(195 days)
The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.
The Perio Control II™ is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C)
Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the Perio Control IITM handpiece.
The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the Perio Control II handpiece is pressed. The pocket depth is now displayed on the electronics unit.
The Perio Control II™ device is cleared based on its substantial equivalence to a predicate device, the Florida Probe (K875076). The provided documentation does not detail a study specifically designed to establish acceptance criteria and prove the device meets them in the way a clinical trial for a novel AI/ML device would. Instead, the submission focuses on demonstrating that the new device performs "as safe and effective as the predicate device."
Here's an analysis based on the provided text, addressing the requested information where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Perio Control II™" are implicitly defined by matching or showing equivalent performance to the predicate device, the Florida Probe (K875076). There are no explicitly stated numerical acceptance criteria beyond those of the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device: Florida Probe K875076) | Reported Device Performance ("Perio Control II ™") |
|---|---|---|
| Intended Use | Screen patients and track disease progression in periodontal disease. | Same |
| Measuring range | 1-10mm | 0-10.5mm |
| Probe tip shape | Rounded edge | Spherical |
| Probe tip dimension | 0.4mm | 0.5mm |
| Probe tip material | Titanium | Stainless steel |
| Sterilization | Autoclave | Same |
| Accuracy | 0.2mm | Same (0.2mm) |
| Probing force | 0.23-0.27 N | 0.17-0.32 N |
| Probing pressure | 183-215 N/cm2 | 100-200 N/cm2 |
Study Proving Device Meets Acceptance Criteria:
The study that "proves the device meets the acceptance criteria" is described as:
- Bench and User Testing: The document states, "The results of bench and user testing indicates that the new device is as safe and effective as the predicate device" and "After analyzing both bench and user testing data, it is the conclusion of Estrad B.V. that the 'Perio Control IITM' is as safe and effective as the predicate device and has no new indications for use, thus rendering it substantially equivalent to the predicate Device."
This indicates a validation approach based on comparison to an existing, legally marketed device rather than a de novo clinical study with pre-defined statistical endpoints for novel performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on:
- The sample size used for the "bench testing" or "user testing."
- The data provenance (e.g., country of origin, retrospective or prospective nature) for these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts involved in the "user testing" or in establishing any "ground truth." Given this is a physical measurement device being compared for substantial equivalence, the "ground truth" during testing would likely be based on established metrological standards for accuracy and comparisons with the predicate device.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging or diagnostic AI systems where human readers interpret cases with and without AI assistance. The Perio Control II™ is a direct measurement device, not an interpretive system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "bench testing" would represent a standalone evaluation of the device's physical and measurement characteristics (e.g., measuring range, accuracy, probing force, probing pressure) independent of a human operator, to ensure it met specifications similar to the predicate device. The "user testing" would then evaluate its performance with human interaction.
7. The Type of Ground Truth Used
For the bench testing, the ground truth would be based on metrological standards and direct comparison to the specifications of the predicate device. For example, accuracy (0.2mm) and probing force (0.23-0.27 N for predicate, 0.17-0.32 N for new device) are established against known physical standards. For user testing, the "ground truth" would likely involve clinicians evaluating the device's usability, consistency, and ability to achieve similar measurements to the predicate device in a clinical-like setting. There is no mention of pathology, expert consensus (in the context of image interpretation), or outcomes data as ground truth.
8. The Sample Size for the Training Set
No information is provided regarding a "training set." The Perio Control II™ is a physical measurement device, not an AI/ML system that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.