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The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.

The eG1 Wireless Hand Control System consists of two articles:

1. The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.

2. The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.

The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.

This looks like an FDA 510(k) summary for a medical device called the "eG1 Wireless Hand Control System." The document aims to demonstrate that this new device is substantially equivalent to a previously cleared predicate device ("Foot control pedals used with eG1 High Speed System K133604").

However, the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way you've outlined for diagnostic aids or AI products (e.g., sensitivity, specificity, clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence based on:

• Identical intended use and indications for use.
• Similar technological characteristics where applicable, and where there are differences (e.g., wireless technology, power source, sterilization), verifying that these differences do not raise new questions of safety or effectiveness through specific engineering and regulatory testing.

The "studies" and "acceptance criteria" discussed here are primarily engineering verification and validation tests and compliance with recognized standards.

Let's break down what is available in the provided text in relation to your request, and explicitly state what is not present:

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

• What's available: The document lists several tests performed to assess the device's safety, effectiveness, and compliance with standards. It generally states that "All acceptance criteria are met." However, it does not provide a specific table with quantitative acceptance criteria (e.g., a specific speed range, latency, signal reliability percentage) paired with reported performance metrics from a clinical study or a performance study with human subjects operating the device for diagnostic or therapeutic outcomes.
• Example of what is present as "performance" in this context:
  • Test Category: Design verification analysis
  • Purpose: Verify physical characteristics meet design inputs related to interfaces.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Design verification testing
  • Purpose: Verify functional aspects of the proposed device.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Software Validation
  • Purpose: Developed applying IEC 62304:2015.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Electrical Safety (IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012)
  • Purpose: Basic Safety and Essential Performance.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Electromagnetic Compatibility (IEC 60601-1-2:2014)
  • Purpose: Electromagnetic disturbances.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Radio Emissions (IEC 62311:2007)
  • Purpose: Human exposure restrictions for electromagnetic fields.
  • Reported Performance/Conclusion: Tested according to standard. (Implies compliance, though "compliant" isn't explicitly stated here).
  • Test Category: Sterilization Validation (ISO 11135:2014)
  • Purpose: Ethylene Oxide sterilization for WIRELESS-HC.
  • Reported Performance/Conclusion: Validated according to standard.

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

• Not applicable/Not provided in this document. This device is a surgical tool control, not a diagnostic device relying on patient data. The "test set" here refers to the physical devices and software being tested. There's no mention of patient data, retrospective/prospective studies, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This type of information is relevant for studies involving expert interpretation of medical images or other clinical data to establish a "ground truth." This document describes engineering and regulatory compliance testing for a physical device. Ground truth, in this context, would be defined by engineering standards and specifications.

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

• Not applicable/Not provided. Similar to point 3, this refers to methods for resolving discrepancies among expert interpretations, which is not relevant for the type of testing described here.

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/Not provided. This is explicitly for AI-enabled diagnostic aids. The eG1 Wireless Hand Control System is a physical surgical control device, not an AI system or diagnostic aid.

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

• Not applicable/Not provided. Again, this is for AI algorithms. The device performs its function as designed; there's no "algorithm only" performance separate from the device's operation.

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

• N/A in the context of your question. For this device, "ground truth" equates to adherence to engineering specifications, performance standards (e.g., motor speed control accuracy, signal latency, electromagnetic compatibility limits), and recognized regulatory standards (IEC, ISO, FCC). It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable/Not provided. As above, no training set for this device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a new surgical control device to an existing one by confirming adherence to engineering specifications, recognized safety and performance standards (like IEC and ISO), and regulatory compliance (FCC). It does not present clinical study data with acceptance criteria for diagnostic performance or AI model evaluation as implied by your detailed questions.

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Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.

The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system. The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism. The Anspach Helix™ Dissection Tools are provided sterile.

This document is a 510(k) summary for the Anspach Helix™ Dissection Tools, which are intended for cutting and shaping bone, including the spine and cranium. The submission demonstrates substantial equivalence to a predicate device (K113476).

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Details for Meeting Acceptance Criteria:

The document describes design verification activities rather than a standalone clinical study involving human patients or a multi-reader, multi-case study. The testing focused on technical and performance characteristics compared to a predicate device.

