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Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

This FDA 510(k) summary is for a medical device (Twist Drills), not an AI/ML algorithm. Therefore, many of the requested categories related to algorithm performance, training data, and expert review are not applicable.

Here's an analysis of the provided document based on the available information:

This document describes the FDA's decision to clear the Biomet Microfixation Twist Drills (K213208) as substantially equivalent to a predicate device (Twist Drills K062842).

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

The document states that "Design verification and validation testing were performed on the subject devices" and "The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not provided in this summary document. The performance is reported as meeting these unspecified criteria.

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

This document discusses performance testing for a physical medical device, not a data-driven AI/ML algorithm. Therefore, terms like "test set" and "data provenance" in the context of data analysis are not directly applicable. The document refers to "design verification and validation testing," which would involve physical samples of the drill. The sample size for these physical tests is not specified in this summary.

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)

This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

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

This is not applicable for a physical medical device without a diagnostic component.

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

This is not applicable as the document describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical medical device.

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

For a physical medical device like a drill, "ground truth" generally refers to objective physical and mechanical properties. The validation would typically involve comparing the device's performance against predefined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. The document generally refers to "predetermined acceptance criteria" and "design verification and validation tests."

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the document describes a physical medical device.

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The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.

This document, K192162, describes a 510(k) premarket notification for the "NeuroVention Cranial Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily relates to mechanical performance and material biocompatibility.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them:

Key Takeaway: This document does not describe a clinical study or an AI/algorithm-driven device. It is for a physical medical device (cranial fixation system) and relies on mechanical testing and material equivalence to demonstrate substantial equivalence to a predicate device.

Therefore, many of your requested points regarding AI/algorithm performance, human readers, ground truth establishment for training/test sets, and expert consensus are not applicable to this specific submission.

However, I can extract the relevant information from the document that addresses mechanical performance, which serves as the "study" for this type of device.

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document primarily relies on mechanical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly that the "Subject device [is] equivalent or better than the predicate devices" and that "All testing met or exceeded the requirements as established by the test protocols and applicable standards."

Here's a table summarizing the "acceptance criteria" (implied through performance comparison to predicates and standards) and the reported performance for the mechanical tests:

Addressing Other Requested Information (and why some are not applicable):

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

   • Sample Size: Not specified in terms of number of physical test articles for each mechanical test. This is common for 510(k) mechanical testing summaries, where the focus is on meeting standards rather than statistical clinical significance as in a clinical trial.
   • Data Provenance: Not applicable as this is mechanical/biocompatibility testing, not clinical data from patients. The testing would have been conducted by the manufacturer or a contracted testing lab.

2. 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. The "ground truth" for this device is established by engineering principles, mechanical test standards (e.g., ASTM F543-13), and material specifications (e.g., ASTM F67, F136, F2026). No clinical experts (like radiologists) are involved in establishing ground truth for mechanical performance.

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

   • Not Applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical data interpretation (e.g., reading medical images). Mechanical testing results are objective measurements against defined standards.

4. 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 physical cranial fixation system, not an AI or imaging system. No human reader studies (MRMC) would be relevant here.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Ground Truth: For mechanical testing, the "ground truth" is defined by widely accepted engineering test standards (e.g., ASTM standards) and the specifications of the predicate device. For biocompatibility, it's defined by the material's conformity to established standards (e.g., ASTM F67-13, ASTM F136, ASTM F2026) and its history of safe use as an implantable material.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

In summary, the provided document is a 510(k) clearance for a traditional physical medical device. The "study" proving it meets "acceptance criteria" consists of mechanical performance testing (as outlined in the table above) and biocompatibility assessments, which demonstrated substantial equivalence to a legally marketed predicate device (Stryker Universal Neuro 3 System). The concept of AI performance metrics, expert reviews, and large human data sets is outside the scope of this type of device and submission.

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IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

The provided text is a 510(k) Summary for the Medtronic POWEREASE™ System. It discusses the device's substantial equivalence to a predicate device, IPC™ POWEREASE™ SYSTEM (K111520), and outlines some performance data. However, it explicitly states that no new testing was performed for the subject devices, and instead relies on a "confirmatory validation" to ensure minor modifications do not introduce new safety or effectiveness issues.

Therefore, the document does not report on a study that establishes acceptance criteria and demonstrates that the device meets those criteria through new performance testing. Instead, it asserts substantial equivalence based on the device being identical to the predicate in key aspects.

