(117 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainagefree period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Echelon Hip Stems are designed for single use only.
The Echelon Hip Stems are manufactured from cobalt chrome (CoCr) material, either forged or cast and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
The provided text is a 510(k) summary for the Echelon Hip Stems, a medical device for hip replacement. As such, it's focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria through a standalone study with acceptance criteria in the way an AI/ML device submission might.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of document because the regulatory pathway is different.
Here's an analysis based on the information provided and what can be inferred about this type of submission:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table with specific, quantifiable "acceptance criteria" and "reported device performance" in the way one would for a new AI/ML algorithm measuring a specific metric (e.g., sensitivity, specificity). The acceptance criterion for a 510(k) submission is typically substantial equivalence to a predicate device.
The document states: "Data indicate that the Echelon Hip Stems are substantially equivalent to legally marketed devices." This is the overarching "performance" claim.
2. Sample sized used for the test set and the data provenance:
Not applicable in the context of this 510(k) submission. This is a traditional medical device (hip implant), not a diagnostic algorithm that processes a "test set" of data. The "data" referred to in this submission would relate to engineering tests (e.g., mechanical strength, wear), materials testing, and comparisons to predicate device specifications. These are not typically presented as a "test set" for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth" establishment in the context of evaluating an algorithm. The "ground truth" for a hip stem would be its physical properties, biocompatibility, and clinical outcomes, evaluated through various means (bench testing, clinical experience with similar devices, literature).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No "test set" in the AI/ML sense exists for this traditional medical device.
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 is not an AI-assisted device, and no MRMC study or human reader improvement with AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated in terms of a "ground truth" study in the provided text. For a hip implant, the "ground truth" for its performance and safety would be based on:
- Engineering specifications and testing (e.g., fatigue strength, pull-out strength, material composition)
- Biocompatibility data
- Clinical history and performance of the predicate devices
- Clinical experience and literature supporting similar designs and materials.
8. The sample size for the training set:
Not applicable. There is no "training set" for this traditional medical device.
9. How the ground truth for the training set was established:
Not applicable.
Summary for the Echelon Hip Stems (K983834):
- Acceptance Criteria & Reported Performance: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. The "reported performance" is that "Data indicate that the Echelon Hip Stems are substantially equivalent to legally marketed devices." The specific details of the data (e.g., mechanical test results, material comparisons) are not included in this summary but would have been part of the full 510(k) submission.
- Study Type: This is a 510(k) premarket notification based on substantial equivalence, not a performance study of an AI/ML algorithm. The "study" involves comparing the technological characteristics and performance characteristics (e.g., design, materials, intended use, mechanical properties) of the Echelon Hip Stems to predicate devices.
- Predicate Devices:
- Echelon Revision Hip Stem (Smith & Nephew)
- DePuy AML® Hip Stem (DePuy)
- DePuy Replica™ Hip Stem (DePuy)
This 510(k) summary is typical for a traditional medical device, where the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving a specific performance metric against a benchmark.
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2/24/99
Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary device name: Common or usual name:
Classification name:
510(k) Summary
Smith & Nephew, Inc. 1450 Brooks Road, Memphis, TN 38116 901-399-5861 JoAnn Kuhne September 28, 1998 Echelon Hip Stems Prosthetic Hip Joint - Porous Hip Stem
21 CFR 888.3358 hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis-Class II
21 CFR 888.3353 hip joint metal/ceramic/polymer semiconstrained porous coated uncemented prosthesis- Class II
Substantially Equivalent Legally Marketed Devices
- Echelon Revision Hip Stem Smith & Nephew .
- . DePuy AML® Hip Stem - DePuy
- DePuy Replica™ Hip Stem DePuy .
Device Description
The Echelon Hip Stems are manufactured from cobalt chrome (CoCr) material, either forged or cast and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
Device Intended Use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainagefree period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Echelon Hip Stems are designed for single use only.
Technological characteristics:
The Echelon Hip Stems are similar to the legally marketed devices listed above. All of these devices are indicated for total hip replacement, are similar in design to the Echelon Hip Stems and have the same technological characteristics.
Performance characteristics:
Data indicate that the Echelon Hip Stems are substantially equivalent to legally marketed devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is composed of three curved lines, and it is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Mr. David Henley Requlatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road 38116 Memphis, Tennessee
K983834 Re: Echelon Hip Stems Trade Name: Requlatory Class: II Product Codes: LPH and JDI Dated: January 15, 1999 Received: January 19, 1999
Dear Mr. Henley:
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, Druq, 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. ਉ 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 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 regulations.
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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 diaqnostic 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,
a 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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Indications Statement Echelon Hip Stems
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
prescaption use Yes
OVER the county Use M
docote
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983834
CONFIDENTIAL
§ 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.