C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability.
The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of:

Carbon Fiber Frame ●
Hydraulics with Servo Motor ●
Electronics .
Distal Tube Clamp ●
. Upper Joint
Shin Tube Adapter
Components of the C-LEG (3C100) are the following:
Electronic Knee Joint 3C87 ●
2R90 Tube Adapter or .
Tube Adapter with Torsion Adapter 2R91 .
Rotation Adapter 4R57 .
Accessories are the following:
• 757L17 Charging Device
Power Unit ● 757L16
Prosthetic Foot 1D10, 1D25, 1A30 .
Foam Cover ● 3826
. 4X70 Slider Software
Extension Cable . 4X72
4X71 PC Interface .
4R302 Transportation Case ●

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the format requested.

The document is a 510(k) summary for the Otto Bock C-LEG (3C100), which declares its substantial equivalence to a legally marketed predicate device (Otto Bock's 3C1). In the context of 510(k) submissions, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, rather than meeting specific performance thresholds through a new, independent clinical study as might be required for a PMA or de novo submission.

Here's a breakdown of why many of your requested items cannot be fulfilled based on the provided text:

No detailed performance study with acceptance criteria: The document focuses on demonstrating substantial equivalence, not on presenting a standalone performance study with specific metrics and acceptance thresholds.
No information on sample sizes, ground truth, experts, or adjudication methods for a performance study: Since a detailed performance study proving specific acceptance criteria isn't described, these details are absent.
No MRMC study information: This type of study would be part of a comprehensive performance evaluation, which is not detailed here.

However, I can extract information related to the device and its intended use, which indirectly relates to its "acceptance" for market clearance:

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, the primary "acceptance criterion" for market clearance is substantial equivalence to a predicate device.

Acceptance Criterion (for market clearance)	Reported Device Performance (as stated in 510(k))
Substantial Equivalence to a predicate device (Otto Bock's 3C1)	C-LEG (3C100) is substantially equivalent to Otto Bock's 3C1, a Class I Exempt Device according to 21 CFR Part 890.3420. Differences in technical specifications, physical appearance, and design do not affect safety and effectiveness.
Intended Use	Intended for use in the fitting of lower limb prostheses for highly mobile individuals and/or those needing additional stance stability.
User Weight Limit	Recommended for lower limb amputees weighing up to 110 kg (220 pounds).
Functional Level	Recommended for amputees with a moderate (level 2 or 3) functional level.

The study that proves the device meets the acceptance criteria:

The document states: "The C-LEG (3C100) is substantially equivalent to Otto Bock's 3C1, a Class I Exempt Device according to 21 CFR Part 890.3420. Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the C-LEG (3C100)."

This suggests that the "study" was primarily a comparative analysis demonstrating that the C-LEG (3C100) is sufficiently similar to the predicate device, and any differences do not raise new questions of safety or effectiveness. This is typical for a 510(k) submission. No specific patient study with acceptance criteria, sample sizes, or ground truth establishment is described in this summary.

Details that cannot be extracted from the provided text:

Sample size used for the test set and the data provenance: Not applicable/not provided for a comparative equivalence submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
Adjudication method: Not applicable/not provided.
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. The device is a prosthetic knee joint, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a prosthetic knee joint, not an algorithm.
The type of ground truth used: Not applicable/not provided.
The sample size for the training set: Not applicable (not an AI/ML device, and no training set for a performance study is mentioned).
How the ground truth for the training set was established: Not applicable.

Summary

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JUL 8 1999

Image /page/0/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is underlined. The text below the line says "ORTHOPEDIC INDUSTRY INC."

ORTHOPEDIC INDUSTRY, INC

Kq91590

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1.	Submitter's Name:	Otto Bock Orthopedic Industry, Inc.
2.	Address:	3000 Xenium Lane NorthMinneapolis, MN 55441
3.	Telephone:	612-553-9464
4.	Contact Person:	John Hendrickson
5.	Date Prepared:	May 6, 1999
6.	Registration Number:	2182293
B. Device
1.	Name:	C-LEG (3C100)
2.	Trade Name:	C-LEG (3C100)
3.	Common Name:	External Limb Prosthetic Component (Knee)
4.	Classification Name:	External Limb Prosthetic Component (Knee)
5.	Product Code:	89 ISY
6.	Class:	I, Exempt
7.	Regulation Number:	890.3240

A COMPANY OF THE OTTO BOCK GROUP

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C. Identification of Legally Marketed Devices

3C1 1. Name:
Exempt 2. K Number:
Exempt 3. Date Cleared:

D. Description of the Device

C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability.

The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of:

Carbon Fiber Frame ●
Hydraulics with Servo Motor ●
Electronics .
Distal Tube Clamp ●
. Upper Joint
Shin Tube Adapter �

Components of the C-LEG (3C100) are the following:

Electronic Knee Joint 3C87 ●
2R90 Tube Adapter or .
Tube Adapter with Torsion Adapter 2R91 .
Rotation Adapter 4R57 .

Accessories are the following:

• 757L17	Charging Device
----------	-----------------

Power Unit ● 757L16
Prosthetic Foot 1D10, 1D25, 1A30 .
Foam Cover ● 3826
. 4X70 Slider Software
Extension Cable . 4X72
4X71 PC Interface .
4R302 Transportation Case ●

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E. Intended Use Statement

The C-LEG (3C100) is intended for use in the fitting of lower limb prostheses. It can be used by highly mobile individuals as well as those who need additional stance stability.

F. Technological Characteristics Summary

The C-LEG (3C100) is substantially equivalent to Otto Bock's 3C1, a Class I Exempt Device according to 21 CFR Part 890.3420.

Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the C-LEG (3C100).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 8 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Hendrickson President Otto Bock Orthopedic Industry, Inc. 3000 Xenium Lane North Minneapolis, Minnesota 55441

Re: K991590 Trade Name: C-LEG (3C100) Regulatory Class: II Product Code: ISW and KFX Dated: May 6, 1999 Received: May 7, 1999

Dear Mr. Hendrickson:

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 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 (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. A 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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2 - Mr. John Hendrickson

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K99 เร90

Device Name: C-LEG (3C100)

Indications for Use:

Fitting of lower limb prosthesis .
Highly mobile individuals and/or individuals who need stance stability .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OVER-THE-COUNTER USE (optional Form 1-2-96)

Dalee

(Division Sign-Off) Division of General Restorative Devices 510(k) Number _

Regulation Number and Section

§ 890.3500 External assembled lower limb prosthesis.

(a)
Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.