Search Results
Found 1 results
510(k) Data Aggregation
(386 days)
The EBERLE shaver system C3 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, cutting and resecting of fibrous tissue, cartilage tissue and bone.
The EBERLE shaver system accessories are designed to use with the EBERLE shaver system for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.
The EBERLE Shaver System C3 and shaver blades is a powered instrument system and consists of a control unit, a foot switch, handpiece(s), and accessories - associated sterile shaver blades for single use.
The control unit C3 includes three software systems. The other components of the shaver system C3 e.q. handpiece or footswitch consist only of hardware components. All software systems on the control unit are running on microcontrollers.
The Eberle Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector consist of Polyoxymethylen (POM), the tubes consists of stainless steel. The shaver blades are provided in a sterile packaging and are intended for single use. The shaver blades are sterilized using EO sterilization with a Sterilization Assurance Level (SAL) of 10-6.
The Eberle Handpieces with switch buttons have three buttons to select the direction of rotation depending on the user assignment of functionalities to the buttons. It consists of Stainless Steel and Aluminum.
The Eberle Drill and the Saw - Handpieces also consist of Stainless Steel and Aluminum. The Drill Handpiece has two buttons to select the direction of rotation and the saw has an operator lever.
All these components are designed, constructed and intended to be operated exclusively as a system. EBERLE Shaver System C2 and C3 use the same shaver blades. The shaver blades are identical with the once already cleared under the predicated device K092977 - Eberle Shaver System Accessories. Eberle has added addition blades to provide a broader offering.
EBERLE Shaver System C2 and C3 have common handpieces and use the same kind of adapters.
While the provided document details the testing performed for the EBERLE Shaver System C3 to demonstrate substantial equivalence to its predicate devices, it does not explicitly state "acceptance criteria" in the typical quantitative sense for each test. Instead, the document describes the compliance with recognized standards and a demonstration of substantial equivalence as the desired outcome of the testing.
Therefore, for the purpose of answering your request, I will interpret "acceptance criteria" as the successful demonstration of compliance with the referenced standards and the achievement of substantial equivalence, as reported in the "Results" column of the summary table.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|---|
| Electrical safety and Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1 and IEC 60601-1-2 standards. Demonstration of substantial equivalence to predicate device. | Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device. |
| Biocompatibility testing | Compliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11. Demonstration of substantial equivalence to predicate device. | The following non clinical tests were performed on the subject or equivalent device: Cytotoxicity, Sensitization, Irritation and Acute systemic toxicity and demonstrated to be substantially equivalent to the predicate device. |
| Software Verification and Validation Testing | Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304. Demonstration of substantially equivalent performance to identified predicate device. | Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device. |
| Sterilization Validation | Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7. Sterility assurance level (SAL) of 10^-6. Residual EO < 4 mg and ECH < 9 mg after 1 day of aeration. Package and product integrity tested in accordance with ISO11607-1. Demonstration of substantial equivalence to predicate device. | Validation was performed on the subject device and demonstrated to be substantially equivalent to the identified predicate devices. Residual EO < 4 mg and ECH < 9 mg. SAL was 10^-6. Package and product integrity tested. |
| Bench Tests (Functional and Usability) | Compliance with IEC 62366 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices. Demonstration of substantially equivalent performance to identified predicate device. | Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of number of devices or cases for the performance tests. The testing appears to be conducted on the EBERLE Shaver System C3 itself, rather than on a dataset of patient information.
For the Biocompatibility testing, it mentions "the subject or equivalent device," implying samples of the device materials were used.
For the Sterilization Validation, it refers to "the EBERLE Shavers" as the subject of validation.
The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing processes. The studies are retrospective in the sense that they are conducted after the device design is largely finalized, but they are not based on retrospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance testing described (electrical safety, EMC, biocompatibility, software verification, sterilization, bench tests) does not involve expert review or adjudication of medical images or patient data to establish ground truth. These are engineering and laboratory-based assessments against defined standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of expert review or consensus as typically seen in clinical evaluation of AI/diagnostic devices. The outcomes of the engineering and lab tests are based on direct measurement and comparison to predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical shaver system, not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.
6. Standalone Performance Study
Yes, a standalone study (i.e., algorithm only without human-in-the-loop performance) was effectively done for the software components. The "Software Verification and Validation Testing" specifically states that "Conformity of software with the user needs and intended use of the device were performed through the 'Validation' phase of the EBERLE Shaver System C3 device," implying the software was tested independently to confirm its correct function according to its requirements.
7. Type of Ground Truth Used
For the specific tests described:
- Electrical safety and EMC: Ground truth is established by recognized international standards (IEC 60601-1, IEC 60601-1-2).
- Biocompatibility: Ground truth is established by recognized international standards (ISO 10993 series) and FDA guidance.
- Software Verification and Validation: Ground truth is established by software requirements specifications, design specifications, and relevant standards (FDA guidance, IEC 62304).
- Sterilization Validation: Ground truth is established by recognized international standards (ISO 11135, ISO 14937, ISO 10993-7) for sterility assurance level, residual levels, and package integrity.
- Bench Tests (Functional and Usability): Ground truth is established by the device's functional design specifications and usability engineering standards (IEC 62366).
8. Sample Size for the Training Set
Not applicable. The device is a physical surgical instrument system with software components. It does not employ machine learning or AI that would require a "training set" of data in the typical sense. The software development follows a traditional software lifecycle process (design, implement, test) rather than a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model. The software's "ground truth" (i.e., its correct functionality) is established through its design specifications and validation against those specifications and relevant regulatory standards.
Ask a specific question about this device
Page 1 of 1