(132 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 and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
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 and cutting of cranial bone in cranial surgery.
The provided text is a 510(k) summary for the KLS Martin Individual Patient Solutions (IPS) Planning System. It details the device, its intended use, and comparisons to predicate and reference devices. However, it does not describe specific acceptance criteria and a study dedicated to proving the device meets those criteria in the typical format of a diagnostic AI/ML device submission.
Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (K182889) and leveraging existing data from that predicate, as well as two reference devices (K182789 and K190229). The "performance data" sections describe traditional medical device testing (tensile, biocompatibility, sterilization, software V&V) and a simulated design validation testing and human factors and usability testing rather than a clinical study evaluating the accuracy of an AI/ML algorithm's output against a ground truth.
Specifically, there is no mention of:
- Acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
- A test set with sample size, data provenance, or ground truth establishment details for AI/ML performance evaluation.
- Expert adjudication methods, MRMC studies, or standalone algorithm performance.
The "Simulated Design Validation Testing" and "Human Factors and Usability Testing" are the closest sections to a performance study for the IPS Planning System, but they are not framed as an AI/ML performance study as requested in the prompt.
Given this, I will extract and synthesize the information available regarding the described testing and attempt to structure it to address your questions, while explicitly noting where the requested information is not present in the provided document.
Acceptance Criteria and Device Performance (as inferred from the document)
The document primarily states that the device passes "all acceptance criteria" for various tests, but the specific numerical acceptance criteria (e.g., minimum tensile strength, maximum endotoxin levels) and reported performance values are generally not explicitly quantified in a table format. The closest to "performance" is the statement that "additively manufactured titanium devices are equivalent or better than titanium devices manufactured using traditional (subtractive) methods."
Since the document doesn't provide a table of acceptance criteria and reported numerical performance for an AI/ML model's accuracy, I will present the acceptance criteria and performance as described for the tests performed:
| Test Category | Acceptance Criteria (as described) | Reported Device Performance (as described) |
|---|---|---|
| Tensile & Bending Testing | Polyamide guides can withstand multiple sterilization cycles without degradation and can maintain 85% of initial tensile strength. Titanium devices must be equivalent or better than those manufactured using traditional methods. | Polyamide guides meet criteria. Additively manufactured titanium devices are equivalent or better than traditionally manufactured ones. |
| Biocompatibility Testing | All biocompatibility endpoints (cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic, material-mediated pyrogenicity, indirect hemolysis) must be within pre-defined acceptance criteria. | All conducted tests were within pre-defined acceptance criteria, adequately addressing biocompatibility. |
| Sterilization Testing | Sterility Assurance Level (SAL) of 10^-6 for dynamic-air-removal cycle. All test method acceptance criteria must be met. | All test method acceptance criteria were met. |
| Pyrogenicity Testing | Endotoxin levels must be below the USP allowed limit for medical devices that have contact with cerebrospinal fluid ( |
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).