Search Results
Found 2 results
510(k) Data Aggregation
(323 days)
The ProtoMED DigiGuide System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
The ProtoMED DigiGuide System consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models in order to plan and implement a maxillofacial surgery.
The ProtoMED DigiGuide System is primarily concerned with the manufacturing process and the dimensional accuracy of the physical outputs (models and templates) derived from digital imaging data. The provided document does not detail specific acceptance criteria or a study related to the clinical or diagnostic performance of a software algorithm in a human-in-the-loop or standalone scenario as might be expected for an AI/ML powered medical device. Instead, the focus is on process validation, material biocompatibility, and sterilization, which are standard for manufacturing medical devices.
Therefore, many of the typical questions for AI/ML device performance summarized in the table below cannot be directly answered from this document.
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Planning/Design Process Validation | Successful execution of validations for installation, operational, and process. Comprised of: 1) use STL files from patient anatomy as input for both anatomical model and template manufacturing input, 2) process the files using currently validated software versions and procedures, 3) output digital files that meet requirements. | The final output STL files and physical models/templates demonstrated dimensional and clinical equivalency to STL files used as inputs. This equivalency was demonstrated through overlay of parts for comparison analysis. All Design, Process, and other Verification and Validation testing showed conformity to pre-established specifications and acceptance criteria. |
| Physical Output Accuracy | Manufacture models and templates from output digital files that meet requirements. Dimensional and clinical equivalency to input STL files. | The final output STL files and physical models/templates demonstrated dimensional and clinical equivalency to STL files used as inputs. This equivalency was demonstrated through overlay of parts for comparison analysis. |
| Biocompatibility | In accordance with international standard ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Address biocompatibility for output devices and their intended use (cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, and implantation). | The results of the testing adequately address biocompatibility for the output devices and their intended use. Biocompatibility testing on the final finished device included: cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, and implantation. |
| Sterilization | In accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," to a sterility Assurance Level (SAL) of 1x10-6. | Sterilization validation was conducted to a sterility Assurance Level (SAL) of 1x10-6. All test method acceptance criteria (for sterilization) were met. (Note: The device is provided non-sterile and sterilized by the end-user, so this criterion likely applies to the method developed/validated for end-user sterilization rather than a pre-sterilized product). |
Study Details (as far as can be gleaned from the document):
The document describes Verification and Validation testing rather than a traditional "study" in the context of clinical or diagnostic performance.
-
Sample size used for the test set and the data provenance:
- The document mentions "use STL files from patient anatomy as input" for validation. However, it does not specify the number of patient cases or STL files used in this testing.
- The data provenance (e.g., country of origin, retrospective/prospective) is not specified. It is likely retrospective, using existing patient CT scans.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided about experts used to establish a "ground truth" for a test set in the traditional sense of diagnostic accuracy.
- The development of the "DigiPlan" involves a "physician in conjunction with company technicians," and later, "ProtoMED engineers, technicians, and the physician" for virtual movement of anatomy. This implies clinical input in the creation of the plan, but not necessarily for independent ground truth assessment of a test set.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described as there isn't a stated independent expert review or ground truth establishment for a test set.
-
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:
- No MRMC comparative effectiveness study was conducted or described. The device is a planning and manufacturing system for surgical guides, not an AI-assisted diagnostic tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study of an algorithm is described in terms of diagnostic or clinical accuracy. The "DigiGuide System" involves a collaborative process between company technicians/engineers and a physician, and its performance is assessed via dimensional accuracy and equivalency, not standalone algorithmic output interpretation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the dimensional accuracy of the outputs appears to be the input STL files of patient anatomy and the ability to demonstrate "dimensional and clinical equivalency" through "overlay of parts for comparison analysis." This is effectively comparing the manufactured product to the digital design.
-
The sample size for the training set:
- No information is provided on a "training set" as this is not an explicitly AI/ML software development where a model is trained on data. The software processes input data, but there's no mention of a learning algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable, as no training set is described.
Ask a specific question about this device
(284 days)
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides and case reports for use in the marking of cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options.
The KLS Martin Individual Patient Solutions (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 cranial 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, guides, and case reports for use in the marking of cranial bone in cranial surgery.
The KLS Martin Individual Patient Solutions (IPS) Planning System is a software system and image segmentation system used for transferring imaging information from a CT scan. The system processes input data to produce output data files, which can be digital models or physical outputs like anatomical models, guides, and case reports for cranial surgery. It is also a pre-operative software tool for simulating surgical treatment options.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Tensile & Bending Testing | Polyamide guides withstand multiple sterilization cycles without degradation and maintain 85% of initial tensile strength after 6 months. Additively manufactured titanium devices are equivalent to or better than traditionally manufactured titanium devices. |
| Biocompatibility Testing | Polyamide devices meet pre-defined acceptance criteria (cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic toxicity, material-mediated pyrogenicity, indirect hemolysis). Titanium devices (including acute systemic toxicity, material-mediated pyrogenicity, indirect hemolysis) meet pre-defined acceptance criteria. |
| Sterilization Testing | All output devices (polyamide, epoxy/resin/acrylic, titanium) achieve a sterility assurance level (SAL) of $10^{-6}$ using the biological indicator (BI) overkill method for steam sterilization. |
| Pyrogenicity Testing | Devices contain endotoxin levels below the USP allowed limit for medical devices in contact with cerebrospinal fluid ( |
Ask a specific question about this device
Page 1 of 1