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The GEISTER® K-Rex™ rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

Geister Geister® K-Rex™ rongeurs are reusable stainless steel instruments that are coated with TiAIN that are sterilizable and packaged non-sterile.

The provided FDA 510(k) clearance letter for the Geister K-Rex Rongeurs does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/software device. Instead, the document describes a traditional medical device (surgical rongeurs) and its clearance process.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) as the provided text does not pertain to an AI/software device or a study involving such elements.

The documentation focuses on:

• Device Description: Manual, reusable stainless steel instruments coated with TiAIN, used for cutting or biting bone.
• Intended Use: Cutting or biting bone during surgery involving the skull or spinal column.
• Substantial Equivalence: Comparison to existing legally marketed rongeurs (predicate devices) based on intended use, technological characteristics (materials, bite size, length, jaw opening/angles, footplates, detachable, ejector), and performance.
• Non-Clinical Performance Data: Biocompatibility testing (ISO 10993), Reprocessing/Cleaning/Sterilization validation (ANSI/AAMI ST98:2022, ISO 17665, ISO 17664), and a "Cutting performance test" of 10,000 cycles compared to the predicate device to show similar performance.
• Clinical Performance Data: Stated that no clinical testing was required as the device is equivalent to predicate devices with proven safety and efficacy.

In summary, the provided document describes the clearance of a mechanical surgical instrument, not an AI/software-based medical device. Thus, the specific metrics and study methodologies typically associated with validating AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) are not present in this 510(k) clearance letter.

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The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.

This document describes the premarket notification (510(k)) for the SQ.line KERRISON manual rongeur. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of devices or tests performed per device) for the cutting test, performance test, or mechanical performance after reprocessing.

For biocompatibility, the sample size or specific test article numbers are not provided.

The data provenance is not specified (e.g., country of origin). The studies appear to be internal non-clinical evaluations conducted by the manufacturer, Aesculap, Inc. All studies are retrospectively performed as part of the 510(k) submission process.

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

This information is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the human diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical tests and do not involve human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is a manual surgical instrument (rongeur), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable. The device is a manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the cutting test, performance test, and mechanical performance after reprocessing, the "ground truth" is established by engineering specifications and predefined performance thresholds based on the device's intended function and safety requirements.

For biocompatibility, the "ground truth" is established by compliance with internationally recognized standards (ISO 10993).

8. The Sample Size for the Training Set

This information is not applicable. The device is a manual surgical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

The REBELLION is a Bone Punch and it is available in the length 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.

The FDA 510(k) clearance letter for the Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) indicates that it is a manual rongeur, a Class II device. The nature of this device (a surgical tool for cutting and removing bone and tissue) means that the acceptance criteria and study information typically associated with AI/ML-powered diagnostic or predictive devices are not applicable.

This device is not an AI/ML product. The document describes a traditional medical device (a surgical instrument). Therefore, many of the requested categories for acceptance criteria and study details (like expert adjudication, MRMC studies, standalone algorithm performance, training set details) are irrelevant.

Here's an interpretation based on the provided document regarding this specific traditional medical device:

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

• Product Code (HAE)
• Class (II)
• Regulation # (882.4840)
• Classification Name (Manual, Rongeur)
• Indication for Use (Identical)
• Anatomical location (Skull and spine)
• Sterility (Sterile)
• Re-Use (No)
• Material (Stainless Steel: 420, 304 and 302; Polymer: PVC, ABS, PA6 GF60, TPE, Fluoropolymer)
• Patient Contacting Materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer)
• Design features (Manual Rongeur)
• Bone Removal (Suctional function)
• Shaft-length (160, 200 and 250 mm)
• Jaw opening (14 mm)
• Bite size (2 - 4 mm)
• Cutting angulation (90° up-biting)
• Packaging (double packed in a PET/PP composite film)
• Shelf life (packaging) |
  | Material Biocompatibility | Patient-contacting materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer) are the same as predicate devices, implying biocompatibility acceptance. |
  | Sterilization & Packaging Integrity | Passed shelf-life validation according to ISO 11607-1 for 5 years for the sterile barrier system (SBS). Predicate device had a 2-year shelf-life, and the subject device improved this to 5 years. |
  | Device Functionality/Performance | The subject device does not represent a new worst-case compared to predicate devices (K200768 and K221818), implying comparable cutting and bone/tissue removal functionality. |

