(24 days)
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- · Patients who require a total hip replacement.
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.
The provided text is a 510(k) summary for the Klassic HD® Hip System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on design control activities. However, it does not contain the specific information required to complete the table and answer the study-related questions.
The document focuses on demonstrating substantial equivalence through design control activities and worst-case fatigue testing, rather than a clinical study measuring device performance against specific acceptance criteria in a patient population. It outlines that the "modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met the pre-determined acceptance criteria for the verification activities" and that "The fatigue and characterization results demonstrated that the modified stems are substantially equivalent to the predicate components."
Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, study design parameters (sample size, data provenance, expert truth, etc.), or comparative effectiveness studies.
Based on the provided text, here's what can be inferred and what is missing:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-determined acceptance criteria for verification activities (specific criteria not detailed) | Modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met these criteria. |
| Compliance with worst-case fatigue testing (specific thresholds not detailed) | Fatigue results demonstrated substantial equivalence. |
| Porous coating characterization (specific parameters not detailed) | Characterization results demonstrated substantial equivalence. |
| Compliance with LAL testing requirements for orthopedic implants | Klassic HD® Hip System is in compliance. |
Study Details (Information NOT present in the provided text):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. The document refers to "verification activities" and "fatigue testing" but does not detail a test set of patient data, so no sample size or provenance is available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No human expert ground truth is mentioned as this is not a study assessing diagnostic or prognostic performance of an AI/human-in-the-loop device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. See above.
- 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 present. This is a hip implant, not an AI diagnostic tool. No MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This refers to a physical device (hip implant), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be the specific quantitative results of the fatigue and characterization tests compared against established engineering standards and predicate device performance. No patient-related ground truth (like pathology or outcomes) is mentioned.
- The sample size for the training set: Not applicable/Not present. This is a physical medical device, not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable/Not present. See above.
In summary: The provided document is a regulatory submission for a medical device (hip implant) seeking substantial equivalence, not a clinical study report for an AI/diagnostic device. As such, it details engineering tests and verification activities, but does not include the specific types of studies and data points (e.g., patient sample sizes, expert ground truth, MRMC studies) you've requested for AI device evaluations.
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July 24, 2017
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Total Joint Othopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K171962
Trade/Device Name: Klassic HD® Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL, LZO Dated: June 29, 2017 Received: June 30, 2017
Dear Chris Weaber:
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
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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 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 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
510(k) Number (if known)
K171962
Device Name Klassic HD® Hip System
Indications for Use (Describe)
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- · Patients who require a total hip replacement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117 |
|---|---|
| Contact: | Mr. Chris WeaberProduct Development, Regulatory Manager |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800Fax: 202.552.5798 |
| Date Prepared: | June 29, 2017 |
| Device Trade Name: | Klassic HD® Hip System |
| Common Name: | Femoral Hip Stem |
| Classifications: | 21 CFR 888.3358 - Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis |
| 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis | |
| Class II | |
| Product Codes: | LPH, LZO, MBL |
Indications for Use:
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular ● necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement. ●
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Device Description:
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.
Predicate Devices:
The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System (K100445, K151440) with respect to indications, design, materials and function. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met the pre-determined acceptance criteria for the verification activities.
Substantial Equivalence:
The company performed worst case fatigue testing of the Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems, as well as porous coating characterization. The fatigue and characterization results demonstrated that the modified stems are substantially equivalent to the predicate components. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.