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Found 65 results
510(k) Data Aggregation
(28 days)
Minnesota 55416-1334
Re: K240567
Trade/Device Name: CustomizedBone Service Regulation Number: 21 CFR 882.5330
| | |
| Regulation Number | 882.5330
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- removal of tumours;
- reabsorption of autologous bone;
- rejection of other prosthetic materials;
- congenital malformations.
CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:
- macro-pores,
- interconnecting pores,
- micro-pores.
This material is biocompatible.
The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.
The provided text describes a 510(k) premarket notification for a medical device called "CustomizedBone Service." It focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the device's design, material, intended use, and a minor change in fixation method.
Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML medical device performance studies. The document describes a traditional medical device submission, not an AI/ML-driven device.
Therefore, I cannot extract the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training data, or ground truth for training data as these concepts are not discussed in the provided text.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions tests for "Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)" and "Usability of an alternative method of fixation." However, these are mechanical/usability tests for a physical implant, not performance metrics for an AI/ML algorithm.
In summary, the provided content is insufficient to answer the prompt because it describes a hardware medical device (cranioplasty plate) and not an AI/ML-driven device requiring the specified performance evaluations.
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(299 days)
Florida 32246
Re: K230211
Trade/Device Name: CranioXpand Regulation Number: 21 CFR 882.5330 Regulation
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| Regulation Numbers: | 882.5330
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| Regulation Numbers: | 882.5330
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the KLS-Martin L.P. CranioXpand device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets clinical performance acceptance criteria through the types of studies you've queried (e.g., MRMC studies, standalone AI performance, expert ground truth adjudication).
The CranioXpand device is a physical implant (spring system) used for cranial conditions in pediatric patients, not an AI or software-based diagnostic tool. Therefore, the types of studies and acceptance criteria you've asked about, which are common for AI-driven image analysis or diagnostic devices, are not applicable to the information contained within this 510(k) submission.
The "studies" conducted for this device are non-clinical performance bench testing and biocompatibility testing, designed to show that the CranioXpand is as safe and effective as its predicate device.
However, I can extract the information relevant to their acceptance criteria and performance studies for this type of medical device:
Here's a breakdown based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CranioXpand device, as reported in this 510(k), are focused on bench testing to demonstrate performance equivalence to the predicate device and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018 for long-term implants in contact with tissue/bone for the springs, and external communicating devices with limited contact for the instruments, covering endpoints such as cytotoxicity, sensitization, irritation, pyrogenicity, carcinogenicity, implantation, acute/subacute/subchronic/chronic toxicity. | The CranioXpand device and accessories were evaluated per FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Process" and found to comply with the requirements of ISO 10993-1:2018 thus are considered biocompatible. |
| Spring Testing (Performance Bench Test) | Force measurements during cyclical testing (compressing to 10mm, holding 5s, decompressing, repeated 6 times) must show performance comparable to the predicate device. The exact quantitative criteria for "comparable" are not explicitly stated, but the conclusion is a "Pass." | "A comparison of the performance of the subject and predicate springs via force measurements during cyclical testing was conducted... The acceptance criteria of the test were met, thus demonstrating that the performance of the subject device is substantially equivalent to that of the predicate device." Concluded: Pass |
| Insertion Instruments Testing | Instrument must appropriately open, close, and pick up the spring. Measurements to verify the instrument could compress spring legs sufficiently ( |
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(133 days)
21030
Re: K231920
Trade/Device Name: Longeviti ClearFit OTS Cranial Implant Regulation Number: 21 CFR 882.5330
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| Classification: | 882.5330
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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(303 days)
Trade/Device Name: PEEK Patient Specific Craniofacial Implant(PSCI) Regulation Number: 21 CFR 882.5330
II |
| Regulation Number: | 21 CFR § 882.5330 |
|---|---|
| Regulation number | 21 CFR § 882.5330 |
The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.
The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for a medical device (PEEK Patient Specific Cranial/Craniofacial Implant).
It details:
- The device's identification and intended use
- Comparison to a predicate device
- Non-clinical testing for biocompatibility and performance (compression, fitting, fixation)
- A statement that no clinical tests were performed.
Therefore, there is no mention of acceptance criteria based on device performance in a clinical study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets. This information would typically be found in a clinical study report, which is not present here.
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(199 days)
Trade/Device Name: MedCAD AccuShape Titanium Patient-Specific Cranial Implant Regulation Number: 21 CFR 882.5330
| Classification Name: Preformed nonalterable cranioplasty plate (21 CFR 882.5330
The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.