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

• Sample Size: Not explicitly stated as a single number for all tests. For the Helix Ball Bur Chatter/Cut and Shape Verification, it mentions "each group of same-size Helix ball burs" and "Each Helix ball bur used to cut into the Bi-resin samples." This implies multiple burs were tested across different sizes. However, specific quantities (e.g., "n=X burs per size") are not provided.
• Data Provenance: The tests utilized simulated bone (Bi-resin) and a tolerance analysis. This is laboratory-based data, not human patient data. There is no country of origin for data as it's not a clinical study. It's prospective in the sense that these tests were conducted specifically for this submission.

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

• Not applicable. This was not a study requiring expert readers or ground truth established by medical professionals. The "ground truth" was based on engineering specifications, physical measurements, and comparison to the performance of the predicate device.

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

• Not applicable. No expert adjudication was described for these engineering and performance tests. The acceptance criteria were objectively defined (e.g., statistical significance for chatter, visual inspection for fracture, tolerance ranges).

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 done. This device is a surgical tool, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a manual surgical tool that requires human operation; it is not an algorithm or AI system.

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

• For technical specifications (mating, compatibility): Engineering tolerance analysis and physical measurements.
• For performance (chatter, cut and shape, fracture): Quantitative measurements for chatter (statistical comparison to predicate) and visual inspection against a predicate device for cutting/shaping and integrity.
• The predicate device's established performance served as a de facto "ground truth" for comparison.

8. The sample size for the training set:

• Not applicable. This device did not involve a training set as it is not an AI/machine learning system.

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

• Not applicable. There was no training set.

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When used with the ANSPACH Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

The OCM-G1 (Otologic Curved Micro) Attachment is an accessory to the G1 electric drill system. It is a one-piece straight attachment that is manufactured from 17-4PH and 303 stainless steels (ASTM A564 and ASTM A582). The OCM-G1 Attachment can be connected and disconnected to the distal end of the handpiece via a locking mechanism by the user. After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies. The OCM-G1 Attachment is provided non-sterile and is reusable.

This document describes the OCM-G1 Attachment, an accessory for surgical drills used in otology procedures. The submission is a 510(k) premarket notification, indicating a comparison to a predicate device demonstrating substantial equivalence.

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

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

• Locking feature compatibility: Tested and demonstrated.
• Temperature: Tested and demonstrated safe external temperatures.
• Disconnect without tools: Tested and demonstrated.
• System functionality: Tested and demonstrated proper functionality.
• Simulated use study: Demonstrated the OCM-G1 Attachment and curved cutting burrs perform as intended in cutting and shaping bone, similarly to the predicate. |
  | Cleaning and Reprocessing | Criterion: Ability to be cleaned and sterilized effectively to achieve a Sterility Assurance Level (SAL) of 10^-6 without adverse effects. |
  | | Performance: The OCM-G1 Attachment's characteristics are considered equal to or less challenging to sterilize than the currently validated "worst case" predicate device. This implies that existing validated cleaning and sterilization processes are capable of achieving the required SAL. |

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

The document does not explicitly state the sample sizes for the test sets in the performance data section. The performance data seems to be based on bench testing and simulated use studies rather than clinical data from human subjects.

• Provenance: All testing appears to be internal verification and validation conducted by the manufacturer, The Anspach Effort, Inc., or its affiliates. No information is provided about the country of origin for the data or whether it was retrospective or prospective in a clinical context, as clinical testing was not performed or deemed necessary.

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. Given that the testing included bench tests and a simulated use study, the "ground truth" would likely be defined by engineering specifications, performance standards, and the intended use of the device, rather than expert clinician consensus on patient data.

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

Not applicable. This type of adjudication method is typically used in clinical studies involving multiple readers evaluating medical images or diagnoses against a predefined ground truth. The studies described are engineering verification tests and a simulated use study, which would not involve such a method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices. The OCM-G1 Attachment is a mechanical surgical handpiece accessory, not an AI device.

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

Not applicable. The OCM-G1 Attachment is a mechanical device, not an algorithm, so a standalone algorithm performance study is not relevant. Its performance is always in conjunction with a human operator and other surgical system components.

