(249 days)
The PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.
The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.
The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.
The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.
The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
The provided text is a 510(k) Premarket Notification from the FDA regarding the OsteoMed Pinnacle Driver. This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or a medical imaging system that would typically have acceptance criteria focused on diagnostic performance (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria and performance data presented here are related to the safety and functionality of a mechanical medical device (a surgical drill/driver). Therefore, I cannot extract the information required for questions 2, 3, 4, 5, 6, 7, 8, and 9 as they are specific to AI/ML driven diagnostic/imaging devices.
I can, however, provide the table of acceptance criteria and reported device performance from the provided text, focused on the mechanical and electrical aspects of the device.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test | Acceptance Criteria (Implied from Test Method Summary & Results) | Reported Device Performance |
|---|---|---|
| Design Verification Testing (DVT) | The device must perform as intended (drilling pilot holes, seating screws, removing screws) over repeated cycles. | The cycle was repeated 99 times, and the subject device performed as intended after the 99 cycles. |
| Screw Characterization | Data on torque and seat value for various screw lengths and diameters must be retrievable and suitable as input for torque-limiting software. | The data collected was used as an input into the torque limiting software. |
| Sterilization Validation | A Sterility Assurance Level (SAL) of 10^-6 must be achieved per AAMI TIR12:2010 using defined sterilization parameters. | Having met the predetermined acceptance criteria, the method outlined on the IFU was validated as an effective means of sterilizing the subject device. |
| Reprocessing (Cleaning) Validation | Automatic cleaning must be validated as effective based on AAMI TIR 30, following FDA Guidance "Reprocessing Medical Devices..." | Automatic cleaning was validated as an effective means of cleaning the subject device. |
| Packaging & Shipping Validation | Packaging must fully contain and protect the device from normal shipping hazards, and the device must function as intended after shipment. | The packaging fully contained and protected the device from exposure to normal shipping hazards and the device functioned as intended after shipment. |
| Battery Safety Testing | The device must comply with requirements in IEC 60086-4 (ed.3) and the Sixth Revised Edition of Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria. | The subject devices comply with requirements in the applicable standards. |
| Biocompatibility | The device materials must be considered non-toxic and biocompatible as per FDA Blue Book Memorandum #G95-1. | The subject devices are considered non-toxic and biocompatible. |
| Electrical Safety and EMC Testing | The device must comply with requirements in IEC 60601-1, IEC 60086-4, and ES60601-1 standards. | Subject device complies with requirements in the applicable standards. |
| Software Verification and Validation | Software documentation and testing must confirm a "minor" level of concern as per FDA Guidance for Software in Medical Devices. | Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern as documented in this submission. |
Information not available from the provided text for an AI/ML diagnostic device:
- Sample sizes used for the test set and the data provenance: Not applicable to this type of device (mechanical/electrical, not AI/ML diagnostic).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device involves functional tests, not expert interpretation of medical images/data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 document does not describe an AI-assisted diagnostic system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering specifications and functional performance.
- The sample size for the training set: Not applicable. This document is not describing a machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).