The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect.
The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.
The provided document describes the MedCAD AccuShape Titanium Patient-Specific Cranial Implant and its substantial equivalence to a predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant) based on non-clinical performance testing.
It is important to note that this document does not describe an AI/ML-driven device or study parameters typical for such devices (e.g., ground truth establishment for a training set, human reader studies, or expert consensus on clinical data). The device described is a physical cranial implant, and the study referenced in the document is a series of non-clinical performance tests designed to assess the physical and mechanical properties of the implant, not its diagnostic or predictive accuracy in an AI context.
Therefore, many of the requested bullet points, particularly those pertaining to AI/ML device evaluation (like sample size for test/training sets of data, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to the information provided in this document.
However, I can extract information relevant to the device's acceptance criteria and the non-clinical performance testing performed for this physical device.
Here's an interpretation of the "acceptance criteria" and "study" as presented for a physical medical device, rather than an AI/ML diagnostic:
Device: MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357)
Purpose of the "Study" (Non-Clinical Performance Testing): To demonstrate the substantial equivalence of the MedCAD AccuShape Titanium Patient-Specific Cranial Implant to its predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant, K110684) by evaluating its physical and mechanical properties.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Inferred from "Results" and "Test Method Summary") | Reported Device Performance (Results) |
|---|---|---|
| MR Compatibility Testing | To characterize the device's behavior in a Magnetic Resonance Environment per ASTM F2503-20. The acceptance is a clear designation regarding MR compatibility (e.g., safe, unsafe, conditional). | The subject device was characterized to be MR Unsafe. This designation is noted in the labeling. |
| Screw Fixation Testing | Verification that fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model. | PASS: The fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model. |
| Evaluation of Fit Testing | Manufactured implant, based on worst-case CT data (1.25mm scan thickness) from historical cases, must optically align with the 3D model and must fit over the corresponding defect in a representative anatomical model when evaluated by qualified inspectors. Predetermined acceptance criteria must be met. | PASS: All samples met the predetermined acceptance criteria. |
| Comparative Strength | The subject device must demonstrate substantial equivalence in strength to the predicate device (K110684 AccuShape PEEK) when subjected to a load/displacement test until failure, ensuring similar mechanical performance for the same defect geometry and fixation. | PASS: The subject device was substantially equivalent to the predicate device. (Implies that the load/displacement curves and failure points demonstrated comparable mechanical performance to the predicate when tested under identical conditions). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- Evaluation of Fit Testing: "3 large defect predicate historical cases (K110684)" were used to generate "worst case CT data". The number of manufactured implants tested is implied to be at least 3 (one for each case). The phrase "All samples" in the result suggests a specific number of manufactured implants were produced and tested, but the exact number isn't quantified beyond the 3 cases used for input data.
- Comparative Strength: "Identical subject and predicate devices" were used, implying at least one (and likely more for statistical significance, though not stated) of each type (titanium and PEEK) for comparative testing.
- Screw Fixation: Not explicitly stated, but implies multiple tests to determine "at least as strong as" criteria.
- MR Compatibility: At least one device (or representative sample) would be tested.
- Data Provenance: The "worst case CT data" for the Evaluation of Fit testing came from "3 large defect predicate historical cases (K110684)". This suggests a retrospective use of previously acquired clinical data (CT scans) from actual patients. The country of origin is not specified but is implicitly USA, given this is an FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not directly applicable in the context of this device's non-clinical testing. The "ground truth" (or reference standard) is based on engineering specifications, material properties, and established test methodologies (e.g., ASTM standards, previous FDA-cleared device performance).
- For the "Evaluation of Fit Testing," "qualified inspectors" performed the evaluation. Their qualifications (e.g., years of experience, specific certifications) are not detailed beyond "qualified".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers interpreting medical images, where discrepancies need to be resolved. This document describes physical, non-clinical tests.
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 a physical implant, not an AI/ML diagnostic tool, and no human reader study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The manufacturing software is mentioned (same as predicate device), but its
performancein terms of design output is assessed through the physical device tests (e.g., Evaluation of Fit), not as a standalone AI model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests is based on:
- Engineering Specifications/Standards: e.g., ASTM F2503-20 for MR compatibility.
- Predicate Device Performance: For comparative strength, the performance of the legally marketed predicate device (K110684 PEEK implant) served as the benchmark.
