(196 days)
The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.
The SMARTO is a sterile battery powered screwdriver. The device includes a DC motor, battery, switch and holder for the rotation attachment. It is disposable.
The provided document describes a 510(k) submission for the SMARTO surgical motor unit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on a defined performance standard.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, an AI algorithm, or detailed statistical analysis, is not applicable to this type of regulatory submission. This document describes a traditional medical device (a surgical motor unit), not an AI-powered device or one that requires extensive clinical performance studies to achieve marketing clearance via the 510(k) pathway.
Here's a breakdown of the available information and why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate | Performed "Bench testing on mechanical properties; motor speed, torque." Results show "safety and effectiveness of the SMARTO." |
| Mechanical properties (motor speed) | Bench test results indicate safety and effectiveness. |
| Mechanical properties (torque) | Bench test results indicate safety and effectiveness. |
| Safety and Effectiveness | Bench test results indicate safety and effectiveness. |
| Intended Use | Matches predicate: drive screws, drilling for craniofacial, craniotomies, hand, foot, wrist, extremity reconstruction. |
| Technology | Substantially equivalent to predicate. |
| Energy Source | DC motor, battery; substantially equivalent to predicate. |
| Claims | Substantially equivalent to predicate. |
| Material Composition | Substantially equivalent to predicate. |
| Sterile, Single Use | Yes, designed to be sterile and for single use. |
Explanation: For a 510(k) submission like this, "acceptance criteria" are primarily established by demonstrating substantial equivalence to a legally marketed predicate device. The performance criteria are therefore implied to be met if the new device performs comparably to the predicate for its intended use. Bench testing of mechanical properties (motor speed, torque) is mentioned as evidence of safety and effectiveness, which are the fundamental requirements.
Information NOT available or NOT applicable based on the provided document:
- 2. Sample size used for the test set and data provenance: Not applicable. The document refers to "bench testing" on mechanical properties, but details such as sample size, specific test configurations, or data provenance (country, retrospective/prospective) are not provided. This is not a clinical study with a "test set" in the sense of patient data.
- 3. Number of experts used to establish ground truth and qualifications: Not applicable. There is no mention of "ground truth" established by experts in this context as this is a mechanical device, not an AI or diagnostic tool.
- 4. Adjudication method: Not applicable. No expert review or adjudication process is described.
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not applicable. This type of study is for diagnostic devices where human readers interpret data, often with AI assistance. The SMARTO is a surgical motor.
- 6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. The SMARTO is a physical surgical tool, not an algorithm.
- 7. Type of ground truth used: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome for a diagnostic or AI study. For a surgical motor, the "truth" is its mechanical performance and functional safety.
- 8. Sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
- 9. How the ground truth for the training set was established: Not applicable. No AI model or training set.
In summary, the provided document is a 510(k) summary for a surgical motor. Its primary goal is to establish substantial equivalence through bench testing of mechanical properties and comparison of intended use, technology, energy source, claims, and material composition with a predicate device. It does not contain the detailed study information typically associated with AI/ML devices or complex clinical performance studies.
§ 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.