FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

GENERATION 4 Bone Cement is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty procedures.

Device Description

GENERATION 4 Bone Cement System is a self-curing agent comprised of two sterile components (liquid and powder) mixed in the Vacuum Pac delivery system forming polymethyl methacrylate (PMMA) bone cement. The liquid component (monomer) is comprised of Methyl methacrylate monomer (98%), N,N-dimethyl-p-toluidine (2%), and Hydroquinone (60ppm). The powder component is comprised of Methyl methacrylate - stryrene copolymer (90%) and Barium sulfate, U.S.P. (10%).

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, GENERATION 4 Bone Cement. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device's performance against specific acceptance criteria in a clinical setting with AI.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from this document.

Here's what can be inferred related to your request, with an explanation of why other parts are not applicable:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" discussed here are related to demonstrating substantial equivalence to a legally marketed predicate device (Surgical Simplex P Radiopaque Bone Cement). This means the GENERATION 4 Bone Cement must be similar in terms of:
  - Indications for use
  - Intended use
  - Technological characteristics
  - Material
- Reported Device Performance: The document describes the chemical composition and polymerization process of the GENERATION 4 Bone Cement but does not provide quantitative performance metrics (e.g., strength, set time, biocompatibility test results) that would typically be associated with clinical acceptance criteria. Instead, it asserts that these characteristics are "typical constituents of PMMA bone cement," implying their equivalence to established standards and the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: This document does not describe a clinical study with a test set of data. The submission is based on the chemical formulation and existing knowledge of PMMA bone cements, and comparison to a predicate device, not on evaluating performance on a patient dataset.
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: No clinical test set requiring ground truth established by experts is mentioned in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set or adjudication method is described.
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 document is about a bone cement, not an AI device or a diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: As no clinical study or test set is presented, no ground truth data is discussed. The "ground truth" for this submission is essentially the established performance and safety profile of the predicate device and the known properties of PMMA bone cement.
The sample size for the training set:
- Not Applicable: This device does not involve a training set as it is not an AI/machine learning model.
How the ground truth for the training set was established:
- Not Applicable: No training set is involved.

Summary based on the provided document:

The regulatory submission for GENERATION 4 Bone Cement does not include a study with acceptance criteria and device performance in the way you've outlined for AI or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (Surgical Simplex P Radiopaque Bone Cement).

The "acceptance criteria" for this type of submission are that the new device shares the same:

Indications for Use
Intended Use
Technological Characteristics (composition and polymerization process are similar to typical PMMA cements)
Materials (components are common in PMMA cements)

The document reports the chemical composition of the cement and broadly describes its polymerization process, asserting that these are typical for PMMA bone cements and therefore equivalent to the predicate. No clinical performance data against specific quantitative metrics or a study involving human readers/AI is presented.

Summary

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”