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Integrated Drive/Pump System functions as a powered The instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.

The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology, Neurological Surgical, Orthopedic, and Spinal procedures.

The Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece cord, a high speed handpiece, high speed drill, cranial perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.

The provided text describes the "Integrated Drive/Pump System" by Linvatec Corporation and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study detailing device performance against such criteria.

The document states:

• "Testing has been done to prove safety and effectiveness of the devices." (Page 3 of 5, Section G)

But it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for any test sets.
• Details about experts, ground truth establishment, or adjudication methods.
• Information about MRMC or standalone studies.
• Training set details.

Therefore, I cannot provide the requested table and detailed study information based on the input text. The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results with acceptance criteria.

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The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The field of application is Otolaryngology surgical procedures.

The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology surgical procedures. Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec Integrated Drive/Pump System, submitted to the FDA in 1998. This type of document is a premarket notification for certain medical devices and typically focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for performance in the same way clinical trials do for novel devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of device performance metrics, sample sizes, expert ground truth establishment, or clinical comparative effectiveness studies.

Here's why the requested information is not present and what the document does provide:

• Acceptance Criteria & Reported Performance: The document does not define specific performance metrics (e.g., speed of resection, accuracy of cut, flow rate of irrigation) with corresponding acceptance criteria or report quantitative performance results against such criteria. Instead, it relies on demonstrating that its design, function, and intended use are similar to predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: There is no detailed study described that measures performance against pre-defined acceptance criteria. The document states: "Testing has been done to prove safety and effectiveness of the devices." However, it does not elaborate on the nature of this testing, its methodology, or the results in a way that aligns with the requested information format (e.g., sample sizes, ground truth, expert opinions). This generally refers to verification and validation testing (e.g., electrical safety, biocompatibility, mechanical testing) to ensure the device performs as intended and is safe, but not typically comparative effectiveness or performance criteria studies like those for AI or drug-like interventions.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are relevant to studies demonstrating clinical effectiveness or accuracy, especially for AI/algorithms. Since this document focuses on substantial equivalence based on design and intended use to existing predicate devices, rather than a novel clinical performance claim, these types of details are not included. The "testing" mentioned would likely be engineering or bench testing, not clinical studies.

In summary, the provided text describes a submission for substantial equivalence based on the device's design, function, and intended use being similar to existing cleared devices, rather than a study demonstrating performance against specific, quantitative acceptance criteria.

The key takeaway is that for a 510(k), the primary focus is often on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness. This is a different regulatory pathway than, for example, a Premarket Approval (PMA) application, which typically requires more extensive clinical data to demonstrate safety and effectiveness.

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