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

The "ground truth" for the performance data appears to be based on:

• Engineering Specifications and Standards: For tests like locking feature compatibility, temperature, disconnect without tools, and system functionality. These are likely evaluated against predefined design requirements and industry standards.
• Intended Use Performance: For the simulated use study, the ground truth is the successful cutting and shaping of bone as intended for otology procedures, evaluated by direct observation and measurement against expected outcomes.
• Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the device performs "the same as the predicate (K131053)" in various aspects, implying the predicate's established safety and effectiveness serve as a practical ground truth.

8. The sample size for the training set

Not applicable. The OCM-G1 Attachment is a mechanical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this mechanical device.

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The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

The Anspach eG1 High Speed System, which consists of a control console, handpiece, and various attachments, is an electrically powered surgical drill that handles a range of surgical procedures ranging from power-demanding applications to delicate dissection.

This submission is for a 510(k) premarket notification for a Class II medical device, the Anspach eG1 High Speed Electric System, an electrically powered surgical drill. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove safety and effectiveness. Therefore, the information typically found in acceptance criteria documentation for novel devices (e.g., studies with test sets, ground truth establishment, MRMC studies) is generally not present in such FDA documents.

Based on the provided text, here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Derived from Substantial Equivalence to Predicate): The device must perform as intended, utilizing similar materials, features, and functions as the predicate device (Anspach eMax Drill System, K011444), and raise no new safety or effectiveness issues.

Reported Device Performance:

Study Information

For a 510(k) submission, the "study" is primarily a "Design Verification" and "Performance Testing" against the design requirements, not a clinical study on human subjects or an AI algorithm performance study.

2. Sample size used for the test set and the data provenance: Not applicable. This submission describes physical and functional testing of the device itself, not an algorithm using a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic or AI/ML algorithm evaluation (e.g., radiologist consensus) is not relevant here. The "ground truth" for the device's functional integrity would be engineering specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The testing described is design verification, likely performed by engineers, not subjective human assessment needing 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 not an AI/ML device or a diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical drill system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device would be engineering specifications, functional requirements, and performance standards. Testing would be against these predefined technical parameters.

8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm with a training set.

9. How the ground truth for the training set was established: Not applicable. There is no training set for this device.

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The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.

When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection.

The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert.

The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.

The provided text describes a 510(k) premarket notification for a surgical device, not an AI or imaging diagnostic device. Therefore, the information typically required for describing the acceptance criteria and study proving device performance for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, effect size, standalone performance, ground truth types) is not present in this document.

This submission focuses on demonstrating substantial equivalence to predicate devices for a mechanical surgical instrument based on its physical characteristics, materials, and functional testing.

Here's an analysis of what is available regarding acceptance criteria and performance:

1. Acceptance Criteria and Reported Device Performance (based on mechanical and biocompatibility testing)

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

• Sample Size: Not explicitly stated as numerical sample sizes for "test sets" in the context of an AI/diagnostic device. For this surgical instrument, testing would involve a certain number of units for various mechanical, thermal, and biocompatibility tests. For example, "a series of biocompatibility tests" and "several performance tests" imply multiple tests on one or more samples, but specific quantities are not provided.
• Data Provenance: The tests were likely conducted internally by The Anspach Effort, Inc. or by contract labs on their behalf, in accordance with regulatory standards (e.g., GLP for biocompatibility). The country of origin and retrospective/prospective nature are not specified, but typically this would be a prospective testing program for a new medical device.

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

This is not applicable to a mechanical surgical device as there's no "ground truth" to be established by clinical experts in the same way as an AI diagnostic algorithm for image interpretation. The performance is assessed through objective physical and biological tests. A "simulated use study" implies assessment by skilled personnel, possibly surgeons or engineers, but their qualifications and numbers are not detailed.

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

Not applicable. This concept belongs to studies where human experts are making subjective judgments (e.g., reading medical images) that need to be reconciled. For mechanical device testing, outcomes are typically measured quantitatively against defined specifications.

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 specific to AI/diagnostic imaging devices.

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

Not applicable. This is specific to AI/diagnostic algorithms. The device is a physical surgical instrument that always requires a human operator.