Given this, I cannot fully answer all parts of your request as there isn't a detailed study report with new acceptance criteria and performance data in the provided document. I will fill in what can be inferred from the text.

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

Based on the provided text, no specific quantitative acceptance criteria or new device performance metrics are presented for the subject device. The document states that the subject instruments are "identical to the predicate devices in terms of fundamental technology, intended use and indications for use." The "confirmatory validation" is not described with numerical acceptance criteria or performance results.

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The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.

The device under review is a family of cranial drill bits and accessories. These cranial drill bits and accessories are applied to create a hole through the skull in support of neurological procedures. Cranial drill bits are twist drill bits used for drilling holes in the skull, supporting access to the brain for brain biopsy, brain contacting electrode placement, electrode accessory placement such as Anchor Bolts or other needs as determined by the user. The cranial drill bit variations are 16 cm to 30 cm length and 2.4 mm to 3.2 mm outer diameter. Accessories to the cranial drill bits include: Drill Stop, Drill Stop Wrench, Drill Sleeve Guide, Guide Block.

The provided document is a 510(k) summary for Ad-Tech Medical Instrument Corporation's Cranial Drill Bits and Accessories. It outlines the device's indications for use, technological characteristics, and performance tests for demonstrating substantial equivalence to predicate devices. This document does not pertain to an AI/ML powered medical device, an autonomous AI device, or other medical device software. Therefore, the questions regarding acceptance criteria and studies for AI-powered devices are not applicable.

Here's an analysis of the provided information, addressing the closest relevant aspects:

Acceptance Criteria and Device Performance for (Non-AI) Cranial Drill Bits and Accessories

The acceptance criteria are not explicitly titled as "acceptance criteria" but are embedded within the "Summary of Requirement" for the performance tests conducted. The device performance is reported as "Pass" for all listed tests.

1. Table of Acceptance Criteria and Reported Device Performance

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Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.

Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).

The provided document describes the Synthes Taps for Resorbable Screws (K153587) and the performance testing conducted to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Simulated Use/Bioskills Lab:
  • Sample Size: 5 individual participants (users) and 4 cadaveric cephaluses (heads).
  • Data Provenance: Prospective, from cadaveric cephaluses. Likely from the US, given the submission to the FDA.
• Saw Bones Lab:
  • Sample Size: 4 users and an unspecified number of "saw bones" (synthetic bone models). The test involved 36 total insertions (implying 3 subject taps x 3 tapped holes x 4 users).
  • Data Provenance: Prospective, using synthetic bone models (Sawbones).
• Mechanical Tests (Torsional, Axial Load, Hex Coupling Validation):
  • Sample Size: For Torsional Testing, all three sizes of RapidSorb Self-Drilling Taps (1.5, 2.0, and 2.5 mm) were tested. For Axial Load, adjustable length taps (311.100, 311.101, 311.102, 311.110, 311.111, 311.112) of 1.5, 2.0, and 2.5mm were compared. For Hex Coupling Validation, 12 taps were driven by "all participants" (number not specified but implied to be multiple, likely the same 5 as the simulated use or similar).
  • Data Provenance: In-vitro / bench testing. No specific country of origin or retrospective/prospective distinction is given for the collected data, but it is implied to be newly generated for this submission.
• Biocompatibility Testing:
  • Sample Size: Not specified for the extract, but presumably standard in-vitro cell culture methods.
  • Data Provenance: In-vitro lab testing.

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

The concept of "experts" establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here as this is a medical device for surgical procedures (taps).

• Simulated Use/Bioskills Lab: "The users are independent from the design of the subject device." No specific qualification (e.g., surgeon, resident) or experience level is mentioned for the 5 participants.
• Saw Bones Lab: 4 users. No specific qualifications mentioned.

For mechanical and biocompatibility testing, the "ground truth" is established by the physical and biological properties being measured against established engineering and biological standards.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1 consensus) is described for any of the performance tests. The tests appear to involve direct measurement (mechanical tests) or observed outcomes (simulated use, Sawbones lab), with success defined by meeting the specified acceptance criteria. For the "Simulated Use/Bioskills Lab," "The results indicated full validation... All acceptance criteria were met," suggesting a pass/fail outcome rather than a consensus on a specific finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual surgical instrument, not an AI or imaging diagnostic tool where MRMC studies are typically performed.

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

This question is not applicable. The device is a physical, manual surgical instrument. There is no "algorithm" or AI component to this device.

