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510(k) Data Aggregation
(96 days)
Stryker Pediatric Mandibular Distractor 2
The Stryker Pediatric Mandibular Distractor 2 is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandibular Distractor 2 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 Stryker Pediatric Mandibular Distractor 2 (PMD 2) system is a distraction system consisting of the following major components: distractor with integrated footplates, integrated anti-reverse feature, removable activation rod, deactivation instrument, and a small activation handle/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 small activation handle/activation key used to initiate the distraction of the bone segments. The anti-reverse feature is deactivated with the corresponding deactivation instrument.
The Stryker Pediatric Mandibular Distractor 2 (subject device) includes the distractor body. integrated footplates, a sliding footplate, integrated anti-reverse feature, and the activation joint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm) and right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.
The provided text describes the regulatory clearance of the Stryker Pediatric Mandibular Distractor 2 (PMD 2) and highlights its acceptance criteria through various non-clinical tests. However, it does not include information about a study involving human readers, AI assistance, or the specifics of ground truth establishment for such a study. This is a medical device approval document, not an AI/ML algorithm validation report.
Therefore, many of the requested fields cannot be filled.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Test | Acceptance Criterion | Reported Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Verify biocompatibility in regards to cytotoxicity through in vitro indirect extract tests per ISO-10993-5 and ISO 10993-12. | Acceptance criterion were met; tests were passed. |
| GC/MS Fingerprint | Verify biocompatibility in regards to GC/Fingerprint through in vitro indirect extract tests per ISO-10993-18 and ISO 10993-12. | Acceptance criterion were met; tests were passed. | |
| Corrosion | Verify corrosion behavior of implant and instruments. | Corrosion resistance was proven; tests were passed. | |
| Performance | Dynamic Compression and Tensile Force | Verify that unintended movement of the sliding footplate is properly prevented with an activated "anti-reverse" mechanism. | Acceptance criterion were met; tests were passed. |
| Distraction Force | Verify the distraction force and the ability of small activation handle to transmit sufficient torque. | Acceptance criterion were met; tests were passed. | |
| Anti-Reverse Mechanism Functionality | Verify that activation and deactivation of the anti-reverse feature is possible within shelf life. | Acceptance criterion were met; tests were passed. | |
| Torque to Failure of Anti-Reverse Mechanism | Verify that the torque to failure is high enough that the resistance caused by turning against the activated anti-reverse mechanism is recognizable by the user before breakage. | Acceptance criterion were met; tests were passed. | |
| Deactivation Instrument Lifetime Usage | Verify that deactivation of "anti-reverse" feature is always possible with the deactivation instrument within its lifetime usage. | Acceptance criterion were met; tests were passed. | |
| Effect of Blood Contact on Anti-Reverse Mechanism Functionality | Verify that the functionality of the anti-reverse feature is given after contact with blood. | Acceptance criterion were met; tests were passed. | |
| End User Validation | Validate that the end user needs of the PMD 2 system are fulfilled. | Acceptance criterion were met; tests were passed. | |
| Shelf Life | Aging | Verify that the device, including the anti-reverse feature, maintains properties and characteristics within shelf life. | Acceptance criterion were met; tests were passed. |
| Sterile Packaging | Simulation of handling and transportation from Stryker's stock to end customer and investigation of the integrity of the packaging system, following ISO 11607-1 and ASTM D4169. | Acceptance criterion were met; tests were passed. | |
| Sterilization | Gamma Sterilization Validation | VDmax25 Method for substantiation of 25 kGy as sterilization dose according to ISO 11137-1, -2 and -3 for multiple production batches for verifying compliance with EN 556 to achieve a SAL 10-6. | |
| Microbiological Testing Methods to verify the suitability of of the microbiological test methods used for the bioburden determination and sterility testing for the subsequently planned verification experiment to validate gamma sterilization in accordance to ISO 11737-1 and -2. | Method Validated (for each part of the test). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical (bench) testing, not a clinical study with a "test set" of patients or data in the typical sense. Therefore, "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable to these engineering/materials performance tests. The tests were performed on the device itself and its components.
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)
This is not applicable as the document describes physical and material performance tests for a medical device, not a diagnostic or prognostic algorithm requiring expert-established ground truth from images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for interpretation of clinical or imaging data, not for these types of engineering performance tests.
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
No such study was conducted or mentioned. This document pertains to a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" would be the established scientific and engineering principles, international standards (e.g., ISO, ASTM), and internal company specifications for material properties, mechanical performance, and biocompatibility. The tests verify that the device meets these predefined objective standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm.
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