(116 days)
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatment or devices have failed.
The Arcos One-piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
The Arcos One-piece Femoral Revision System is to be used as a femoral stem component in hip replacement surgery. The system is designed for both primary and revision total hip and hemi hip arthroplasty. All implants included in this system are intended for single use only. The system also includes implant specific instrumentation for all stem variants.
This document is a 510(k) premarket notification for the Arcos One-piece Femoral Revision System, a hip prosthesis. It does not describe an AI/ML powered medical device. Therefore, it does not contain the specific information requested in the prompt, such as acceptance criteria for AI performance, details of a study proving AI performance, sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or training set details.
The document focuses on demonstrating substantial equivalence of the new device to existing legally marketed predicate devices based on design, materials, and principle of operation, along with non-clinical performance data.
Below is a summary of what is available in the document related to performance and equivalence, which stands in for the requested "acceptance criteria and reported device performance" as much as possible given the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria typical for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new device shares similar technological characteristics and performance (where applicable) to its predicate devices, or that any differences do not raise new questions of safety and effectiveness.
| Performance Aspect (as described for a mechanical device) | Reported Device Performance (as described in the document) |
|---|---|
| Technological Characteristics | The Arcos One-piece Femoral Revision System has the same design, material, and principle of operation as the predicate devices (K090757 Moduar Femoral Revision System (Arcos) and K000760 Reach Femoral Component), with "slight modifications." |
| Monolithic variant | It is a monolithic variant of the Modular Femoral Revision System (Arcos) (K090757), designed as a porous-coated femoral stem available in multiple lengths and proximal bodies for primary and revision procedures. |
| Material Equivalence | The reference devices (K150503, K070274) were used to demonstrate equivalence in implant materials/instrument materials/Type I taper Trunnion and implant stem diameters. |
| Non-clinical Tests | Femoral Stem Fatigue: Performed (details not provided). Range of Motion: Performed (details not provided). |
| Clinical Tests | None provided as a basis for substantial equivalence. |
| Safety and Effectiveness Conclusion | Differences from predicates "do not raise new questions of safety and effectiveness" and "the proposed device is at least as safe and effective as the marketed predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation in the way an algorithm would. The "tests" mentioned are non-clinical (e.g., fatigue), and no specific sample sizes for these tests are provided in the summary.
3. 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. Ground truth, in the context of expert consensus, is not relevant for this type of mechanical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a mechanical device like this is typically established through engineering standards, material science testing, and clinical experience with predicate devices, rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Biomet Incorporated % Mr. Paul Cutlan Regulatory Affairs Manager (Hips) Waterton Industrial Estate Bridgend. Bridgend CF31 3XA UNITED KINDOM
Re: K151603 Trade/Device Name: Acros One-piece Femoral Revision System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWL, LWJ, KWZ, JDI, OQG, OQH, OQI, PBI, KWY Dated: September 15, 2015 Received: September 17, 2015
Dear Mr. Cutlan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151603
Device Name
Arcos One-piece Femoral Revision System
Indications for Use (Describe)
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
Revision procedures where other treatment or devices have failed.
The Arcos One-Piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Arcos One-piece Femoral Revision System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Manufacturing Corp.56 East Bell DrivePO Box 587Warsaw, IN 46581-0857Phone Number: (574) 267-6639Fax Number: (574) 371-1027Establishment Registration Number: 1825034 |
|---|---|
| Contact: | Paul CutlanRegulatory Affairs Manager |
| Date: | October 2nd 2015 |
| Subject Device: | Trade Name: Arcos One-piece Femoral Revision SystemCommon Name: Hip Prosthesis |
| Classification Name: | |
| ●LPH - Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3358) | |
| ●LZO - Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR 888.3353) | |
| ●KWL - Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (21 CFR 888.3360) | |
| ●LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (21 CFR 888.3360) | |
| ●KWZ - Hip joint metal/polymer constrained cemented or uncementedprosthesis (21 CFR 888.3310) | |
| ●JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350) |
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- . OQG - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3358)
- OQH - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)
- OQI - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
- . PBI – Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
- KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390)
Legally marketed device(s) to which equivalence is claimed:
Reference Devices:
Labeling and Biocompatibility:
-
· K143009 Echo Bi-Metric Microplasty Hip Stem (Biomet).
Implant Materials/Instrument materials/Type I taper Trunnion: -
K150503 Echo Bi-Metric Microplasty Line Extension (Biomet).
Implant Stem Diameters: -
K070274 Echo Bi-Metric Press Fit Stems (Biomet).
Device Description:
The Arcos One-piece Femoral Revision System is to be used as a femoral stem component in hip replacement surgery. The system is designed for both primary and revision total hip and hemi hip arthroplasty. All implants included in this system are intended for single use only. The system also includes implant specific instrumentation for all stem variants.
Intended Use and Indications for Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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-
- Rheumatoid arthritis.
- Correction of functional deformity. 3.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision procedures where other treatment or devices have failed.
The Arcos One-piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
Summary of Technical Characteristics:
The rationale for substantial equivalence is based on consideration of the following:
- The technological characteristics of the Arcos One-piece Femoral Revision System are the same as those of predicate devices (K090757 and K000760) in terms of design, material, and principle of operation with the exception of slight modifications as described within the 510(k).
- . The Arcos One-piece Femoral Revision System is a monolithic variant of the Modular Femoral Revision System (Arcos) (K090757). Like the modular system, the Arcos Onepiece is designed as a porous-coated femoral stem available in multiple lengths and proximal bodies for primary and revision procedures.
Summary of Performance Data (Non-clinical and/or Clinical) :
Non-clinical Tests:
- Femoral Stem Fatigue
- Range of Motion
Clinical Tests:
None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion:
The proposed Arcos One-piece Femoral Revision System has the same intended use and similar indications for use as the predicate devices. The proposed device has similar technological characteristics to the predicates, and the information provided herein demonstrates that:
- . any differences do not raise new questions of safety and effectiveness; and
- the proposed device is at least as safe and effective as the marketed predicate device.
§ 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.