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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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The 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 SE5 Small Joint Shaver in the wrist for 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 Hermes aspect of this device allows the surgeon to remotely control the input parameters (panel selection options) through voice control technology, via a headset. Optional pendant control (wired remote), and conventional footswitch control are also available. The HERMES system allows voice and pendant control of the SE5 Shaver with buttons handpiece only.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for "The HERMES-Ready™ Total Performance System," stating that the device is substantially equivalent to legally marketed predicate devices.

The letter discusses:

• The trade name and regulatory class of the device.
• The FDA's determination of substantial equivalence.
• General controls and additional controls that may apply.
• Contact information for various FDA offices.
• The intended indications for use of the device, which include cutting, drilling, reaming, decorticating, and smoothing bone and other bone-related tissue in various surgical procedures, as well as the placement of screws, wires, pins, and other fixation devices. It also mentions the use of endoscopic applications with the SE5 Small Joint Shaver and the voice/pendant control features of the HERMES system.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details on a study, sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information about a multi-reader multi-case (MRMC) study or standalone algorithm performance.
• The type of ground truth used or details about training sets.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

Ask a specific question about this device