Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
DDH/CDH
Revision procedures where other treatments or devices have failed
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The MiniHip Stem is indicated for cementless use only.

Device Description

The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MiniHip Stem, a femoral hip stem. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as accuracy, sensitivity, or specificity.

The "Non-Clinical Testing" section mentions "mechanical fatigue testing, range of motion testing and coating characterization," and states that "The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." However, it does not provide the quantitative acceptance criteria for these tests, nor the reported performance data from these tests.

The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This means no human-based clinical studies, including those for the purpose of demonstrating clinical performance or comparative effectiveness (MRMC studies), were conducted or submitted for this 510(k).

As a result, I cannot populate the requested table or answer most of your specific questions related to acceptance criteria and device performance studies because the information is not present in the provided text.

Here's a summary of what can be extracted or directly inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that non-clinical testing (mechanical fatigue, range of motion, coating characterization) was performed, and the results showed the device is "expected to be safe and effective" and "substantially equivalent." However, it does not list specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") or the device's measured performance against those criteria.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. No clinical or standalone device performance testing data on a "test set" (in the context of AI/diagnostic device evaluation) is presented. The non-clinical tests would have used physical device samples, but details on their quantity or "data provenance" are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned.

4. Adjudication method for the test set

Not applicable / Not provided.

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. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This includes MRMC studies.

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

No. The device is a physical medical implant (femoral hip stem), not an algorithm or diagnostic software that operates in a "standalone" mode.

7. The type of ground truth used

Not applicable / Not provided. In the context of a hip stem, "ground truth" would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document relies on non-clinical testing for mechanical and material properties, and substantial equivalence to predicate devices for clinical safety and effectiveness rather than direct clinical ground truth generation.

8. The sample size for the training set

Not applicable / Not provided. The device is a physical implant, not an AI model that requires a "training set."

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

Not applicable / Not provided.

Summary

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polymer semi-constrained cemented or 5. Classification Name: nonporous uncemented prosthesis (21CFR 888.3353) Legally Marketed Devices to which Substantial Equivalence is claimed: 6. Howmedica Osteonics Secur-Fit Max Hip and Secure-Fit Plus Max Hip Stems a. (K051738)

Aesculap Implant Systems Metha Short Stem Hip System (K080584) b.
Zimmer MAYO Conservative Hip Prosthesis (K030733) C.
d. Smith & Nephew MIS Hip Stem (K072417)

Device Description: 7.

、

1. Intended Use / Indications:

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K083312 (pg. 2 of 2)

The indications for the MiniHip Stem as a total hip arthroplasty include:

Non-inflammatory degenerative joint disease including osteoarthritis and o avascular necrosis
Rheumatoid arthritis O
Correction of functional deformity o
DDH/CDH 0
Revision procedures where other treatments or devices have failed o
Treatment of non-union, femoral neck and trochanteric fractures of the proximal O femur with head involvement that are unmanageable using other techniques.

The MiniHip Stem is indicated for cementless use only.

1. Summary of Technologies/Substantial Equivalence:
  The MiniHip Stem has the same intended use and indications as the four predicate devices. In addition, the MiniHip Stem is similar in design and available in sizes within the range of the MIS Hip Stem (K072417). The stem is manufactured from the same material and demonstrates similar characteristics as all four predicate devices. The proximal coating of plasma-sprayed HA over plasma-sprayed titanium is the equivalent to that applied to the Secur-Fit Max Hip and Secur-Fit Plus Max Hip Stems (K051738). Based on these similarities, Corin believes that the MiniHip Hip Stem is substantially equivalent to the predicate devices.
1. Non-Clinical Testing:
  Non-clinical testing and analysis included mechanical fatigue testing, range of motion testing and coating characterization. The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.

11. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Corin U.S.A % Ms. Ashlea Bowen, AA, RAC Regulatory Affairs Associate 10500 University Center Drive, Suite 190 Tampa, Florida 33612

APR - 5 2010

Re: K083312 Trade/Device Name: MiniHip Stem Regulation Number: 21 CFR 8888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LZO Dated: February 26, 2010 Received: March 1, 2010

Dear Ms. Bowen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see,above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Ms. Ashlea Bowen, AA, RAC

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark A. Milliken

Mark N Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. INDICATIONS FOR USE

510(k) Number (if known): _ KO 83312

Device Name: MiniHip Stem

Indications for Use:

The indications for the MiniHip Stem as a total hip arthroplasty include:

o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis 0
Correction of functional deformity o
DDH/CDH O
Revision procedures where other treatments or devices have failed ೧
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur 0 with head involvement that are unmanageable using other techniques.

The MiniHip Stem is indicated for cementless use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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 Surgical, Orthopedic,
and Restorative Devices

510(k) Number K083312

Page 1 of 1

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.