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical surgical instrument, not a data-driven system. Testing would involve physical devices. The non-clinical performance mentioned refers to evaluating the sterile barrier system and comparing material/design characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic/AI devices, refers to an agreed-upon clinical truth. For a surgical instrument, the "truth" is its ability to perform its intended mechanical function and safety characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is a traditional manual surgical tool, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense of AI/diagnostic devices. For this device, "ground truth" relates to the physical and material properties meeting established standards and being equivalent to predicate devices. This is established through engineering and physical tests (material testing, sterilization validation, dimensional checks) rather than clinical "ground truth" derived from patient data.

8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML product that undergoes training.

9. How the ground truth for the training set was established: Not applicable.

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The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

The Rebellion is a Bone Punch and it is available in the length 160 mm with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer-Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.

The provided text is a 510(k) premarket notification for a medical device called the "Rebellion; Phantom Multi-Bite Kerrison Rongeur." This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a study.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance from a study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone algorithm performance study.
• Type of ground truth used in a study.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document states:

Acceptance Criteria and Study that Proves the Device Meets Acceptance Criteria:

The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission. The "study" in this context is the comparison presented in the 510(k) itself.

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

The document doesn't present a table of acceptance criteria in the typical sense of numerical thresholds for performance metrics. Instead, it compares the technological characteristics of the subject device (Rebellion; Phantom Multi-Bite Kerrison Rongeur) to its predicate device (Rebellion, K200768) and a reference device (Fehling-punches, K153243) to demonstrate substantial equivalence. The "performance" is implicitly demonstrated through this comparison and non-clinical testing.

The table below summarizes the comparison of characteristics, which are implicitly the "criteria" for substantial equivalence:

The document concludes that the "Different characteristics do not raise different questions of safety and effectiveness, and scientific methods were applied to evaluate different characteristics' effects on safety and effectiveness."

Non-Clinical Performance Testing:

The document states: "The subject device does not represent a new worst-case when compared to the previously cleared Morpheus Rebellion Rongeur (K200768)." This implies that previous non-clinical testing for the predicate device is considered sufficient, and the new device performs at least as well or does not introduce new risks.

7.1 Clinical performance testing:

"Clinical performance testing was not submitted in this 510(k)."

Disclaimer: This response is based solely on the provided text. The document is for a 510(k) submission, which often relies on substantial equivalence rather than extensive clinical efficacy studies to demonstrate safety and effectiveness for Class II devices.

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KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

The KLS Martin Neuro Rongeurs are manual, reusable, stainless-steel instruments. They are provided non-sterile and must be cleaned and sterilized by the end user before use. Validated methods are provided in the instructions for use that accompany each device. The instruments are available coated or uncoated in a variety of styles, with options for a range of cutting angles, shaft lengths and profiles, jaw widths, and handle designs. Additionally, the KLS Martin Neuro Rongeurs can have a push button opening mechanism to allow separation of the long shafts allowing for improved cleaning and sterilization.

This document is a 510(k) Summary for the KLS Martin Neuro Rongeurs, a manual surgical instrument. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in the conventional sense for medical device performance. Instead, the performance testing section describes the types of tests conducted and uses phrases like "No corrosion detected," "Smooth cuts achieved, pass," and "Comparable to reference device" as outcomes.

Based on the "Performance Testing - Non-clinical" section, here's a table summarizing the tests and results, which serve as the implicit acceptance criteria and reported performance:

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

• Sample Size for Test Set: The document does not specify the exact number of KLS Martin Neuro Rongeurs or individual components tested for the non-clinical performance and functional tests. It mentions "Comparative testing was completed versus the reference device," implying a sample of both the subject device and the reference device was used, but quantities are not provided.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission for a new device, the performance testing would typically be prospective, conducted by the manufacturer (KLS-Martin L.P. is based in Jacksonville, Florida, USA).

