(167 days)
The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.
The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.
This document describes the OsteoMed smartflex Cranial Spring Distraction System and its comparison to predicate devices for 510(k) clearance. The study presented is not a diagnostic device study, but rather a mechanical performance verification and clinical data comparison for a surgical implant. Therefore, several of the requested categories are not directly applicable or are interpreted differently in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating "substantial equivalence" to predicate devices in terms of safety and effectiveness. This is achieved through engineering tests and comparison to clinical outcomes of similar devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Stress on Infant Cranial Bone (below yield strength) | Finite Element Analysis showed stress on cranial bone was 80% below the stress of the predicate Cranial Distractor. |
| Maximum Distraction Distance (safe and effective range) | Maximum possible distraction distance of 55mm was identified as safe. 91 clinical cases with similar devices showed 31 cases reaching 55mm and 60 cases going beyond 55mm with only one skin infection and 3 spring repositioning complications. |
| Distraction Rate (comparable to clinical practice for similar devices) | Average distraction rate of 1.39mm per day (over a six-week duration) was obtained from clinical data and compared to the predicate's 1mm per day (0.5mm twice a day). |
| Spring Geometry and Force Targets (as described in literature/design specification) | Spring geometry was verified using an optical comparator. Force was measured during compression between footplates to simulate initial implantation force, verifying targets were met. |
| Biocompatibility (Medical Grade Stainless Steel per ASTM F-138) | Stated as "Biocompatible" and comparable to the predicate device OsteoMed External Mandibular Distraction System (K063792) which uses similar material. |
| Sterility (Provided Sterile) | Stated as "Provided Sterile (Gamma)" and comparable to predicate device K922211 for sterility method. |
| Overall Safety and Effectiveness (comparable to predicate devices) | "In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices." Substantiated by similarities in intended use, indications for use, function, performance, operational principle, and materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Finite Element Analysis: The sample size is not explicitly stated beyond "Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created," implying a comparison of two models. Data provenance is implied to be simulated data based on infant skull properties.
- Distraction Distance and Rate Clinical Data:
- Sample Size: 91 clinical cases.
- Data Provenance: Clinical data obtained by surgeons, with cranial spring devices similar to the device, manufactured by a physician. No country of origin is specified, but it's referred to as "clinical data," suggesting retrospective human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Finite Element Analysis: Not applicable in the context of expert ground truth. The "ground truth" here would be established by engineering principles and validated models.
- Distraction Distance and Rate Clinical Data: The data was obtained by "surgeons." The number of surgeons is not specified. Their qualifications are implicitly that they are "a physician in cranial distraction," suggesting expert practitioners in the field.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense of multiple experts reviewing and reaching consensus on an output, as this is not a diagnostic study. For the clinical data, the "ground truth" appears to be the observed clinical outcomes as recorded by the treating surgeons. There is no mention of independent expert review or adjudication of these historical clinical outcomes for the purpose of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study compares the performance of the new device to predicate devices and existing clinical data, but not in a multi-reader, human-AI assisted vs. human-only paradigm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical surgical implant, not an algorithm or AI system. Therefore, the concept of "standalone" algorithm performance is not applicable. The performance described relates to mechanical characteristics and clinical outcomes of the physical device.
7. The Type of Ground Truth Used
- Finite Element Analysis: Engineering models and "infant skull properties" as established physical parameters.
- Distraction Distance and Rate: Clinical outcomes data (observed distraction distances and rates, and complications) from actual patient cases.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The clinical data on 91 cases mentioned for distraction distance and rate appears to be the primary observational data used for performance comparison and justification, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly defined "training set" for an algorithm in this submission. The 91 clinical cases' outcomes were established by the treating surgeons and their medical records.
§ 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).