The Eidosmed EDG is a depth gauge measuring device intended for various medical purposes including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants.

Device Description

The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge measuring device intended for various medical purposes, including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants. In addition to mechanically measuring and displaying depth using an analog scale, the EDG displays this information using a digital readout. The EDG, referred to as the EDG 4.0 version, is a completely disposable device. It is intended to be used on one patient, over the course of one surgical procedure.

AI/ML Overview

The information provided describes the Eidosmed Electronic Depth Gauge (EDG) and its performance relative to a predicate device. While it mentions "acceptance criteria" through the lens of equivalence to the predicate device and specific performance metrics, it does not explicitly state a pre-defined set of acceptance criteria in the typical sense (e.g., "device must achieve X accuracy"). Instead, the study's goal was to demonstrate substantial equivalence and superior performance in certain aspects.

Here's an organized breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify explicit, pre-defined acceptance criteria with pass/fail thresholds. Instead, it demonstrates the device's performance through comparison to a predicate device and established benchmarks. The acceptance is implied by demonstrating substantial equivalence and superior performance in the stated metrics.

Performance Metric	Implied Acceptance Criteria (via comparison/benchmark)	Reported Device Performance (EDG)
Gauge R & R (Repeatability & Reproducibility)	Below 10% industry benchmark and comparable to predicate.	2.48% (signifies excellent precision)
Accuracy	Outperform the analog predicate device.	Outperformed the accuracy of the analog predicate device (with an alpha = .0005)
Substantial Equivalence	Equivalent with respect to intended use, design, risks, device characteristics, and performance aspects to the predicate device (Acromed Interbody Depth Gauges, K873191).	Demonstrated as substantially equivalent in various aspects.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the Gauge R & R (GR&R) testing or the accuracy comparison.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). This appears to be a laboratory/bench test rather than a clinical study involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. Given that the testing involved GR&R and accuracy of measuring depth against a predicate device, it's more likely to be a bench test where the "ground truth" would be established by precise measurement tools or calibrated standards, rather than expert judgment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. As mentioned above, the nature of the tests (GR&R, accuracy comparison of a depth gauge) suggests objective measurements rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the performance of a measuring device (depth gauge) itself, not on human interpretation of images or data, nor on the effect of AI assistance on human readers.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done in the sense that the device's performance (EDG) was evaluated independently and then compared to the predicate device. The EDG itself is a standalone measuring device, and its GR&R and accuracy were measured directly. The document states: "Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."

7. Type of Ground Truth Used

The type of ground truth used was likely measurement against calibrated standards or highly precise mechanical references for depth. For the Gauge R & R (Repeatability & Reproducibility) testing and accuracy comparison, the "ground truth" would originate from the known, true depths being measured by the device and the predicate. It is not an expert consensus, pathology, or outcomes data, as this is a physical measuring device.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the EDG is a mechanical/electronic measuring device, not an AI/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" and its associated ground truth establishment are not applicable to this device.

Summary

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510(k) SUMMARY

K091992

EIDOSMED LLC

DEC - 9 2009

EDG Depth Gauge

Page 1 of 2, 510(k) Summary

Date Prepared	September 30, 2009
Summay prepared by:	John KimEidosmed LLC2312 Wabansia Unit 1Chicago IL 60647Phone: (312) 450-5143 (P)johnkim@eidosmed.com
Applicant	EIDOSMED LLC2312 Wabansia Unit 1Chicago IL 60647Phone: (312) 450-5143Fax (312) 277-6464
Device Name	Electronic Depth Gauge
Trade Name	EDG
Common Name	Depth Gauge
Classification	Class: IIProduct Code: OOLRegulation: 21 CFR 888.3030
Identification ofPredicate Devices andSummary of SubstantialEquivalence	The Electronic Depth Gauge is substantially equivalent withrespect to intended use, design, risks, device characteristics andperformance aspects to:Acromed Interbody Depth Gauges, K873191 Buckman Co., Inc.
Device Description	The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gaugemeasuring device intended for various medical purposes, includingbut not limited to, measuring the depth of a passageway in a boneor other tissue to enable insertion of properly sized screws andimplants. In addition to mechanically measuring and displayingdepth using an analog scale, the EDG displays this informationusing a digital readout. The EDG, referred to as the EDG 4.0version, is a completely disposable device. It is intended to beused on one patient, over the course of one surgical procedure.