7. The Type of Ground Truth Used

The "ground truth" primarily relies on:

• Performance against engineering specifications: For mechanical tests (torsional, axial load, hex coupling), the ground truth is defined by the device's ability to withstand forces, prevent stripping, and couple correctly according to established engineering benchmarks and statistical comparisons with null hypotheses.
• Direct observation of functional performance: For the Simulated Use and Saw Bones labs, the ground truth is observed successful drilling/tapping and accommodation of screws by human users, as per the defined acceptance criteria.
• Biological standards: For biocompatibility, the ground truth is the absence of cytotoxicity, evaluated against ISO 10993-5 guidelines.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm. The performance data presented are for validation/verification testing.

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

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

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The DSG™ Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

The DSG™ Zavation Screw System is a modification to the cleared DSG™ Threaded Drill System and consists of the DSG™ Electronic T-handle, Ratcheting Handle, DSG™ Pin (active stylet), and the previously cleared Zavation Spinal System (K153404). These components are purchased and shipped as a complete system from Zavation, with the DSG™ Threaded Drill System components and Zavation Spinal System components individually packaged. The complete system is provided with the modified instructions for use of the DSG™ Zavation Screw System.

All of the patient-contacting materials are categorized per FDA's guidance on ISO 10993-1 as externally communicating materials that are in contact with the body for a limited duration, and are unchanged from the prior clearance. Certain components of the device are single-use while others are re-usable; certain components are provided sterile while others are sterilized by the end user.

The device is intended for use by surgeons in a professional healthcare environment, and utilizes sensing technology to detect the impediately surrounding tissues while inserting pedicle screws either through a previously drilled pilot hole or directly into bone. The surgeon can either drill and/or tap the screw hole prior to inserting the pedicle screw, or can use the system to directly insert the screw into the bone without a pilot hole. As the screw is manually advanced into the bone, the distal sensor measures the electrical impedance of the immediately surrounding tissues. The device produces real-time visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.

The provided text describes the 510(k) summary for the SpineGuard DSG™ Zavation Screw System. It outlines the device, its intended use, and comparative information with a predicate device. However, it does not detail specific acceptance criteria with numerical targets or a comprehensive study plan with the level of detail requested for AI/device performance.

Based on the information provided, here's what can be extracted and what is missing:

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

The document describes "performance testing" but does not define explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of values for mechanical properties). Instead, it states that "All tests were passed, demonstrating equivalent performance according to device specifications and thus supporting substantial equivalence." The tests are:

Missing Information: Specific quantitative acceptance criteria (e.g., "placement accuracy within X mm" for cadaver testing, or specific thresholds for mechanical integrity). The "Pass" result indicates that the device met internal specifications, but these specifications are not detailed in the provided text.

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

• Test Set Sample Size: Not specified for any of the performance tests. For "Cadaver Testing," the sample size (number of cadavers, or number of pedicle screws inserted) is not mentioned. For "Mechanical Testing," the number of units tested is also not specified.
• Data Provenance: Not specified. It's unclear if the cadaver testing was performed in the US or another country. The document notes the sponsor is in France.
• Retrospective or Prospective: Not explicitly stated, though cadaver testing would typically be considered prospective for the device evaluation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For cadaver testing, it would likely involve surgeons, but their number and experience are not mentioned.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. If multiple experts were involved (which is not stated), the method for resolving discrepancies (e.g., 2+1, 3+1, none) is not described.

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:

This device is not an AI/ML-driven diagnostic or image analysis tool for "human readers." It's a surgical guidance system providing real-time feedback (visual and audible alerts) based on impedance measurements during pedicle screw insertion. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable to this device. The "feedback to the surgeon" is a direct function for intraoperative guidance, not a tool for interpreting images or data that human "readers" would then review.

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

The device's function is inherently "human-in-the-loop" as it provides feedback to the surgeon. It's not a standalone diagnostic algorithm. The "performance data" describes the device's accuracy and integrity when used by a human. So, a standalone algorithm performance without human involvement is not applicable in the AI sense. Its "standalone" performance would be about the accuracy of its impedance detection, which is implicitly covered by the "Pass" results in the cadaver and mechanical testing.

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

• Cadaver Testing: The "placement accuracy" implies that the true anatomical position and any perforations would be verified (e.g., radiography, CT scan, or direct visual inspection post-dissection), which would serve as the ground truth. However, the specific method for establishing this ground truth is not detailed.
• Mechanical Testing: Ground truth would be based on engineering specifications and measurements (e.g., force, torque, displacement thresholds).

