Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revision where other devices or treatments have failed
Correction of functional deformity
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
Non-coated (Interlok®) devices are indicated for cemented application only.

Device Description

Manufactured from Ti-6Al-4V
Bi-planer tapered stem
30 grit blested Interlok® surface finish
Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment hole
Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.

AI/ML Overview

The provided text is a 510(k) summary for the Interlok® Bio-Modular® Shoulder Humeral Stems. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML device evaluations.

Instead, this document is a premarket notification for a medical implant (shoulder humeral stems) that demonstrates substantial equivalence based on design, materials, and processing similarities to a previously cleared device. Therefore, the questions related to AI/ML device performance, ground truth, experts, and sample sizes are not applicable to this specific regulatory submission.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance

None provided. The document states "Clinical/Non-Clinical Testing: None provided." This indicates that no specific performance metrics or acceptance criteria, as would be generated from a performance study, were included in this 510(k) submission. For medical implants seeking substantial equivalence, often the equivalence is based on materials, design, and manufacturing processes being similar to a predicate device, rather than specific performance numbers from a new study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set was used for a performance study.

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. No ground truth determination by experts was required for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set was used.

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. This is a hardware medical device, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth was established as there was no performance study of this nature.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable.

Key takeaway from the document:

The device (Interlok® Bio-Modular® Shoulder Humeral Stems) received 510(k) clearance based on its substantial equivalence to a previously cleared predicate device (The Bio-Modular® Shoulder System cleared in 510(k) K992119). The justification for this equivalence rested on the "design, materials and processing of the device are similar to the predicate device." No new clinical or non-clinical performance studies were provided for this specific submission as stated in the document: "Clinical/Non-Clinical Testing: None provided."

Summary

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SEP - 5 2003

510(k) Summary

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Patricia Sandborn BeresSenior Regulatory SpecialistTelephone: (219) 267-6639Fax: (219) 372-1683

Proprietary Name: Interiok® Blo-Modular® Shoulder Humeral Stems

Common Name: Shoulder Humeral Stem

Classification Name:

1. Prosthesis, Shoulder, non-constrained, Cemented (21 CFR Section 888.3650)
1. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3660)
1. Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented (21 CFR Section 888.3690)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Devices are a modification of The Bio-Modular® Shoulder System cleared in 510(k) K992119.

Device Description:

◆ Manufactured from Ti-6Al-4V
. Bi-planer tapered stem
30 grit blested Interlok® surface finish ●
Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment . hole
. Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.

Intended Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
Revision where other devices or treatments have failed 3)
1. Correction of functional deformity
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate 5)
Difficult clinical management problems, Including cuff arthropathy, where other methods of 6) treatment may not be suitable or may be Inadequate

Non-coated (Interlok®) devices are indicated for cemented application only.

Summary of Technologies: The design, materials and processing of the device are similar to the predicate device.

Clinical/Non-Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

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SEP - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K032507 Trade/Device Name: Interlok® Bio-Modular® Humeral Stems Regulation Number: 21 CFR 888.3650, 888.3660, 888.3690 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis, Shoulder joint metal/polymer semi-constrained cemented prosthesis, Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: KWT, KWS, HSD Dated: August 13, 2003 Received: August 14, 2003

Dear Ms. Beres:

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. Patricia Sandborn Beres

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Millburn

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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510(k) Number (if known):

Device Name: Interlok® Bio-Modular Shoulder Humeral Stems

Indications For Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Revision where other devices or treatments have failed
1. Correction of functional deformity
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Non-coated (Interlok®) devices are indicated for cemented application only.

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.”