(80 days)
The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.
The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole.
The provided text describes a 510(k) summary for "The Implex Modular Elliptical Porous Acetabular Cup," an orthopedic implant. The information primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a performance study with detailed acceptance criteria and results as would be typical for an AI/software device.
Therefore, many of the requested elements for a study proving device adherence to acceptance criteria, especially those pertaining to AI/software performance validation, are not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured and the target value) | Reported Device Performance (Achieved value in test) |
|---|---|
| Mechanical Performance: | |
| Push-out strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Lever-out strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Torsion strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Material Equivalence: | |
| Manufactured from similar materials to predicate devices | Yes, manufactured from similar materials. |
| Design Equivalence: | |
| Similar insert locking mechanisms to predicate devices | Yes, similar insert locking mechanisms. |
| Intended Use Equivalence: | |
| Similar or the same indications for use as predicate devices | Yes, similar or the same indications for use. |
| Surgical Technique Equivalence: | |
| Utilizes similar surgical techniques and instrumentation | Yes, utilizes similar surgical techniques and instrumentation. |
Note: The document states the device "possesses performance characteristics similar to several legally marketed devices" for the mechanical tests. It does not provide specific numerical acceptance criteria or numerical reported performance values. The acceptance criterion is implicitly being "similar to legally marketed predicate devices" as evaluated against FDA Guidance Documents and ASTM Standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not specified in the document. The document refers to "testing" but does not give the number of samples tested for push-out, lever-out, or torsion.
- Data provenance: Not applicable in the context of an orthopedic implant's mechanical testing as described here. The data would originate from laboratory testing of the manufactured devices. It is not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is an orthopedic implant, and its performance is evaluated through mechanical testing, not by expert interpretation of data or images. Ground truth for mechanical properties would be established by physical measurements using standardized equipment and methods.
4. Adjudication Method for the Test Set
Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies involving human interpretation or consensus, not for mechanical laboratory testing of an implant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is for evaluating the performance of diagnostic devices or AI systems, often in comparison to human readers. It is not relevant for an orthopedic implant's mechanical performance assessment as described here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No. This concept applies to AI algorithms. The device described is a physical orthopedic implant. Its performance is inherent to its design and manufacturing, evaluated through mechanical testing.
7. The Type of Ground Truth Used
For the mechanical performance data (push-out, lever-out, torsion), the ground truth is established through physical measurement of the device's properties according to established ASTM Standards and FDA Guidance Documents. It is not based on expert consensus, pathology, or outcomes data in the traditional sense. The "similarity" to predicate devices serves as the benchmark for "truth."
8. The Sample Size for the Training Set
Not applicable. This device is an orthopedic implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is an orthopedic implant, not an AI model requiring a training set.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS OCT 8 1999
The Implex Modular Elliptical Porous Acetabular Cup
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | John Schalago or Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | July 19, 1999 |
| Device Trade Name: | The Implex Modular Elliptical Porous Acetabular Cup |
| Device CommonName: | Acetabular Cup |
| Classification Numberand Name: | 21 CFR § 888.3358 |
| SubstantialEquivalence: | The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal Food,Drug and Cosmetic Act, as amended and as appliedunder 21 CFR 807, Subpart E under which a devicecan be marketed without premarket approval orreclassification. A determination of substantialequivalency under this notification is not intended tohave any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters.No statements related to, or in support of substantialequivalence herein shall be construed as anadmission against interest under the US Patent Lawsor their application by the courts. |
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.
| Device Description(cont'd): | 510(k) Summary (Continued) | ||
|---|---|---|---|
| The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole. | |||
| Indications for Use: | The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty. | ||
| Predicate Devices: | The Implex Elliptical Porous Acetabular Cup System (non-modular). The Biomet Ringloc Acetabular Cup System. The DePuy Duraloc Acetabular Cup System. | ||
| Device TechnologicalCharacteristics andComparison toPredicate Device: | The subject device and the predicate devices are manufactured from similar materials, have similar insert locking mechanisms, have similar or the same indications for use, and utilize similar surgical techniques and instrumentation. | ||
| Performance Data: | Push-out, lever-out, and torsion testing per applicable FDA Guidance Documents and ASTM Standards (or draft standards) of the insert liner and shell assembly showed that the subject device possesses performance characteristics similar to several legally marketed devices. | ||
| Conclusion: | The Implex Modular Elliptical Porous Acetabular Cup is substantially equivalent to the identified predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Mr. John A. Schalago, RAC Manager, Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale. New Jersey 07401-1600
Re: K992409
Trade Name: The Implex Modular Elliptical Porous Acetabular Cup Regulatory Class: II Product Code: LPH, JDI Dated: July 19, 1999 Received: July 20, 1999
Dear Mr. Schalago:
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 Ouality 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.
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Page 2 - Mr. John A. Schalago
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celia 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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Implex Corp
510(k) Number (if known) :
K 992409
Device Name:
The Implex Modular Elliptical Porous Acetabular Cup
Indications For Use:
The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992409 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
|---|---|
| --------------------------------------- | ----- |
OR...
| Over-The-Counter Use | No |
|---|---|
| ---------------------- | ---- |
(Optional Format 1-2-96)
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.