(122 days)
The Modified Bencox Hip System is intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
The Modified Bencox Mirabo Hip System consists of the following components,
- Acetabular Insert Bencox Mirabo PE Liner (Std. & Elevated), .
- Femoral Stem Bencox ID Stem (Offset), .
- Femoral Head Bencox Delta Head (XL), ●
- Instrumentation Bencox Total Hip System Instrumentation. .
The components are modification of Acetabular Insert cleared in K120924 (& K103431), Femoral Stem cleared in K112019 & specification inclusion of Femoral Heads cleared in K121665. The modified components are cementless, metal-onpolyethylene hip system for hip arthroplasty similar to devices cleared in respective mentioned 510(k)'s.
Modified Bencox Mirabo PE Liner is manufactured from similar material cleared under K120924 & K103431, conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation similar to predicate device Bencox Mirabo PE Liner and other predicates such as Stryker Crossfire.
Modified Bencox ID Stem (Offset) is similar to the predicate device Bencox ID Stem cleared in K112019, except for the slightly thicker neck geometry and horizontal offset.
Bencox Delta Head XL specification inclusion consists of diameters 32, 36 & 40 mm design is similar to the 510k cleared devices, Bencox Delta Head (K121665). The specification is also similar with other predicate devices and has the same supplier, CeramTec, AG.
This document describes the Modified Bencox Hip System, a hip implant. The information provided outlines the performance data rather than the acceptance criteria for an AI/ML device. Therefore, it is important to note that the following analysis is based on the provided text, which details the performance testing conducted for a medical device (hip implant components), not an AI/ML algorithm.
Given the context of a hip implant system, the "acceptance criteria" are typically related to the physical and mechanical properties of the device, ensuring it meets established international standards for safety and performance in the human body. The "study" refers to the mechanical and material testing performed on the device to demonstrate its substantial equivalence to previously cleared predicate devices.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance (Applied to a Medical Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bencox Mirabo PE Insert: | |
| Conformity to ISO 14242 (Wear) | Performed comparable to predicate devices. |
| Conformity to ASTM F1820 (Liner Torsion & Lever Out) | Performed comparable to predicate devices. |
| Conformity to ASTM F2582 (Push Out and Impingement) | Performed comparable to predicate devices. |
| Material Characterization (ASTM 2565) | Obtained values of various parameters were comparable to predicate devices. |
| Bencox ID Stem (Offset): | |
| Conformity to ISO 7204-4 (Fatigue) | Satisfied the standards and performed similar to predicate devices. |
| Conformity to ISO 7204-6 (Range of Motion) | Satisfied the standards and performed similar to predicate devices. |
| Bencox Delta Heads XL: | |
| Reference to predicate device submission, K121665 and CeramTec Device Master File (Implies meeting the established standards for these components) | Performance refers to predicate device submission K121665 and CeramTec Device Master File. |
| Overall: No new issues of safety or efficacy from technological differences | Differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. |
Regarding the specific questions intended for AI/ML device evaluation, the provided document does not contain information for most of these points, as it describes a physical medical device. However, I will address them to the best of my ability based on the information not present or by inferring the closest equivalent for a physical device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of "test set" samples as one would for an AI/ML model. For physical devices, "sample size" typically refers to the number of units tested. The document mentions "worst case combination" for the Bencox ID Stem, implying specific device configurations were selected for testing. The number of individual components or assemblies tested to meet standard requirements is not detailed.
- Data Provenance: Not applicable in the context of an AI/ML model's data. The testing was physical and performed to international standards. The manufacturer is Corentec Co., Ltd. from South Korea.
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 this context would be the objective criteria defined by the ISO and ASTM standards and the measurements taken during mechanical and material testing. No human experts are used to "establish ground truth" in the way they would for labeling in an AI/ML diagnostic task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert labels for AI/ML training/testing data. For medical device testing, adjudication is typically not performed in this manner; results are objectively measured against established standard thresholds.
