Osteoarthritis
Rheumatoid arthritis
Tumor conditions involving the upper third of the femur of the Acetabular
Ankylosing spondylitis
Psoriatic arthritis
Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive protein
Non-union of femoral neck fracture or avascular necrosis of the femoral head
Post-traumatic fracture/dislocation of the hip
Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem.

Device Description

The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Ceramic Ball Heads), not an AI/ML device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training set" are not applicable in the context of AI/ML device evaluation.

The provided document describes a traditional medical device submission seeking substantial equivalence to a predicate device. Here's how the relevant information from the document addresses your request, interpreted for a non-AI/ML device:

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

For non-AI/ML devices submitted via 510(k), "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of indications for use, technological characteristics, and performance testing, often against recognized standards.

Acceptance Criteria (Demonstrating Substantial Equivalence)	Reported Device Performance (Summary)
Indications for Use / Intended Use: Must be substantially equivalent to the predicate device.	The Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem for primary and revision total hip arthroplasty due to disease or trauma, aiding in relieving hip pain and restoring motion. The specific conditions listed (Osteoarthritis, Rheumatoid arthritis, etc.) are comparable to the predicate. They are to be used only with Plus Orthopedics AG hip stems. This was deemed substantially equivalent to the predicate.
Technological Characteristics: Must be substantially equivalent or modifications do not raise new questions of safety or effectiveness.	The Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474. Available in various sizes (28, 32, 36 mm). The comparison was based on design control documentation and predicate device information. This was deemed substantially equivalent to the predicate.
Performance Standards & Testing: Compliance with recognized standards and design verification/validation (bench testing) to demonstrate safety and effectiveness.	The device complies with ISO 6474:1994 (Implants for surgery -- Ceramic materials based on high purity alumina), ISO 7206-10, 2003 (Implants for surgery -- Partial and total hip-joint prostheses --Part 10), and AAMI / ANSI / ISO 11137:1994 (Sterilization). Bench testing was performed according to FDA's Design Control Requirements (21 CFR Part 820.30).

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

This information is not applicable. This is a submission for a non-AI/ML medical device, and the "test set" concept in the context of data used to evaluate AI performance does not apply here. The evaluation relies on design control documentation, compliance with established standards, and bench testing, not on human-read data sets.

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)

This information is not applicable. "Ground truth" in the context of human expert adjudication for AI model evaluation is not relevant for this traditional medical device submission. The "truth" is established by adherence to engineering specifications, material science, and performance testing against recognized standards.

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

This information is not applicable. Adjudication methods are specific to AI/ML device evaluation where human experts resolve discrepancies in ground truth labeling. This concept does not apply to the safety and performance evaluation of a ceramic hip ball head.

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

This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which is entirely outside the scope of evaluating a physical hip implant component.

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

This information is not applicable. There is no algorithm or AI component in this device.

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

For this type of device, what could be considered "ground truth" relates to:

Material specifications: Conforming to the requirements of ISO 6474:1994 for high purity alumina.
Mechanical performance: Meeting the test criteria established in ISO 7206-10, 2003 for hip-joint prostheses (bench testing).
Sterilization efficacy: Adherence to AAMI / ANSI / ISO 11137:1994 for radiation sterilization.
Design intent: Verification and validation carried out according to FDA's Design Control Requirements (21 CFR Part 820.30) to ensure the device performs as intended and is safe.

8. The sample size for the training set

This information is not applicable. There is no AI/ML model, and therefore no "training set."

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

This information is not applicable as there is no training set for an AI/ML model.

Summary

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K070928

AUG - 1 2007

Premarket Notification 510(k) Summary

1.0 Submitter Information

Company Name	Plus Orthopedics AG
Company Address	Erlenstraße 4aCH-6343 RotkreuzSwitzerland
Contact Name	Pamela J. Weagraff, Principal ConsultantQuintiles Consulting
Contact Address	18 Bridie LaneNorfolk, MA 02056
Contact Telephone	508-528-1745
Contact Facsimile	978-752-1225
Contact E-mail	pamela.weagraff@quintiles.com

2.0 Date Prepared: June 8, 2007

3.0 Name of Device

3.1 Device Name: Ceramic Ball Heads, various sizes
3.2 Common Name: Ceramic Ball Heads
3.3 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis, Title 21 CFR Part 888.3353

4.0 Substantial Equivalence Claimed to Predicate Device

Portland Ceramic (BIOLOX® forte), K061564 Need to add CoCrMo taper predicate used with Portland

5.0 Device Description

These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.

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6.0 Indications for Use

The Plus Orthopedics AG Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:

Osteoarthritis 1.
Rheumatoid arthritis 2.
Tumor conditions involving the upper third of the femur of the Acetabular 3.
1. Ankylosing spondylitis
1. Psoriatic arthritis
Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive 6. protein
1. Non-union of femoral neck fracture or avascular necrosis of the femoral head
1. Post-traumatic fracture/dislocation of the hip
ರ್ Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
1. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
1. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.

These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.

7.0 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics

The comparison of the Ceramic Ball Heads was based on a review of the Design Control documentation, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was obtained from the FDA web site. The comparison considered technical characteristics and the indications for use / intended use.

8.0 Performance Data

8.1 Performance Standards: no performance standards applicable to this device, Hip Joint Metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis, Title 21 CFR Part 888.3353; Product Code: LZO, have been adopted under Section 514 of the Food Drug and Cosmetic Act.
8.2 The Ceramic Ball Heads comply with the following FDA recognized standards:
- 8.2.1 ISO 6474:1994, Implants for surgery -- Ceramic materials based on high purity alumina
- 8.2.2 ISO 7206-10, 2003, Implants for surgery -- Partial and total hip-joint prostheses --Part 10

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AAMI / ANSI / ISO 11137:1994, Sterilization of health care products Requirements 8.2.3 for validation and routine control -- radiation sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002).
Performance Testing: Design verification and design validation, e.g., bench testing was 8.3 performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.

9.0 Conclusion

The information and data provided in this 510(k) Premarket Notification establish that the Ceramic Ball Heads, various sizes, are substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are arranged in a way that they form the body and wings of the bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2007

Plus Orthopedics AG % Ms. Pamela Weagraff Principal Consultant 18 Bridie Lane Norfolk, Massachusetts 02056

Re: K070928

Trade/Device Name: Ceramic Ball Heads, 28, 32 and 36 mm Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: March 30, 2007 Received: April 3, 2007

Dear Ms. Weagraff:

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. Iisting 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

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Page 2 - Ms. Pamela Weagraff

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.

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) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark N. Milkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ODE Indications for Use Statement

510(k) Number (if known): K070928

Device Name: Ceramic Ball Heads, 28, 32 and 36 mm

Indications for Use:

1. Osteoarthritis
Rheumatoid arthritis 2.
Tumor conditions involving the upper third of the femur of the Acetabular 3.
1. Ankylosing spondylitis
Psoriatic arthritis 5.
Old osteomyelitis with a long infection-free period and a normal WBC. ESR and C-6. reactive protein
1. Non-union of femoral neck fracture or avascular necrosis of the femoral head
1. Post-traumatic fracture/dislocation of the hip
Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or 9. where low back pain or knee pain is becoming disabling
· 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
1. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.

These ceramic ball heads are to be used only hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart D)

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)

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

Indications for Use Statement

510(k) Number_

Page C-2 of C-2

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.