(103 days)
REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions
The Rel-k is an artificial limb prosthesis indicated for individuals that have undergone a trans-femoral amputation. The Rel-k is intended to replace a missing or deformed limb and functions in both normal/standing (static) and dynamic walking. The Rel-k consists of: Pyramidal Head, Angular Sensor, Force sensor, Servo assisted Hydraulic Damper (MPC damper), Removable Battery and electronics compartment, Carbon Fiber Shell (outer casing), Attachment for a standard 30mm diameter tube.
The provided 510(k) summary for the Rel-k Artificial Limb Prosthesis does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/software devices. This document is for a physical medical device (an artificial limb), not a software algorithm or AI model, hence the typical metrics for software performance (sensitivity, specificity, AUROC, etc.) are not applicable here.
The 510(k) process for devices like the Rel-k focuses on demonstrating "substantial equivalence" to a predicate device, primarily through engineering principles, physical testing (e.g., fatigue, static load), material compatibility, and sometimes clinical performance in human use for the specific physical device.
Therefore, many of the requested fields regarding AI/algorithm performance and ground truth establishment cannot be filled from this document.
However, I can interpret the request in the context of the provided document by focusing on the "demonstration of substantial equivalence" which is the core of this type of 510(k).
Here's an attempt to address the prompt based on the available information, noting where information is not present:
Acceptance Criteria and Study for Rel-k Artificial Limb Prosthesis
The provided 510(k) summary for the Rel-k Artificial Limb Prosthesis focuses on establishing substantial equivalence to a legally marketed predicate device (Otto Bock C-Leg, K991590), rather than defining and meeting specific, quantifiable acceptance criteria for an AI or software model. The "study" in this context refers to the comparison and analysis performed to demonstrate this equivalence.
This device is a physical knee joint for a prosthetic limb, and the regulatory pathway does not involve the type of performance metrics, training sets, or expert adjudication typically associated with AI/ML diagnostic or prognostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a physical device submission focused on substantial equivalence, the "acceptance criteria" are implied by the features and performance of the predicate device, and the "reported device performance" is the demonstration that the Rel-k is comparable.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Rel-k) |
|---|---|
| Intended Use: Replace a missing or deformed limb for static and dynamic deambulation. | Intended Use: "REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions." (Matches predicate's function). |
| Technological Characteristics: Functionality comparable to Otto Bock C-Leg (3C100). | Technological Characteristics: "The Rel-k is substantially equivalent to the Otto Bock C-Leg (C100)... Differences that exist... related to the technical specifications, physical appearance and design does not raise new questions of safety and effectiveness." (Demonstrated comparable technology.) |
| Safety and Effectiveness: No new questions of safety or effectiveness compared to predicate. | Safety and Effectiveness: "demonstrates that the Rel-k device is at least as safe and effective as the legally marketed Otto Bock C-Leg (C100) device." (Asserted and accepted by FDA through clearance.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm's test set. For a physical device submission, this would typically involve mechanical testing (e.g., fatigue, static load tests) on a specific number of manufactured units, or potentially a limited human factors or clinical study if new questions of safety/effectiveness arose. This document does not detail specific physical testing numbers.
- Data Provenance: Not applicable for AI/ML data provenance. Any testing data would have been generated in a lab setting, or potentially from a limited clinical trial (though none is explicitly mentioned as part of the equivalence demonstration for this Class I device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for an AI/ML model.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, this is not applicable as the device is a physical prosthetic component, not an AI-based diagnostic/assistant tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is not applicable. The Rel-k is a physical device that functions in conjunction with a human wearer.
7. The type of ground truth used
- Type of Ground Truth: Not applicable for AI/ML ground truth. For a physical device, "ground truth" relates to engineered specifications, material properties, and the established performance profile of the predicate device against which the new device is compared. This would be established through engineering standards, mechanical tests, and potentially clinical evaluations of the predicate itself.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This concept pertains to AI/ML models.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
OCT 1 3 2010
A. General Information
| 1. | Submitter's Name: | Rizzoli Ortopedia, S.p.A. |
|---|---|---|
| 2. | Submitter's Address: | Via C. Battisti 44 - 40054 BUDRIO (BO) - ITALIA |
| 3. | Submitter's Telephone: | +390516930735 |
| 4. | Contact Person: | Diane C. Tiernan, MS RACConsultantMcCormick LifeScience Consultants58A Bates RoadWatertown, MA 02472 |
| 5. | Date Prepared: | July 1, 2010 |
| 6. | Registration Number: | not yet assigned |
| B. Device | ||
| 1. | Name: | Rel-k |
| 2. | Trade Name: | Rel-k |
| 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 |
C. Identification of Legally Marketed Devices
| 1. Name: | C-Leg (3C100) |
|---|---|
| 2. 510(k) Number: | K991590 |
-
- Date Cleared: July 8, 1999
{1}------------------------------------------------
D. Description of the Device
The Rel-k is an artificial limb prosthesis indicated for individuals that have undergone a trans-femoral amputation. The Rel-k is intended to replace a missing or deformed limb and functions in both normal/standing (static) and dynamic walking.
The Rel-k consists of:
- . Pyramidal Head
- Angular Sensor .
- . Force sensor
- . Servo assisted Hydraulic Damper (MPC damper)
- Removable Battery and electronics compartment .
- Carbon Fiber Shell (outer casing) �
- . Attachment for a standard 30mm diameter tube.
E. Intended Use Statement
The Rel-k is prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions.
F. Technological Characteristics Summary
The Rel-k is substantially equivalent to the Otto Bock C-Leg (C100), a Class I Exempt Device per 21CFR Part 890.3420.
Differences that exist between the Rel-k and the C-Leg (C100) devices related to the technical specifications, physical appearance and design does not raise new questions of safety and effectiveness; and demonstrates that the Rel-k device is at least as safe and effective as the legally marketed Otto Bock C-Leg (C100) device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Rizzoli Ortopedica S.P.A. % McCormick LifeScience Consultants Ms. Diane C. Tiernan, MS RAC Consultant 58A Bates Road Watertown, Massachusetts 02472
OCT 1 3 2010
Re: K101859
Trade/Device Name: Rel-k Artificial Limb Prosthesis Regulation Number: 21 CFR 890.3420 Regulation Name: External limb prosthetic component Regulatory Class: Class I Product Code: ISY Dated: September 29, 2010 Received: September 30, 2010
Dear Ms. Tiernan:
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. Ilsting 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
{3}------------------------------------------------
Page 2 - Ms. Diane C. Tiernan, MS RAC
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/CDRH/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,
For Ditta Desdir
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
K101859 OCT 1 3 2010
Device Name: Rel-k Artificial Limb Prosthesis
Indications For Use:
REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Yung D. Nguyen
Divis (Division Sign-city), Orthopedic, and Restorative Devices
510(k) Number K101859
§ 890.3420 External limb prosthetic component.
Link to an amendment published at 90 FR 55994, Dec. 4, 2025. (a)
Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.