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The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).

The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text details the FDA clearance for the OrthoPediatrics Corp. RESPONSE™ Rib and Pelvic System. However, this document does not describe an AI/ML device or its associated studies.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biocompatibility testing performed for the physically implanted medical device, not a software-based AI/ML diagnostic or prognostic tool.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to a software AI/ML device.
• Sample size used for a test set (in the context of AI/ML).
• Data provenance for AI/ML.
• Number of experts or their qualifications for ground truth in AI/ML.
• Adjudication method for AI/ML.
• MRMC comparative effectiveness study for AI/ML.
• Stand-alone performance for an AI/ML algorithm.
• Type of ground truth (clinical outcomes, pathology, expert consensus) for AI/ML.
• Sample size for training set for AI/ML.
• How ground truth for training set was established for AI/ML.

The document states:

• Performance Data (Section VII):
  • "The Biocompatibility assessment and testing for the RESPONSE™ Rib and Pelvic System were performed in conformance with ISO 10993-1."
  • "The implants of RESPONSE™ Rib and Pelvic System were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such."
  • "Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; axial and torsional grip testing per ASTM F1798; and screw torsional strength, insertion torque, and removal torque testing per ASTM F543; and engineering analysis."
  • "Results of the mechanical testing/analysis demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate."

This indicates that the acceptance criteria were based on established ASTM and ISO standards for mechanical performance and biocompatibility of implantable devices, and the device met these engineering and material standards to demonstrate substantial equivalence to predicate devices. It is a physical product, not a software algorithm.

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