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The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.

The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.

This document describes the Sonex Health SX-One MicroKnife, a manual surgical instrument for carpal tunnel release. The information provided is primarily related to its regulatory clearance (510(k) submission) and does not contain details about acceptance criteria, clinical study results, or AI/software performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC studies, as the provided text explicitly states "No clinical data was required" and describes a mechanical device with no mention of AI or software.

The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing related to sterilization, biocompatibility, and shelf life for a mechanical surgical instrument.

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The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

This document describes a 510(k) premarket notification for the Stryker Imbibe Needle, a manually operated surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria. Therefore, several requested fields related to a detailed performance study are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The comparison points are primarily design features and intended uses, implying that if the new device shares these characteristics and performs similarly, it meets the "acceptance criteria" for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of a performance study. The document mentions "Preclinical bench data supplied including mechanical and cadaveric testing." However, the exact number of devices tested, samples used in mechanical tests, or cadavers utilized is not provided.
• Data Provenance: The testing appears to be internal preclinical bench and cadaveric testing conducted by Orthovita, Inc. (now Stryker). The country of origin is not specified but implicitly within the US given the FDA submission. It is retrospective in the sense that the data was collected prior to the submission, but the tests were presumably prospective in their execution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable (N/A): This type of information is pertinent to studies involving human interpretation (e.g., imaging studies, diagnostic tools). The described tests are mechanical and cadaveric, which do not typically involve experts establishing a "ground truth" through consensus or interpretation. The performance is assessed against engineering specifications or physical outcomes.

4. Adjudication Method for the Test Set:

• N/A: As explained above, this concept is not relevant to the type of preclinical bench and cadaveric testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A: This submission is for a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A: This submission is for a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• For the mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and expected mechanical responses (e.g., force, torque, fatigue limits).
• For the cadaveric testing, the "ground truth" would be the observed physical outcome and ability to perform the intended surgical actions (e.g., successful aspiration, accurate guidewire placement) in a simulated anatomical environment. This is typically assessed against established surgical techniques and anatomical knowledge.

8. The Sample Size for the Training Set:

• N/A: This concept is relevant for machine learning or AI models. This submission is for a physical medical device and therefore does not have a "training set" in that context. The development process would involve iterative design, prototyping, and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

• N/A: As above, this concept is not applicable to the development and testing of a physical surgical instrument.

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Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .

Self-Retaining Lumbar Retractor

The provided document is a 510(k) premarket notification letter from the FDA to Koros USA, Inc. regarding a Self-Retaining Lumbar Retractor. It is a regulatory approval document confirming substantial equivalence to a predicate device.

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a Class I device and does not typically require extensive performance studies for 510(k) clearance. The information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typically found in the 510(k) submission itself or in a detailed study report, not in the FDA's clearance letter.

Therefore, I cannot fulfill your request using the provided input.

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