(85 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Tibial bearings are indicated for use with both cemented and uncemented Biomet tibial trays.
All-polyethylene patellar components are indicated for cemented use only.
The E1® Series A® Patellae is an all-polyethylene, 3-peg patella series intended for replacement of part of the knee joint in conjunction with a femoral and tibial component in primary or revision applications. Patella components are available in standard and asymmetric configurations. The proposed devices are manufactured from UHMWPE per ASTM F648 exposed to 100 kGy gamma irradiation and Vitamin E (α-tocopherol).
The provided text is a 510(k) Summary for a medical device called the E1® Series A® Patellae, a component of a total knee replacement. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Key Takeaway: This 510(k) summary is for a medical device (patella component for knee replacement), not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, experts, and reader studies are not applicable. The "acceptance criteria" here are related to proving mechanical and material equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" for this mechanical medical device are implicitly defined by the demonstration of "substantial equivalence" to predicate devices through specific engineering analyses and mechanical tests. There are no explicit quantitative performance metrics listed in the way one would see for an AI algorithm (e.g., sensitivity, specificity).
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary of Performance Data) |
|---|---|
| Intended Use: Same as predicate devices | The proposed E1® Series A® Patellae and predicate patella devices have the same intended use. |
| Indications for Use: Same as predicate devices | The proposed E1® Series A® Patellae and predicate patella devices have the same indications for use. |
| Materials: Manufactured from UHMWPE per ASTM F648, similar to predicate and existing E1 Tibial Bearings | The proposed E1® Series A® Patellae and predicate patella devices are manufactured from UHMWPE per ASTM F648. Utilizes the same material/manufacturing process as Biomet E1 Tibial Bearings (K080528). |
| Design Features: Incorporate same design features as predicate devices | The proposed E1® Series A® Patellae incorporate the same design features as the predicate patella devices. |
| Sterilization: Same methods as predicate devices | The proposed E1® Series A® Patellae and predicate devices are provided sterile via the same sterilization methods for single-use. |
| Mechanical Performance & Safety: Equivalent mechanical stability, contact area stress, and peg shear strength to predicate devices | Results from mechanical tests and engineering analyses demonstrate the proposed E1® Series A® Patellae are substantially equivalent to the predicate patella devices. These include: |
- Contact area stress analysis and engineering analysis
- Mechanical stability analysis and engineering analysis
- Peg shear testing |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/software study. For this mechanical device, the "test set" would refer to the physical samples of the device undergoing mechanical testing. The document does not specify the number of units tested.
- Data Provenance: Not applicable as there is no data set of patient information or images. The "data" here refers to mechanical test results and engineering analyses. These tests are presumably performed in a lab setting by the device manufacturer, Biomet Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no "ground truth" established by experts in the context of interpreting medical images or clinical outcomes for this device in this submission.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies among expert readers in image interpretation or clinical diagnosis. It does not apply to mechanical testing or engineering analyses of a physical implant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No.
- Effect Size: Not applicable. This type of study and metric are for evaluating the impact of AI assistance on human reader performance, which is not relevant for this device submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: No. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the traditional sense of AI/software development (e.g., pathology, outcomes data, expert consensus on images). For this device, the "truth" is established by adherence to engineering principles, material specifications (ASTM F648), and comparative mechanical performance metrics against predicate devices. The "ground truth" essentially validates that the device performs mechanically as intended and as safely as equivalent existing devices.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This concept belongs to machine learning and AI model development.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. This concept belongs to machine learning and AI model development.
Summary Context:
This 510(k) submission is for a traditional medical device (a knee implant component). The "study" proving it meets acceptance criteria consists of engineering analyses and mechanical laboratory tests designed to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This framework does not involve clinical trials, human reader studies, or AI algorithm performance evaluations. The acceptance criteria are essentially that the device performs mechanically and in terms of material properties, design, and intended use as safely and effectively as legally marketed predicate devices.
§ 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.