(15 days)
The NexGen LPS Trabecular Metal Monoblock Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen LPS TM Monoblock Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
Here's an analysis of the provided documents regarding your request for acceptance criteria and study information:
Analysis of Provided Document for Acceptance Criteria and Study Information:
The provided documents are a 510(k) Summary of Safety and Effectiveness and an FDA Clearance Letter for "The NexGen LPS TM Monoblock Tibia." These types of documents are regulatory filings for medical devices and do not typically contain detailed information about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as one would find in a clinical trial report or a scientific publication.
The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to an already legally marketed device (predicate device), not to prove de novo safety and effectiveness through extensive clinical trials for a novel device. Therefore, much of the requested information is not present in these documents.
Missing Information:
Crucially, the provided material does not include any data or studies that would directly prove the device meets specific acceptance criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, accuracy). This type of information is common for AI/ML-based diagnostic devices, but this document is for a physical orthopedic implant (a knee replacement component).
For a physical implant, "acceptance criteria" and "study" would typically refer to:
- Mechanical Testing standards: e.g., fatigue life, strength, wear testing, fixation strength, and biocompatibility testing. These are usually conducted according to ISO or ASTM standards.
- Clinical Outcomes (often much later stage/post-market): e.g., revision rates, patient reported outcomes, complication rates. These are rarely part of a 510(k) submission unless there's a significant change to a previously cleared device.
The 510(k) summary only states that the device is "substantially equivalent to the identified predicate devices." This substantial equivalence is typically based on:
- Similar Indications for Use.
- Similar Technological Characteristics: This refers to materials, design principles, and sometimes mechanical testing data showing comparable performance to the predicate device under specific standardized conditions. However, the details of these tests are not in the summary.
- Safety Profile: Implied to be similar to the predicate device.
Based on the provided text, here is what can be inferred or explicitly stated regarding your questions:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., "X% sensitivity", "Y% accuracy"). For an orthopedic implant, acceptance criteria would typically be defined by compliance with recognized standards for mechanical properties, biocompatibility, and manufacturing quality, and demonstration of similar characteristics to a predicate device. The document states a "Conclusion: The NexGen LPS TM Monoblock Tibia is substantially equivalent to the identified predicate devices." This "substantial equivalence" is the overarching acceptance criterion addressed.
- Reported Device Performance: No specific performance data (e.g., fatigue life, wear rates, clinical success rates) is reported in these summary documents. The performance is implied to be equivalent to the predicate devices.
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 / Not Provided: As this is a 510(k) for a physical implant demonstrating substantial equivalence, there isn't a "test set" in the context of diagnostic algorithm validation. The "study" here refers to the comparison against predicate devices and any underlying engineering or biocompatibility tests, the details of which are not disclosed in this 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 / Not Provided: This question is relevant for diagnostic devices that rely on expert interpretation for ground truth. For a physical implant, "ground truth" would relate to its physical and biological performance, evaluated through engineering tests, material science, and potentially animal studies (though not mentioned here). Expert review would be internal to the manufacturer and FDA, not typically published in this format.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: This pertains to expert consensus for diagnostic interpretation, which is not relevant for this type of device and submission.
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 type of study is specifically for AI-assisted diagnostic tools that human readers interact with. The NexGen LPS TM Monoblock Tibia is a physical knee implant and does not involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable: This is an AI/algorithm-specific question and does not apply to a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred based on device type: For an orthopedic implant, the "ground truth" for demonstrating substantial equivalence and safety would involve:
- Material properties data: Chemical composition, mechanical strength, porosity.
- Biocompatibility testing: Standardized tests for cytotoxicity, sensitization, irritation, etc. (often in vitro or animal studies).
- Mechanical testing: Fatigue, wear, pull-out strength, etc., typically performed to industry standards (e.g., ISO, ASTM).
- Design comparison: Detailed comparison of the geometric features and manufacturing processes to the predicate device.
- None of these are explicitly detailed in the provided summary.
8. The sample size for the training set:
- Not Applicable: This question applies to machine learning algorithms. There is no concept of a "training set" for a physical implant submission like this 510(k).
9. How the ground truth for the training set was established:
- Not Applicable: As above, this is an AI/ML-specific question and does not apply.
Summary of Device and Regulatory Context (from the provided text):
- Device Name: The NexGen LPS™ Monoblock Tibia
- Manufacturer: Implex Corp.
- Device Type: Tibial Component (for knee replacement surgery)
- Material: Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
- Indication for Use: "severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty."
- Regulatory Pathway: 510(k) Premarket Notification
- Key Determination: Substantial Equivalence to predicate devices.
- FDA Clearance Date: February 20, 2002 (corrected from original letter date of Feb 12, 2002 via K020295).
In conclusion, the provided documents are insufficient to answer the majority of your questions because they are summaries of a 510(k) submission for a physical medical implant, which follows a different regulatory and validation paradigm than AI/ML diagnostic tools.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| The NexGen LPS TM Monoblock Tibia | |
|---|---|
| Submitter Name: | Implex Corp. |
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Les Heimann |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | January 24, 2001 |
| Device Trade Name: | The NexGen LPS Trabecular Metal Monoblock Tibia |
| Device CommonName: | Tibial Components |
| Classification Numberand Name: | 21 CFR § 888.3560 |
| SubstantialEquivalence: | The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal FoodDrug 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. |
| Device Description: | The NexGen LPS TM Monoblock Tibia is manufacturedfrom Trabecular Metal (Hedrocel Porous Tantalum) withdirect compression molded ultra-high molecular weightpolyethylene (UHMWPE). |
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The NexGen LPS TM Monoblock Tibia Special 510(k) Premarket Notification
510(k) Summary (Continued)
The NexGen LPS TM Monoblock Tibia is intended for use Indications for Use: where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen LPS TM Monoblock Tibia is substantially Conclusion: equivalent to the identified predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
FFB 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Les Heimann Director of Regulatory Affairs Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401
Re: K020295
Trade Name: NexGen LPS TM Monoblock Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotbibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: January 25, 2002 Received: January 28, 2002
Dear Mr. Heimann:
This letter corrects our substantially equivalent letter of February 12, 2002, regarding the trade name.
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). 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 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); 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.
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Page 2 - Mr. Les Heimann
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Miriam C. Provost
for 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
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Implex Corp.
510(k) Number (if known) :
Device Name:
The NexGen LPS TM Monoblock Tibia
Indications For Use:
The NexGen LPS Trabecular Metal Monoblock Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Muriam C. Provost
eral. Restorative and Neurological Devices
026295 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR. . .
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.