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The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The ULP Rongeur and accessory devices are used to access the neural foramen and decompress targeted areas. The Rongeur attaches to a needle wire and is pulled into the foramen with the distal handle also attached to the needle wire. Tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The accessories include a probe, guide and needle wire, which are used to explore the foramen, and position the needle wire through soft tissue and the skin.

The provided text describes a 510(k) submission for a medical device (Baxano Ultra Low Profile Rongeur) and does not contain the typical structure of a study report with defined acceptance criteria and detailed quantitative performance results. The focus is on demonstrating "substantial equivalence" to a predicate device.

Therefore, many of the requested fields cannot be directly extracted or are not applicable in the context of this document. I will fill in what can be inferred and explicitly state what information is missing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not explicitly stated. The text mentions "multiple cadaver studies," but the number of cadavers or specific cases is not provided.
• Data Provenance: Cadaver studies. The country of origin is not specified but is presumably the US given the context of a US-based company submitting to the FDA. The studies were likely "prospective" in the sense that they were designed to test the modified device, but performed on "retrospective" biological material (cadavers).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not explicitly stated. The text mentions "physicians skilled in procedures for decompressing neural foramen and lateral recess."
• Qualifications of Experts: "Physicians skilled in procedures for decompressing neural foramen and lateral recess." No specific number of years of experience or board certifications are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not mentioned. It's unclear how "comparable decompression" was assessed or whether multiple physicians independently assessed and then adjudicated findings.

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

• MRMC Study: No, this was not an MRMC study and does not involve AI assistance. The study described is a mechanical performance and cadaver study on a surgical instrument.

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

• Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The "ground truth" was likely assessed by expert physicians through observation and potentially measurements during cadaver studies, focusing on the ability to achieve "comparable decompression." This falls under expert assessment/observation in a cadaveric setting.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This refers to performance testing and cadaver studies involving a physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical surgical rongeur.

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The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The ULP Rongeur and Access Tools are used to access the neural foramen and decompress targeted areas. The Rongeur is pulled into the foramen with the distal handle and tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The Access accessories include a probe, guide and needle wire.

Since this is a 510(k) premarket notification for a medical device (a surgical rongeur), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally framed around demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance targets like those for AI/Software as a Medical Device (SaMD).

Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where information typical for AI/SaMD studies is not present for this type of device:

Acceptance Criteria and Device Performance Study for the Baxano Ultra Low Profile Rongeur (K062711)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Description: The "test set" in this context refers to the cadaver studies and mechanical performance tests.
• Sample Size:
  • Mechanical Performance Tests: Not specified.
  • Cadaver Studies: "multiple cadaver studies." The exact number of cadavers or individual tests is not quantified in the provided text.
• Data Provenance: Not explicitly stated, but cadaver studies are typically conducted in a laboratory or research environment. It is not "retrospective or prospective" in the medical record sense, but rather an experimental study. The country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated, but referred to as "physicians skilled in procedures for decompressing neural foramen and lateral recess."
• Qualifications: "skilled in procedures for decompressing neural foramen and lateral recess." Specific specialties (e.g., neurosurgeon, orthopedic spine surgeon) or years of experience are not provided.
• Ground Truth Establishment: The physicians' feedback and observations during the cadaver studies, regarding "comparable decompression with no visible damage to neural structures" and "ease of use," served as the qualitative assessment against the "standard of care" (commercially available rongeurs).

4. Adjudication Method for the Test Set

• No formal adjudication method (like 2+1, 3+1 consensus) is described. The results appear to be based on the observations and feedback of the participating "skilled physicians" during the cadaver studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" as understood in imaging or AI contexts was not performed. This device is a manual surgical instrument, not an AI or imaging diagnostic tool. The performance assessment was based on human expert evaluation of its use in a cadaveric setting compared to standard tools.
• Therefore, an "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only without human-in-the-loop performance) study was not done. This device is a manual surgical rongeur and does not involve any algorithms or AI components.

7. Type of Ground Truth Used

• The ground truth in this context was expert assessment/consensus (from skilled physicians during cadaver studies) regarding the device's ability to achieve "comparable decompression with no visible damage to neural structures" and "ease of use comparable to the standard of care," alongside mechanical performance data against design specifications. It is not pathology or outcomes data from live patients.

8. Sample Size for the Training Set

• This concept is not applicable as the device is a manual surgical instrument and does not involve machine learning or AI models with training sets.

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

• This concept is not applicable given the nature of the device.

Summary of Device-Specific Context:

It's crucial to understand that this document describes a traditional medical device (a surgical tool), not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" and "study" focus on demonstrating substantial equivalence to existing, legally marketed predicate devices through:

• Comparison of Indications for Use.
• Comparison of Technological Characteristics (materials, design).
• Non-Clinical Performance Data (mechanical tests and cadaver studies) to confirm that the device performs as intended and introduces no new safety or effectiveness concerns compared to established methods/devices.

The type of rigorous, quantitative performance metrics and study designs common for AI/SaMD are not typically found in these types of 510(k) submissions for manual surgical instruments.

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