(290 days)
The hip prosthesis AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, theumatoid polyarthritis, or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
The AMIStem-H Proximal Coating femoral stems are line extensions to the Medacta Total Hip Prosthesis system and are comprised of the following products:
- AMIStem-H Proximal Coating STD, Stem #s 1 9 ●
- AMIStem-H Proximal Coating LAT, Stem #s 1 8 ●
These prostheses are straight femoral stems manufactured from titanium (Ti) alloy (ISO 5832-11:1994, Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminum 7niobium alloy). The subject devices have a titanium and hydroxyapatite dual layer coating at the proximal end of the shaft and a sandblasted surface at the distal end.
The instruments used with the AMIStem-H Proximal Coating stems were previously cleared as part of the AMIStem Implants family (K093944, K103189, and K121011). Additional instrumentation, included within the subject 510(k), can be used in lieu of the previously cleared instruments.
The provided document describes a 510(k) premarket notification for a hip prosthesis, the AMIStem-H Proximal Coating. This is a medical device traditionally regulated and does not fall under the purview of AI/ML-driven software as a medical device (SaMD). Therefore, the concepts of acceptance criteria, test sets, ground truth establishment, training sets, and MRMC studies, which are pertinent to validating performance of AI/ML models, do not apply to this document.
The document details the device's indications for use, material composition, design similarities, and differences to predicate devices, and the non-clinical studies conducted to support its substantial equivalence. These non-clinical studies primarily focus on mechanical and material performance rather than diagnostic accuracy or AI model performance.
Therefore, I cannot extract the requested information about acceptance criteria for AI/ML performance, sample sizes for AI test/training sets, expert consensus, adjudication methods, or MRMC studies, as these aspects are not relevant to the evaluation of this traditional medical device.
The closest analogue to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context would be:
Acceptance Criteria (General to the Device Type):
- Mechanical Integrity: The device must withstand anticipated physiological forces over its design life without fracture or significant deformation.
- Biocompatibility: The materials used must be safe for implantation in the human body.
- Coating Adhesion: The coating must adhere sufficiently to the substrate.
- Sterility: The device must be provided sterile.
- Fatigue Life: The device must demonstrate sufficient resistance to fatigue failure.
Study Proving Acceptance (from the document):
The document lists the following non-clinical studies that aim to demonstrate these general acceptance criteria:
- Fatigue testing: In accordance with ISO 7206-4:2010 and ISO 7206-6:1992.
- Range of Motion Analysis: In accordance with EN ISO 21535:2009 (specifically Tilting and Rotation Stability).
- Pull Off Testing: In accordance with ASTM F2009-00 (likely for coating adhesion).
- Coating Tests: To evaluate coating properties.
- Cleaning and Sterilization Validation: To ensure the device can be properly sterilized.
- Bacterial endotoxin testing: To ensure it meets pyrogenicity standards.
- Shelf-life studies: To determine the stability of the device over time.
No human reader studies, AI model performance metrics, or related data are presented in this document.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Medacta International SA Stefano Baj Regulatory Affairs Manager Strada Regina 6874 Castel San Pietro (CH) Switzerland
Re: K161635 Trade/Device Name: AMIstem-H Proximal Coating Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, KWY, LZY, LPH Dated: February 28, 2017 Received: March 1, 2017
Dear Mr. Stefano Baj:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161635
Device Name
AMIStem-H Proximal Coating
Indications for Use (Describe)
The hip prosthesis AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, theumatoid polyarthritis, or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Pg.1/4 K161635
Medacta International SA
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs Manager Date Prepared: March 28, 2017
II. Device
| Device Proprietary Name: | AMIStem-H Proximal Coating |
|---|---|
| Common or Usual Name: | Femoral Stems |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis |
| Regulation Number(s): | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360,21 CFR 888.3358 |
| Product Code: | LZO, MEH, KWY, LZY, LPH |
| Device Classification | II |
Predicate Device III.