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

The "ground truth" for this device's performance is established through objective test methods and specifications. For instance:

• Biocompatibility: Adherence to ISO standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization), with results compared against pass/fail criteria.
• Functionality: Measurements of power, speed, temperature, durability (after repeated cycles), efficacy of cleaning/sterilization methods, and successful cutting/shaping of target material (e.g., bone surrogate) as intended.
• Simulated Use: Demonstration that the device "perform[s] as intended in cutting and shaping bone properly." This would likely involve visual inspection and perhaps quantitative assessment of the cutting performance on a model.

8. The sample size for the training set

Not applicable. This refers to AI model development.

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

Not applicable. This refers to AI model development.

In summary: This 510(k) submission relies on demonstrating substantial equivalence through a combination of:

• Comparison of technological characteristics with predicate devices.
• Biocompatibility testing to assure material safety.
• Performance testing to demonstrate proper functionality, thermal safety, durability, and effectiveness in simulated use, aligning with the intended purpose and implicitly meeting industry standards for such devices.

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Dissection tools are intended for cutting and shaping bone including spine and cranium.

The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems. The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system. Dissection Tools are sterilized, individually packaged, are for single use and disposable.

The provided text is a 510(k) Premarket Notification for "Dissection Tools" by The Anspach Effort, Inc. It describes a medical device, its intended use, and the performance testing conducted. However, it does not include detailed acceptance criteria or the specific study data that would allow a comprehensive answer to the requested questions regarding AI/ML device evaluation.

The device described is a physical surgical tool, not an AI/ML software device. Therefore, many of the questions related to AI/ML specific evaluation metrics, such as sample size for test sets and training sets, ground truth establishment for AI models, multi-reader multi-case studies, and human-in-the-loop performance, are not applicable to this submission.

Here's what can be extracted and what cannot based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The document states:

• "Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools."
• "These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards."

While it mentions that tests verified "established physical characteristics, functional requirements and performance standards," no specific quantitative acceptance criteria or corresponding device performance results are listed.

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

Not applicable/Not provided. This question is relevant for AI/ML device validation, typically referring to a dataset of medical images or patient data. For this physical device, "test set" would refer to the number of units tested, but this information is not provided.

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

Not applicable/Not provided. "Ground truth" in this context typically refers to expert-labeled data for AI/ML models. For a physical device, testing its mechanical function would not involve "expert-established ground truth" in the same way.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This is relevant for resolving discrepancies in expert labeling for AI/ML ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, not done. MRMC studies are used to evaluate the diagnostic accuracy of AI/ML systems, often comparing human readers with and without AI assistance. This device is a physical dissection tool, so an MRMC study is not relevant.

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

No, not applicable. A "standalone" study refers to the performance of an AI algorithm without human input. This is not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As described above, the concept of "ground truth" for AI/ML model training/testing does not apply here. The device went through "design verification" tests to ensure it met "design requirements" and "performance standards," which are forms of ground truth for mechanical devices.

8. The Sample Size for the Training Set

Not applicable/Not provided. This question is for AI/ML models.

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

Not applicable/Not provided. This question is for AI/ML models.

In summary:

The provided document is a 510(k) for a physical medical device (dissection tools), not an AI/ML driven device. Therefore, the questions related to AI/ML specific evaluation methodologies are not addressed in this filing. The filing only states that "Design verification was conducted on the proposed design change of the locking mechanism...These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards." No specific acceptance criteria or quantitative performance data are detailed in the publicly available summary.

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The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

The Cranial Perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device. The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm). The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cranial Perforator:

The provided text describes a 510(k) submission for a Cranial Perforator. The primary goal of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically the Acra-Cut DGR-1 and Codman 26-1221. The performance testing focuses on demonstrating that the Anspach Cranial Perforator's declutch features are equivalent to the predicate, and that it meets user requirements for cutting rate and hole quality, without gross mechanical failures.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states testing was performed on "human cadaver test samples." No specific number of cadaver samples or perforations is provided.
• Data Provenance: Human cadaver test samples. The country of origin is not explicitly stated, but given the US regulatory context and submitter, it's likely US-sourced cadavers. The study was prospective in the sense that the Anspach Cranial Perforator was directly tested, but the comparison to predicate devices uses their established performance as a benchmark.

