(18 days)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthoplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
The Zimmer Trabecular Metal Humeral Stem is intended to be a single use only implant that is used to replace a shoulder joint. This humeral stem uses Trabecular Metal around the proximal part of the stem for biological ingrowth. It also has an anti-rotational fin, a proximal stem collar, suture holes, and a distal fluted stem body. The product line has been extended to include 6mm and 8mm humeral stems.
This Zimmer 510(k) submission describes a device modification (new sizes 6mm and 8mm) to an already cleared Trabecular Metal Humeral Stem. The submission explicitly states that "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem, Sizes 6mm and 8mm is as safe and effective as the predicate device."
This is a Special 510(k), which is typically used for well-understood modifications to existing devices where the fundamental technology, materials, and intended use remain the same. In such cases, extensive new clinical trials or complex performance studies are often not required. The primary focus is on demonstrating that the modification does not negatively impact the safety and effectiveness established for the predicate device.
Given this context, the document does not contain the detailed, quantitative acceptance criteria and AI performance study information that would be expected for a novel AI/ML device. Instead, it relies on demonstrating equivalence to a predicate device through non-clinical testing.
Here's an analysis based on the provided document, acknowledging its limitations regarding typical AI/ML performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The implicit acceptance criterion for this Special 510(k) is that the modified device (new 6mm and 8mm sizes) performs as safely and effectively as the predicate device (Zimmer Trabecular Metal Humeral Stem, K041459) through non-clinical testing. The critical aspects for equivalence in orthopedic implants typically include mechanical strength, durability, and biocompatibility in the context of the intended use. While specific numerical acceptance criteria (e.g., minimum fatigue strength, maximum wear rates) are inherent to the non-clinical tests conducted, they are not explicitly enumerated in this summary document.
Reported Device Performance:
| Performance Metric (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety & Effectiveness | "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem, Sizes 6mm and 8mm is as safe and effective as the predicate device." |
Note: The document does not provide specific numerical results from the non-clinical tests (e.g., specific fatigue life in cycles, ultimate tensile strength, etc.). It only provides a high-level conclusion of equivalence.
The subsequent points (2-9) are not applicable to this 510(k) submission as they relate specifically to the evaluation of AI/ML-driven devices with a focus on diagnostic performance, reader studies, and training data. This submission is for a medical implant and relies on demonstrating equivalence through mechanical and material-based non-clinical testing, not AI/ML performance evaluation.
To directly address the prompt's structure in the context of this document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes the modification of a medical implant, not an AI/ML device. The "test set" would refer to mechanical samples used in non-clinical testing (e.g., fatigue specimens, wear simulators), not a dataset of medical images or patient records. The document does not specify the number of physical samples tested or their "provenance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of AI/ML typically refers to expert labels on data. For an implant, "ground truth" would be established by validated engineering tests and measurements, comparing the performance of the new sizes to the predicate device. This does not involve medical experts establishing image-based ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in reader studies for AI/ML diagnostics to resolve discrepancies in expert interpretation of data. This is irrelevant to the engineering and materials testing performed for an orthopedic implant.
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
- Not applicable. MRMC studies are specifically designed for evaluating the performance of AI/ML diagnostic tools, often in conjunction with human readers. This submission is for a physical medical device (humeral stem), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm operating independently. The device described is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Implicit. For this kind of device, the "ground truth" for non-clinical testing would be derived from established engineering standards and performance metrics for orthopedic implants. This would include parameters like material properties (tensile strength, yield strength), fatigue life, and wear characteristics, as measured by standardized testing procedures in a lab setting, rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
- Not applicable. This submission does not involve an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, this question is not relevant.
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zımmer
Special 510(k): Device Modification
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene T. Binkley, RACSenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605 |
| Date: | March 22, 2005 |
| Trade Name: | Zimmer Trabecular Metal™ Humeral Stem, Sizes6mm and 8mm |
| Common Name: | Total Shoulder System |
| Classification Nameand Reference: | Shoulder joint metal/polymer non-constrainedcemented prosthesis. 21 CFR § 888.3650Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis. 21 CFR § 888.3690 |
| Predicate Device: | Zimmer Trabecular Metal Humeral Stem,manufactured by Zimmer, Inc., K041459, clearedSeptember 3, 2004. |
| Device Description: | The Zimmer Trabecular Metal Humeral Stem isintended to be a single use only implant that is usedto replace a shoulder joint. |
This humeral stem uses Trabecular Metal around
the proximal part of the stem for biological
ingrowth. It also has an anti-rotational fin, a
proximal stem collar, suture holes, and a distal
fluted stem body. The product line has been
extended to include 6mm and 8mm humeral stems.
| Intended Use: | Prosthetic replacement with this device may beindicated for the treatment of severe pain orsignificant disability in degenerative, rheumatoid, ortraumatic disease of the glenohumeral joint;ununited humeral head fractures of long duration; |
|---|---|
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/1/Picture/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is black and bolded, and the circle around it is white with a black outline. The word "zimmer" is in lowercase letters and is also black and bolded. The font appears to be sans-serif.
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| irreducible 3-and 4-part proximal humeral fractures;avascular necrosis of the humeral head; or otherdifficult clinical management problems wherearthrodesis or resectional arthoplasty is notacceptable. The assembled humeral component maybe used alone for hemiarthroplasty or combinedwith the glenoid component for total shoulderarthroplasty. Humeral heads with heights of 27mmor greater may be used for difficult clinicalmanagement problems involving rotator cuffdeficiency where arthrodesis or conventionalnonconstrained arthroplasty is not acceptable. | |
|---|---|
| Comparison to Predicate Device: | The Zimmer Trabecular Metal Humeral Stem ispackaged, manufactured, and sterilized using thesame materials and processes as the predicatedevice. The subject device also has the sameintended use and fixation methods as the predicatedevice. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Non-clinical testing demonstrated that the ZimmerTrabecular Metal Humeral Stem, Sizes 6mm and8mm is as safe and effective as the predicate device |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing people or families, in a flowing, interconnected manner.
APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley, RAC Senior Associate, Corporate Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw. Indiana 46581-0708
Re: K050761
Trade/Device Name: Zimmer Trabecular Metal™ Humeral Stem, Sizes 6mm and 8mm Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/ polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT, HSD Dated: March 22, 2005 Received: March 24, 2005
Dear Ms. Binkley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 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); 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.
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Page 2 -- Ms. Binkley, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
A. Michael G. Barnett, Ph.D.
C. 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):
Device Name:
Zimmer Trabecular Metal™ Humeral Stem, Sizes 6mm and 8mm
Indications for Use:
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical mana gement problems where arthrodesis or resectional arthoplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
Prescription Use X (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)
Stup Llodn
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Page 1 of 1
510(k) Num
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”