(30 days)
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, 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
AMIStem-C is a straight triple tapered cemented femoral stem of rectangular cross-section, for use in total or partial hip arthroplasty for primary or revision surgery. The material is High Nitrogen Stainless steel in accordance with ISO 5832-9. Its superficial feature is a mirror polishing on the neck and the body: the whole body is mirror polished in order to minimize the wear due to the occasional contact between neck and cup, particularly in case of double-mobility cups, and to optimize the load transfer from stem to cement avoiding the stress shielding. The AMIStem-C femoral stem size 00 is a line extension to the stems to the currently marketed Amistem-C product line.
This document is a 510(k) premarket notification for a medical device, specifically a femoral stem for hip replacement. It generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find in an AI/ML device submission.
Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, effect sizes of AI assistance) are not applicable as this submission is for a physical orthopedic implant, not an AI/ML-based diagnostic or treatment device.
However, I can extract the relevant information regarding performance testing that was leveraged from the predicate device to support the substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it states that the performance testing from the predicate device was leveraged because the new size does not create a new worst-case scenario. The acceptance is implicitly that the device performs equivalently to the predicate and passes the specified ISO standards.
| Acceptance Criteria (Implicit) | Reported (Leveraged) Device Performance |
|---|---|
| Pass neck fatigue testing per ISO 7206-4:2010 | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to pass neck fatigue testing per ISO 7206-4:2010 based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Pass shaft fatigue testing per ISO 7206-6:2013 | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to pass shaft fatigue testing per ISO 7206-6:2013 based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Demonstrate acceptable Range of Motion (ROM) | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have acceptable Range of Motion (ROM) evaluation based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Demonstrate acceptable Bacterial Endotoxin levels (LAL test and USP <151>) | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have acceptable Bacterial Endotoxin Testing (LAL test and USP <151>) based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Sterilization validated | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have undergone sterilization validation based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Shelf-life validated | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have undergone shelf-life testing based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Substantial equivalence to predicate device (K103189, Medacta Total Hip Prosthesis System AMIStem C & QUADRA C Short Neck) in terms of materials, surface finish, biocompatibility, device usage, sterility, shelf-life, and packaging, and biomechanical performance. | The AMIStem C size 00 standard femoral stem is considered as safe and effective and substantially equivalent to the predicate device. The subject device's smaller stem length and neck offset do not introduce a new worst case. |
2. Sample size used for the test set and the data provenance
These concepts (test set, data provenance, country of origin, retrospective/prospective) are mostly associated with clinical studies or AI/ML evaluations. For this submission, which relies on engineering performance testing of a physical implant and leveraging predicate data:
- Sample Size: Not explicitly stated for each test (e.g., how many stems were tested for fatigue). The "test set" here refers to the physical samples used for the engineering tests.
- Data Provenance: The data is from engineering performance testing based on predicate device data, conducted to international standards (ISO). The specific country of origin for the testing or whether it's retrospective/prospective in a clinical sense is not directly relevant or stated, as it's mechanical testing data leveraged from an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is an orthopedic implant being cleared based on mechanical performance and substantial equivalence to a predicate, not an AI/ML diagnostic requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for expert consensus on ground truth in clinical or image-based studies. This submission relies on objective engineering measurements against ISO standards.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is objective compliance with international engineering standards (ISO 7206-4:2010, ISO 7206-6:2013) and established biocompatibility/sterility standards (LAL test, USP <151>). The performance of the new design (size 00) is considered equivalent if it does not create a "new worst case" compared to the predicate device that has already demonstrated compliance with these standards.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not Applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
January 9, 2020
Re: K193433
Trade/Device Name: AMIStem-C 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, JDI Dated: December 10, 2019 Received: December 10, 2019
Dear Chris Lussier:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193433
Device Name AMIStem-C
Indications for Use (Describe)
The hip prosthesis AMStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for 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, 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
| 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) |
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3.0 510(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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: December 10, 2019 Date Revised: January 3, 2020
II. Device
| Device Proprietary Name: | AMIStem-C |
|---|---|
| Common or Usual Name: | Femoral Stem |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented or Non-Porous, Uncemented |
| Primary Product Code: | LZO |
| Secondary Product Codes: | JDI |
| Regulation Number: | 21 CFR 888.3353 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Medacta Total Hip Prosthesis System AMIStem C & QUADRA C Short Neck, ● K103189, Medacta International SA
The following device is referenced in the submission: AMIStem-P stems ● K173794, Medacta International
IV. Device Description
AMIStem-C is a straight triple tapered cemented femoral stem of rectangular cross-section, for use in total or partial hip arthroplasty for primary or revision surgery. The material is High Nitrogen Stainless steel in accordance with ISO 5832-9.
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Its superficial feature is a mirror polishing on the neck and the body: the whole body is mirror polished in order to minimize the wear due to the occasional contact between neck and cup, particularly in case of double-mobility cups, and to optimize the load transfer from stem to cement avoiding the stress shielding.
The AMIStem-C femoral stem size 00 is a line extension to the stems to the currently marketed Amistem-C product line.
V. Indications for Use
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for 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 arthrosis, 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, partial ● hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
VI. Comparison of Technological Characteristics
The subject AMIStem-C femoral stem and the predicate AMIStem-C femoral stems are identical with respect to materials of construction, surface finish, biocompatibility, device usage, sterility, shelf-life, and packaging.
The subject AMIStem-C femoral stem provides a smaller stem length and neck offset than the currently available AMIStem-C femoral stems. These differences do not introduce a new worst case from a clinical point of view or with respect to the biomechanical performance of the implants.
VII. Performance Data
The introduction of the AMIStem-C size 00 standard femoral stem does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission:
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- neck fatigue testing per ISO 7206-4:2010; ●
- shaft fatigue testing per ISO 7206-6:2013; ●
- Range of Motion (ROM) Evaluation ●
- Bacterial Endotoxin Testing (LAL test and USP <151>); .
- sterilization validation; and ●
- shelf-life testing. .
VIII. Conclusion
The information provided within this submission supports that the AMIStem C size 00 standard femoral stem is as safe and effective as the predicate device; therefore, the AMIStem-C is substantially equivalent to the predicate device.
N/A