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The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the spinal column.

The iO-Tome Device is a design modification of the iO-Flex MicroBlade Shaver. It is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting bone for the purpose of removing a facet joint (facetectomy) in the lumbar spinal column. The flexible cutting platform is comprised of two parallel cutting elements that run along a flat flexible metallic substrate. The metallic substrate has two plastic protectors that temporarily cover the parallel cutting elements during introduction of the device into the foramen and protect the underside of the cutting platform during bimanual reciprocations. After the device is introduced and positioned within the foramen with the use of the iO-Flex System accessories and connected to the iO-Wire and Distal Handle, the user pulls up on the handles thereby exposing the parallel cutting elements. The user can then proceed with bimanual reciprocations cutting through the targeted facet joint.

Here's an analysis of the provided text regarding the iO-Tome Device, structured to address your specific points:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:

  • Biocompatibility: Not explicitly stated, but typically involves a number of samples for each test type (e.g., 3-5 replicates per test for ISO 10993 studies).
  • Sterility: Sample size for bioburden, characterization, and dose map verification studies is not specified in the provided text. These studies usually involve a representative number of units from manufacturing lots.
  • Stability: Not explicitly stated, but stability studies require a set number of units tested at various time points.
  • Functional/Structural (Bench Testing): Not explicitly stated, but generally involves multiple units to demonstrate robustness.
  • Cadaveric & In Vivo Porcine Testing: The exact number of cadavers or animals used is not specified.

• Data Provenance: Not explicitly stated. The studies are described as "bench tests," "cadaveric," and "in vivo porcine testing." The location where these tests were conducted or the origin of the cadavers/animals is not provided. It is likely prospective testing specifically for this device's clearance.

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

This information is not provided in the document. The studies mentioned (biocompatibility, sterility, stability, functional/structural, cadaveric, in vivo porcine) are primarily engineering and biological performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes for ground truth.

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

This information is not applicable/provided as the studies described are laboratory and animal model tests, not human clinical studies involving expert adjudication of diagnostic outcomes.

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

An MRMC comparative effectiveness study was not conducted. The iO-Tome device is a surgical instrument (manual rongeur), not an AI-powered diagnostic or imaging tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

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

This is not applicable. The iO-Tome is a physical surgical device, not an algorithm. Its performance is inherent in its mechanical function, material properties, and biological interaction, not in a standalone algorithmic capability.

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

The "ground truth" for the performance of the iO-Tome device is established through:

• Biocompatibility Standards: Compliance with ISO 10993-1 and FDA 21 CFR Part 58, which define established biological responses (e.g., no cytotoxicity, no sensitization).
• Sterility Standards: Adherence to ANSI/AAMI/ISO standards (e.g., 11737-1, 11137-2) for demonstrating a specified Sterility Assurance Level (SAL).
• Stability Standards: Compliance with ASTM standards (e.g., F1980-07, D4332-01, D4169-08, F2096-04, F88-09) that define accepted methods for evaluating shelf life and package integrity.
• Functional/Structural Integrity: Bench test results showing the device meets its design and performance specifications. This implies engineering specifications (e.g., cutting force, flexibility, durability) are the ground truth.
• Cadaveric and In Vivo Porcine Testing: Confirmation that the device meets all design and performance specifications for its intended use (cutting bone for facetectomy) in a relevant biological model. This would involve surgical success (e.g., ability to cut the bone as intended, absence of damage to surrounding structures, proper device function without breakage).

8. The sample size for the training set

This is not applicable. The iO-Tome device is a mechanical surgical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven algorithm development. Its design and manufacturing are based on engineering principles and material science, not data training.

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

This is not applicable as there is no training set for this type of device. The design and validation are based on established engineering principles, material properties, and regulatory standards for medical devices.

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

This 510(k) pre-market notification describes a modification solely to the iO-Flex Wire. The modifications include an additional surface finish process that employs heat treatment and a subsequent chemical etching process applied to the proximal wire section intended to improve the fatigue stress resistance. There were no changes in the wire material and a small change to one nominal dimension.

The modified iO-Flex Wire is manufactured from nickel-titanium ("Nitinol") and is designed to connect to the distal end of the Neuro Check Device and MicroBlade® Shaver device for placement and allows manual control of the MicroBlade Shaver and Neuro Check devices in the neural foramen. The iO-Flex Wire is packaged with the Neuro Check Device and available as a separately packaged accessory device.

