(86 days)
The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as a in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.
The Implex Hedrocel® Replacement Cup Inserts, cemented, are compatible with the family of Hedrocel® acetabular cups in OD sizes from 40 to 70 mm. The replacement inserts are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0°, 10°, and 20° face angles.
This document describes the regulatory submission for the Implex Hedrocel® Replacement Cup Insert, a medical device. The information provided heavily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than detailed performance study results in the context of typical AI/software acceptance criteria.
Therefore, many of the requested details regarding acceptance criteria, study design for AI, expert involvement, and ground truth establishment are not directly applicable or available in the provided text. The device is a physical medical implant, not an AI/software product.
However, I can extract the relevant information within the context of a traditional medical device submission if analogy to AI acceptance criteria is made.
Acceptance Criteria and Device Performance (Analogous to AI/Software)
For this physical medical device, the primary "acceptance criterion" from a regulatory perspective is substantial equivalence to predicate devices. This is established by demonstrating that the device has similar technological characteristics and performs comparably in relevant tests.
| Acceptance Criteria (Analogous) | Reported Device Performance (Analogous) |
|---|---|
| Technological Characteristics Substantial Equivalence to predicates (e.g., materials, design, intended use). | A comparison of the principal device technological characteristics to the predicate devices demonstrates that the bearing surface is substantially equivalent to commercially available polyethylene bearing surfaces. |
| Fatigue Characteristics to meet defined laboratory conditions. | Testing conducted to evaluate the fatigue characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence. |
| Intended Use (as an in-situ replacement polyethylene bearing surface). | The device is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use. This aligns with the function of predicate devices. |
Breakdown of Study Information (Interpreted for a Physical Device)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For a physical device like this, the "test set" would refer to the number of devices or components subjected to mechanical testing. This information is typically found in the full test reports, not the summary K983128 document.
- Data Provenance: The document states "Testing conducted to evaluate the fatigue characteristics of the device under defined laboratory conditions." This indicates prospective laboratory testing. The country of origin of the data is not specified, but given the submitter's address (Allendale, New Jersey, USA) and the FDA submission, it's highly probable the testing was conducted in the USA or by a facility adhering to US regulatory standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the AI Sense: For a physical device, "ground truth" for mechanical testing is established by engineering standards and measurement accuracy, not by human experts interpreting data. The "experts" would be the engineers and technicians designing and conducting the tests, ensuring they follow recognized standards (e.g., ISO, ASTM for material properties, fatigue, wear). Their qualifications would be in materials science, biomechanical engineering, or related fields. The document does not specify the number or qualifications of these testing personnel.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication is typically for resolving discrepancies in human interpretation (common in AI studies or clinical trials). For mechanical testing, if there were any ambiguities in results, standard statistical methods or re-testing would be employed, not an adjudication panel.
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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 physical medical device. MRMC studies, human reader improvement, and AI assistance are concepts specific to diagnostic AI or image analysis software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device. There is no algorithm or human-in-the-loop performance component. The "standalone" performance here refers solely to the mechanical performance of the implant itself in a laboratory setting.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance would be the physical properties and mechanical integrity measurements derived from standardized laboratory tests (e.g., resistance to fatigue under specified load cycles). These are objective measurements following established engineering protocols, rather than subjective human interpretation, pathology, or patient outcomes data as "ground truth" for a performance claim in this type of submission. Patient outcomes are relevant for post-market surveillance.
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The sample size for the training set:
- Not Applicable: This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering development based on material science principles and prior device knowledge, not an iterative training process on data.
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How the ground truth for the training set was established:
- Not Applicable: As there is no training set in the AI sense, there's no ground truth established for it. The analogous process for a physical device would be the verification and validation of manufacturing parameters and material specifications against industry standards and design requirements.
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:
K983128
IMPLEX Hedrocel® Replacement Cup Insert, Cemented
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Robert Poggie, PhD or John Schalago, RAC |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | September 3, 1998 |
| Device Trade Name: | Implex Hedrocel® Replacement Cup Insert |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Cemented |
| Predicate Devices: | Implex Hedrocel® Porous Acetabular Cup System, ImplexReplacement Acetabular Cup Insert System, Osteonics GAP IIRestoration Acetabular shell with Omnifit® Polyethylene InsertBearing. |
| Device Description: | The Implex Hedrocel® Replacement Cup Inserts, cemented, arecompatible with the family of Hedrocel® acetabular cups in ODsizes from 40 to 70 mm. The replacement inserts are availablewith four ID size options (22 mm, 26 mm, 28 mm and 32 mm)and in 0°, 10°, and 20° face angles. |
| Intended Use: | The Implex Hedrocel® Replacement Cup Insert, cemented, isintended for use as a in-situ replacement polyethylene bearingsurface under circumstances of joint instability, wear and/ordamage caused by the patient during use. |
| Device TechnologicalCharacteristics andComparison toPredicate Device: | A comparison of the principal device technologicalcharacteristics to the predicate devices demonstrates that thebearing surface is substantially equivalent to commerciallyavailable polyethylene bearing surfaces |
| Performance Data: | Testing conducted to evaluate the fatigue characteristics ofthe device under defined laboratory conditions wasprovided to support a finding of substantial equivalence. |
| Conclusion: | The Implex Hedrocel® Replacement Cup Insert issubstantially equivalent to the identified predicate devices. |
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and the comments of the comments of
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Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of three human profiles facing right, with flowing lines representing movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1998
John A. Schalago, RAC Regulatory Affairs Manager Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
K983128 Re: Implex Hedrocel® Replacement Cup Insert Trade Name: Requlatory Class: II Product Code: JDI Dated: September 4, 1998 Received: September 8, 1998
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 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 requlations 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 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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Page 2 - John A. Schalago, RAC
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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,
Celia M. Witten, Ph.D., M
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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510(k) Number (if known):
Device Name:
Implex Hedrocel® Replacement Cup Insert
Indications For Use:
The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.
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| Prescription Use(Per 21 CFR 801.109) | X |
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OR...
| Over-The-Counter Use | |
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| ---------------------- | -- |
| (Optional Format 1-2-96) | |
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| -------------------------- | -- |
| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K983128 |
Concurrence of CDRH; Office of Device Evaluation (ODE)
§ 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.