(259 days)
The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
The Orthogenesis LPS components are designed to be implanted for the replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total of roovenon and renoration in those cases where no part of the femur can be salvaged.
The provided text describes a 510(k) summary for the Orthogenesis LPS System, a total femur/proximal tibial replacement prosthesis. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific performance acceptance criteria.
The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to existing ones rather than extensive novel studies with acceptance criteria.
Therefore, the input does not contain the information required to answer the prompt in detail, as it pertains to a different type of regulatory submission. The requested information (acceptance criteria, specific study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is typically found in documentation for clinical trials or performance studies that aim to prove a device's performance against predefined metrics, which is not the primary purpose of a 510(k) summary.
However, based on the information available, I can report the following in relation to substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance thresholds from a novel study.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as claimed in 510(k)) |
|---|---|
| Similarity in Indications for Use | The Orthogenesis LPS System's indications for use are similar to those of the predicate devices. These include replacement of mid-shaft/intercalary femur, proximal/distal/total femur, and proximal tibia for conditions like metastatic diseases, NIDJD, IJD, severe arthropathy, and revision cases requiring extensive resection. |
| Similarity in Design | The Orthogenesis LPS System is designed to be implanted for extensive resections, similar to predicate systems used for oncology cases and end-stage revisions. (Specific design similarities are implied by the claim of substantial equivalence but not detailed in the provided text). |
| Similarity in Materials | The materials used in the Orthogenesis LPS System are claimed to be similar to the predicate devices. (Specific material types are not detailed in the provided text, but implied to be standard for such prostheses: metal/polymer components). |
| Similarity in Sterilization | The sterilization method for the Orthogenesis LPS System is claimed to be similar to the predicate devices. (Specific method not detailed). |
| Similarity in Packaging | The packaging for the Orthogenesis LPS System is claimed to be similar to the predicate devices. (Specific packaging details not provided). |
| Conformance with Voluntary Performance Standards | The determination of substantial equivalence for this device was based on a detailed device comparison, performance testing, and conformance with voluntary performance standards. (Specific standards are not listed in the provided text). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a 510(k) substantial equivalence submission in the context of a performance study. No separate "test set" in the sense of a clinical trial or algorithm validation dataset is described. The submission relies on comparison to existing, legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information is not part of a 510(k) summary where the primary assessment is regulatory review against predicate devices rather than expert-adjudicated ground truth data.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts is described in this 510(k) summary.
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 device is a physical prosthesis, not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical prosthesis, not an algorithm, so standalone performance in the context of AI is irrelevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For a 510(k), the "ground truth" for demonstrating substantial equivalence is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed equivalent if it raises no new questions of safety and effectiveness and performs as well as or better than the predicate. Direct 'ground truth' from pathology or outcomes data specifically for the new device's own clinical study is typically not required for 510(k) clearance, though design verification and validation testing (e.g., mechanical testing) would occur.
8. The Sample Size for the Training Set
Not applicable. This pertains to AI/machine learning model development, which is not relevant for this physical medical device and its 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As above, this pertains to AI/machine learning model development.
Summary of the Study (510(k) Assessment for Substantial Equivalence):
The "study" presented here is a 510(k) premarket notification to the FDA. The objective was to demonstrate substantial equivalence of the Orthogenesis LPS System to several predicate devices already on the market.
-
Predicate Devices:
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Methodology: The determination of substantial equivalence was based on a detailed comparison of the new device's:
- Indications for use
- Design
- Materials
- Sterilization
- Packaging
- Performance testing (implied, not detailed, likely mechanical/biocompatibility testing to show similar performance characteristics to predicates)
- Conformance with voluntary performance standards (not specified which ones).
-
Conclusion of the 510(k): The FDA reviewed the submission and determined that the Orthogenesis LPS System is substantially equivalent to the referenced predicate devices, allowing it to be marketed. This determination was made on June 27, 2001.
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( 003182
JUN 2 7 2001
510(k) Summary Orthogenesis LPS System
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907
B. Device Information:
| Proprietary Name: | Orthogenesis LPS System |
|---|---|
| Common Name: | Total Femur Replacement ProsthesisProximal Tibial Replacement Prosthesis |
| Classification Name andRegulatory Class: | Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis: Class II per 21CFR §888.3560Hip joint metal/polymer semi-constrained cementedprosthesis: Class II per 21 CFR §888.3350Hip joint metal/polymer/metal semi-constrainedporous coated uncemented prosthesis: Class II per 21CFR §888.3358 |
| Product Code: | 87 JWH, 87 JDI, 87 LPH |
C. Indications for Use:
The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. . avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not . respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, . distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
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D. Device Description:
The Orthogenesis LPS components are designed to be implanted for the replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and mroximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total of roovenon and renoration in those cases where no part of the femur can be salvaged.
KOO 3187
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E. Substantial Equivalence:
The substantial equivalence of the Orthogenesis LPS System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the S-ROM Noiles In marea. Ion and Tor assess of 30, K896048, K905810 and K924940), the Sulzer Orthopedics MOST™ System (K973087), Wright Medical Segmented Orthopaedic System (SOS) (K933281) and the Howemedica MRS (K972401 and K965164).
The determination of substantial equivalence for this device was based on a detailed device I he withinmance or esting and conformance with voluntary performance standards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2001
Ms. Janet G. Johnson Group Leader, Regulatory Submissions DePuv Orthopaedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw. Indiana 46581
Re: K003182
Trade Name: Orthogenesis LPS System Regulatory Number: 888.3560 and 888.3350 Regulatory Class: II Product Code: JWH and JDI Dated: May 3, 2001 Received: May 4, 2001
Dear Ms. Johnson:
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 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.
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Page 2 - Ms. Janet G. Johnson
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Memhleeeto fo)
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) Device Name
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Orthogenesis LPS System
Indications for Use
The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. . avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not . respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, . distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Bmitchelling for chu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K003182
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.