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510(k) Data Aggregation
(445 days)
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.
MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.
The document discusses:
- Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
- Device Description: The system consists of plates, screws, and meshes made from titanium.
- Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
- Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
- Biocompatibility: Stated as supported by a reference device (K182758).
- Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."
Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.
Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.
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(341 days)
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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(217 days)
The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Sterile NS System." This notification seeks to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes the comparison to predicate devices rather than a standalone study with defined acceptance criteria and performance metrics for the novel device itself.
Based on the provided text, the following information can be extracted and interpreted regarding the "acceptance criteria" and "study."
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the traditional sense, such as specific thresholds for sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical tests to verify compliance with design specifications and standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Non-Clinical Testing) | Reported Device Performance (from "Non-Clinical Test Summary") |
|---|---|
| Functional Equivalence: Same intended use as predicate devices. | "The Sterile NS System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures." (Same as predicate) |
| Material Equivalence: Same materials as predicate devices. | Plate: Pure titanium Grade4 (ASTM F67); Screw: Titanium alloy (Ti-6AL-4V ELI, ASTM F136) (Same as predicate) |
| Design Feature Equivalence: Same design features (thickness, dimensions, surface) as predicate devices. | Plate: Plate thickness 0.3mm ~ 1.0mm, Surface: Anodized; Screw: Screw Outer Dia. 1.4 ~ 1.8mm, Screw Length 2.2~5.0mm, Surface: N/A (Same as predicate). Compliance ensured by "Dimension test" for both plate and screws. |
| Biocompatibility: Conform to relevant standards. | "Conform" (Same as predicate) |
| Sterilization Efficacy & Safety: New sterilization method (radiation-sterile) does not raise new safety or performance issues compared to predicate's non-sterile (steam sterilization by user). | "The performance test data provided in this submission proves that this differences do not raise new issues in safety and performance." (Specific results of these "performance tests" for sterilization are not detailed in this summary, but are implied to be part of the submission.) |
| Compliance with Standards & Worst Case Criteria: Device meets all design specifications and applicable standards. | "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." (Specific standards and precise results are not detailed but are stated as met. Implied tests: Dimension test for plate and screws.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical studies were considered necessary and performed." Therefore, there is no test set in the sense of patient data. The "test set" refers to the physical devices that underwent non-clinical testing. The sample size for these non-clinical tests (e.g., how many plates or screws were dimensionally tested) is not specified in the provided text. The data provenance is also not specified beyond the manufacturer being in Korea.
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. This device is a physical medical implant, not an AI/diagnostic software, and no human ground truth establishment (e.g., by clinicians or radiologists) is described or relevant for the substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a diagnostic device involving human interpretation, adjudication methods are not 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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and established standards (e.g., ASTM F67, ASTM F136). The tests (e.g., "Dimension test") verify that the manufactured devices conform to these pre-defined specifications.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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