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The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The provided text describes the Stryker HERMES-Ready™ Total Performance System, but it does not contain a study that proves the device meets specific acceptance criteria related to its performance characteristics.

Instead, the document primarily focuses on:

• Premarket Notification (510(k)) Summary: This outlines the device's intended use, its substantial equivalence to previously cleared devices, and general information required for FDA submission.
• Regulatory Classification: It details the device's classification and the regulatory controls it falls under.
• Voluntary Standards: It lists the voluntary standards (e.g., IEC 601-1, UL 2601-1) that the device will be designed and tested to. This indicates the intent to meet certain safety and performance benchmarks, but not the results of such testing or specific acceptance criteria.
• Indications for Use: This section describes the medical procedures and applications for which the device is intended.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document confirms the device's regulatory clearance based on substantial equivalence, but it does not elaborate on specific performance testing results or a study proving its acceptance criteria have been met.

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