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K Number
K022094
Device Name
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
Manufacturer
BIOMET, INC.
Date Cleared
2002-07-25

(28 days)

Product Code
JDI
Regulation Number
888.3350
Type
Special
Panel
OR
Reference & Predicate Devices
K000254
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications for the PAR 5 Acetabular component are as follows:

  1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  2. Rheumatoid arthritis
  3. Correction of functional deformity
  4. Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
  5. Revision procedures where other treatment or devices have failed
Device Description

The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.

AI/ML Overview

The provided documentation is a 510(k) premarket notification for a medical device, the PAR 5 Acetabular Component, and focuses on demonstrating substantial equivalence to a predicate device. It explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."
"Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device."

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets those criteria (especially related to AI/software performance) is not present in this document. This submission relies on an engineering justification and comparison to a predicate device rather than extensive clinical or statistical performance studies in humans.

Here's a breakdown of why each requested point cannot be answered:

  1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance metrics or acceptance criteria for a clinical or AI study described. The "performance" being evaluated is substantial equivalence based on material properties and design similarity to a predicate device.
  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for performance comparison is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no test set requiring ground truth establishment by experts.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set 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 is a medical device (hip implant component), not an AI diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in this context. The "ground truth" for this 510(k) is the existing predicate device and its established safety and effectiveness.
  8. The sample size for the training set: Not applicable. No machine learning model or training set is involved.
  9. How the ground truth for the training set was established: Not applicable. No machine learning model or training set is involved.

In summary, this 510(k) submission for the PAR 5 Acetabular Component does not contain information about clinical performance studies or AI/software validation. The basis for its substantial equivalence is an engineering justification and comparison to a previously approved predicate device.

§ 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.