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510(k) Data Aggregation
(266 days)
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
The acceptance criteria and study proving the device meets them can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | Demonstrated through extensive comparison of technological characteristics: |
| - Indications for Use | The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures. (Stated as substantially equivalent to predicate devices, expanding on previous indications). |
| - Intended Use | Cutting soft tissue and bone (Similar to predicate devices). |
| - Controller | Console with foot pedal (Similar to predicate devices). |
| - Energy Source | Electrical (Similar to predicate devices). |
| - Speed Indication | Digital (Similar to predicate devices). |
| - Functions | Drill and Microdebrider (Similar to predicate devices). |
| - Drill Motor Speed | Max 80,000 rpm (Similar to predicate devices). |
| - Irrigation | 1 peristaltic pump integrated into console for irrigation (Similar to predicate devices). |
| - Sterilization (Micromotors, Handpieces) | Steam Autoclave, AAMI TIR 12, ISO 17664, ISO 17665 (Similar to predicate devices). |
| - Direct Contact Material (for the proposed device, considering the additional diamond grit) | Stainless Steel / Diamond Grit (Differences in direct contact material related to diamond grit were addressed by biocompatibility testing, demonstrating no impact on safety or effectiveness). |
| Safety and Effectiveness: | |
| - Compliance with Internal Functional Specifications (including software) | Verification/validation testing demonstrated that the device is safe and effective, and performs comparably to and is substantially equivalent to the predicate devices. This included traceability of verification/validation tests to software requirements and software risk hazards. |
| - Operating Temperatures | Testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. |
| - Electrical Safety and Electromagnetic Compatibility (EMC) | Device complies with relevant voluntary safety standards, specifically IEC standards 60601-1 and 60601-1-2. |
| - Biocompatibility (for diamond grit, a new direct contact material) | Cytotoxicity (ISO 10993-5): No cytotoxic potential (MEM Elution method). |
| Irritation/Intracutaneous Reactivity (ISO 10993-10, ISO 10993-12): Not reactive (Intracutaneous Reactivity in Rabbits with two extracts: 0.9% NaCl; sesame oil). | |
| Hemolysis (ISO 10993-4): No hemolytic effect (Material/surface-mediated hemolysis). | |
| Sensitization (ISO 10993-10): No sensitization (Sensitization in Guinea Pigs). | |
| Acute System Toxicity (ISO 10993-11): No evidence of AST observed (Acute System Toxicity in Mice). | |
| - Endotoxin | Met acceptance criterion (< 2.15 EU/device) (Gel-clot-method & Quantitative LAL test). The material-mediated pyrogenicity potential was also adequately evaluated. |
| - Sterilization and Shelf Life (for accessories sold sterile for single use) | Relevant successful sterilizations and shelf life studies have been provided to support the labeled expiration dates. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for a "test set" in the context of clinical data or patient samples. The testing described focuses on engineering verification and validation, biocompatibility, electrical safety, and EMC.
- Engineering Tests (Functional, Software, Operating Temperatures): The "sample size" here would refer to the number of devices or components tested. This is not explicitly specified, but the statement "Test were performed on the OSSEODUO Shaver and Drill System" implies that the relevant device components were subjected to these tests. Given the nature of these tests, it is standard practice to test a representative number of units to ensure compliance.
- Biocompatibility Tests: These tests were performed on "all materials, manufacturing processes and aids used in the manufacture of the patient-contacting device components." The specific number of animals (rabbits, guinea pigs, mice) used for each biocompatibility test is implied by the method (e.g., "Sensitization in Guinea Pigs").
- Data Provenance: The studies are non-clinical, focusing on device performance and safety with respect to its engineering characteristics and material interactions. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective) to report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This is a non-clinical evaluation report for a medical device's engineering and material safety, not a study involving human diagnostic accuracy or clinical outcomes where expert-established ground truth would be required. The "ground truth" here is defined by compliance with established engineering standards, regulatory requirements, and validated test methods.
4. Adjudication Method for the Test Set:
Not applicable. As this is a non-clinical evaluation, there is no need for expert adjudication of results typically found in clinical or image-based studies. Test results are objectively measured against pre-defined acceptance criteria from standards or internal specifications.
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. This submission is for an electromechanical surgical device (shaver and drill system), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. There is no AI algorithm in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing comprises objective measurements against:
- Established engineering specifications (functional performance, software requirements).
- Voluntary safety standards (IEC 60601-1, IEC 60601-1-2).
- Biocompatibility standards (ISO 10993-4, 5, 10, 11, 12).
- Sterilization standards (AAMI TIR 12, ISO 17664, ISO 17665).
- Regulatory guidance documents (e.g., "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").
8. The sample size for the training set:
Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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