(87 days)
The PLUS-FIT 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-FIT Acetabular 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 document describes a 510(k) submission for the PLUS-FIT Acetabular Cup, a cementless total hip prosthesis. The acceptance criteria and the study proving the device meets them are outlined in the "Performance data" section.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparability to leading competitive cups | "All tests showed that the PLUS-FIT Acetabular Cup was comparable to, or exceeded, cementless competitive acetabular cups." |
| Specifically, the device was compared to "cups of other leading manufacturers" and showed comparable or superior biomechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "biomechanical laboratory tests" comparing "cups of other leading manufacturers" to the PLUS-FIT Acetabular Cup. This implies a comparative study involving multiple cups, but the exact number of units tested for each type is not provided.
- Data Provenance: The tests were "biomechanical laboratory tests." The country of origin of the data is not specified, but the submission is from HHL Consulting for PLUS Orthopedics in San Diego, California, suggesting the tests were likely conducted within a similar regulatory or research environment. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For biomechanical performance tests of an orthopedic implant, the "ground truth" is typically established through direct measurement and objective physical and mechanical properties, not through expert consensus on interpretation.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "performance data" refers to biomechanical laboratory tests, not subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The performance data presented are from biomechanical laboratory tests, not clinical studies involving human readers or interpretation of medical images/cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical implant (acetabular cup), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the "Performance data" was based on objective biomechanical measurements and physical properties observed during laboratory testing. This includes characteristics like stability, load transfer, and potentially other mechanical properties that are intrinsic to the device's design and materials.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no AI/ML algorithm involved, there is no "training set" or ground truth for one.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for HHL Consulting. The letters "HHL" are in a bold, sans-serif font and are larger than the word "CONSULTING", which is also in a bold, sans-serif font. The text is black and the background is white.
NOV 1 3
ﺗﺎ ﮨ
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 14, 1997
PLUS-FIT Acetabular Cup Trade name:
Cementless Total Hip Prosthesis, Acetabular Component Common name:
Hip joint metal/polymer/metal semi constrained porous Classification name: coated uncemented prosthesis
We are claiming substantial equivalency to the cementless RIMFIX Equivalence: Cup, marketed by Surgical Implants, Inc., Sarasota, Florida (K-Number unknown).
The PLUS-FIT Acetabular Cup is a cementless acetabular cup, Characteristics: 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-FIT Acetabular Cup is intended for all types of arthrosis, Indications: 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.
Contraindications include acute or chronic infections (local or Contraindications: 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.
Performance data: Biomechanical laboratory tests were performed comparing cups of other leading manufacturers to the PLUS-FIT Acetabular Cup. All tests showed that the PLUS-FIT Acetabular Cup was comparable to, or exceeded, cementless competitive acetabular cups.
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Mr. Hartmut Loch ·President HHL Consulting Representing Plus Orthopedics 835 Cortez Lane Foster City, California 94404
Re: K973077 PLUS-FIT Acetabular Cup Trade Name: Requlatory Class: II Product Code: LWJ Dated: October 24, 1997 Received: October 27, 1997
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 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 regulation 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 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.
{2}------------------------------------------------
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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of of 1 a
12 21 PH 197 KS73077 Aug 18 510(k) Number (if known):
Device Name: _____PLUS-FIT ACETABULAR CUP
Indications for Use:
The PLUS-FIT 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
t.co/xeep
510(k) Number
Prescription Use ਮ (Per 21 CFR 801.109)
ﻟﻠﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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.