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K Number
K051569
Device Name
RINGLOC BI-POLAR ACETABULAR COMPONENT
Manufacturer
BIOMET, INC.
Date Cleared
2005-09-29

(107 days)

Product Code
JDI,KWY,LPH,LZO,MEH
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
K833175,K991990
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
    1. Rheumatoid arthritis
    1. Correction of functional deformity
    1. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Device Description

The Bi-Polar device consists of a large outer shell with a polyethylene insert that captures a modular head component of a femoral hip stem. The outer surface of the shell is highly outshed in order to articulate with the natural acetabular bone. Outer diameters of 41mm to 70mm allow politically of a fill the acetabular cavity. Inserts accept two size modular heads, 22mm and 28mm. The insert is held in place by a thin metal ring that is pre-assembled into the shell which snaps into a groove in the insert.

AI/ML Overview

The provided text describes a 510(k) submission for the RingLoc® Bi-Polar Acetabular Component. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study with a detailed protocol.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them. Instead, it relies on demonstrating equivalence to predicate devices based on technological characteristics and mechanical testing.

Here's a breakdown of why each point cannot be answered from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific, pre-defined performance thresholds for the new device.
  2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of a performance study is described. The non-clinical testing mentioned is "Mechanical testing of the assembly and disassembly forces," but no details on sample size or data provenance for this testing are given.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment by experts is described.
  4. Adjudication method for the test set: Not applicable. No clinical test set or adjudication process is 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: Not applicable. This device is a medical implant, not an AI diagnostic tool. No MRMC study is mentioned.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical implant, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth is established for this 510(k) submission, as it does not involve a clinical performance study.
  8. The sample size for the training set: Not applicable. No training set is relevant for this type of device submission.
  9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is relevant.

In summary, the provided 510(k) summary explicitly states "Clinical Testing: None provided." This means the submission did not include a clinical study designed to establish acceptance criteria and prove performance against them as typically understood in a clinical trial or performance study context. Instead, the basis for approval is substantial equivalence to existing legally marketed devices, supported by non-clinical mechanical testing and verification of similar technological characteristics.

§ 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.