(266 days)
Indications for use in total hip replacement include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The metal/metal hip system consists of metal femoral heads and an acetabular cup. The acetabular cup is a metal shell with a polyethylene liner that has a machined feature to accept a metal articulating inlay. The polyethylene components are manufactured from materials conforming to ISO 5834-2 and the metal components are manufactured from materials conforming to ASTM F799. The design features of these parts are identical to those previously cleared under K003250.The metal shells are available with outside diameters of 48mm to 66mm (in 2mm increments). The shells accept a nolyethylene liner with a metal articulating inlay with inner diameters of 28mm, 32mm, 34mm, and 38mm. The femoral heads are available in diameters of 28mm, 32mm, 34mm, and 38mm. The size changes referenced in this 510(k) are the additional 32mm, 34mm, and 38mm components.
The provided text is a 510(k) premarket notification for a medical device: Encore Medical, L.P.'s Metal/Metal Hip System. This submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way a clinical trial for a novel device would.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, and training set details will not be explicitly found in this type of regulatory document. This document primarily details the device's description, intended use, and comparison to existing products.
Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study. The "acceptance criteria" in this context are for regulatory approval, primarily demonstrating substantial equivalence to a legally marketed predicate device (K003250). This means the device must share the same materials, design features, and indications for use as the predicate.
- Reported Device Performance: No clinical performance metrics are reported in this summary. The focus is on the physical characteristics and intended use.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Device materials conform to ISO 5834-2 (polyethylene) and ASTM F799 (metal). | Polyethylene components manufactured from materials conforming to ISO 5834-2. Metal components manufactured from materials conforming to ASTM F799. |
| Design features are identical to predicate device K003250. | Design features are identical to those previously cleared under K003250. |
| Indications for Use are consistent with predicate. | Indications for Use provided are for total hip replacement for specified conditions (degenerative joint disease, rheumatoid arthritis, etc.). (These are comparable to the predicate). |
| Device dimensions (e.g., diameters) are within specified range. | Metal shells: 48mm to 66mm (2mm increments). Polyethylene liner with metal inlay inner diameters: 28mm, 32mm, 34mm, 38mm. Femoral heads: 28mm, 32mm, 34mm, 38mm. (Note: The 32mm, 34mm, and 38mm components are the additional sizes in this 510(k)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided. This is a 510(k) summary, not a clinical study report. There is no mention of a "test set" in the context of clinical performance data.
- Data Provenance: Not applicable/Not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts/Qualifications: Not applicable/Not provided. There is no mention of a "test set" requiring ground truth established by experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, this type of study is not mentioned or described in the document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable/Not provided in the context of clinical performance data. The "ground truth" for this submission would be adherence to material specifications, design similarity to the predicate, and established indications for use.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This is not a machine learning or algorithm-based device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable/Not provided.
In summary: The provided document is a 510(k) premarket notification for a Class III medical device (Metal/Metal Hip System). Its purpose is to demonstrate substantial equivalence to a predicate device already on the market (K003250). This process does not typically involve extensive clinical performance studies with acceptance criteria, test/training sets, or expert ground truth as would be required for novel devices or AI/software as a medical device (SaMD) clearances. The "proof" is in meeting the design, material, and intended use specifications that are identical or highly similar to the predicate device.
{0}------------------------------------------------
NOV - 4 2004
EXHIBIT Ib
Summary of Safety and Effectiveness
Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Metal/Metal Hip System
Common Name: Total Hip Prosthesis, Semi-constrained
Classification Name: Hip joint metal/metal semi-constrained with an uncemented acetabular component prosthesis, 21CFR 888.3330
Description: The metal/metal hip system consists of metal femoral heads and an acetabular cup. The acetabular cup is a metal shell with a polyethylene liner that has a machined feature to accept a metal articulating inlay. The polyethylene components are manufactured from materials conforming to ISO 5834-2 and the metal components are manufactured from materials conforming to ASTM F799. The design features of these parts are identical to those previously cleared under K003250.The metal shells are available with outside diameters of 48mm to 66mm (in 2mm increments). The shells accept a nolyethylene liner with a metal articulating inlay with inner diameters of 28mm, 32mm, 34mm, and 38mm. The femoral heads are available in diameters of 28mm, 32mm, 34mm, and 38mm. The size changes referenced in this 510(k) are the additional 32mm, 34mm, and 38mm components.
Intended Use: The Metal/Metal Hip System used in total hip replacement is intended for conditions of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include same materials, design, and indications.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Affairs Encore Medical L.P. 9800 Metric Boulevard Austin, Texas 78758
Re: K040354
Trade/Device Name: Metal/Metal Hip System Regulation Number: 21 CFR 888.3330 Kegulation Name: 21 OFFC 8061535 Regulation Name: Hip joint metal metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: October 5, 2004 Received: October 6, 2004
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass blated in the enactment date of the enactment date of the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma letter watification. The FDA finding of substantial equivalence of your device to a legally premaince medicate 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), please it you assno operate at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Macer Eacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millman
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
{3}------------------------------------------------
Indications for Use
:510 (k) Number (if known): K040354"
Device Name: Metal/Metal Hip System
Indications for Use:
Indications for use in total hip replacement include: degenerative joint disease including mulcations for use in total mp replass theumatoid arthritis; correction of functional osteoarthritis and avasoalar necrested other treatments or devices have failed; and delorminy, revision procedures where ond trochanteric fractures of the proximal femur ucatifient of nonanced, which is unmanageable using other techniques.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melhusso
Sion- F Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K040354
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.