(97 days)
The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
The provided text describes a 510(k) summary for the PLUS EPF Acetabular Cup, a cementless total hip prosthesis. It outlines the device's characteristics, indications, contraindications, and performance data used to establish substantial equivalence. However, it does not detail specific acceptance criteria in a quantitative manner, nor does it describe a study that proves the device meets such criteria with numerical thresholds.
Instead, the document states: "In all tests the PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups." This implies a comparative study was performed against predicate devices, with the acceptance criteria being that the PLUS EPF Cup performs at least as well as or better than the predicate cups in the measured biomechanical properties.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Out-force to unseat titanium cup from acetabulum: Performance comparable to or exceeding competitive cups. | PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups. |
| Push-out force to push polyethylene liner out of cup: Performance comparable to or exceeding competitive cups. | PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups. |
| Force required to seat acetabular cups into foam block: Performance comparable to or exceeding competitive cups. | PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of cups tested) for each biomechanical test. It mentions comparing "four cups of other leading manufacturers to the PLUS EPF Cup," which suggests that for each test, at least one PLUS EPF Cup was compared against four predicate cups. However, the exact number of replicates for each type of cup is not specified.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective, as it involves testing manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The "ground truth" for these biomechanical tests would be the physical measurements themselves, not expert opinion.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as the tests are objective biomechanical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The described studies are biomechanical tests of the device itself, not studies involving human readers or clinical outcomes.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies described are standalone performance tests of the device's physical properties. They do not involve human intervention in the measurement process, aside from operating the testing equipment.
7. The Type of Ground Truth Used
The ground truth used was objective physical measurements (forces) obtained from biomechanical testing.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This type of device (hip prosthesis) does not typically involve a "training set" in the context of machine learning or AI. The biomechanical tests are for performance validation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no concept of a "training set" or "ground truth for a training set" in the context of these device performance tests.
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510(k) Summary of Safety and Effectiveness Information
(as required by 807.92c), prepared by Hartmut Loch, President of HHL Consulting for PLUS Orthopedics in San Diego, California August 6, 1997
NOV 1 3 1997
Trade name: PLUS EPF Acetabular Cup
Common name: Cementless Total Hip Prosthesis, Acetabular Component
Classification name: Hip joint metal/polymer/metal semi constrained porous coated uncemented prosthesis
Equivalence: We are claiming substantial equivalency to the cementless Press-fit Cup, marketed by Encore Orthopedics, Austin, Texas (K-961526).
Characteristics: The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
The PLUS EPF Cup is intended for all types of arthrosis, such as Indications: advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
Contraindications: Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
The following three biomechanical tests were performed Performance data: comparing four cups of other leading manufacturers to the PLUS EPF Cup: out force necessary to unseat the titanium cup from the acetabulum, 2) the push-out force necessary to push the polyethylene liner out of the cup, and 3) the force required to seat the acetabular cups into a block of foam that simulated the reamed acetabulum. In all tests the PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups.
☎ 415.572.0100 fax 415.572.0901 pager 415.202.6680
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hartmut Loch ·President HHL Consulting Representing Plus Orthopedics 835 Cortez Lane Foster City, California 94404
v. 13, 1997
K972931 Re: Plus EPF Acetabular Cup Trade Name: Requlatory Class: II Product Code: LWJ Dated: October 27, 1997 October 27, 1997 Received:
Dear Mr. Loch:
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 regulations affecting your device can be found in the Code of Federal Requlations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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 - Mr. Hartmut Loch
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,
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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(97293 510(k) Number (if known): K-972931
Device Name: PLUS EPF ACETABULAR CUP
Indications for Use:
The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
.. *
OR
Over-The-Counter Use
(Optional Format 1-2-96
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.