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.

Device Description

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.

AI/ML Overview

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.

Summary

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.<972642

EXHIBIT 2

JAN 2-6 1998 ESTRAD B.V. Westeinde 46 7711 CL NIEUWLEUSEN The Netherlands Phone +31(529)481543 Fax: +31(529)484999 Contact name: H. E. Schuldink July 10, 1997

510(k) Summary of Safety and Effectiveness per 21 CFR 807.92

1. Identification of the Device: Proprietary-Trade Name: "Perio Control IITM" Classification Name: Probe, Periodontal 76EIX. Common/Usual Name: Electronic Periodontal Probe Measuring Device
Equivalent legally marketed devices This product is similar in design and 2. function to the FLORIDA PROBE. 510(k) Number: K875076

3. Indications for Use (intended use)

Description of the Device: 4.

ડ. Safety and Effectiveness, comparison to predicate device.

The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.

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Characteristic	Predicate device: TheFlorida probe (K875076)	New device: "PerioControl II ™"
Intended Use:	Screen patients and to trackdisease progression in the targetpopulation of patients who aresuspected of having or alreadyhave periodontal disease. Bothpediatric and adult patients maybe tested.	Same
Physical characteristics:
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
Probing force	0.23-0.27 N	0.17-0.32 N
Probing pressure	183-215 N/cm2	100-200 N/cm2

Substantial Equivalence Chart 6.

7. Conclusion

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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 1998

Estrad B.V. ·c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

K972642 Re: Trade Name: Perio Control II Requlatory Class: I Product Code: EIK Dated: October 22, 1997 October 28, 1997 ----Received:

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Daniel Kamm, P.E.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at " its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and Geheral Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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d) Indications for Use

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Device Name: "Perio Control II TM" Periodontal Probing and Measurement Device.

Indications for Use:

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.

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 is at a specific reference point. In this position one of the buttons on the "Perio Control IITM" handpiece is pressed. The pocket depth is now displayed on the electronics unit.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972642

Prescription Use(Per 21 CFR 801.109)	OR Over the Counter Use ______
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Regulation Number and Section

§ 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.