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 is designed to be flexible, with a low profile to allow access to compromised neural areas in the spinal column. The accessories include a Probe, Distal Handle and the iO-Flex Wire. The fundamental scientific technology and operating controls remain unchanged from the predicate iO-Flex Wire design.

Acceptance Criteria and Study for MicroBlade Shaver Device and Accessories

This document describes the acceptance criteria and a summary of the study used to demonstrate that the modified iO-Flex Wire, part of the MicroBlade Shaver Device and Accessories, meets these criteria.

This submission focuses on a modification to the iO-Flex Wire, specifically an additional surface finish process (heat treatment and chemical etching) to improve fatigue stress resistance, and a small change to one nominal dimension. The fundamental scientific technology and operating controls of the MicroBlade Shaver and its accessories remain unchanged from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified iO-Flex wire are based on demonstrating equivalence to the predicate device's performance characteristics.

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

The document states that "Mechanical bench top comparison testing was conducted on the modified and non-modified iO-Flex Wire designs". However, the specific sample sizes used for this testing are not provided in the submitted summary.

The data provenance is implied to be from benchtop laboratory testing, which is prospective in nature, demonstrating performance of newly manufactured modified devices against existing predicate devices. No information on country of origin for the data is provided, but it is typically generated by the manufacturer, Baxano, Inc., located in San Jose, CA, USA.

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

This information is not applicable and not provided. The study described is a mechanical benchtop comparison testing of a medical device component. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense (e.g., for diagnostic imaging or clinical outcomes). The "ground truth" for this testing is based on objective, quantifiable physical and mechanical properties measured against engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the study involves objective mechanical testing rather than subjective assessments, there is no need for an adjudication method. The results are compared directly against predefined numerical specifications.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The current submission relates to a physical modification of a surgical device component and involves mechanical benchtop testing.

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

No. This question is not applicable. The device is a surgical instrument and accessories; it is not an algorithm or an AI-powered system that would have a "standalone" or "human-in-the-loop" performance. The testing described is for the physical and mechanical properties of a device component.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on engineering specifications and the established performance characteristics of the predicate device. The modified iO-Flex Wire was tested to verify that it meets these current design specifications and performance characteristics, thus demonstrating equivalence to the predicate. The criteria are quantitative measurements of physical properties (e.g., dimensions, tensile strength, fatigue cycling durability, connectivity).

8. The Sample Size for the Training Set

Not Applicable. This submission describes a modification to an existing medical device component and involves mechanical benchtop testing. There is no machine learning component, and therefore no "training set."

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

Not Applicable. Refer to point 8. No training set was used.

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The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems.

The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.

Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications.

In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience.

This 510(k) summary describes a device modification, so the study primarily focuses on demonstrating that the modified device remains as safe and effective as its predicate, rather than establishing efficacy for a new device. Therefore, acceptance criteria generally relate to ensuring the device meets relevant safety and performance standards after modification.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified table with corresponding performance. Instead, it describes general non-clinical tests conducted to confirm the modified device meets design specifications and performance characteristics based on its intended use and complies with relevant electrical and safety standards. The performance is indirectly "reported" as compliance with these standards and equivalency to the predicate device.

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

• Sample Size: Not specified. The document states "Mechanical performance tests were conducted" and "The modified Neuro Check Device was subjected to electrical safety and compatibility testing," implying that specific units of the device were tested. However, the exact number of devices or test repetitions is not provided in this summary.
• Data Provenance: The tests are described as "non-clinical tests" conducted on the modified device itself. This indicates laboratory testing, not human or observational data. The provenance is internal to the manufacturer or an approved contract facility for sterilization validation.

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

• Number of Experts: Not applicable/not specified. The "ground truth" for non-clinical performance and safety standards is the standard itself (e.g., IEC 60601-1). The validation of sterilization was done by an "approved contract facility." There's no mention of human expert adjudication for the non-clinical tests described.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. For non-clinical tests like mechanical, electrical, and sterilization, the "adjudication" is typically against pre-defined engineering specifications and regulatory standards. There is no multi-reader or human consensus method involved for these types of tests.

