PLUS FRACTURE HEAD PROSTHESIS by PLUS ORTHOPEDICS

The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all PLUS hip stem prostheses, which have the appropriate 12/14 Morse Taper.

Device Description

The PLUS Fracture Head Prosthesis comes in 12 different sizes and in two neck lengths. The PLUS Fracture Head Prosthesis is made of CoCrMo and its highly polished metal surface minimizes friction between the implant and the acetabulum. The standard cone allows various possible combinations with all PLUS hip stems. This makes it possible to obtain better stress distribution, which can reduce wear on the acetabulum and pain for the patient. The PLUS Fracture Head Prosthesis can be changed into a total hip prosthesis without replacing the femoral components.

AI/ML Overview

The provided text is a 510(k) Summary for the PLUS Fracture Head Prosthesis, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) Summary, especially for a device like a prosthesis, does not typically contain information about "acceptance criteria" or detailed "study data" in the way one might expect for a diagnostic or AI-driven device. The emphasis is on demonstrating equivalence based on design, materials, and intended use, often supported by comparisons to predicate devices and well-established engineering principles (e.g., material testing for strength or biocompatibility, if applicable). Clinical performance studies with defined acceptance criteria and specific numerical outcomes are rare for 510(k) submissions of this nature unless there's a novel feature or indication requiring such data.

Based on the provided text, the answer is that the document explicitly states "None provided at this time. Performance data:". Therefore, the following information cannot be extracted from the given input.

However, to address your request in the context of what would be expected if such data were present, I will outline what each point would entail if this were a study on an AI/diagnostic device, and explicitly state that the information is not found in the provided text.

Summary of Acceptance Criteria and Device Performance (Not Found in Document)

Metric	Acceptance Criteria (Not Provided)	Reported Device Performance (Not Provided)
[Example: Sensitivity]	[e.g., > 90%]	[e.g., N/A - no performance data reported]
[Example: Specificity]	[e.g., > 85%]	[e.g., N/A - no performance data reported]
[Example: Accuracy]	[e.g., > 92%]	[e.g., N/A - no performance data reported]
[Example: Other metric]	[e.g., Precision, F1-score]	[e.g., N/A - no performance data reported]

Explanation for Absence of Data:
The provided document explicitly states under the "Performance data" section: "None provided at this time." This indicates that the 510(k) submission for the PLUS Fracture Head Prosthesis did not include a study with acceptance criteria and measured device performance that would fall under the categories typically associated with AI or diagnostic device evaluation. For a hip prosthesis, the FDA clearance via a 510(k) often relies on substantial equivalence regarding materials, design, mechanical properties, and biocompatibility to a predicate device, rather than clinical performance studies with numerical acceptance criteria.

Further Specific Details (Not Found in Document):

Sample size used for the test set and the data provenance:
- Not Found. The document does not mention any test set, sample size, or data provenance (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Found. No ground truth establishment is mentioned, as there is no reported performance study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Found. No adjudication method is mentioned.
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 Found. This type of study (MRMC for AI assistance) is not relevant to a hip prosthesis and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Found. This is not applicable to a hip prosthesis and no such study is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Found. No ground truth is mentioned.
The sample size for the training set:
- Not Found. No training set is mentioned.
How the ground truth for the training set was established:
- Not Found. No training set or ground truth establishment is mentioned.

Conclusion:

The provided 510(k) Summary for the PLUS Fracture Head Prosthesis explicitly states "None provided at this time. Performance data:". Therefore, no information regarding acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment is available in the document. The clearance of this device would have relied on demonstrating substantial equivalence to a predicate device through other means, typically involving engineering safety and material specifications.

Summary

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3/15/99

K990309

, ウノコ 4ココムサムサ

510(k) Summary of Safety and Effectiveness

February 19, 1999

PLUS Fracture Head Prosthesis Trade name:
Prosthesis, hip, femoral head Common name:

Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Classification Prosthesis 21 CFR 888.3360 (87 KWL) name:

Johnson & Johnson ULTIMA Unipolar Head (K965156, SE date Equivalence: 01/24/97) and the Foundation Unipolar Femoral Head (K973614, SE date 12/18/97).
The PLUS Fracture Head Prosthesis comes in 12 different sizes and in Characteristics: two neck lengths. The PLUS Fracture Head Prosthesis is made of CoCrMo and its highly polished metal surface minimizes friction between the implant and the acetabulum. The standard cone allows various possible combinations with all PLUS hip stems. This makes it possible to obtain better stress distribution, which can reduce wear on the acetabulum and pain for the patient. The PLUS Fracture Head Prosthesis can be changed into a total hip prosthesis without replacing the femoral components.
The PLUS Fracture Head Prosthesis is intended for use in fractures of Indications: the femoral neck and fractures or avascular necrosis of the femoral head with all PLUS hip stem prostheses, which have the appropriate 12/14 Morse Taper.
Contraindications include acute or chronic infections (local or Contraindications: systemic) or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity; bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment.

None provided at this time. Performance data:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122

Re: K990309 PLUS Fracture Head Prosthesis Trade Name: Regulatory Class: II Product Code: KWL Dated: January 29, 1999 February 1, 1999 Received:

Dear Mr. Loch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Hartmut Loch

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Page 1 of 1

K 990309 510(k) Number (if known):

Device Name: PLUS Fracture Head Prosthesis

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Derson Sign ""

Restorative Devices 1990309

Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter-Use

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.