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

The text does not mention the use of experts to establish ground truth for the test set in the traditional sense (e.g., radiologists interpreting images). The assessment of "Plunge and Early Declutch failures," "cutting rate," "clean holes," and "gross mechanical failures" appears to be based on direct physical measurement and observation during cadaver testing, likely by engineers or technicians overseeing the mechanical performance test.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the performance metrics seem to be objective measurements or direct observations of mechanical function rather than subjective assessments requiring expert consensus.

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

No. An MRMC comparative effectiveness study was not conducted. This device is a mechanical surgical tool, not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone Performance Study

Yes. A standalone performance study of the Anspach Cranial Perforator was performed. The "Performance Testing" section states: "The Anspach Cranial Perforator (75-0002-1) was tested for performance and safety: refer to Verification Report 06-0708, using a comparative method to predicate cranial perforators Acracut and Codman." This testing evaluated the device's ability to:

• Perform without Plunge or Early Declutch failures (compared to predicates).
• Achieve a cutting rate equal to or greater than 0.24 mm/sec.
• Create clean holes.
• Operate without gross mechanical failures.

While a "comparative method" was used for some aspects (Plunge/Early Declutch), the other metrics (cutting rate, clean holes, no gross failures) indicate standalone performance evaluation against defined criteria.

7. Type of Ground Truth Used

The ground truth used is primarily physical performance metrics and direct observation on human cadaver bone, compared against established performance characteristics of predicate devices and user requirements. This isn't "expert consensus" or "pathology" in the medical imaging sense, but rather engineering-based verification.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no training set for a mechanical device.

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The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.

The eMax 2 Plus System is an electrically powered drill motor with a series of attachments designed for use on the bones of the cranium and spine. The system components include a control console, the motor hand piece and foot control switch. The control console supplies power to the motor through a detachable cable. This system is non-sterile.

The provided text is a 510(k) summary for the eMax 2 Plus System, which is an electrically powered drill motor designed for cutting and shaping bone in cranium and spine. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical performance study for an AI/CADe device would.

Instead, this 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (the eMax Drill System, K011444). The FDA's 510(k) pathway is for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Therefore, many of the requested categories (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment here is primarily based on comparing the new device's specifications and performance to an already cleared predicate device, rather than an independent clinical study against a predefined set of performance metrics.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: No explicit acceptance criteria or target performance values are defined in this document for the eMax 2 Plus System itself. The entire premise of a 510(k) is to demonstrate "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states that the eMax 2 Plus System is made of the same materials and contains features and functions similar to the currently available eMax Drill System (K011444). The same cutters, attachments, and accessories will interface with both systems. This implies that its performance is expected to be equivalent to the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the context of a performance study for the eMax 2 Plus System. The evaluation is based on comparing its design and specifications to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as it's not a diagnostic AI/CADe device being evaluated.

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 device is a surgical drill, not an AI/CADe system for image interpretation.

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.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

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

Summary based on the document:

The eMax 2 Plus System is cleared based on its substantial equivalence to the predicate eMax Drill System (K011444). The performance demonstration is implicitly through the assertion that the new device has technological characteristics similar to the predicate device, including materials, features, functions, and compatibility with accessories. The FDA's role in this 510(k) process is to confirm that these similarities allow the new device to be marketed without raising new questions of safety and effectiveness, assuming it meets general controls and manufacturing practices.

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The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility. The iMRI Drill System foot control was tested with the Drill System within Zone IV. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use.

The provided text is a 510(k) summary for the Anspach iMRI Surgical Drill System. It describes the device, its indications for use, and its substantial equivalence to predicate devices, focusing on material changes to ensure MRI compatibility. However, the document does not contain specific acceptance criteria or details of a study with performance metrics in the format requested.

It primarily outlines:

• Device Description: A pneumatic drill system modified for use in an MRI environment by replacing ferrous metals with low or non-magnetic susceptibility materials.
• Indications for Use: Intra-operative (non-imaging) use within a 1.5 Tesla or less MRI environment for cutting, shaping, and removal of bone (skull and spine).
• Contraindications: Presence in Zone IV of an iMRI system during actual imaging due to potential image distortion.
• Performance Standards: Lists various ASTM, ISO, and AAMI standards related to materials, biological evaluation, sterilization, and risk management. It explicitly states, "Full conformance to these standards is not intended to be implied or declared, as implementation of various specific aspects of the standards are not yet fully established."
• Substantial Equivalence: Claims equivalence to other Anspach pneumatic drill systems (MicroMax, original 65K) with primary differences in materials, indications for use, and a modified locking mechanism to prevent interchangeability.

