Search Results

The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.

The KLS Martin Individual Patient Solutions (IPS) Preprosthetic system is comprised of patient-specific models and metallic bone plates with integrated pillars used in conjunction with metallic bone screws for internal fixation of the implant to maxillofacial / midface and mandibular bones. The integrated pillars will serve as the base for temporary dentures as well as a permanent prosthesis. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

The KLS Martin IPS Planning System is utilized to plan and design the IPS Preprosthetic implant. The IPS Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, implants, and case reports.

Implants are provided non-sterile, range in thickness from 1.2 - 10.0 mm, and are manufactured using additive methods from Ti-6Al-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.

Implants have a minimum of two (2) transgingival pillars for the attachment of dental prostheses. The straight pillars (0° to the occlusal plane) have a diameter of 4 mm and are provided at lengths up to 20 mm.

The provided document is a 510(k) summary for the KLS Martin IPS Preprosthetic device and does not contain information about acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The device described, the KLS Martin IPS Preprosthetic, is a patient-specific subperiosteal dental implant, not an AI or CADe system.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample size used for the test set and data provenance for an AI/CADe system.
• Number of experts and their qualifications used to establish ground truth for an AI/CADe system.
• Adjudication method for the test set of an AI/CADe system.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study for an AI/CADe system.
• Standalone performance for an AI/CADe system.
• Type of ground truth used for an AI/CADe system.
• Sample size for and establishment of ground truth for the training set of an AI/CADe system.

The document does mention "Software Verification and Validation" on page 10, stating:
"Software verification and validation was performed on individual software applications that are used in the planning and design of the implant based on the patient's images (CT). Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing required as a result of risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications."

This section indicates that there was software used in the planning and design of the implant, which is based on CT images. This software underwent verification and validation, including "user acceptance testing" and conformity with "pre-defined specifications and acceptance criteria." However, it does not provide the specifics of these acceptance criteria, the study design, or any performance metrics in the format requested for an AI/CADe system. It is a general statement about software V&V, not a study proving the performance of an AI-driven diagnostic or CADe device in a clinical context.

The "Performance Testing - Clinical" section (page 11) discusses the clinical outcomes of the implant device itself (implant loosening, reduced post, exposed/removed screws, infections/abscesses, partial exposure of underlying framework), not the performance of any AI or CADe software used in its design.

Ask a specific question about this device