(335 days)
The Reverse Shoulder is indicated for use in patients with a grossly rotator cuff deficient shoulder joint and one of the following:
- Pseudoparalysis of the shoulder.
- Severely painful and functionally impaired shoulder joint.
- Failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
The Reverse Shoulder Prosthesis is a total shoulder prosthesis designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis'. Unlike traditional total shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.
The provided text is a 510(k) premarket notification for the Encore Reverse Shoulder Prosthesis. This type of regulatory document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or meet specific performance criteria beyond those of the predicate.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets said criteria in the way you've outlined for a typical diagnostic algorithm or AI study. Instead, it relies on demonstrating that the new Encore Reverse Shoulder is substantially equivalent to the DePuy Delta Shoulder (K0231478).
Here's why the information you're asking for isn't present in this type of document:
- Medical Device Equivalence: 510(k) clearances are for demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is often done through comparison of technological characteristics, indications for use, and possibly bench testing or non-clinical data, but not typically through new clinical trials with acceptance criteria for performance metrics like sensitivity, specificity, accuracy, etc.
- Physical Prosthesis vs. AI/Diagnostic Device: The Encore Reverse Shoulder Prosthesis is a physical implant, not a diagnostic algorithm or an AI-powered device. Therefore, the concepts of a "test set," "ground truth," "expert adjudication," "MRMC study," or "standalone algorithm performance" are not applicable in this context. Performance for such devices usually relates to biocompatibility, mechanical strength, surgical outcomes (which would be tracked post-market), and safety, rather than classification metrics.
In summary, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training, number/qualifications of experts, adjudication, MRMC, standalone performance, ground truth types, etc.) is not present in the provided 510(k) document because it pertains to a different type of device and regulatory approval pathway.
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el
K041066
Summary of Safety and Effectiveness
Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-834-6237
MAR 2 4 2005
Trade Name: Encore Reverse Shoulder Prosthesis
Common Name: Cemented semi-constrained total shoulder
Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660
Indications:
millications:
The Reverse Shoulder is indicated for use in patients with grossly rotator cuff deficient The Neverse Bhoulder is mother is meetiously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Description:
The Reverse Shoulder Prosthesis is a total shoulder prosthesis designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis'. Unlike traditional total shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.
Substantial Equivalence
The Encore Reverse Shoulder is equivalent to the DePuy Delta Shoulder (K0231478).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Ms. Christie Shumaker Regulatory Affairs Specialist 9800 Metric Blvd Austin, Texas 78758
Re: K041066
Trade/Device Name: Encore Reverse Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/ polymer semi-constrained prosthesis Regulatory Class: II Product Code: KWS Dated: February 28, 2005 Received: March 1, 2005
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merclore, market the as not include requirements for annual registration, listing of general controls provisions of the fiel 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 If your device is classified (600 a00 70) of cols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation thay be subject to such additions, 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 or any I ederal statuates and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K F art 6077, adoning (27 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 -- Ms. Christie Shumaker
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premitsel notification. The PDA mianing of basification 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), please If you desire specific advice for your do not on on the splease note the regulation entitled, and colliact the Office of Comphanes at (21 t 7 ) = 1 / 21 FR Part 807.97). You may obtain " Misoranding by responsibilities to premainceased in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 of Manufacturers, International and Consumer instruction.cov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Charles
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number (if known): ★6 4L0L ん
Encore Reverse Shoulder Prosthesis Device Name:
Indications for Use:
The Reverse Shoulder is indicated for use in patients with a grossly rotator cuff a grow The Reverse Shoulder is indicated for ass in parchise will and one of the spossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected I he pattent's John must be analomically and becessary to use the device. The glenoid
implant(s), and a functional deltoid muscle is necessary to use comment for fixetion implant(s), and a functional denold musele is necessary to as the more for fixation. The humeral stem is intended for cemented use only.
X Prescription Use _ (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)
Hipt. Dworlus
Division of General, Restorative, and Neurological Devices
KO41066 510(k) Number __
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”