(86 days)
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.
The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.
The provided text describes a 510(k) premarket notification for the OSSEOSTAP Microdrill System, focusing on its substantial equivalence to a predicate device. This document does not describe an AI/ML powered device, nor does it contain information typically associated with studies proving acceptance criteria for such devices (e.g., performance metrics like sensitivity, specificity, F1-score, sample sizes for AI models, expert ground truth establishment, MRMC studies, or standalone performance).
The information provided pertains to a traditional surgical drill and its components comparing to an existing drill (the Skeeter Ultra-Lite Oto-Tool Drill). The "acceptance criteria" here are based on demonstrating that the new device is "at least as good" as the predicate device in terms of handling, cutting performance, and noise level, and that it meets established safety and performance standards for medical devices (e.g., sterilization, biocompatibility, electrical safety).
Therefore, I cannot fulfill your request as it's designed for an AI/ML medical device submission. However, I can extract the relevant non-clinical performance data and the general approach to demonstrating "acceptance" within the context of this 510(k) submission for a non-AI device.
Based on the provided text, the device is not an AI/ML powered device. As such, the standard acceptance criteria, study methodologies, and performance metrics typically associated with AI/ML device submissions (e.g., AUROC, sensitivity, specificity, expert readers, ground truth establishment for AI) are not applicable or present in this document.
However, I can describe the non-clinical performance and acceptance criteria for this traditional medical device based on the provided FDA 510(k) summary.
Description of Acceptance Criteria and Study for OSSEOSTAP Microdrill System
The OSSEOSTAP Microdrill System is a traditional surgical device and its acceptance criteria primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device (Skeeter Ultra-Lite Oto-Tool Drill) through non-clinical performance testing, material safety, and adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| Bench Testing Comparison to Predicate: | |
| Handling Performance | At least as good as the predicate (Skeeter) |
| Cutting Performance | At least as good as the predicate (Skeeter) |
| Noise Level | At least as good as the predicate (Skeeter) |
| Material & Durability: | |
| Bur Resistance | Evaluated on basis of repeated running, traction tests, repeated sterilization cycles |
| Handpiece Functionality after Reprocessing | Confirmed with a cycle test after multiple reprocessing cycles |
| Cleaning Validation (Handpiece) | Validated in an external lab using proteins as marker |
| Moist Heat Sterilization Validation (Handpiece) | Validated based on lab validation of 2 related devices sharing similar components but with more complex geometry |
| Cleaning Validation (Reusable Burs) | Validated by an external lab |
| Steam Sterilization Validation (Reusable Burs) | Validated by an external lab |
| Biocompatibility | Evaluated according to ISO 10993-1. Materials (stainless steel for handpiece, stainless steel/diamond/carbide for burs) are suitable for limited direct contact with bone/tissue. |
| Software, Electrical Safety, and EMC: | |
| Software Level of Concern | Classified as minor level of concern (validation documents available) |
| Electrical Safety | Certified through IEC 60601-1 3rd edition |
| EMC Certification | Certified according to IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance:
- This information is not applicable for the type of testing described. The "test set" here refers to specific units of the OSSEOSTAP device and its components (burs, handpiece) being subjected to bench and lab-based performance, durability, and safety assessments. No patient data or imagery is involved. The studies are non-clinical, likely conducted in a lab environment (as indicated by "external lab" for validation).
- Data Provenance: The studies were conducted by the manufacturer (Bien-Air Surgery SA, Switzerland) and external labs. The nature of these tests (e.g., material stress tests, cleaning validation) doesn't typically involve "country of origin of the data" in the same sense as clinical or imaging data; it refers to the location of the test facilities.
- Retrospective/Prospective: These are non-clinical, prospective tests specifically designed to evaluate the manufactured device against pre-defined performance and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as the studies are non-clinical performance tests for a traditional surgical device. There is no "ground truth" to be established by clinical experts in the context of diagnostic interpretation or clinical outcomes. Performance criteria are based on engineering specifications, material standards, and comparative testing against a predicate device.
4. Adjudication Method for the Test Set:
- Not applicable for these non-clinical, objective performance tests. The results are typically quantitative measurements or pass/fail assessments against established standards and predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-powered diagnostic or screening devices involving human readers interpreting clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm-only or AI-powered device.
7. The Type of Ground Truth Used:
- Not applicable in the context of AI/ML. For this device, the "ground truth" or reference for performance is established by:
- Predicate Device Performance: The primary reference is the performance of the Medtronic Xomed Inc. Skeeter Ultra-Lite Oto-Tool Drill (K041523).
- Industry Standards: Compliance with international standards such as ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).
- Engineering Specifications: Internal design specifications for bur resistance, handpiece functionality, rotation speed, etc.
- Laboratory Validation Results: Objective measurements from external lab validations for cleaning and sterilization.
8. The Sample Size for the Training Set:
- Not applicable as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as this is not an AI/ML device.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.