ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES by SYNVASIVE TECHNOLOGY, INC.

The eLIBRA® Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.

Device Description

The device consists of two units, the force sensing unit and an electronic display. The eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee Replacement is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The eLIBRA Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Force Sensing Unit. The unit displays a number from 0-19 for both the for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). Each number is equivalent to 0.5 pounds of force.

AI/ML Overview

The provided 510(k) summary for the eLibra® Uni Soft Tissue Force Sensor (K093046) describes the device, its intended use, and claims substantial equivalence to a predicate device (K070108 eLibra Dynamic Knee Balancer). However, it does not contain the detailed performance study information typically required to fully answer all aspects of your request regarding acceptance criteria and a study demonstrating performance against those criteria.

The summary states: "Performance: Both bench and test laboratory testing was performed. Bench testing included mechanical testing, radio frequency, and sterility testing, including EO residues. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

This statement indicates that performance testing was conducted, but it does not provide specific acceptance criteria, reported performance metrics, sample sizes, ground truth establishment, or details about the study design (e.g., MRMC, standalone). The focus of the summary is on demonstrating substantial equivalence rather than presenting detailed performance validation against specific, quantified acceptance criteria.

Therefore, for many of your questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Specified	"Satisfactory" and "revealed no concerns over safety and effectiveness as compared to our predicate device." "Demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

Note: The document states that "Each number [displayed on the unit] is equivalent to 0.5 pounds of force." This is a functional specification, but not an acceptance criterion against which performance was directly measured and reported in terms of accuracy or precision.

2. Sample size used for the test set and the data provenance

Not specified. The document mentions "bench and test laboratory testing" but does not give sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not describe any study involving human experts establishing ground truth for a test set. The validation seems to be primarily through engineering and comparative testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified. This type of adjudication method is typically used in clinical studies with human readers interpreting data, which is not described here.

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

No. An MRMC study was not described, nor is this device an "AI" device in the conventional sense (it's a force sensor and display). The device directly aids the surgeon with a display of force, not by processing complex imaging or clinical data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not explicitly detailed as such. The device itself is designed to provide real-time information to a surgeon. The "performance" described is the device's ability to measure and display force. Bench testing would inherently be "standalone" in that it tests the device's intrinsic functions, but the details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated. For mechanical and RF testing, ground truth would likely be established using calibrated reference instruments (e.g., highly accurate force gauges, RF measurement equipment). For "sterility testing," the ground truth would be the absence of viable microorganisms as per validated sterilization methods.

8. The sample size for the training set

Not applicable/Not specified. This device does not appear to be an AI/machine learning device that requires a "training set." It's a sensor and display unit.

9. How the ground truth for the training set was established

Not applicable. As above, a training set is not relevant for this type of device.

In summary, the 510(k) process for this device focused on demonstrating substantial equivalence through bench and laboratory testing without providing detailed quantitative performance metrics or descriptions of clinical studies in the summary document. The information provided is insufficient to answer most of your detailed questions about acceptance criteria and study particulars.

Summary

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510(K) Summary, K093046 Synvasive Technology, Inc. 4925 Robert J. Mathews Pkwy El Dorado Hills, CA 95762 Phone: 916-939-3913 Contact: Michael G. Fisher Date prepared: April 7, 2010

Trade Name: eLibra® Uni Soft Tissue Force Sensor 1. Common Name: Intraoperative orthopedic joint assessment aid Classification Name: Stereotaxic instrument., product code ONN, Regulation: 882.4560 Class of device: Class 2.
The legally marketed device to which we are claiming equivalence {807.92(a)(3)] : . 2. K070108 eLibra Dynamic Knee Balancer, Synvasive Technology
Description of device: The device consists of two units, the force sensing unit and an 3. electronic display. The eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee Replacement is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The eLIBRA Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Force Sensing Unit. The unit displays a number from 0-19 for both the for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). Each number is equivalent to 0.5 pounds of force.
Intended use: The eLIBRA® Display Unit is a reusable battery powered device 4. designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for Partial Knee Replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.
Technological characteristics: The technological characteristics are essentially న్న identical to our predicate device.
Performance: Both bench and test laboratory testing was performed. Bench testing 6. included mechanical testing, radio frequency, and sterility testing, including EO residues. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Synvasive Technology, Inc. % Kamm & Associates Mr. Daniel Kamm 8870 Ravello Court Naples, Florida 34114

MAR 2 2 2011

Re: K093046

Trade/Device Name: eLibra Uni Soft Tissue Force Sensor Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: ONN Dated: February 28, 2011 Received: March 4, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Daniel Kamın

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.

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/CDRHOffices/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,

A.J. B. R.h.

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 30 46

Device Name: eLibra Uni Soft Tissue Force Sensor

Indications For Use:

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

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)

for M. Melkoon

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(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093046

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).