(134 days)
The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.
The Pediatric Mandible Distractor (PMD) System is a distraction system consisting of the following major components: distractor with integrated footplates, a removable activation rod and an activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external activation key used to initiate the distraction of the bone segments.
The Pediatric Mandible Distractor (Subject Device) includes the distractor body. integrated footblates, a sliding footblate, and the activation ioint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm), right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.
The Stryker Pediatric Mandible Distractor received 510(k) clearance based on non-clinical performance testing. No clinical testing was performed.
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Fulfilled criteria in accordance with DIN EN ISO 10993 ff as valid 2013: Part 1 Evaluation and testing within a risk management system. | The Subject Device fulfilled all set acceptance criteria for biocompatibility in accordance with ISO specifications. |
| Bench Testing | Fulfilled criteria in accordance with ASTM F 382 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM STP 731 (Tables for Estimating Median Fatigue Limits) for static and dynamic four-point bending, compression force, and distraction force tests. | The Subject Device fulfilled all set acceptance criteria for static and dynamic four-point bending test, compression force tests, and distraction force tests in accordance with ASTM specifications. |
| Cleaning Validation | Internally predetermined acceptance criteria. | The Subject Device fulfilled all set acceptance criteria for cleaning validation. |
| Sterilization Validation | Fulfilled criteria in accordance with various ISO standards for sterilization (e.g., ISO 11138-1, DIN EN ISO 11737-1/2, DIN EN ISO 14161, DIN EN ISO 14937, EN ISO 15883-1, DIN EN ISO 17664, DIN EN ISO 17665-1, DIN ISO/TS 17665-2). | The Subject Device fulfilled all set acceptance criteria for sterilization validation in accordance with ISO specifications. |
| Corrosion | Internally predetermined acceptance criteria. | The Subject Device fulfilled all set acceptance criteria for corrosion. |
| Simulated Aging | Internally predetermined acceptance criteria. | The Subject Device fulfilled all set acceptance criteria for simulated aging. |
| Residual Moisture after Sterilization | Internally predetermined acceptance criteria. | The Subject Device fulfilled all set acceptance criteria for residual moisture after sterilization. |
| Handling of System (End Use Test) | Internally predetermined acceptance criteria. | The Subject Device fulfilled all set acceptance criteria for handling of system (end use test). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical testing was performed and therefore no expert-established ground truth on patient data was required. Acceptance criteria were based on recognized engineering and material standards or internally predetermined criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing involving human reviewers or adjudication of cases was performed.
5. 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
Not applicable, as this device is a physical medical implant and not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable, as this device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing was defined by the specific requirements and limits set forth in the referenced ISO or ASTM standards, or by internally predetermined acceptance criteria when no external standards were applicable. This type of ground truth can be characterized as:
- Standard-based performance metrics: For categories like biocompatibility, bench testing, and sterility, the device's performance was compared against the objective, quantifiable requirements and limits specified in applicable international (ISO) and American (ASTM) standards.
- Engineering specifications/Internal criteria: For other categories (cleaning validation, corrosion, simulated aging, residual moisture, handling), the device was evaluated against internally predetermined specifications and criteria. These likely originated from engineering design requirements, risk assessments, and manufacturing specifications.
8. The sample size for the training set
Not applicable, as this device is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for this physical medical device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.