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EIDOSMED LLC EDG Depth Gauge Page 2 of 2, 510(k) Summary

Intended Use andIndications	The Eidosmed EDG is a depth gauge measuring device intended forvarious medical purposes including but not limited to, measuringthe depth of a passageway in a bone or other tissue to enableinsertion of properly sized screws and implants.
TechnologicalCharacteristics andSubstantial Equivalence	The Eidosmed EDG has many similar technological characteristicsand is substantially equivalent to the predicate.The method of use for the EDG device is exactly the same as thepredicate. Both devices use a hook inserted, in a linear motion,into the passageway until the indented hook purchases the distalend of the bone. The user then visually aligns the thumb slide withthe analog scale printed on the outer housing, correlating to thedepth of the bone. Finally, the hook is removed from thepassageway.The material used in the EDG is also similar to those used in thepredicate. Both devices use medical grade 316 stainless steel forthe probe/hook inserted into the bone or tissue. The Lexan plastichas been evaluated and found compliant to the most stringentbiocompatibility test standards.Both the EDG and the predicate device have GR&R values wellbelow the 10% industry benchmark.
PerformanceTesting/Data	Tests were performed on the device which demonstrated that thedevice is safe and effective, performs comparably to and issubstantially equivalent to the predicate device.The results for the Gauge R & R testing resulted in a statisticallysignificant value of 2.48% which signifies excellent precision.Additionally, the accuracy of EDG outperformed the accuracy ofthe analog device (with an alpha = .0005). Because both the EDGand the predicate device have below 10% values for GR&R, it canbe concluded that the devices are substantially equivalent

Intended Use andIndications

The Eidosmed EDG is a depth gauge measuring device intended forvarious medical purposes including but not limited to, measuringthe depth of a passageway in a bone or other tissue to enableinsertion of properly sized screws and implants.

TechnologicalCharacteristics andSubstantial Equivalence

The Eidosmed EDG has many similar technological characteristicsand is substantially equivalent to the predicate.The method of use for the EDG device is exactly the same as thepredicate. Both devices use a hook inserted, in a linear motion,into the passageway until the indented hook purchases the distalend of the bone. The user then visually aligns the thumb slide withthe analog scale printed on the outer housing, correlating to thedepth of the bone. Finally, the hook is removed from thepassageway.The material used in the EDG is also similar to those used in thepredicate. Both devices use medical grade 316 stainless steel forthe probe/hook inserted into the bone or tissue. The Lexan plastichas been evaluated and found compliant to the most stringentbiocompatibility test standards.Both the EDG and the predicate device have GR&R values wellbelow the 10% industry benchmark.

PerformanceTesting/Data

Tests were performed on the device which demonstrated that thedevice is safe and effective, performs comparably to and issubstantially equivalent to the predicate device.The results for the Gauge R & R testing resulted in a statisticallysignificant value of 2.48% which signifies excellent precision.Additionally, the accuracy of EDG outperformed the accuracy ofthe analog device (with an alpha = .0005). Because both the EDGand the predicate device have below 10% values for GR&R, it canbe concluded that the devices are substantially equivalent

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Eidosmed, LLC % Mr. Daniel Kamm Kamm & Associates 8726 Ferrara Ct. Naples, Florida 34114

DEC 9 2009

Re: K091992 Trade/Device Name: Eidosmed, Model EDG4.0 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: 'OOL Dated: October 31, 2009 Received: November 3, 2009

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Daniel Kamm

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jonitu.z

Image /page/3/Picture/6 description: The image contains a signature that appears to read "Jen". The signature is written in a cursive style with a flourish on the "J" and a connecting stroke between the "e" and "n". The signature is in black ink against a white background.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K09 | 992 Device Name: Electronic Depth Gauge (EDG):

The Eidosmed EDG is an electronic depth gauge, a measuring device intended for various medical purposes including, but not limited to, measuring the depth of a passageway in a bone or other tissue. The EDG enables the proper sizing of screws and implants in medical procedures.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soutin
(Division Sign-Off) for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091992

Page 1 of 1

Regulation Number and Section

N/A