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510(k) Data Aggregation
(269 days)
Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Fehling-Punches are reusable stainless steel instruments that are coated with CERAMO® that are sterilizable and packaged non-sterile. The instruments are offered in various sizes and with different features to accommodate the variations of patient anatomy and access. Instruments are available with the following features: 0.8-8 mm bite sizes; 9 – 19 mm jaw openings; 40° and 90° up/down cutting angles; up/down curved; reqular and thin profile footplates; standard and ejector tips; 110 - 400 mm shaft lengths; and various handle and shaft styles, detachable and non-detachable. Fehling-Punches are distributed under the following brand names: CERAMO® CONCEPT X, CERAMO® CONCEPT CLASSIC, CERAMO® CONCEPT APART, CERAMO® GENTLE, CERAMO® GENTLE "SINGER", CERAMO® TRADITION X, CERAMO® FIST. CERAMO® EJECTOR, CERAMO® SUBLAMINAR, CERAMO® APART, CERAMO® KERRISION. The instruments are made of stainless steel according to ASTM F899 and are coated with CERAMO®. CERAMO®is an AlTiN coating. A reusable screwdriver (item code TXW-9X) is offered with the Fehling Punches for the assembly and disassembly.
The acceptance criteria table and device performance based on the provided document are as follows. Please note that the document does not describe a study involving an AI/algorithmic device. The device described is a manual surgical instrument (bone punches). Therefore, many of the requested categories related to AI/MRMC studies, ground truth methodology, and training/test set details are not applicable as they pertain to AI algorithms, not manual instruments.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | No cytotoxic potential | No cytotoxic potential to L-929 mouse fibroblast cells. |
| Sensitization | Not considered a sensitizer (per ISO 10993-10) | Not considered a sensitizer in the guinea pig maximization model. |
| Hemolysis | Non-hemolytic | Direct contact and extract were non-hemolytic (mean hemolytic index < 2%). |
| Acute Systemic Toxicity | No significant systemic toxicity or mortality (per ISO 10993-11) | No evidence of significant systemic toxicity or mortality. |
| Intracutaneous Study | Met requirements of Intracutaneous injection test (per ISO 10993-10) | Met requirements of the Intracutaneous injection test. |
| Pyrogenicity | Non-pyrogenic (for devices that have undergone validated cleaning and sterilization) | Non-pyrogenic. |
| LAL-Test (Bacterial Endotoxin) | Non-pyrogenic (for devices that have undergone validated cleaning and sterilization) | Non-pyrogenic. |
| Performance Testing | ||
| Dynamic (Fatigue Resistance) | Maintained integrity after 12,500 cutting simulations | Confirmed integrity after 12,500 cutting simulations. |
| Static (Cutting Force) | Comparable mean force required to operate to predicate device | Mean force required comparable to the predicate device. |
| Coating Thickness Verification | Coating thickness present on all relevant surface areas and within an advantageous range | Coating thickness verified to be present and within an advantageous range. |
| Dimensional Verification | Conformed to actual specifications | Dimensional and functional specifications verified. |
| Performance Tests | Passed defined parameters for worst-case and extended use | Devices passed tests (one deviation noted but attributed to misplacement). |
| Processing Validation | ||
| Automated Cleaning Validation | Automated cleaning validated (per AAMI TIR 30) | Automated cleaning was validated. |
| Sterilization Validation | Sterilization process validated (per ISO 17665, AAMI TIR 30) | Sterilization process was validated (full cycle 132°C and 4 min). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing of physical device properties and biocompatibility, not analysis of a "test set" of data in the context of an AI/algorithmic device. Therefore, typical metrics for data-driven test sets (e.g., country of origin, retrospective/prospective) are not applicable.
- Biocompatibility Tests: Sample sizes for each specific biocompatibility test (cytotoxicity, sensitization, etc.) are not explicitly stated within the summary, but they were conducted on the "Fehling-Punches" device.
- Performance Tests: The "dynamic test" involved 12,500 cutting simulations, implying a test set for fatigue evaluation. Other performance tests (static, coating, dimensional) were conducted on the device itself.
- Data Provenance: The tests were conducted by the manufacturer or their contracted labs as part of the 510(k) submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a manual surgical instrument, and its performance was evaluated through laboratory testing and engineering analysis against established standards and predicate devices, not by human experts establishing "ground truth" in the context of an AI algorithm's output.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" requiring adjudication by multiple experts in the context of an AI device. Performance was determined by objective measurements and standardized testing protocols.
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
This is not applicable. The device is a manual surgical instrument and does not involve AI assistance or human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical, manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Established industry standards: E.g., ISO 10993 for biocompatibility, AAMI TIR 30 and ISO 17665 for cleaning and sterilization.
- Comparison to legally marketed predicate devices: Establishing substantial equivalence by demonstrating similar performance characteristics (e.g., cutting force, fatigue resistance) and safety profiles.
- Dimensional and functional specifications: Internal engineering and design specifications for the device.
8. The Sample Size for the Training Set
This is not applicable. The device is a manually operated surgical instrument, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There was no training set or AI algorithm involved.
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