- Established Biomechanical Principles: For screw fixation, comparison to "axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model" serves as the reference.
- 3D Digital Models/Physical Prototypes: For "Evaluation of Fit," the 3D digital model of the implant and representative anatomical models served as the reference for fit.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML system that requires a "training set" of data in the machine learning sense. The manufacturing process uses patient-specific CT scan data as input for design, but this is not a training set for an AI model.
9. How the ground truth for the training set was established
- Not applicable, as there is no AI/ML training set in this context.
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(341 days)
Trade/Device Name: Meticuly Patient-Specific Titanium Mesh Implant Regulation Number: 21 CFR 882.5330
| Review Panel: | Neurology (NE) |
| Regulation: | 882.5330
Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.
Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.
The provided text describes the Meticuly Patient-Specific Titanium Mesh Implant and its substantial equivalence determination by the FDA. However, it does not contain the specific information requested regarding an AI/ML powered device, specifically:
- It does not describe acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or F1-score, which are typical for AI/ML devices.
- It does not specify sample sizes for test or training sets in terms of patient numbers or image counts, nor data provenance (country of origin, retrospective/prospective).
- It does not mention the number or qualifications of experts used for ground truth, any adjudication methods, or MRMC comparative effectiveness studies.
- It does not refer to standalone performance for an algorithm or the type of ground truth (e.g., pathology, outcomes data).
Instead, the document details the performance testing for a physical medical device (a patient-specific titanium mesh implant). The performance tests focus on material properties, manufacturing quality, biocompatibility, sterilization, packaging, and mechanical properties. The "comparative device modeling with Finite Element Analysis (FEA)", "comparative mechanical testing with modified compression test", and "comparative roughness testing" are all hardware-related validation activities, not AI/ML algorithm validation.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details for an AI-powered device based on the provided text, as the text describes a physical implant and its regulatory submission, not an AI/ML device.
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(59 days)
Florida 32043-3443
Re: K212414
Trade/Device Name: OSSDSIGN Cranial PSI Regulation Number: 21 CFR 882.5330
Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
The provided text is a 510(k) summary for a medical device called OSSDSIGN Cranial PSI. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not include the detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be necessary to fully answer your request.
The document states that "Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device," and mentions "in vivo studies show biocompatibility, adequate resorption rate and osteoconduction." but doesn't provide the acceptance criteria for these.
Based on the provided text, I can only provide the following information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | In vivo studies show biocompatibility |
| Adequate Resorption Rate | In vivo studies show adequate resorption rate |
| Osteoconduction | In vivo studies show osteoconduction |
| Safety and Effectiveness | Nonclinical tests demonstrate as safe and effective as predicate device |
Note: The document implies these as critical performance aspects, but does not explicitly state quantitative acceptance criteria or detailed performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 52-week sheep implantation study. The exact number of sheep is not specified.
- Data Provenance: In vivo (animal study - sheep). The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study mentioned is an in vivo implantation study, which typically relies on pathological analysis rather than expert human interpretation of imaging.
4. Adjudication method for the test set:
This information is not provided in the document.
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:
This information is not provided in the document. The device, OSSDSIGN Cranial PSI, is a patient-specific implant for cranial reconstruction, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. As mentioned, the device is an implant, not an algorithm.
7. The type of ground truth used:
For the in vivo implantation study, the ground truth would typically be established through histopathological analysis of tissue samples from the implanted area to assess biocompatibility, resorption, and osteoconduction.
8. The sample size for the training set:
This information is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not provided in the document, as it's not relevant to this type of device.
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(69 days)
Re: K212058
Trade/Device Name: Longeviti ClearFit OTS Cranial Implants Regulation Number: 21 CFR 882.5330
| | | | |
| Classification: | 882.5330
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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(30 days)
21030
Re: K210616
Trade/Device Name: Longeviti ClearFit Cranial Implant Regulation Number: 21 CFR 882.5330
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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(33 days)
55082
Re: K203349
Trade/Device Name: Longeviti ClearFit Cranial Implant Regulation Number: 21 CFR 882.5330
Classification | Product Code: GXN, PJN
Class II , 21CFR 882.5330
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:
- A table of acceptance criteria and reported device performance (for an AI/CADe).
- Sample sizes or data provenance for a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Information about MRMC comparative effectiveness studies or effect sizes for human readers.
- Stand-alone performance data for an algorithm.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- 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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