(69 days)
The Press-fit Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used in a press fit mode.
The femoral stem is straight. The proximal body is trapezoidal in cross-sectional geomety. A Morse type taper is used to receive modular heads. The Press-Fit is fabricated from wrought Ti-6A1-4V. The entire stem is grit blasted. The stem is available in eight sizes.
This document is a 510(k) premarket notification for a medical device called the "Press-Fit Stem," a component of a hip replacement system. It is submitted to the FDA for review and approval to market the device. The document states that the device is substantially equivalent to existing predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and associated studies:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there is no specific table of acceptance criteria or detailed performance metrics that would typically be associated with a clinical study for a new medical device. The document primarily focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk devices.
The "Test Results" section is very brief and general:
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Mechanical Integrity (Fatigue) | "FEA fatigue analysis" (Results not detailed) |
| Mechanical Integrity (Taper) | "testing on the Morse type taper" (Results not detailed) |
| Geometric Similarity | "The Press-Fit Stem has similar geometry... as the predicate devices." (Implicitly met for substantial equivalence) |
| Material Composition | "is manufactured from the same material [wrought Ti-6A1-4V]... as the predicate devices." (Implicitly met for substantial equivalence) |
| Intended Use/Indications | "has the same indications as the predicate devices." (Implicitly met for substantial equivalence) |
Important Note: For a 510(k) submission like this, the "acceptance criteria" are largely centered on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often relies on similarity in design, materials, manufacturing processes, and sometimes some bench testing, rather than extensive clinical efficacy trials typically seen for novel, high-risk devices. The details of the "FEA fatigue analysis" and "testing on the Morse type taper" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not describe a clinical "test set" or human subject data. The "Test Results" specifically mention:
- FEA fatigue analysis: This is a computational simulation (Finite Element Analysis), not a test on human subjects or even physical devices in a clinical setting. There is no "sample size" in the traditional sense, as it involves computer modeling.
- Testing on the Morse type taper: This refers to bench testing (laboratory testing) of the mechanical interface between the stem and the modular head. The sample size for this bench test is not mentioned in the document.
Therefore, there is no data provenance (country of origin, retrospective/prospective) for a test set involving human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since there is no human subject "test set" described, there is no mention of experts establishing a ground truth in this context. The evaluation described is mechanical/computational.
4. Adjudication Method for the Test Set:
Not applicable, as no human subject "test set" is described for which adjudication would be necessary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers (e.g., radiologists) interpreting medical images or data, with and without AI assistance, to assess the impact of AI on their performance. The described "tests" are mechanical and computational.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not directly applicable to the device described. The "Press-Fit Stem" is a physical orthopedic implant, not a software algorithm or an AI-powered diagnostic tool. The "FEA fatigue analysis" could be considered a standalone computational assessment, but it's not an "algorithm" in the typical sense of AI.
7. The Type of Ground Truth Used:
For the mechanical testing (FEA fatigue, taper testing), the "ground truth" would be established by:
- Engineering principles and material science standards for fatigue life.
- Industry-recognized mechanical testing standards (e.g., ISO standards for orthopedic implants) for taper integrity.
There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in the reported "Test Results."
8. The Sample Size for the Training Set:
This question is not applicable. The Press-Fit Stem is a physical device, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI model.
In summary: This 510(k) submission relies on demonstrating substantial equivalence to predicate devices primarily through similarity in design, materials, and intended use, supported by basic mechanical and computational testing. It does not involve human subject trials, AI algorithms, or extensive clinical performance data typically associated with your questions.
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19806
APR 1 6 1998
Summary of Safety and Effectiveness
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Press-Fit Stem Trade Name:
Common Name: Press-fit hip stem
Classification Name: Hip joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3350 and Hip joint Femoral (hemi-hip) metallic uncemented prosthesis per 21 CFR 888.3360
The femoral stem is straight. The proximal body is trapezoidal in cross-sectional Description: geomety. A Morse type taper is used to receive modular heads.
The Press-Fit is fabricated from wrought Ti-6A1-4V. The entire stem is grit blasted. The stem is available in eight sizes.
Intended Use: The Press-Fit Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional 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, which is unmanageable using other techniques.
Comparable Features to Predicate Device(s): The Press-Fit Stem has similar geometry, is manufactured from the same material, and has the same indications as the predicate devices.
Test Results: Testing on this device included FEA fatigue analysis and testing on the Morse type taper.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Ms. Debbie De Los Santos ·Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K980473 Press-Fit Stem Requlatory Class: II Product Codes: LZO, LWJ, and KWY Dated: February 5, 1998 Received: February 6, 1998
Dear Ms. De Los Santos:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulation (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 requlatory 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. Debbie De Los Santos
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, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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,
Stephen Edwards
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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| 510(k) Number (if known): | K980 473 |
|---|---|
| Device Name: | Encore Press Fit Stem |
Indications For Use:
Press-fit Stem Indications For Use
The Press-fit Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used in a press fit mode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) X
OR
Over-The-Counter Use
(Optional Format 1-2-96)_
Dlupton Plurla
al Restorative Devices 510(k) Number
§ 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.