(28 days)
in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity:
- Revision procedures where other treatments or devices have failed; and
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The INFINTY® Titanium Anodized Distal Femoral Component is a product line addition to the INFINTY® Hip System. This modular system consists of a distal femoral component and a trochanteric module which are assembled by the surgeon at the time of surgery to yield a collared or collarless femoral hip prosthesis. The INFINTY® Hip System is designed for use with cobalt chrome or ceramic femoral heads. The INFINTY® Titanium Anodized Distal Femoral Components are available in standard and microtaper designs. Indications, design features, and functional requirements remain the same. The INFINTY® Titanium Anodized Distal Femoral Components are intended to be used in cemented or uncemented applications. The stems are manufactured from titanium alloy in conformance with ASTM F 136, and are anodized in an additional step to improve resistance to fretting corrosion and improve fatigue characteristics.
The provided text describes the INFINTY® Titanium Anodized Distal Femoral Component, a hip prosthesis. The information focuses on its design, intended use, and a summary of its testing.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate fatigue strength | "Fatigue testing resulted in runout of all test specimens, demonstrating adequate fatigue strength of the INFINTY® Titanium Anodized Distal Femoral Component coupled with an INFINTY® trochanteric module." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "all test specimens" were used for fatigue testing. However, it does not specify the exact number of specimens or the data provenance. This type of testing is typically prospective, conducted in a laboratory setting. The country of origin for the testing data is not mentioned, but given the submission to the FDA, it is likely that the testing was conducted in the USA or by a globally recognized testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical implant, not a diagnostic or interpretative system. Therefore, the "ground truth" for its performance (fatigue strength) is established through standardized engineering testing rather than expert consensus on medical images or patient data. No human experts are used to establish "ground truth" for the fatigue test results themselves, as it's a quantitative measurement based on physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this involves physical testing of a medical device, not an assessment requiring adjudication by experts. The results of fatigue testing are typically quantitative and objective measurements against predefined engineering 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 a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the physical medical device alone through fatigue testing, without human "in-the-loop" for interpretation. In this context, the fatigue testing is a standalone assessment of the device's mechanical properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on engineering standards and physical testing results (specifically, fatigue testing runout). The device's ability to resist fatigue is objectively measured against a predefined standard for "adequate fatigue strength."
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the evaluation of its mechanical properties.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, there is no ground truth established for it in this context.
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16 1997
Contact Person: Kim Tompkins Date Prepared: September 17, 1997
510(k) Summary
IRLINE
Trade Name: Common Name: Product Classification: Predicate Device:
INFINTY® Titanium Anodized Distal Hip Component Semi-constrained hip prosthesis
INFINTY® Hip System manufacture by Wright Medical Technology, Inc. and the Axis Fixation System manufactured by Sofamor Danek
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
II
Description/Intended Use
The INFINTY® Titanium Anodized Distal Femoral Component is a product line addition to the INFINTY® Hip System. This modular system consists of a distal femoral component and a trochanteric module which are assembled by the surgeon at the time of surgery to yield a collared or collarless femoral hip prosthesis. The INFINTY® Hip System is designed for use with cobalt chrome or ceramic femoral heads. The INFINTY® Titanium Anodized Distal Femoral Components are available in standard and microtaper designs. Indications, design features, and functional requirements remain the same. The INFINTY® Titanium Anodized Distal Femoral Components are intended to be used in cemented or uncemented applications. The stems are manufactured from titanium alloy in conformance with ASTM F 136, and are anodized in an additional step to improve resistance to fretting corrosion and improve fatigue characteristics.
Testing Summary
Fatigue testing resulted in runout of all test specimens, demonstrating adequate fatigue strength of the INFINTY® Titanium Anodized Distal Femoral Component coupled with an INFINTY® trochanteric module.
00085
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 1997
Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K973530 Trade Name: Infinity® Titanium Anodized Distal Hip Component Regulatory Class: II Product Codes: LPH, JDI, and LZO Dated: September 17, 1997 Received: September 18, 1997
Dear Ms. Tompkins:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Kim Tompkins
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, permils your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 the Office of Compliance at (301) 594-4639. Also, please note 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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Indications For Use of the Device C.
Page 1 of 1
| 510(k) Number (if known): | K973530 |
|---|---|
| Device Name: | INFINTY® Titanium Anodized Distal FemoralComponents |
| Indications for Use: | |
| in total hip arthroplasty for reduction or relief of pain and/orimproved hip function in skeletally mature patients with thefollowing conditions: | |
| 1. | Non-inflammatory degenerative joint disease such asosteoarthritis, avascular necrosis, ankylosis, protrusioacetabuli, and painful hip dysplasia; |
| 2. | Inflammatory degenerative joint disease such asrheumatoid arthritis; |
| 3. | Correction of function deformity: |
| 4. | Revision procedures where other treatments or deviceshave failed; and |
| 5. | Treatment of nonunion, femoral neck, and trochantericfractures of the proximal femur with head involvement thatare unmanageable using other techniques. |
| (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 General Restorative Devices | |
| 510(k) Number | K973530 |
Prescription Use_X_ Or (Per 21 CFR 801.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
0000009
§ 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.