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The Baxano, Inc. MicroBlade, Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The modified MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The modified Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the GuideWire. The Distal Handle Accessory is comprised of a handle to accommodate the GuideWire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check devices.

The provided document is a 510(k) premarket notification for a medical device, the MicroBlade Shaver Device and Accessories. It details the device's description, intended use, technological characteristics, and a claim of substantial equivalence to predicate devices based on non-clinical performance data.

However, the document does not contain information related to acceptance criteria, specific performance metrics, or a study design typical of AI/ML device evaluations. It describes bench performance, functional testing, and cadaveric analyses to verify that the device (a mechanical surgical tool) meets design specifications and performance characteristics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/ML performance metrics. The information requested (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is not applicable to this type of device and the information provided in this 510(k) summary.

The 510(k) summary focuses on demonstrating that the modified device is substantially equivalent to previously cleared versions and does not raise new questions of safety or effectiveness, primarily through non-clinical bench and cadaveric testing.

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The Baxano, Inc. Microblade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The Microblade Shaver and Accessories are used to access the neural foramen and decompress targeted areas. The Microblade Shaver is pulled into the foramen with the Distal Handle and tissue is removed by pulling up on the distal handle to cut the targeted soft tissue and bone. The Accessories include a Probe, Guide, Needle Wire and Distal Handle. The Microblade Shaver is made of stainless steel and is flexible, with a low profile, to allow access to compromised neural areas when exposure is otherwise difficult to obtain.

The provided text describes a 510(k) premarket notification for the Microblade Shaver and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through specific acceptance criteria and detailed clinical studies with reported metrics like sensitivity, specificity, and accuracy for diagnostic devices.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-driven diagnostic devices, is not present in this document.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and cadaver studies used to demonstrate equivalency to predicate devices, not to meet specific quantitative performance metrics as would be the case for AI-enabled diagnostic tools.

Here's an analysis of what is available in the document, framed as closely as possible to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are qualitative and focused on demonstrating functional equivalence and safety in a simulated surgical environment, rather than quantitative performance thresholds.

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

• Sample Size for Test Set: "multiple cadaver studies" - The exact number of cadavers or procedures is not specified.
• Data Provenance: Cadaver studies. The country of origin is not specified, but the submission is to the U.S. FDA. The studies were prospective in the sense that the device was used in a controlled simulation environment.

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

• Number of Experts: Not specified, but described as "physicians skilled in procedures for decompressing neural foramen and lateral recess."
• Qualifications: "skilled in procedures for decompressing neural foramen and lateral recess." Specific years of experience or board certifications are not provided.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1 consensus) is described. The results are from direct observation and assessment by the participating physicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study (MRMC for comparing human readers with/without AI assistance) is not relevant to a mechanical surgical instrument. The comparison was between the Microblade Shaver and "commercially available rongeurs" by skilled physicians in cadaver studies. No AI component is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a manual surgical instrument; there is no 'algorithm only' component.

7. The Type of Ground Truth Used

• Expert Observation and Assessment: The "ground truth" was established by the participating physicians based on their direct observation of tissue removal, neural structure integrity, and ease of use in the cadaveric setting, compared to existing predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device.

Summary of Device and Study Focus:

This 510(k) submission is for a mechanical surgical instrument. The "study" referenced is a series of non-clinical mechanical performance tests and cadaver studies. The purpose of these studies was to demonstrate functional equivalence and safety compared to existing predicate devices already on the market, not to establish performance metrics (like sensitivity/specificity) against a "ground truth" derived from patient data, as would be the case for a diagnostic AI device. The criteria are largely qualitative and revolve around successful operation and comparable outcomes in a simulated environment.

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