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

• Was it done?: No, an MRMC comparative effectiveness study was not done or described. This submission is for a device modification (510(k)), which typically focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicates, rather than extensive clinical efficacy studies comparing human reader performance with and without AI assistance. The device is a "Nerve locator" which assists a surgeon, but this filing does not involve any AI component or human interpretation of images requiring an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Was it done?: Not applicable/not described. This device is not an algorithm, but a physical medical device. Its "performance" is primarily assessed through its physical, electrical, and sterilization characteristics in non-clinical settings, not through an algorithm's standalone performance. The device is intended to be used with a commercial EMG system and a surgeon ("human-in-the-loop"), so "standalone algorithm performance" (without human interaction) does not apply.

7. Type of Ground Truth Used:

• Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established industry and regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 11137-1:2006, ISO 11137-2:2006) and the device's own design specifications.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This document does not describe the development or testing of an AI algorithm, so there is no "training set."

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

• How Established: Not applicable, as there is no AI algorithm or training set discussed.

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The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication.

The iO-Flex Catheter is designed for use with the iO-Flex Wire.

The iO-Flex Catheter is comprised of two primary components: (1) Y-Adapter with a rotating hemostasis valve (RHV) and (2) a flexible catheter body. The Y-Adapter consists of two ports: (1) a central guidewire port with rotating hemostasis valve and (2) a side port for connection of a standard syringe for the irrigation, injection and / or aspiration of fluids at the surgical site. The central guidewire port with RHV allows for insertion of the iO-Flex Catheter over the Baxano iO-Flex Wire. The flexible catheter shaft contains external markers for depth adjustment by the clinician.

The Baxano iO-Flex Catheter underwent several non-clinical performance studies to demonstrate its functional performance and ensure it met product specifications.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Bench Performance Testing: The specific sample size for each bench test (dimensional, flexibility, leak, etc.) is not explicitly stated. The nature of these tests suggests multiple units were tested to ensure consistency and reliability. Data provenance is implied to be from internal testing conducted by Baxano, Inc.
• Biocompatibility Testing: Not specified for each test, but standard procedures typically involve a sufficient number of samples to meet GLP regulations and ISO 10993-1 guidelines. Data provenance is from GLP-compliant testing conducted according to FDA and ISO standards.
• Cadaver Model Testing: Not specified, but "a cadaver model" suggests a limited number of cadavers were used for the design validation testing. The data is prospective, generated specifically for this validation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number or qualifications of experts used to establish a ground truth for a test set in the traditional sense of a clinical study with expert review.

• For the bench performance testing, acceptance criteria would have been established by engineering and quality assurance experts at Baxano, Inc., based on product specifications and industry standards.
• For the biocompatibility testing, ground truth was established by adherence to recognized international standards (ISO-10993-1) and FDA guidance, with testing conducted by qualified personnel in a GLP-compliant environment.
• For the cadaver model testing, "clinician" input is implied for assessing performance (e.g., ease of introduction). While not explicitly stated as "experts," these would be individuals with medical expertise in relevant spinal procedures.

4. Adjudication Method:

No formal adjudication method (like 2+1 or 3+1) is mentioned in the context of expert review for establishing ground truth, as this was not a comparative clinical trial. Performance was assessed against pre-defined engineering and biological safety specifications.

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

No MRMC comparative effectiveness study was performed or is mentioned. This device is a catheter, and the evaluation focused on its physical and functional performance, not on interpretation by human readers.

6. Standalone Performance:

Yes, all the performance data presented (bench testing, biocompatibility, and cadaver model testing) represents the standalone performance of the iO-Flex Catheter. The tests assess the device's inherent characteristics and functionality without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

• Bench Performance Testing: Ground truth was established by adherence to pre-defined product specifications (e.g., dimensional tolerances, tensile strength values, flow rates).
• Biocompatibility Testing: Ground truth was based on the results of validated biological tests (e.g., cytotoxicity assays, irritation tests) as interpreted against the acceptance limits of the ISO 10993-1 standard.
• Cadaver Model Testing: Ground truth was based on functional observation and assessment by clinicians/testers against pre-defined performance requirements related to ease of use, fluid delivery, and compatibility.

8. Sample Size for the Training Set:

This document describes pre-market testing for a medical device (catheter), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The presented studies are validation studies for the device itself.

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

As there is no AI component or training set, this question is not applicable. The device's performance was validated against established engineering, biological, and functional specifications directly.

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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. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.

