(34 days)
The SMARTO is intended for use in drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.
The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.
The provided text describes the SMARTO device, a surgical motor unit, and outlines its technical specifications and comparison with a predicate device for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of AI-driven performance metrics (e.g., sensitivity, specificity, AUC).
The document is a 510(k) summary for a surgical motor unit. The "acceptance criteria" discussed are related to electrical safety, electromagnetic compatibility, and performance tests for torque and speed, using existing standards (IEC 60601-1, IEC 60601-1-2) and internal standards. These are typical for hardware medical devices.
Therefore, I cannot fulfill parts of your request that pertain to performance metrics like sensitivity, specificity, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these types of studies and criteria are generally associated with AI/software medical devices that interpret images or data for diagnostic or prognostic purposes.
Here is what can be extracted from the document regarding the acceptance criteria and study, based on the provided text's focus on a physical medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Standard/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Compliance with IEC 60601-1 | "The test results demonstrated that the proposed device complies with the following standards" |
| Electromagnetic Compatibility | IEC 60601-1-2 | Compliance with IEC 60601-1-2 | "The test results demonstrated that the proposed device complies with the following standards" |
| Performance Test (Torque) | Internal standard | Met internal standard for torque based on changed specifications of DC motor and unit of battery. | For DC Motor: 45 Ncm (increased from 24 Ncm) |
| For 111-ED-031: 30 Ncm (increased from 24 Ncm) | |||
| For 111-ED-050: 45 Ncm (increased from 24 Ncm) | |||
| For 111-ED-051: 40 Ncm (increased from 24 Ncm) | |||
| For 111-ED-052: 35 Ncm (increased from 24 Ncm) | |||
| Performance Test (Speed - RPM) | Internal standard | Met internal standard for RPM based on changed specifications of DC motor and unit of battery. | For DC Motor: 210 RPM (increased from 160 RPM) |
| For 111-ED-031: 250 RPM (increased from 160 RPM) | |||
| For 111-ED-050: 210 RPM (increased from 160 RPM) | |||
| For 111-ED-051: 165 RPM (increased from 160 RPM) | |||
| For 111-ED-052: 110 RPM (decreased from 160 RPM) |
Notes:
- The document states, "The test was conducted to verify that the proposed device met all design specifications." and "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." This implies that the device did meet these criteria.
- The specific magnitude of the acceptance criteria for the internal standards is not explicitly stated as a pass/fail threshold, but the reported performance values are given. The inference is that the reported performance meets the internal standard.
Regarding the other requested information:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device (physical surgical motor). The "tests" are engineering performance tests, not clinical studies with patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context refers to the measured physical properties of the device against engineering specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical characteristics like torque and speed, the "ground truth" would be the measured physical properties against designed specifications. For electrical safety and EMC, it's compliance with established international standards.
- 8. The sample size for the training set: Not applicable. This device is not an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.