics for an AI algorithm.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not applicable to an implant undergoing a 510(k) for substantial equivalence. The "performance" for such a device is demonstrated through biocompatibility, mechanical testing, and manufacturing consistency, not diagnostic accuracy.
2. Sample sizes used for the test set and data provenance: No "test set" in the context of an AI/ML algorithm exists. Performance is based on material properties and manufacturing processes.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an implant is its physical and biological properties, not a diagnostic read.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI model evaluation. The "ground truth" for the implant itself relates to its physical and chemical properties and biological response.
8. The sample size for the training set: Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

What the document does describe regarding "testing" for this implant is:

• Summary of Testing: "Testing completed by Matrix Surgical USA for their OmniPore implants are applicable to the Longeviti PorousFit implants. This includes biocompatibility evaluations (Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study), mechanical evaluations, impact testing, purity testing per USP, and porosity testing."

This type of testing is standard for physical implants to ensure their safety and effectiveness, and the applicant is leveraging testing done for their predicate device due to identical materials and manufacturing processes.

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

Not Found

This document is a 510(k) clearance letter for the Longeviti ClearFit Cranial Implant. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The "Indications for Use" section describes the intended use of the device but does not include any performance metrics or acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details) from the provided text.

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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.

Not Found

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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The Longeviti Static Cranial Implants are designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.

The Longeviti PMMA Static Cranial Implants are patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are 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. Typical maximum single plate sizes do 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.

The provided documents are a 510(k) Premarket Notification from the FDA to Longeviti Neuro Solutions, LLC for their Longeviti PMMA Static Cranial Implant. This document does not contain information about an AI/ML-driven medical device or any study proving a device meets acceptance criteria related to AI/ML performance.

The content focuses on:

• Substantial Equivalence: The FDA's determination that the Longeviti PMMA Static Cranial Implant is substantially equivalent to legally marketed predicate devices (OsteoSymbionics Patient Specific Cranial Plate K133082 and OsteoSymbionics Patient Specific Cranial Implant K072601).
• Device Description: The device is a patient-specific, implantable prosthetic cranioplasty plate manufactured from polymethyl methacrylate (PMMA) materials using patient CT scan data.
• Indications for Use: To correct bony voids and/or defects of the cranium.
• Testing Summary: Primarily focused on sterilization validation (ISO-14937) and mechanical strength tests (ASTM D638-03, D790-03, D4812-06) to demonstrate material equivalence to the predicate device.

Therefore, I cannot fulfill your request as the provided text does not contain any of the information required to describe acceptance criteria or a study related to an AI/ML device's performance. There is no mention of an algorithm, AI, machine learning, test sets, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance.

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