The provided document is a 510(k) summary for the Baxano Neuro Check Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment methods, and multi-reader multi-case studies are not available in this document.

Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, accuracy, etc. for the device. Instead, it states that:

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

The document does not mention human patient test sets, sample sizes, or data provenance (country of origin, retrospective/prospective). The performance evaluation was based on "mechanical and electrical performance tests" and "animal studies."

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

Not applicable, as no human-read test set is described. Performance was evaluated through engineering tests and animal studies.

4. Adjudication Method

Not applicable, as no human-read test set is described.

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

No MRMC study was done or reported in this 510(k) submission. There is no mention of human readers improving with or without AI assistance, as this is a medical device for nerve localization, not an AI-assisted diagnostic imaging tool.

6. Standalone Performance Study

The document states that "Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use." This indicates some form of standalone testing was performed to ensure the device itself functions as intended. The "animal studies" also demonstrate standalone device performance in a biological setting. However, specific metrics (e.g., probability of correctly locating a nerve) are not provided.

7. Type of Ground Truth Used

For the "mechanical and electrical performance tests," the ground truth would be the expected output or behavior according to engineering specifications and design. For the "animal studies," the ground truth would be the actual anatomical location of nerves as confirmed through direct observation or other validated methods in the animal models.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the typical sense. Its function is based on principles of electrical stimulation and feedback.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of Device and Study Focus:

The Baxano Neuro Check Device is a surgical nerve stimulator/locator. The 510(k) submission (K092729) is for a modification of an existing predicate device (Baxano Neural Localization Probe, K081742) to include monopolar stimulation. The study presented here is a demonstration of substantial equivalence to the predicate device, emphasizing that the fundamental scientific technology remains unchanged, the indications for use are the same, and the modifications do not raise new questions of safety or effectiveness. The performance data relied upon are "mechanical and electrical performance tests" and "animal studies." This type of submission does not typically involve extensive clinical trials with human subjects and corresponding statistical analyses of performance metrics and ground truth as would be seen in a PMA.

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The Baxano, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

The Neural Localization Probe is based on the Baxano Standard Probe (for use with the Ultra Low Profile Rongeur and the Baxano Microblade Shaver) with the modification of circumferential bipolar electrodes. The Neural Localization Probe provides the surgeon additional feedback for localizing the nerve root instead of removing additional bone to improve visualization within the spinal column. A Switch Box directs the stimulus signal so that the nerve can be located on the top, bottom, left or right of the Neural Localization Probe.

The Neural Localization Probe is made of stainless steel shaped to enable the surgeon to utilize both direct visualization and tactile feedback in order to evaluate foraminal bone and soft tissue landmarks during placement of Baxano cutting devices. The Switch Box allows energy to be directed from a commercial EMG system to one of four pair of bipolar electrodes so that the surgeon gets feedback as to the relative location of the nerve root to the probe placement.

The provided text describes the Baxano Neural Localization Probe, but it does not contain specific numerical acceptance criteria for its performance or a detailed study report that would typically be associated with AI/ML device evaluations. This document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with predetermined acceptance criteria for AI performance.

Therefore, I cannot populate all the requested information as it is not present in the given text.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number. The text mentions "animal studies including blinded studies."
• Data Provenance: Animal studies. No country of origin is specified. The studies were retrospective or prospective is not mentioned, though "blinded studies" suggests a structured, prospective approach.

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

• Not specified. The statement implies the ground truth was established by direct observation or histological examination in the animal model, but it doesn't detail the involvement of human experts in establishing truth for a test set as would be typical for an AI/ML device.

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

• Not applicable/Not specified. This refers to consensus methods for human readers, which is not described for this device evaluation.

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:

• Not applicable. This device is not an AI-assisted diagnostic tool for human readers but a surgical instrument that provides direct feedback.

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

• Yes, in a way. The device itself (the probe) is the "standalone" component in the animal studies, where it demonstrated its ability to identify nerve roots without reference to human interpretation of images or data. The "100% identification" was attributed to the probe's function.

7. The type of ground truth used:

• Direct observation/identification of nerve root position in animal models, likely confirmed by anatomical dissection or other physiological markers in the animal studies.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not described as an AI/ML system that undergoes a "training set" phase in the typical sense. It's a hardware device evaluated through mechanical tests and animal studies.

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

• Not applicable. (See #8)

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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. 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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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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