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K Number
K192148
Device Name
Freedom Primary PCK
Manufacturer
Maxx Orthopedics, Inc.
Date Cleared
2019-09-05

(28 days)

Product Code
JWH
Regulation Number
888.3560
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:

· Severe knee joint pain, loss of mobility due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

· Correction of functional deformities.

· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.

  • · Moderate valgus, varus, or flexion trauma.
  • · Knee fractures untreatable by other methods

· Revision surgery where sufficient bone stock and soft tissue integrity are present

The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Freedom Primary PCK" knee prosthesis does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The document is a clearance letter for a physical medical device (a knee implant) and focuses on regulatory aspects like substantial equivalence to predicate devices, general controls, and indications for use. It does not mention any AI/ML components, performance metrics, or clinical study data related to an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance.
  7. Type of ground truth used.
  8. Training set sample size.
  9. Ground truth establishment for the training set.

These details are typically found in the clinical study report or performance evaluation section of a submission for an AI/ML-driven device, which is not present in this regulatory clearance letter for a knee implant.

§ 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.