When used with an appropriate humeral stem from the Coffeld2 Total Shoulder System, 3D Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glonoid component from the Cofield or Neer III Total Shoulder Systems, respectively. When used with an appropriate humeral stem, 3D Humeral Heads are intended for use with bone cement only (i.e. cemented fixation) and for single use only. 3D Humeral Heads are intended for the following indications:

Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component as described above) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in theumatoid arthritis, osteoarthritis, traumatic arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

Device Description

3D humeral heads are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and can be used with existing cobalt chrome humeral stem components from the Cofield' Total Shoulder System previously cleared from market. 3D taper sleeves are manufactured from titanium (Ti-6Al-4V) material conforming to the requirements of ASTM F1472.

AI/ML Overview

Here's an analysis of the provided text regarding the 3D Humeral Heads device, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial or detailed performance study against specific acceptance criteria. Therefore, the information regarding acceptance criteria and the study proving the device meets them is limited.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Details/Context
Material Composition	CoCr (ASTM F799) for humeral heads	Manufactured from forged cobalt chrome (CoCr) material (ASTM F799)	Confirmed by device description
	Titanium (Ti-6Al-4V) for taper sleeves	3D taper sleeves are manufactured from titanium (Ti-6Al-4V) material conforming to ASTM F1472.	Confirmed by device description
Mechanical Performance	Acceptable humeral head distraction performance	Results indicate subject devices meet or exceed acceptable performance.	Mechanical humeral head distraction testing was performed. Specific numerical criteria are not provided.
Ion Release	Acceptable ion release analysis	Results indicate subject devices meet or exceed acceptable performance.	Ion release analysis was performed. Specific numerical criteria are not provided.
Technological Characteristics	Similar to predicate devices	Similar in design and have the same technological characteristics as listed predicate devices.	Comparison to AequalisTM Shoulder System and Anatomica Humeral Stems/Heads.
Intended Use	Consistent with predicate devices	Intended use matches or is substantially equivalent to predicate devices for hemiarthroplasty and total shoulder arthroplasty.	Compared with predicate devices; indications are described.
Substantial Equivalence	Data indicates substantial equivalence to legally marketed devices.	Data indicate that 3D Humeral Heads are substantially equivalent to legally marketed devices.	Basis for 510(k) clearance; based on comprehensive comparison.

Missing/Not Provided:

Specific quantitative acceptance thresholds for mechanical performance (e.g., minimum distraction force, maximum displacement).
Specific quantitative acceptance thresholds for ion release (e.g., maximum allowable concentration of specific ions).
Detailed test methods used for mechanical and ion release testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size used for the mechanical humeral head distraction testing or ion release analysis. It simply states these tests were "performed."
Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it implies the data was generated or compiled for US regulatory purposes, but the actual location of the testing laboratories is not mentioned. The data is retrospective in the sense that the testing was performed, and the results are being reported as part of a premarket submission. It is not a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable or not provided in this 510(k) summary. For device approvals based on substantial equivalence, particularly for mechanical components like humeral heads, "ground truth" is typically established through recognized engineering standards, material specifications (like ASTM F799, ASTM F1472), and established testing methodologies, rather than expert consensus on a test set of clinical cases. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the mechanical and chemical tests, but their specific number or qualifications are not detailed here.

4. Adjudication Method for the Test Set

This is not applicable or not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, symptom severity) require consensus among multiple observers. For mechanical and material property testing, the "adjudication" is based on objective measurements and comparison against predefined engineering 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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic imaging devices often involving AI assistance. The 3D Humeral Heads are orthopedic implants, not a diagnostic tool or an AI-assisted system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this is not applicable. The device is a physical orthopedic implant and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily based on:

Engineering Standards: Adherence to material specifications (ASTM F799, ASTM F1472).
Mechanical Test Results: Objective measurements from distraction testing, compared against implied or unstated "acceptable performance" thresholds.
Chemical Analysis: Objective measurements from ion release analysis, compared against implied or unstated "acceptable performance" thresholds.
Comparison to Predicate Devices: Performance characteristics and safety profiles of previously approved, legally marketed devices.

It does not rely on expert consensus on clinical cases, pathology, or direct patient outcomes data in the context of this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. This device is a physical orthopedic implant, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As a physical orthopedic implant, there is no "training set" or "ground truth for a training set" in the context of machine learning.

Summary

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A 510(k) Summary of Safety and Effectiveness

DEC 1 3 2001

Submitter's name:	Smith & Nephew, Inc., Orthopaedic Division
Submitter's address:	1450 Brooks Road, Memphis, TN 38116
Submitter's telephone number:	901-399-6487
Contact person:	David Henley, Senior Clinical/Regulatory Affairs Specialist
Date summary prepared:	July 25, 2001
Trade or proprietary device name:	3D Humeral Heads
Common or usual name:	Shoulder Joint Prosthesis
Classification name:	21 CFR 888.3660, shoulder joint metal/polymer, semi-constrained cemented prosthesis - Class II

Substantially Equivalent Legally Marketed Devices

AequalisTM Shoulder System Tornier, S.A. .
Anatomica Humeral Stems/Heads Sulzer Orthopedics .

Device Description

Device Intended Use

The subject humeral head devices can be mated with approved humeral stem components from the Cofield Total Shoulder System previously cleared for market under K955767. 3D Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. 3D Humeral Heads are intended for use with bone cement only (cemented fixation) and for single use only. 3D Humeral Heads are intended for the following indications:

Proximal Humeral Prosthesis – (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

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<012378 p 2/2

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthriis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

The assembled humeral stem component (including a 3D Humeral Head) may be used alone for hemiarthroplasty or combined with a Cofield Total Shoulder System glenoid component for use in total shoulder arthroplasty.

Technological Characteristics:

3D Humeral Heads are similar to the legally marketed predicate devices listed above. All of these devices are indicated for total shoulder arthroplasty or hemiarthroplasty, are similar in design to the 3D Humeral Heads and have the same technological characterisitcs.

Performance Characterisitcs:

Mechanical humeral head distraction testing and ion release analysis was performed on these devices. Results indicate that the subject devices meet or exceed acceptable performance. Data indicate that 3D Humeral Heads are substantially equivalent to legally marketed devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K012378

Trade/Device Name: 3D Humeral Heads Regulation Number: 21 CFR §888.3660 and §888.3690 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic cemented or uncemented prosthesis

DEC 1 3 2001

Regulatory Class: Class II Product Code: KWS & HSD Dated: October 25, 2001 Received: October 26, 2001

Dear Mr. Henley:

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 - Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device to a legally premarket nouthoutine the 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 3659. Additionally, for questions on the promotion and advertising of Compination at (301) 59 - 4 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Mulkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Premarket Notification Indications Enclosure

510(k) Number (if known): K012378

Device Name: 3D Humeral Heads

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark N Millersen

astorative

<012378

510(k) Number

Over-the-Counter Use (Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.”