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K Number
K981302
Device Name
SMC 28MM CERAMIC FEMORAL HEADS
Manufacturer
SIGNAL MEDICAL CORP.
Date Cleared
1998-06-25

(77 days)

Product Code
LZO
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
K971681
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Where the use of a more conservative procedure has failed or is unacceptable.
Device Description

The Signal Medical Corporation 28mm Ceramic Femoral Heads are manufactured from zirconium oxide. The design is made available in three (3) sizes identical to the cobalt chrome femoral heads in the Signal Medical Corporation 510K (K971681) (-3.5, 0, +3.5). These ceramic femoral heads should only be used on the Signal Medical Corporation (SMC) femoral component of the hip, and should never be resterilized.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "Signal Medical Corporation 28mm Ceramic Femoral Heads". This document is a regulatory approval, not a scientific study report. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving performance against specific quantitative acceptance criteria in a clinical study.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies for this device based on the given text.

The document primarily states:

  • Device Description: 28mm Ceramic Femoral Heads made from zirconium oxide, available in three sizes, to be used only with Signal Medical Corporation's femoral component.
  • Indications for Use: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, and where conservative procedures have failed or are unacceptable.
  • Regulatory Classification: Class II, Product Code LZO.
  • Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
  • Limitation: "package insert must reflect that Signal Medical Corporation's 28 mm Zirconia Ceramic Femoral Head is only to be used with Signal Medical Corporation's cobalt-chrome hip stems with the 5.708 degree trunnions."

There is no mention of specific performance metrics, acceptance criteria, or any clinical or technical study results in this 510(k) summary document that would allow me to answer your detailed questions.

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.