(154 days)
The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:
- Different handles (Large, Standard, for use with Rotating Shafts)
- Different shaft lengths (6-14 inches)
- Different Bite Sizes (0.5-6 mm)
- Different Angles (40° and 90°, up and down)
- Different Footplates (Standard, Thin and Ultra-Thin)
- With or without ejector
- Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
Here's a breakdown of the acceptance criteria and study information for the Ace Medical Surgical Instruments, based on the provided FDA 510(k) summary:
This device is a manual surgical instrument (rongeur), not an AI/ML-driven device. Therefore, many of the typical AI/ML study components (like expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable. The studies focus on the physical and functional characteristics of the surgical instrument.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The predicate device (Fehling Punches) demonstrated fatigue resistance and appropriate cutting displacement in relation to applied force. The subject device must be identical to the predicate in materials, manufacture, design, and function to meet this. | The subject device is identical to the predicate in materials, manufacture, design, and function. No further mechanical testing was conducted as direct testing on the subject device was deemed unnecessary due to this identity. |
| Cleaning | Instruments must be free of visible soil and meet acceptance criteria for protein and hemoglobin content as specified by AAMI TIR 30:2011. | Instruments were free of visible soil and met acceptance criteria for protein and hemoglobin content per AAMI TIR 30:2011. |
| Sterilization | Sterilization parameters must provide a sterility assurance level (SAL) of 10^-6. | Sterilization parameters will provide a sterility assurance level of 10^-6. |
| Biocompatibility | The device materials and manufacturing processes must be biocompatible, consistent with the predicate. | The subject device is identical to the predicate in materials, manufacturing processes, manufacturer, sterilization, and technical specifications. No further biocompatibility testing was required. |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Strength: The summary indicates that the predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing. The specific sample size for this predicate testing is not provided in this document. The subject device was deemed identical, so no separate test set was used for mechanical strength for the subject device.
- Cleaning: A cleaning validation was performed on a "worst case instrument." This implies a single instrument or a very small sample to represent the most challenging cleaning scenario.
- Sterilization: The validation used a "half-cycle approach," which is a common method for sterilization cycle validation, but the exact sample size (number of devices or cycles performed) is not specified.
- Biocompatibility: No specific test set was used for the subject device as it was determined to be identical to the predicate.
Data Provenance: Not applicable in the context of clinical data for a manual surgical instrument. The tests are laboratory/benchtop validations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for tests related to mechanical, cleaning, sterilization, and biocompatibility of a manual surgical instrument. Ground truth is established by test standards and laboratory measurements.
4. Adjudication Method for the Test Set
Not applicable for these types of benchtop tests. Results are typically determined by measurement against established standards rather than expert adjudication.
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 is a manual surgical instrument, not an AI-driven device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a manual surgical instrument.
7. The Type of Ground Truth Used
- Mechanical Strength: Ground truth is based on the performance characteristics of the predicate device as demonstrated through static and dynamic mechanical testing against engineering specifications for fatigue and cutting displacement.
- Cleaning: Ground truth is established by adherence to a recognized standard: AAMI TIR 30:2011 for protein and hemoglobin content, and visual inspection for soil.
- Sterilization: Ground truth is established by achieving a specific sterility assurance level (SAL) of 10^-6, which is a recognized regulatory benchmark for sterility.
- Biocompatibility: Ground truth is established by the predicate device's proven biocompatibility and the material equivalence of the subject device. Compliance with material standards (ASTM F899) is also implied.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).