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

This type of information is not applicable to this device's performance testing. The KLS Martin Neuro Rongeurs are mechanical surgical instruments. "Ground truth" established by experts (like radiologists reading images) is relevant for diagnostic AI/software devices. For mechanical devices, performance is assessed through objective physical and chemical tests rather than expert interpretation.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers or experts to resolve discrepancies, particularly in diagnostic contexts. Since the performance testing for these rongeurs involved objective physical and chemical tests, an adjudication method for a "test set" is not applicable.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating diagnostic performance, often with AI assistance compared to human-only performance. This device is a manual surgical instrument, not an AI or diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, a standalone study was not done. This question is also typically relevant for AI/software devices that can operate without human intervention. The KLS Martin Neuro Rongeurs are manually operated instruments; they do not have an algorithm or standalone operating mode.

7. The Type of Ground Truth Used

As elaborated in point 3, the concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The performance data is the ground truth based on objective measurements and observations from the physical and chemical tests (e.g., presence/absence of corrosion, measurement of force, observation of cut quality).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument, not an AI/software device that requires a "training set" in the machine learning sense.

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

Not applicable. As stated in point 8, there is no training set for this type of device.

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The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

The Rebellion is a Bone Punch and it is available in two lengths (200 – 250 mm) with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.

This document is a 510(k) Premarket Notification for a medical device called "Rebellion, Phantom Multi-Bite Kerrison Rongeur." The FDA has reviewed and determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values for clinical efficacy. Instead, it describes performance testing related to safety and functionality. Since this is a non-AI based device, the acceptance criteria are focused on demonstrating substantial equivalence to predicate devices in areas like material safety, sterilization, packaging, and basic function. While specific numerical acceptance criteria aren't provided in the same way they would be for an AI device (e.g., sensitivity/specificity thresholds), the document implies acceptance by stating that the device meets the requirements of the standards and passes the tests.

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

• Cadaver Test: The document states that a cadaver test was performed with "two potential users." The sample size for cadavers is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).
• Product Validation (Simulated Bone): The document mentions "maximum life cycle by cutting simulated bone." No sample size for the simulated bone tests or data provenance is provided.
• Biocompatibility, Sterilization, Packaging & Shelf Life: These would involve specific test samples as defined by the respective ISO standards, but the document does not detail the sample sizes used in those validations.

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

This information is not explicitly provided.

• For the cadaver test, "two potential users" were involved, implying they were experts in orthopedic, neurosurgery, or spine surgery. However, their specific qualifications (e.g., years of experience, board certification) are not detailed.
• For other tests (biocompatibility, sterilization, etc.), ground truth is established by adherence to recognized international standards and testing methodologies, not typically by expert consensus on specific cases.

4. Adjudication Method for the Test Set

This information is not explicitly provided. For the functional tests (cadaver and simulated bone), it's implied that the "potential users" or test operators observed and evaluated the device's performance, but no formal adjudication method (like 2+1 or 3+1 consensus) is described. Since this is a mechanical device, ground truth for its function would be based on its physical performance metrics rather than interpretation of medical images or diagnostic outcomes.

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

No, an MRMC comparative effectiveness study was not done. This device is a manual rongeur, not an AI-assisted diagnostic tool. Therefore, studies comparing AI with and without human assistance are not applicable.

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

No, a standalone performance study was not done. This is a physical, manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Functional Performance (Cadaver Test & Simulated Bone): The ground truth for functional performance would primarily be the direct observation of the device's ability to cut and remove bone/tissue as intended, without failure or malfunction, under simulated surgical conditions. This is an objective assessment of the device's mechanical integrity and operational effectiveness.
• Biocompatibility, Sterilization, Packaging: Ground truth for these aspects is established by compliance with published international standards (ISO 10993, ISO 11135, ISO 11607, respectively). The tests performed according to these standards provide objective evidence of safety and performance.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. Since this is a physical medical device (a manual rongeur) and not an AI/software device, there is no "training set" in the context of machine learning.

