(299 days)
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the KLS-Martin L.P. CranioXpand device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets clinical performance acceptance criteria through the types of studies you've queried (e.g., MRMC studies, standalone AI performance, expert ground truth adjudication).
The CranioXpand device is a physical implant (spring system) used for cranial conditions in pediatric patients, not an AI or software-based diagnostic tool. Therefore, the types of studies and acceptance criteria you've asked about, which are common for AI-driven image analysis or diagnostic devices, are not applicable to the information contained within this 510(k) submission.
The "studies" conducted for this device are non-clinical performance bench testing and biocompatibility testing, designed to show that the CranioXpand is as safe and effective as its predicate device.
However, I can extract the information relevant to their acceptance criteria and performance studies for this type of medical device:
Here's a breakdown based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CranioXpand device, as reported in this 510(k), are focused on bench testing to demonstrate performance equivalence to the predicate device and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018 for long-term implants in contact with tissue/bone for the springs, and external communicating devices with limited contact for the instruments, covering endpoints such as cytotoxicity, sensitization, irritation, pyrogenicity, carcinogenicity, implantation, acute/subacute/subchronic/chronic toxicity. | The CranioXpand device and accessories were evaluated per FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Process" and found to comply with the requirements of ISO 10993-1:2018 thus are considered biocompatible. |
| Spring Testing (Performance Bench Test) | Force measurements during cyclical testing (compressing to 10mm, holding 5s, decompressing, repeated 6 times) must show performance comparable to the predicate device. The exact quantitative criteria for "comparable" are not explicitly stated, but the conclusion is a "Pass." | "A comparison of the performance of the subject and predicate springs via force measurements during cyclical testing was conducted... The acceptance criteria of the test were met, thus demonstrating that the performance of the subject device is substantially equivalent to that of the predicate device." Concluded: Pass |
| Insertion Instruments Testing | Instrument must appropriately open, close, and pick up the spring. Measurements to verify the instrument could compress spring legs sufficiently ( |
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).