(59 days)
The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.
The provided text is a 510(k) summary for the FRIOS MicroSaw, a device used in dental and craniofacial surgical procedures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI or diagnostic device.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Study for FRIOS MicroSaw
This 510(k) submission for the FRIOS MicroSaw focuses on demonstrating substantial equivalence to a previously cleared predicate device (OsteoMed Corporation OsteoPower System and Accessories, K971692). This type of submission does not typically involve a clinical study with specific performance acceptance criteria as would be seen for a new diagnostic or AI-driven device. Instead, the acceptance criterion is generally that the device is as safe and effective as the predicate device, based on similar technological characteristics and intended use.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary: Substantial Equivalence to predicate device (OsteoMed OsteoPower System, K971692) in design, function, and intended use. | The FRIOS MicroSaw is stated to be substantially equivalent to the predicate device. "The fundamental technical characteristics of the FRIOS MicroSaw are similar to those of the predicate. The FRIOS MicroSaw is equivalent to the OsteoMed Corporation's OsteoPower System and Accessories in design, function and intended use." |
| Materials: Stainless steel, standard latch lock | The FRIOS MicroSaw cutting instruments are made of stainless steel and incorporate a standard latch lock for use with FRIOS handpieces. |
| Intended Use: Preparing bone in dental and craniofacial surgical procedures. | The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission is based on a comparison of technological characteristics and intended use to a predicate device, not on a test set or clinical data with a sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. Ground truth, in the context of clinical studies with expert consensus, is not relevant for this substantial equivalence submission for a surgical instrument.
4. Adjudication Method for the Test Set:
- Not Applicable. No test set or associated adjudication was performed for this 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 device is a surgical instrument, not an AI or diagnostic tool where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual surgical instrument and does not involve any algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device, as determined by the FDA. The comparison relies on documented design, materials, and functional specifications.
8. The Sample Size for the Training Set:
- Not Applicable. There is no training set as this is not an AI or data-driven device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set was used.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.