(51 days)
The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. All Pinnacle porous-coated acetabular shells are indicated for cementless application.
The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.
The provided text describes the DePuy Orthopaedics, Inc. Pinnacle Acetabular System, which is an acetabular cup prosthesis used in total hip replacement procedures. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with pre-defined acceptance criteria. Therefore, the information requested in points 1-9, which typically relates to clinical studies with specific acceptance criteria and detailed study designs, is not explicitly available in this type of submission.
However, based on the provided text, we can infer some aspects related to "acceptance criteria" in the context of a 510(k) submission.
Summary of Acceptance Criteria and Device Performance (Inferred from 510(k) Equivalence)
Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device, as opposed to proving a new clinical performance claim against a pre-defined threshold. The "device performance" is therefore considered equivalent to the predicate.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Same Intended Use as Predicate Device | "same intended use" |
| Same Material as Predicate Device | "same material" |
| Same Method of Manufacture as Predicate Device | "same method of manufacture" |
| Same Design as Predicate Device | "same design" |
| Same Sterilization and Packaging Methods as Predicate | "same sterilization and packaging methods" |
| Equivalent Performance to Predicate Device | "The Pinnacle Acetabular System demonstrated equivalent performance to the predicate device." |
Detailed Information based on the provided text:
-
A table of acceptance criteria and the reported device performance:
(As provided in the table above, inferred from the basis of substantial equivalence). -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail a specific "test set" or clinical study with a sample size for performance evaluation. The basis of substantial equivalence relies on comparison of design, materials, manufacturing, and intended use with a predicate device (SUMMIT™ Acetabular System, cleared in K983014). Clinical trials with specific test sets and data provenance are generally not required for 510(k) submissions unless the FDA determines that clinical data are necessary to demonstrate substantial equivalence, which is not indicated here. -
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):
Not applicable (N/A). This information would be relevant for clinical studies involving expert assessment of data (e.g., image interpretation), which is not described in this 510(k) submission. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Adjudication methods are typically used in clinical trials where multiple experts assess outcomes and discrepancies need to be resolved. This information is not present as no such clinical trial is described. -
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:
N/A. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This refers to the performance of an algorithm or AI system, which is not applicable to a physical medical device like an acetabular prosthesis. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
N/A for a direct clinical performance study. For a 510(k) submission, the "ground truth" for demonstrating equivalence largely relies on objective engineering and material testing data, design specifications, and comparison to the known performance of the predicate device. The document explicitly states "The Pinnacle Acetabular System demonstrated equivalent performance to the predicate device," implying that performance metrics (likely mechanical, material, and perhaps some in-vitro wear studies, though not detailed here) were compared and found equivalent. -
The sample size for the training set:
N/A. This is a physical medical device, not an AI or machine learning model that requires a training set. -
How the ground truth for the training set was established:
N/A. As there is no training set mentioned or implied, this question is not applicable.
{0}------------------------------------------------
MAR 2 3 : :
Image /page/0/Picture/1 description: The image contains a handwritten word that appears to be "Koo3ob". The writing is in cursive style, with some letters connected. The text is dark against a white background, making it easily readable.
Image /page/0/Picture/2 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle to the left of the name "DePuy" in a bold, sans-serif font. A horizontal line underlines the name, and below the line is the text "a Johnson & Johnson company" in a smaller font.
SUMMARY OF SAFETY AND EFFECTIVENES DePuv Orthopaedics, Inc.
| NAME OF FIRM: | DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 | PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: +1 (219) 267 8143 Fax: +1 (219) 267 7196 |
|---|---|---|
| 510(k) CONTACT: | Lynnette Whitaker Group Leader, Regulatory Affairs | |
| TRADE NAME: | Pinnacle Acetabular System | |
| COMMON NAME: | Acetabular Cup Prosthesis | |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis | |
| DEVICE PRODUCT CODE: | 87 LPH | |
| SUBSTANTIALLY EQUIVALENT DEVICES: | SUMMIT TM Acetabular System |
DEVICE DESCRIPTION AND INTENDED USE:
The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
All Pinnacle porous-coated acetabular shells are indicated for cementless application.
The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle Acetabular System has the following similarities to the acetabular cup liners that were cleared in K983014: same intended use; same material; same method of manufacture; same design; same sterilization and packaging methods. The Pinnacle Acetabular System demonstrated equivalent performance to the predicate device.
0000003
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The logo is black and white.
MAR 2 3 200(
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynnette Whitaker Group Leader, Regulatory Affairs Depuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988
Re: K000306
Trade Name: Pinnacle Acetabular System Regulatory Class: II Product Code: LPH Dated: Febrary 24, 2000 Received: Febrary 28, 2000
Dear Ms. Whitaker:
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 control provisions of the Act. The general control 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 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 regulations.
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.
{2}------------------------------------------------
MAR 2 3 2000
Page 2 - Ms. Lynnette Whitaker
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (2017) 594-4639. Natinonally 120-4639. 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 mormation on your responsionnes and in the research and except of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Kim C. Yeager
57-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
{3}------------------------------------------------
KUDO306
510(k) Number (if known)_Kooo} ab
Device Name Pinnacle Acetabular System
Indications for Use:
The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the nevious hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
All Pinnacle porous-coated acetabular shells are indicated for cementless application.
Concurrence of CDRH, Office of Device Evaluation
Ticnel' Jayan.
(Division Sigri-Off) Division of Ceneral Restorative Devices Koriso 510(k) Number __
Prescription Use no (Per 21 CFR 801.109)
OR
Over-The Counter Use
000004
§ 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.