(28 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics relatable to AI/ML or diagnostic accuracy. Instead, the document is a 510(k) summary for a medical device (Turon e+ Glenoid) and the FDA's clearance letter.
However, based on the information provided regarding the device and its clearance, I can infer the "acceptance criteria" and "study" in a regulatory context, focusing on the equivalence to predicate devices, rather than performance metrics like sensitivity or specificity.
Here's an interpretation based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device has the same intended use and technological characteristics as predicate device, or if different, the differences do not raise new questions of safety and effectiveness. | "Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use." |
| Non-Clinical Performance: Device meets established standards and demonstrates performance for its intended use through bench testing. | "Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity." |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | FDA determined the device is "substantially equivalent...to legally marketed predicate devices." This implies safety and effectiveness have been adequately addressed for regulatory clearance. |
| Indications for Use: Device indications align with predicate devices and accepted medical practice for joint replacement. | Indications for Use listed are consistent with those for shoulder joint prostheses. |
| Materials: Use of materials (UHMWPE and highly crossed-linked UHMWPE infused with Vitamin E) is safe and effective and comparable to predicate devices. | The device uses "both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E," which suggests these materials have been established as safe and effective in similar predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Clinical Testing: None provided." The "test set" in this context refers to the non-clinical tests performed on the physical device, not patient data.
- Data Provenance: Not applicable for a traditional test set with patient data. Non-clinical testing results would be generated in a lab setting, presumably by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts and Qualifications: Not applicable. For non-clinical, bench-top testing, ground truth isn't established by medical experts in the same way it would be for a clinical trial or AI model. The "ground truth" for these tests are the established engineering and material science standards and methodologies which the device must meet.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication typically refers to expert review of clinical cases. For non-clinical testing, the results are compared directly against predefined specifications and standards.
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 MRMC study was done. This information is not relevant to this type of device (a physical implant) or the regulatory submission provided, which explicitly states "Clinical Testing: None provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical shoulder joint prosthesis, not an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this device's non-clinical testing refers to established engineering specifications, material properties, and performance standards for a shoulder joint prosthesis (e.g., specific thresholds for cyclic displacement, pull-out strength, impact resistance, tensile strength, oxidation resistance, biocompatibility, and cytotoxicity). These are objective measurements against predefined limits.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical implant, not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical device.
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510(k) Summary
Date: December 19, 2012
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Michaela Norris Regulatory Affairs Associate Phone: (512) 834-6291 Fax: (512) 834-6313 Email: michaela.norris@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| Turon e+ Glenoid | Class II | KWS - Shoulder joint metal/polymersemiconstrained cemented prosthesis per 21CFR 888.3660PAO - Shoulder joint metal/polymersemiconstrained cemented prosthesis per 21CFR 888.3660 |
Description: The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
Predicate Devices:
DJO Surgical Encore Shoulder System - K080402 DJO Surgical Highly Crossed-Linked VE Polyethylene Material UHMWPE Tibial Insert - K091956
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.
Non-Clinical Testing: Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity.
Clinical Testing: None provided.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 23, 2013
Encore Medical, L.P. % Ms. Michaela Norris Regulatory Affairs Associate 9800 Metric Boulevard Austin, Texas 78758
Re: K123982
Trade/Device Name: Turon e+ Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semiconstrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PAO Dated: December 19, 2012
Received: December 26, 2012
Dear Ms. Norris:
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 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
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Page 2 - Ms. Michaela Norris
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). regulations 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.htmfor 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123982 510(k) Number (if known): J
Device Name: Turon e+ Glenoid
Indications for Use:
Turon e+ Glenoid Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- correction of functional deformity; .
- humeral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Krishna Asundi, PhD Division of Orthopedic Devices
§ 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.”