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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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The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and ncural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

The Titanium Mesh Implant is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67). The sides of the cylinder implants contain concentric oval patterned openings. These openings allow the surgeon to trim the cylinder to the desired length at a pre-specified angle relative to the longitudinal axis of the cylinder. The external surface of the implant contains concentric circular grooves perpendicular to the axis of the cylinder which provides a guide in the event that a perpendicular end is desired.

The provided text is for a 510(k) summary for a medical device called the "Titanium Mesh Implant." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a traditional clinical study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission as it is presented. The FDA's review for such a device primarily relies on comparing its design, materials, and intended use to an already legally marketed device to ensure it is equally safe and effective.

Here's how the available information relates to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. This document does not specify acceptance criteria or report performance data in the way a clinical study would for a new AI or diagnostic device. The basis for clearance here is "substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No test set or associated data provenance is described. The approval is based on comparison to a predicate device.

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. No ground truth establishment by experts is mentioned, as this is not a diagnostic device undergoing performance validation with a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication process is described.

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 a physical implant, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

• Not Applicable. This is a physical implant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable. No specific ground truth is referenced for this type of device submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. There is no training set described.

9. How the ground truth for the training set was established

• Not Applicable. There is no training set described.

Summary of what the document does provide regarding "proof":

The "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which aims to demonstrate substantial equivalence to an already legally marketed predicate device, rather than proving performance against new acceptance criteria.

The key points from the document that serve this purpose are:

• Predicate Device: DePuy Acromed Surgical Titanium Mesh (K003043 and K020522)
• Comparison Statement: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Titanium Mesh Implant is considered substantially equivalent to the legally marketed predicate devices."
• Intended Use: The Titanium Mesh Implant's intended use (thoracolumbar spine (T1 to L5) for total replacement of diseased vertebral bodies due to tumors or fractures, to achieve anterior decompression and restore height, with supplemental fixation and bone graft) is explicitly stated to be the same as the predicate device.
• Device Description: The device is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67), with specific design features (concentric oval openings, concentric circular grooves) which presumably are similar to or justify equivalence to the predicate device.
• FDA Clearance: The FDA's letter (DEC 29, 2004) states they have "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "proof" is the successful demonstration of substantial equivalence based on a comparison of intended use, materials, and biomechanical performance to an existing cleared device, as reviewed and accepted by the FDA.

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