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K Number
K150503
Device Name
Echo Bi-Metric Microplasty Line Extension
Manufacturer
BIOMET, INC.
Date Cleared
2015-03-25

(27 days)

Product Code
LPH,JDI,KWL,KWY,KWZ,LWJ,LZO,OQG,OQH,OQI,PBI
Regulation Number
888.3358
Type
Special
Panel
OR
Reference & Predicate Devices
K050251,K143009
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  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.

Porous coated components are intended for uncemented, biological fixation.

Device Description

The Echo Bi-Metric Microplasty Femoral Stem is a monolithic, collarless, straight stem designed to reduce hip pain for patients and restore joint biomechanics and stability. The femoral stem is designed to fit patient femoral anatomies for primary or revision hip arthroplasties. The stems are manufactured from Ti-6Al-4V per ASTM F136/ASTM F620 and feature a proximal circumferential porous plasma spray (PPS) coating for biological fixation per ASTM F1580.

Patient contacting, reusable implant specific instruments are manufactured from stainless steel and include an aluminum titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD coating.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the Biomet Echo Bi-Metric Microplasty Line Extension, a hip joint prosthesis. The document does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/medical device performance evaluation as you've requested.

Here's why and what's present instead:

  • Type of Device: This is a physical orthopedic implant (hip prosthesis), not an AI-powered diagnostic or assistive device.
  • Regulatory Context: The FDA clearance is for "substantial equivalence" to existing legally marketed predicate devices, meaning it's demonstrated to be as safe and effective as devices already on the market. This is a common pathway for physical medical devices.
  • Performance Data: The "Summary of Performance Data" refers to mechanical tests performed on the physical implant (e.g., fatigue testing, range of motion analysis) to demonstrate its physical integrity and performance, not a study evaluating diagnostic accuracy or AI algorithm performance.

Therefore, your request for:

  1. A table of acceptance criteria and the reported device performance: Not applicable in the AI context. The document mentions mechanical test standards like ISO 7206-6, ISO 7206-4, and ISO 21535, where the "performance" is that the device passes these mechanical tests, demonstrating its durability and function as an implant.
  2. Sample size used for the test set and the data provenance: Not applicable. There's no test set of patient data for AI evaluation.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No ground truth for an AI algorithm.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the FDA clearance for a physical hip implant based on its mechanical performance and substantial equivalence to existing devices, not the performance of an AI model.

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.