(130 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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.
Vanguard™ SSK components are intended for cemented use only.
The Vanguard™ SSK Knee System is a series of femoral components and tibial bearings designed to replace the articulating surfaces during knee replacement surgery.
The provided document is a 510(k) premarket notification for a knee prosthesis, the Vanguard™ SSK Knee System. It states that clinical testing was NOT REQUIRED to demonstrate substantial equivalence to predicate devices. Therefore, a study proving the device meets acceptance criteria based on clinical performance data, as requested in the prompt, was not conducted or provided.
The submission focuses on substantial equivalence through non-clinical testing which indicated that the device is substantially equivalent to predicate devices for the indicated uses. However, detailed acceptance criteria and performance results from this non-clinical testing are not provided in the document.
Given the information provided, it's impossible to fill in most of the requested fields as they pertain to clinical or standalone performance studies based on expert ground truth, which were explicitly stated as not being required.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable or not available:
Acceptance Criteria and Study Details for Vanguard™ SSK Knee System (K042757)
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: The 510(k) summary explicitly states, "Clinical testing was not required for these components to support substantial equivalence." While non-clinical testing was performed, the document does not elaborate on specific acceptance criteria or provide performance data from these tests. The basis for clearance was 'substantial equivalence' to predicate devices based on identical intended use, functional characteristics, and materials.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not Applicable (No clinical test set described)
- Data Provenance: Not Applicable (No clinical test set described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not Applicable (No clinical test set described)
- Qualifications of experts: Not Applicable (No clinical test set described)
4. Adjudication method for the test set:
- Not Applicable (No clinical test set described)
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, an MRMC comparative effectiveness study was not done (or reported). The device is a knee prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (knee prosthesis), not an algorithm or AI. Standalone performance as typically defined for AI/software devices is not relevant.
7. The type of ground truth used:
- Not Applicable (No clinical performance ground truth established for this submission). The regulatory pathway relied on demonstrating similarity to existing legally marketed devices rather than establishing novel clinical performance against a ground truth.
8. The sample size for the training set:
- Not Applicable (No training set described as this is a physical medical device clearance based on substantial equivalence, not a machine learning model).
9. How the ground truth for the training set was established:
- Not Applicable (No training set described).
§ 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.