8. The sample size for the training set:

This device does not appear to be an AI/ML device that requires a distinct "training set" in the context of machine learning. Its operation is based on pre-programmed impedance thresholds for tissue differentiation. Therefore, this question is not applicable in the context of the provided information.

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

As there's no mention of a "training set" in the context of an AI/ML algorithm, this question is also not applicable. The device's impedance thresholds would likely be established through prior research and experimentation on tissue types, rather than a "training set" with established ground truth labels in the machine learning sense.

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The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.

The provided document, a 510(k) summary for the MRII Cranial Drill and Accessories, details performance data and a risk analysis to demonstrate substantial equivalence to a predicate device. It primarily focuses on the device's mechanical performance and safety within an MRI environment, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, many of the requested fields related to AI performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance with humans-in-the-loop, and training set information are not applicable to this device and document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify exact numerical sample sizes for each test in terms of individual devices. It generally refers to "All modified MRI Hand Drills" or "Each Chuck/Shaft sub-assembly." For certain tests like "Drilling Efficiency," it mentions using 3.2, 4.5, and 6.0 mm Drill bits with "each Hand Drill Tested," implying multiple permutations.
• Data Provenance: The data is generated from in-house design verification testing conducted by the company (MRI Interventions, Inc.). This is prospective data from controlled experiments. The country of origin is not explicitly stated but can be inferred as the United States, given the FDA submission.

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

• Not Applicable. This is a mechanical device performance study, not a medical imaging or diagnostic study requiring expert ground truth for interpretation. "User evaluation scores" are mentioned for "Smooth Operation and Vibration During Drilling," "Drill Bit Loading," and "Wet Glove usage," which implies subjective assessment by individuals, but their number and specific qualifications are not detailed beyond being users.

4. Adjudication method for the test set

• Not Applicable. As there is no expert consensus on ground truth, no adjudication method is relevant.

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-powered diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on engineering specifications and measurable physical properties. For example, "0 mm slippage" for axial loading, "under 1 minute" for drilling efficiency, specific force and torque values, and reduction percentages for run-out and deflection. Some aspects involve "user evaluation scores" for subjective qualities like smooth operation and ease of handling.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device, so there is no training set. Design validation is based on physical testing and risk analysis.

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

• Not Applicable. No training set exists.

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The SmartTwist™ MRII Hand Drill and accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.

The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with lancet, depth stop and ruler.

The provided document is a 510(k) summary for the SmartTwist™ MRII Hand Drill, SmartTip™ MRII Drill Bit Kit, 4.5mm, 6.0mm, seeking substantial equivalence to the predicate device, the MRII Cranial Drill, K122456.

The document describes the performance data and acceptance criteria in terms of demonstrating substantial equivalence, rather than a traditional study with strict acceptance criteria and performance metrics for an AI/software device. This is a physical medical device, specifically a hand drill and drill bit kits.

Here's an breakdown based on the provided text, focusing on how the device meets "acceptance criteria" through comparison with its predicate:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (manual surgical drill), "acceptance criteria" are not reported as specific performance metrics (e.g., accuracy, sensitivity) like for diagnostics or AI. Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The performance is therefore reported in terms of equivalence to the predicate and compliance with recognized standards.

Key Differences from Predicate (and how they meet criteria):

• Drill Bit Sizes: Predicate: 2.0mm, 3.2mm. Subject Device: 4.5mm, 6.0mm (addition of two new sizes).
  • Acceptance: This "addition of drill sizes is at the request of clinicians" and is deemed "equivalent in intended use, technological characteristics and principles of operation to the predicate MRII Cranial Drill."
• Packaging: Slight variation (Predicate: Drill is CSR Wrap in Tyvek Peel Pouch, Kit is Sterile, inside tray with Tyvek Lid and external Tyvek Pouch. Subject: Kit: Sterile, inside tray with Tyvek Lid and external Tyvek Pouch).
  • Acceptance: Not highlighted as a safety concern; assumes equivalent sterile barrier properties.

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

This document does not describe a clinical study in the sense of a test set with patient data for determining diagnostic accuracy or treatment outcomes. Instead, it refers to "Performance Data" from "Design Verification" and "Risk Analysis."

• Sample Size: Not specified in terms of patient data or number of devices tested in a formal sample size calculation. The verification likely involved destructive and non-destructive testing on a representative number of devices/components to ensure manufacturing quality and performance.
• Data Provenance: Not applicable in the context of patient data. The "performance data" would originate from internal lab testing, engineering assessments, and risk management activities conducted by MRI Interventions, Inc. in the USA. The data is retrospective in the sense that it's generated during the design and manufacturing process, not from a prospective clinical trial.

