(426 days)
Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer. Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.
The provided text is a 510(k) Summary for the Insurgical™ Single Use Power Equipment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.
Therefore, the requested information elements related to AI/software performance studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission. The "acceptance criteria" here refer to the successful completion of various engineering and safety tests to show the device is safe and effective and similar to a predicate.
Here's an attempt to answer the questions based on the provided text, acknowledging the differences in scope:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance/Outcome |
|---|---|
| IEC 60601-1-2 (Electromagnetic Compatibility) | Successful outcome to establish device safety and equivalence. |
| CISPR 11 (Electromagnetic Disturbance) | Successful outcome to establish device safety and equivalence. |
| IEC 61000-4-2 (Electrostatic Discharge Immunity) | Successful outcome to establish device safety and equivalence. |
| IEC 61000-4-3 (Radiated RF Immunity) | Successful outcome to establish device safety and equivalence. |
| Cadaveric simulated use test | Successful outcome to establish device safety and equivalence. (This test likely evaluated the device's functional performance in a simulated surgical environment.) |
| Laboratory validation of aseptic battery transfer process | Successful outcome to establish device safety and equivalence. (This test likely confirmed that the non-sterile battery could be transferred aseptically to the sterile handpiece, maintaining sterility of the surgical field.) |
| UL1642 (Safety for Lithium Batteries) | Successful outcome to establish device safety and equivalence. |
| ISO 10993-5 (Cytotoxicity) | Successful outcome to establish device safety and equivalence. (This test ensures that materials in contact with the patient do not cause toxic effects.) |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for any of these tests. For most of the engineering and safety standards (IEC, CISPR, UL, ISO), the "sample size" is typically determined by the standard itself (e.g., testing a certain number of units or cycles to demonstrate compliance). For the cadaveric simulated use test, a specific number of cadavers or test runs is not mentioned. Data provenance is not explicitly stated, but it would typically be from internal laboratory testing conducted by the manufacturer or a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a hardware device submission focused on safety and equivalence, not a diagnostic or AI device requiring expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable. This is a hardware device submission.
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 hardware device submission, not an AI or software-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device submission.
7. The type of ground truth used
For the engineering and safety tests, the "ground truth" is compliance with the specific requirements and limits defined by each standard (e.g., passing electromagnetic immunity tests, showing no cytotoxicity). For the cadaveric simulated use test, the "ground truth" would be the successful and safe performance of the intended surgical actions without mechanical failure or other safety concerns.
8. The sample size for the training set
Not applicable. This is a hardware device submission, not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device submission.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.