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 a framework for evaluating diagnostic AI/ML systems. No human readers or AI assistance are involved in the performance testing of a hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of an AI algorithm alone. The "performance" described here is for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a physical medical device, the "ground truth" is defined by the objective, measurable criteria within the referenced ISO and ASTM international standards. These standards specify test methods (e.g., how to measure wear, fatigue strength, material properties) and acceptable performance limits. The device's performance is then compared directly to these limits.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of developing and testing this type of physical medical device. The device itself is manufactured, and specific samples are then tested for performance.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for one. The "ground truth" for the device's performance is the adherence to the published standards as mentioned in point 7.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2015
Corentec Company, Limited Mr. J.S. Daniel Senior Manager/Engineer - RA/QA 8F Chungho Tower, 483 Gangnam-daero, Seocho Gu Seoul 137-040 Republic of Korea
Re: K150007
Trade/Device Name: Modified Bencox Hip 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, KWY, LZO Dated: April, 1, 2015 Received: April 2, 2015
Dear Mr. J.S. Daniel:
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
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Page 2 - Mr. J.S. Daniel
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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): K150007 (page 1/1)
Device Name: Modified Bencox Hip System
The Modified Bencox Hip System is intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
Prescription Use: X (Per 21 CFR 801 Subpart D) AND / OR
Over-The Counter Use :-(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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510(K) SUMMARY Corentec Co., Ltd. Modified Bencox Hip System 3156 Dec., 2014
ADMINISTRATIVE INFORMATION
| Manufacturer | Corentec Co., Ltd. |
|---|---|
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | |
| Cheonan-si, Chungchongnam-do, 331-822 South Korea | |
| Telephone: +82-41-585-7114 | |
| Fax: +82-41-585-7113 | |
| Official Contact | J.S. Daniel |
| Senior Manager/Engineer - RA/QA | |
| Corentec Co., Ltd | |
| 8F Chungho Tower, 483, Gangnam-daero | |
| Seocho Gu, Seoul, Korea 137-040 | |
| Ph: +82 70 4393 3819 | |
| Fax: +82 2 3445 5467 | |
| Email: jsdaniel@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Modified Bencox Mirabo Hip System |
|---|---|
| Common Name: | Total Hip Prosthesis System |
| Classification Regulations: | 21 CFR 888.3358; 888.3390; 888.3353 |
| Class: | II |
| Product Codes: | LPH, KWY, LZO |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
The Modified Bencox Hip System is intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
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a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the
proximal femur with head involvement, unmanageable using other techniques
- d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
[The intended use of the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665]
DEVICE DESCRIPTION
The Modified Bencox Mirabo Hip System consists of the following components,
- Acetabular Insert Bencox Mirabo PE Liner (Std. & Elevated), .
- Femoral Stem Bencox ID Stem (Offset), .
- Femoral Head Bencox Delta Head (XL), ●
- Instrumentation Bencox Total Hip System Instrumentation. .
The components are modification of Acetabular Insert cleared in K120924 (& K103431), Femoral Stem cleared in K112019 & specification inclusion of Femoral Heads cleared in K121665. The modified components are cementless, metal-onpolyethylene hip system for hip arthroplasty similar to devices cleared in respective mentioned 510(k)'s.
Modified Bencox Mirabo PE Liner is manufactured from similar material cleared under K120924 & K103431, conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation similar to predicate device Bencox Mirabo PE Liner and other predicates such as Stryker Crossfire.
Modified Bencox ID Stem (Offset) is similar to the predicate device Bencox ID Stem cleared in K112019, except for the slightly thicker neck geometry and horizontal offset.
Bencox Delta Head XL specification inclusion consists of diameters 32, 36 & 40 mm design is similar to the 510k cleared devices, Bencox Delta Head (K121665). The specification is also similar with other predicate devices and has the same supplier, CeramTec, AG.
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SUBSTANTIAL EQUIVALENCE
Modified Bencox Hip System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below,
| Manufacturer | Trade Name | 510(k) |
|---|---|---|
| Bencox Mirabo PE Insert | ||
| Corentec Co., Ltd. | Bencox Mirabo Cup System &Bencox (Coren) Total Hip System | K120924 &K103431 |
| Osteonics / HowmedicaOsteonics Corp. | Osteonics (Crossfire) PE AcetabularComponents & Trident AcetabularSystem | K974685 &K021911 |
| Bencox ID Stem (Offset) | ||
| Corentec Co. Ltd. | Bencox ID Stem | K112019 |
| Biomet | Taperloc | K043537 |
| Bencox Delta Heads XL | ||
| Corentec Co., Ltd. | Bencox Forte & Bencox Delta | K121665 |
| MEDACTAInternational SA | MectaCer Biolox Delta Heads | K112115 |
| Zimmer, Inc | Biolox delta Ceramic Femoral Head | K071535 |
PERFORMANCE DATA
Performance testing for modified Bencox Mirabo PE Insert was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 14242, ASTM F1820 and ASTM F2582. Mechanical testing of the subject device consisted of wear, liner torsion & lever out, push out and impingement testing. The acetabular cup system performed comparable to the predicate devices. Material characterization as per ASTM 2565 was carried out and obtained values of various parameters were comparable to predicate devices.
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Performance testing for modified Bencox ID Stem (Offset) with worst case combination of Bencox Delta Head XL, 40 mm and was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 7204-4, ISO 7204-6. Mechanical testing of the subject device consisted of fatigue and range of motion testing. The femoral stem satisfied the standards and performed similar to predicate devices.
Performance testing with respect to Bencox Delta Heads XL refers to predicate device submission, K121665 and CeramTec Device Master File.
Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.
Overall, the modified Bencox Hip System components included in this submission has similarities to the predicate devices with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile.
§ 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.