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

This information is not applicable and is not provided, as there is no training set for this type of device.

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The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

The Wiggins Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (AITiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

• Different handles (Large, Standard, for use with Rotating Shafts)
• Different shaft lengths (6-14 inches)
• Different Bite Sizes (0.5-6 mm)
• Different Angles (40° and 90°, up and down)
• Different Footplates (Standard, Thin and Ultra-Thin)
• With or without ejector
• Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

The provided text is an FDA 510(k) summary for Wiggins Medical Surgical Instruments. It details a submission for manual surgical instruments (rongeurs) used for cutting or biting bone during skull or spinal column surgery.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a separate "test set" for the Wiggins Medical Surgical Instruments in the context of typical AI/software device evaluation. Instead, the testing relies heavily on the predicate device (Fehling Punches) for mechanical strength and biocompatibility.

• Mechanical Strength: The predicate device was tested. The sample size for this testing is not specified. Data provenance is implied to be from the manufacturer of the predicate device (Gebruder Zepf Medizentechnik GmbH & Co. KG), which is also the manufacturer of the subject device. The nature of these tests (e.g., specific number of cycles for fatigue) is not detailed.
• Cleaning: "Worst case instrument" was tested. The specific number of instruments or samples is not specified. The test was performed by the manufacturer of the subject device.
• Sterilization: Performed using the "half-cycle approach." The number of samples or cycles is not specified.
• Biocompatibility: Relied on the biocompatibility of the predicate device. The underlying data provenance for the predicate's biocompatibility is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The device is a manual surgical instrument, not an AI/software device that requires expert-established ground truth for its performance evaluation (e.g., diagnostic accuracy). The evaluations are based on physical and biological performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a "test set" that requires expert adjudication for diagnostic or interpretive outcomes.

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

This is not applicable. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically conducted.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the device is a manual surgical instrument, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Objective physical testing: Mechanical strength (fatigue resistance, cutting displacement).
• Chemical/Biological testing: Cleaning validation (absence of soil, protein, hemoglobin), sterilization (sterility assurance level), and biocompatibility (lack of adverse biological response).
• Comparison to a legally marketed predicate device: Substantial equivalence claimed based on identical materials, manufacturing, design, function, and intended use as the predicate device.

8. Sample Size for the Training Set

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

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

This is not applicable.

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The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

• Different handles (Large, Standard, for use with Rotating Shafts)
• Different shaft lengths (6-14 inches)
• Different Bite Sizes (0.5-6 mm)
• Different Angles (40° and 90°, up and down)
• Different Footplates (Standard, Thin and Ultra-Thin)
• With or without ejector
• Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

Here's a breakdown of the acceptance criteria and study information for the Ace Medical Surgical Instruments, based on the provided FDA 510(k) summary:

This device is a manual surgical instrument (rongeur), not an AI/ML-driven device. Therefore, many of the typical AI/ML study components (like expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable. The studies focus on the physical and functional characteristics of the surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Strength: The summary indicates that the predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing. The specific sample size for this predicate testing is not provided in this document. The subject device was deemed identical, so no separate test set was used for mechanical strength for the subject device.
• Cleaning: A cleaning validation was performed on a "worst case instrument." This implies a single instrument or a very small sample to represent the most challenging cleaning scenario.
• Sterilization: The validation used a "half-cycle approach," which is a common method for sterilization cycle validation, but the exact sample size (number of devices or cycles performed) is not specified.
• Biocompatibility: No specific test set was used for the subject device as it was determined to be identical to the predicate.

Data Provenance: Not applicable in the context of clinical data for a manual surgical instrument. The tests are laboratory/benchtop validations.

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

Not applicable for tests related to mechanical, cleaning, sterilization, and biocompatibility of a manual surgical instrument. Ground truth is established by test standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable for these types of benchtop tests. Results are typically determined by measurement against established standards rather than expert adjudication.

