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

BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments.

It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to digitized landmarks of the anatomy.

Example orthopedic procedures for these instruments include, but are not limited to:

· Total Knee Arthroplasty (Primary and Revision)
· Unicompartmental Knee Arthroplasty (Primary and Revision)
· Minimally Invasive Knee Orthopedic Procedures
· Total or Hemi-Hip Arthroplasty (Primary and Revision)
· Minimally Invasive Hip Orthopedic Procedures
· Tumor Resection and Bone/Joint Reconstruction
· Stabilization or Repair of Pelvic/Femoral Fractures

Device Description

BRIGIT Surgical Device assists the surgeon in:

determining reference alignment axes in " relation to anatomical landmarks,
planning the position of instruments relative to these axes,
and providing a stable, accurate and reproducible mechanical guidance of surgical instruments in accordance with said planning, while not directly entering in contact with the patient.

BRIGIT Surgical Device can be shifted into a "cooperative mode" where the surgeon can manually move the arm anywhere in the operating field by simply grabbing the tip. Pinpoint collection of anatomical landmarks is carried out with BRIGIT Surgical Device and its pointing instrument in cooperative mode.

Adequate position of the guide is derived from three-dimensional calculations performed from desired surgical planning parameters and spatial positions of anatomical landmarks.

BRIGIT Surgical Device offers the rigidity essential for accurate and steady support of the guide.

AI/ML Overview

The provided text describes a medical device called "BRIGIT Surgical Device" and discusses its safety and effectiveness. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with statistical analysis.

Here's a breakdown of what is and is not available in relation to your request:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in a quantifiable manner (e.g., "accuracy of X mm with Y% confidence"). The document mentions "Device accuracy tests were performed to validate the accuracy and repeatability of the device," but the specific criteria for "accuracy" and "repeatability" are not provided.
Reported Device Performance: Similarly, the quantitative results of these accuracy and repeatability tests are not presented.

2. Sample size used for the test set and the data provenance:

Sample Size: Not mentioned.
Data Provenance: Not mentioned. It's implied the testing was conducted by or for Zimmer, Inc., but details like country of origin or whether it was retrospective/prospective are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not mentioned. The document does not describe the establishment of a "ground truth" for a test set in the context of accuracy or performance evaluation.

4. Adjudication method for the test set:

Not mentioned.

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. The BRIGIT Surgical Device is a computer-assisted surgical arm designed to guide instruments, not a diagnostic AI system for "human readers." Therefore, an MRMC study with "human readers" and "AI assistance" as typically understood in diagnostic imaging is not relevant to this device's function as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is explicitly described as assisting the surgeon by providing "mechanical guidance of surgical instruments in accordance with said planning, while not directly entering in contact with the patient" and by having a "cooperative mode" where the surgeon can manually move the arm. This indicates it is not a standalone algorithm, but a human-in-the-loop system. The document does not detail standalone algorithm performance.

7. The type of ground truth used:

Not explicitly defined. If "accuracy" tests were performed, the "ground truth" would likely refer to a highly precise measurement of the intended position/orientation versus the device's actual position/orientation. However, the method for establishing this ground truth (e.g., using a reference jig, CMM, etc.) is not detailed.

8. The sample size for the training set:

Not mentioned. The device is electromechanical and computer-controlled, implying software and algorithms, but there's no mention of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable, as no "training set" is mentioned.

In summary:

The provided text focuses on the device description, intended use, and substantial equivalence to predicate devices, along with general statements about safety and performance testing. It lacks specific, quantifiable details regarding acceptance criteria, study methodologies (like sample sizes, ground truth establishment, or expert involvement), and detailed performance results that would allow for a comprehensive answer to your request. The "Performance Data" section primarily states that tests were carried out for electrical safety, electromagnetic compatibility, and device accuracy, but it does not present the results or the criteria for success.

Summary

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).