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

Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for demonstrating the device works as intended comes from established engineering principles, recognized consensus standards, and comparison to the predicate device's cleared performance. Clinician request for the new drill sizes implies clinical input, but not as part of a formal ground truth adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication by multiple experts, as this is a physical device clearance based on substantial equivalence and engineering verification.

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 drill, not an AI/software device, and no MRMC study was conducted.

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

Not applicable. This is a manual surgical drill, not an algorithm, and its use inherently involves human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this submission revolves around:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed MRII Cranial Drill.
• Consensus Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ASTM F2052-05e1 for MRI safety).
• Design Verification Testing: Internal testing to ensure the device meets its own design specifications.
• Risk Analysis: Identification and mitigation of potential risks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no concept of a "training set."

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

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

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The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.

The QFlow 500™ Titanium Bolt Quad Lumen Kit is used to achieve cranial access and to introduce and secure up to four sensors in place for intracranial monitoring. The kit contains a cranial bolt, drill bit, scalpel, sensor introducer with stylet, Touhy Borst fittings and connectors. The cranial bolt contains four lumens with its primary materials being titanium, polyphenylsulfone, polyvinyl chloride and polycarbonate. The primary materials of the sensor introducer are polyether block amide and polycarbonate. The primary materials of the other components in the kit are stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyphenylsulfone, polyvinyl chloride and polycarbonate.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/ML powered device, The current response contains information derived from the provided document.

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

The document describes bench testing, which typically involves laboratory-controlled experiments rather than human or animal subjects. Therefore, the concept of "sample size used for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) as it relates to clinical data is not applicable here. The tests were performed on the device components themselves.

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

Not applicable. The ground truth for this type of performance testing (mechanical and functional bench tests) is based on engineering specifications and physical measurements, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human adjudication of results; it's a series of physical and mechanical bench tests performed according to engineering protocols.

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 mechanical cranial bolt, not an AI/ML system that would involve human readers interpreting output.

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

Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance tests described are standalone in the sense that they evaluate the device's physical properties and function without human interaction beyond operating the test equipment.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on:

• Predetermined Engineering Specifications: These are quantifiable targets for mechanical properties (e.g., torque, tension, leak rates, dimensions).
• Measurable Physical Properties: Direct measurements of the device's behavior under specific test conditions (e.g., actual torque required, actual pull-out force, actual leakage).
• Comparison to Predicate Devices: Performance was also evaluated relative to the performance of existing legally marketed predicate devices (K032337, K002765) and a reference device (K992591) to demonstrate substantial equivalence or improvement.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

The VarioGuide Drill Kit is a set of components that work in conjunction with the VarioGuide and each other to guide a drill bit along a desired trajectory to make an access hole in the skull. The components that comprise the VarioCuide Drill Kit are a Drill Guide, a 3.4mm Drill Bit, a Lancet, two Depth Stops and a Device Guide. The Drill Guide is made from Peek and has a 316L Stainless Steel tip which is pressed into the Drill Guide body. The Drill Guide Tip has two unique features. First, the tip has a double-chamfered edge which allows the unique into the bone and that also prevents the tip from bending over. The second feature is windows that allow drilled material to exit through the tip and thus prevents the drill bit from binding. The Drill Guide is used to constrain the prevents access bal access hole creation to a predetermined to assult the unit on unring. 316L Stainless Steel and is used to create an access hole through the skull. The Drill Bit tip is designed so that the amount of drill walk at the start of drilling is limited. This feature also helps Drill Bit to maintain its trajectory. The Lancet is made from 316L Stainless Steel and has a sharp point at the distal end to allow the Lancet to pierce the Dura and/or Pia. The Lancet has a reduced section (0.60)" long) which allows the Lancet to pass through the skull without any wall interference. The Depth Stops are made from 316L Stainless Steel and are used in conjunction with the Drill Bit and Lancet to set the desired depth. The Device Guide is made from Peek and is used to guide an instrument (such as a catherer) on a predetermined path. The Device Guide is available in two sizes, 0.075" for the small and 0.085" for the large.

This is a 510(k) summary for the MRII Varioguide Drill Kit, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as an AI/ML device would. The document focuses on demonstrating substantial equivalence to a predicate device, which is typical for traditional (non-AI/ML) medical devices.

Therefore, I cannot provide the requested information. The provided text is for a mechanical drill kit, not an AI/ML device, and thus does not include the detailed performance study information typically found in submissions for AI/ML products.

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