Based on the provided text, I cannot complete the requested tables and information because the document does not include:

1. A table of acceptance criteria and reported device performance. The document lists standards applicable to materials and processes but does not detail specific performance metrics, pass/fail criteria, or how the device explicitly met those criteria through a study. The relevant ASTM standards mentioned (F2213-04 for magnetically induced torque and F2052-02 for magnetically induced displacement force) imply acceptance criteria related to MRI compatibility, but the actual performance results against these criteria are not reported.
2. Details of a specific study proving device meets acceptance criteria. There is no mention of a formal clinical or technical study designed to generate performance data for the iMRI Surgical Drill System. The closest references are to standards that should be met (e.g., ASTM standards for MRI safety), but not to data demonstrating compliance.
3. Sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details of training sets. These types of details are typically found in studies evaluating performance (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific functional performance criteria for surgical devices) against a defined ground truth, which this document does not present. The document focuses on regulatory compliance through substantial equivalence, primarily based on material science and safety considerations for MRI compatibility, rather than a performance study as might be conducted for an AI/diagnostic device.

Therefore, many parts of your request cannot be answered from the given text. The 510(k) summary focuses on demonstrating substantial equivalence primarily through material changes and adherence to general safety standards, rather than providing a detailed performance study with quantitative results as a diagnostic or AI-driven device might.

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Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach Irrigation Pump System is a stand-alone pump and pump control system, designed to deliver a constant flow of irrigation fluid by means of a peristaltic pump.
The Irrigation Tube, (the subject of this submission), is a fluid delivery device that functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range.

The provided document, K063688, describes a 510(k) premarket notification for a device modification to a Surgical Irrigation System. This submission is for a device modification, specifically to the Irrigation Tube, and primarily relies on substantial equivalence to a predicate device (K030576). It does not contain an independent study with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study that would generate sensitivity, specificity, or similar metrics for a diagnostic device.

The document focuses on demonstrating that the modified irrigation tube maintains the same technological characteristics and intended use as the predicate device, with the only change being in its inner diameter, outer diameter, and length. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this type of submission.

Here's the information extracted from the document, addressing the prompt's request where applicable:

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

Since this is a device modification for an irrigation tube, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and adherence to relevant standards for materials and safety. There isn't a performance table with specific numerical metrics like accuracy or sensitivity for this type of device.

• Bio-safety - Cytotoxicity ISO10993-5 (EN 30993-5) - Pre-sterilized devices only.
• ANSI/AAMI/ISO 11737-1:1995 Bio burden - Pre-sterilized devices only.
• ANSI/AAMI/ISO 11137:1994 - Pre-sterilized devices only.
• AAMI TIR 27: 2001 Alternative (11137) - Pre-sterilized devices only. |
  | Electrical Safety (for the overall system): The system's electrical components must meet recognized safety standards. | - IEC 60601 and other similar recognized electrical safety standards. |
  | Quality System Compliance: Manufacturing must adhere to established quality management systems. | - Quality System(s) in addition to US Federal requirements: ISO9001, ISO13485. |
  | Functional Equivalence: The irrigation tube must function as a component of the irrigation system to deliver fluid as intended. | The Irrigation Tube functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range. (This is a description of its function, implied to be equivalent to the predicate). |

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

Not applicable. This submission is for a device modification based on substantial equivalence, not a clinical study or performance evaluation requiring a test set of data samples. The modifications are physical dimensions of the tube.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert ground truth was mentioned.

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

Not applicable. No test set requiring adjudication was mentioned.

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 a surgical irrigation tube, not an AI-assisted diagnostic tool or an imaging device to be read by human readers.

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

Not applicable. This device is a physical component (irrigation tube), not an algorithm.

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

Not applicable. Ground truth, in the context of diagnostic or AI performance, is not relevant to this submission. The "ground truth" here is adherence to engineering specifications, material standards, and functional equivalence to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

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