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 is a manual surgical instrument, not an AI-driven device.

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

Not applicable. This is a manual surgical instrument.

7. The Type of Ground Truth Used

• Mechanical Strength: Ground truth is based on the performance characteristics of the predicate device as demonstrated through static and dynamic mechanical testing against engineering specifications for fatigue and cutting displacement.
• Cleaning: Ground truth is established by adherence to a recognized standard: AAMI TIR 30:2011 for protein and hemoglobin content, and visual inspection for soil.
• Sterilization: Ground truth is established by achieving a specific sterility assurance level (SAL) of 10^-6, which is a recognized regulatory benchmark for sterility.
• Biocompatibility: Ground truth is established by the predicate device's proven biocompatibility and the material equivalence of the subject device. Compliance with material standards (ASTM F899) is also implied.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

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The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.

Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.

The document describes a 510(k) premarket notification for the "Steribite®" manual rongeur, which is a device used in surgery involving the skull or spinal column. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "the subject device models, 1-5 mm bite sizes and 8-11 in handles," but does not explicitly state the number of samples (individual devices) used for each mechanical test.
• Data Provenance: The data is generated from laboratory testing of the device itself. There is no mention of country of origin for data or whether it's retrospective or prospective, as it pertains to device performance testing rather than clinical data.

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

This section is not applicable to this submission. The "Steribite®" is a manual surgical instrument, and its performance and safety validation relies on non-clinical mechanical, sterilization, packaging, and biocompatibility testing against established industry standards and comparison to a predicate device. There is no mention of "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy, as would be relevant for software or diagnostic devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints, which are not part of this 510(k) submission for a manual surgical instrument.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/radiology devices where human readers' performance is augmented by AI. The Steribite® is a manual surgical rongeur, not an AI or diagnostic device that involves human readers.

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

No, a standalone study was not performed. This device is a manual surgical instrument and does not incorporate an algorithm or AI component.

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

This section is not applicable in the traditional sense. The "ground truth" for the non-clinical tests conducted is defined by established engineering principles, industry standards (e.g., ISO, AAMI, ASTM), and the expected performance characteristics of a manual rongeur compared to its predicate. For example, for "cut performance," the ground truth is a "full profile cut in simulated use" as per a specific test standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical surgical instrument and does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As there is no training set, there is no ground truth established for one.

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The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).

The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the device "Symmetry Sharp Kerrison® Rongeur":

This document describes a medical device called the "Symmetry Sharp Kerrison® Rongeur," which is a manual rongeur used for cutting bony tissue of the spine. The information provided heavily emphasizes comparison to a predicate device (K130541 Kerrison Disposable Tip Rongeur) to establish substantial equivalence for FDA 510(k) clearance. The testing described primarily focuses on validating the safety and performance characteristics for a mechanical surgical instrument, not an AI/ML-driven device. Therefore, many standard questions related to AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) are not applicable or directly addressed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test (e.g., number of rongeurs tested for cleaning, sterilization, or durability). It refers to standard validation activities but doesn't quantify the number of units or cycles performed for each test.

• Data Provenance: The studies are described as "Design verification and validation testing" which are prospective tests conducted by the manufacturer specifically for this submission. The origin (e.g., country) is not specified beyond the manufacturer's location (Antioch, TN, USA).

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

This information is not applicable and not provided. The "ground truth" for a mechanical device like a rongeur is based on objective performance metrics (e.g., sterilization efficacy, cutting performance, corrosion resistance) measured against defined standards or engineering specifications, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

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 is a mechanical surgical instrument, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a mechanical surgical instrument.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance tests relies on:

• Established Standards: Primarily ISO standards for sterilization (SAL of 10-6), ASTM standards for shelf life.
• Engineering Specifications: Criteria for residual proteins/hemoglobin/carbohydrates, number of cuts/reuse cycles for durability, and absence of corrosion. These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this mechanical device.

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