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K Number
K100048
Device Name
E1 ANTIOXIDANT INFUSED TECHNOLOGY
Manufacturer
BIOMET MANUFACTURING CORP.
Date Cleared
2010-03-09

(60 days)

Product Code
OIY,JDI,JWH,LPH,LWJ,LZO,MAY,OQG,OQH,OQI
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K080528,K070364,K070399,K073102,K090103
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

E1™ Tibial Bearings:

  1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  2. Correction of varus, valgus, or posttraumatic deformity.
  3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
    For cemented and un-cemented use.

E1™ Acetabular Liners:

  1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
  2. Rheumatoid arthritis.
  3. Correction of functional deformity.
  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
  5. Revision of previously failed total hip arthroplasty.
    Cemented and Uncemented Applications (as based on mating shell)
Device Description

The device descriptions of the E1™ Tibial Bearings and the E1 ™ Acetabular Liners have not changed from the original predicate submissions.

AI/ML Overview

The provided 510(k) submission for the Biomet Manufacturing Corp.'s E1™ Antioxidant Infused Technology (E1™ Tibial Bearings and E1™ Acetabular Liners) does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML device evaluations.

This submission is for a medical device that is a physical implant (joint replacement components), not a software or AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific performance metrics, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this document.

Here's a breakdown of the relevant information provided in the document:

1. Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device must show it is as safe and effective as a legally marketed device.
  • Reported Device Performance:
    • Non-Clinical Testing: "Further testing showed no decreases in the mechanical properties after accelerated aging." and "In contrast to the control materials, the E1™ hip and the E1™ knee materials showed no evidence of oxidation or oxidative degradation." This indicates that the E1™ technology performed robustly under accelerated aging conditions and resisted oxidation.
    • Clinical Testing: "None provided." The submission explicitly states that no clinical testing was performed or provided for this 510(k) submission. This is common for devices seeking substantial equivalence where non-clinical data (e.g., mechanical testing, material characterization) is deemed sufficient.

2. Sample size used for the test set and the data provenance:

  • Not applicable. This device is a physical implant. The "test set" in this context refers to laboratory tests of the material, not a dataset of patient images or medical records. The document only mentions "further testing" without specifying sample sizes for mechanical properties or oxidation studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable.

4. Adjudication method 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:

  • No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

  • No. This is not an AI/ML device.

7. The type of ground truth used:

  • Not applicable in the context of AI/ML ground truth. For this type of device, the "ground truth" for non-clinical testing is typically direct measurement of material properties and observation of degradation.

8. The sample size for the training set:

  • Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

  • Not applicable. This is not an AI/ML device.

In summary, the 510(k) submission for the E1™ Antioxidant Infused Technology relies on demonstrating substantial equivalence through non-clinical laboratory testing of the material's mechanical properties and resistance to oxidation, rather than clinical trials or AI/ML performance metrics.

§ 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.