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K Number
K990712
Device Name
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
Manufacturer
HOWMEDICA OSTEONICS CORP.
Date Cleared
1999-07-20

(138 days)

Product Code
MJT
Regulation Number
N/A
Type
Traditional
Panel
OR
Reference & Predicate Devices
K955731
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications for the Osteonics Solar™ Shoulder Bipolar System are:

  • Aseptic necrosis of the humeral head .
  • Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis or post-traumatic arthritis.
  • . Proximal humeral fracture and/or dislocation
  • Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
  • Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
Device Description

The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Osteonics® Solar™ Shoulder Bipolar System. It outlines the device description, intended use, and claims of substantial equivalence to a predicate device. This type of submission generally does not include detailed performance studies with acceptance criteria in the way that, for example, a submission for diagnostic software would.

Here's an analysis of why the requested information is largely absent in this document, based on the nature of a 510(k) for a medical implant:

  • Medical Device Class III (Prosthesis): The device is classified as Class III (Shoulder joint metal/polymer Semi-constrained cemented prosthesis and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis). For Class III devices, substantial equivalence is key in a 510(k). This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. This often relies on bench testing, materials testing, and mechanical/wear testing rather than clinical studies with "acceptance criteria" and "device performance" in the terms usually associated with AI or diagnostic device performance.

  • Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the Osteonics® Solar™ Shoulder Bipolar System is "substantially equivalent" to an existing, legally marketed device (the Biomet Bi-Angular Bi-Polar Shoulder System). This means the focus is on comparing the design, materials, and intended use to the predicate, not necessarily on new, independent clinical studies with performance metrics.

  • Missing Information: The document does not contain the following information as it is generally not required for this type of 510(k) submission:

    • Table of acceptance criteria and reported device performance: This document doesn't provide specific performance metrics like sensitivity, specificity, or accuracy that would be found in a study for a diagnostic device. The "performance" in this context would likely refer to mechanical and material properties compared to the predicate.
    • Sample size and data provenance for a "test set": There isn't a "test set" in the context of clinical images or patient data for algorithmic performance.
    • Number of experts and qualifications for ground truth: Ground truth in this context would likely involve engineering specifications, material standards, and clinical outcomes from the predicate device's history, not expert consensus on image interpretation.
    • Adjudication method: Not applicable for this type of device.
    • Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for a physical implant, not a diagnostic algorithm involving human readers.
    • Standalone algorithm performance: Not applicable, as this is not an algorithm.
    • Type of ground truth used: For mechanical devices, ground truth is typically engineering specifications, material properties, and established clinical success of predicate devices.
    • Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device requiring training data.

Summary of Information Available in the Provided Text (and what is not):

Based on the provided text, the device is a medical implant (shoulder bipolar system), and the submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the questions related to clinical study performance metrics, AI/ML algorithms, and expert ground truth are not addressed in this type of document.

What is present:

  • Predicate Device: Biomet Bi-Angular Bi-Polar Shoulder System.
  • Intended Use/Indications: Aseptic necrosis of the humeral head; Painful, disabling joint disease of the shoulder (degenerative, rheumatoid, post-traumatic arthritis); Proximal humeral fracture and/or dislocation; Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; Pathological conditions or age considerations that indicate a more conservative glenoid procedure and avoidance of bone cement in the glenoid.
  • Device Components & Materials: Bipolar Humeral Head Component, 22 mm Solar™ Shoulder Bipolar Modular Head, and Solar™ Shoulder Humeral Stem. Metallic shell is ASTM F75 cobalt chromium alloy. Modular head is ASTM 1537 cobalt chromium alloy. UHMWPE insert and locking ring in the bipolar head component.
  • Claim of Equivalence: The subject devices (Bipolar Humeral Head and Bipolar Modular Head) are substantially equivalent to the bipolar components of the predicate (Biomet Bi-Angular Bi-Polar Shoulder System Components) in all material and design aspects, indications, and intended use.

In conclusion, the requested information regarding "acceptance criteria" through a "study that proves the device meets the acceptance criteria" as defined by performance metrics (like sensitivity/specificity) and clinical study design (sample sizes, expert ground truth, MRMC, etc.) is not present in this 510(k) summary because this type of submission for a physical implant does not typically involve such studies. Instead, the "proof" for substantial equivalence relies on comparison of design, materials, manufacturing, and intended use to a legally marketed predicate device, along with bench testing/materials testing to ensure equivalent safety and performance.

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