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For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.

The Physician Industries' ACCUMETER. Polycarbonate barrel, plunger, and body, containing display software and electronics; Rubber plunger tip. Sterile (100% EtO) and non-pyrogenic (LAL).

The provided text describes the submission and clearance of a device called the "Physician Industries' ACCUMETER: Piston / control / discography syringe" (K033739). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document details:

• Device Identification: Device name, classification, regulation numbers, product code.
• Predicate Devices: A list of previously cleared devices considered substantially equivalent to the ACCUMETER, and why they are considered SE.
• Description: Materials and sterility of the ACCUMETER.
• Intended Use: For discography procedures involving contrast medium injection to view spinal disks using X-ray or photofluorographic systems, under the direction of a licensed clinician.
• Substantial Equivalence Rationale: General indications, similar characteristics, materials, manufacturing, software to predicates, and lack of adverse events in FDA databases.
• Safety and Effectiveness: Asserts no substantive differences from predicate devices, adherence to quality management systems, and compliance with standards.
• FDA Clearance Letter: Formal communication from the FDA confirming the device's substantial equivalence to legally marketed predicate devices and allowing marketing.
• Indications for Use Statement: A specific declaration for the diagnosis of herniated or otherwise diseased intervertebral disks in the human spine, explicitly stating it has not been evaluated for vertebroplasty.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, or details of a study, as this information is not present in the provided text. The document focuses on the regulatory submission process for substantial equivalence rather than reporting an independent performance study with defined acceptance criteria.

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