Substantial equivalence is claimed to the following devices:
Primary Predicate:
-
Medacta Total Hip Prosthesis AMIStem H, Quadra S and Quadra H femoral stems, ● K093944, Medacta International SA
Additional Predicates: -
Avenir® Müller Stem, K123392, Zimmer GmbH
Reference Device: -
AMIStem and Quadra – Line Extension, K121011, Medacta International SA
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Device Description IV.
The AMIStem-H Proximal Coating femoral stems are line extensions to the Medacta Total Hip Prosthesis system and are comprised of the following products:
- AMIStem-H Proximal Coating STD, Stem #s 1 9 ●
- AMIStem-H Proximal Coating LAT, Stem #s 1 8 ●
These prostheses are straight femoral stems manufactured from titanium (Ti) alloy (ISO 5832-11:1994, Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminum 7niobium alloy). The subject devices have a titanium and hydroxyapatite dual layer coating at the proximal end of the shaft and a sandblasted surface at the distal end.
The instruments used with the AMIStem-H Proximal Coating stems were previously cleared as part of the AMIStem Implants family (K093944, K103189, and K121011). Additional instrumentation, included within the subject 510(k), can be used in lieu of the previously cleared instruments.
V. Indications for Use
The hip prosthesis AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, ● rheumatoid polyarthritis, or congenital hip dysplasia
- Avascular necrosis of the femoral head ●
- Acute traumatic fracture of the femoral head or neck ●
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
VI. Comparison of Technological Characteristics
The design features, and materials of the subject devices are substantially equivalent to those of the predicate devices.
The AMIStem-H Proximal Coating and the predicate devices share the following characteristics:
- Same materials of construction
- Same sizes (stem length and neck offset) ●
- Same product design (shape and macrostructures) ●
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- Similar titanium and hydroxyapatite double coating as seen in the Avenir® Müller Stem ●
- Same sterilization method ●
The AMIStem-H Proximal Coating femoral stems are technologically different from the predicate devices in that the subject devices are double coated at the proximal end of the femoral stem whereas the entire surface of the Avenir® Müller Stems, with the exception of the polished neck area, is double coated.
A comparison of the subject and predicate devices is provided in the table below.
Technological comparison
| Subject Device | Medacta Total HipProsthesis – AMIStemH, Quadra S &Quadra H FemoralStems(K093944) | Avenir® Müller Stem,(K123392) | |
|---|---|---|---|
| Material ofConstruction | Titanium alloy(ISO 5832-11) | Same | Titanium alloy |
| Coating | Titanium (ASTM F1580)Hydroxyapatite (ASTMF1185) | Hydroxyapatite (ASTMF1185) | Titanium +Hydroxyapatite |
| Sizes | STD Stem #s 1 - 9LAT Stem #s 1 - 8 | STD Stem #s 0 – 9LAT Stem #s 1 - 8 | STD Stem #s 1 - 9LAT Stem #s 1 - 9 |
| Stem Shape | Straight and symmetrical | Same | Same |
| Macrostructures | Horizontal grooves in theproximal stemVertical grooves in thedistal stem | Same | Same |
| SterilizationMethod | Gamma Irradiation | Same | Same |
| Device Usage | Single Use | Same | Same |
Discussion
As seen above, the fundamental scientific technology of the subject devices has not changed relative to the predicate devices.
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Performance Data VII.
The following performance data were provided or leveraged in support of the substantial equivalence determination.
Non-Clinical Studies
- Fatigue testing in accordance with ISO 7206-4:2010 and ISO 7206-6:1992 ●
- Range of Motion Analysis in accordance with EN ISO 21535:2009
- o Tilting and Rotation Stability
- Pull Off Testing in accordance with ASTM F2009-00
- Coating Tests
- o Cleaning and Sterilization Validation
- Bacterial endotoxin testing ●
- Shelf-life studies ●
Conclusion VIII.
The information provided above supports that the AMIStem H-Proximal Coating is as safe and effective as the predicate devices. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the AMIStem-H Proximal Coating is substantially equivalent to the predicate devices.
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§ 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.