RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS

• K Number: K032396
• Device Name: RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-08-21 ( 17 days)
• Product Code: JDI , LPH
• Regulation Number: 888.3350
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K970501 , K974558

Intended Use

The indications for use of the Biomet hip replacement prosthesis include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of nonunion, 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.
   These devices are intended for either cemented or uncemented use.

Device Description

The RingLoc® 36mm Liners are manufactured from ArCom® processed ultra-high molecular weight polyethylene (UHMWPE) conforming to ASTM F648. The Modular Femoral Heads are manufactured from wrought Co-Cr-Mo conforming to ASTM F1537. They incorporate the standard Biomet Type I taper and come in neck sizes -- 6mm, -3mm, STD, +3mm, +6mm, +9mm, and +12mm. The +9mm and +12mm heads incorporate a skirt to maintain the same point of rotation.

AI/ML Overview

The provided text is a 510(k) summary for the Biomet RingLoc® 36mm Liners and Modular Femoral Heads. This document describes a medical device and its substantial equivalence to previously marketed devices. It does not contain information about a study that establishes acceptance criteria for an AI/CADe device or its performance. Instead, it focuses on demonstrating that the new device (hip replacement components) performs similarly to existing, legally marketed predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input text. The questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment are not applicable to the content provided.

The document explicitly states:

• "No clinical testing was necessary for determination of substantial equivalence."
• "Mechanical testing and published literature determined that 36mm liners and heads presented no new unacceptable risks, and are therefore, substantially equivalent to the predicate devices."

This indicates that the "study" for this device was a comparison to predicate devices, primarily through mechanical testing and review of existing literature, rather than a clinical trial with performance metrics against acceptance criteria as might be expected for an AI/CADe device.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.