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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 MRII Cranial Drill and accessories is 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 field 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 is a hand held manual drill with a 3:1 gear ration. It is in intended for use with the drill kit accessory kits consisting of a 2.0 or 3.2 mm drill bit, lancet, depth stop and ruler.

The provided 510(k) summary for the MRII Cranial Drill does not describe acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, the Integra Hand Drill (K961113), primarily through a comparison of technological characteristics and bench testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is conspicuously absent:

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

Not provided in the document. The submission states that "Testing to applicable standards has been completed with acceptable outcomes" and "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill, with acceptable results." However, it does not explicitly list specific acceptance criteria (e.g., maximum deflection under load, specific torque requirements, material strength thresholds) or quantitative performance data against those criteria.

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

Not provided in the document. The submission mentions "Bench testing," but no details about sample size, test methodologies, or the provenance of any data (e.g., human or animal cadavers for drilling tests) are included.

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 typically relevant for studies involving subjective human assessment (like image interpretation). For a mechanical device like a drill, "ground truth" would be established through objective physical measurements or functional tests, not expert consensus in the diagnostic sense. The document does not describe any such expert involvement.

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

Not applicable/Not provided. Adjudication methods are specific to studies involving multiple readers or assessors to resolve discrepancies, often in diagnostic imaging. This concept does not apply to the type of bench testing described for a manual cranial drill.

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 section is entirely irrelevant to the MRII Cranial Drill, which is a manual surgical instrument and not an AI-powered diagnostic tool. No MRMC study was performed or described.

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

Not applicable. This section is entirely irrelevant to the MRII Cranial Drill. As a manual surgical instrument, it does not possess an "algorithm" in the sense of AI or software-driven performance that would operate in a standalone manner.

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

Not provided/Implied by "Bench Testing". For a mechanical device, "ground truth" would typically refer to objective measurements of physical properties, functional performance (e.g., drilling time, force required, material integrity post-drilling), and compliance with engineering specifications. The submission only states "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill." It does not specify the exact parameters measured or how success was defined.

8. The sample size for the training set

Not applicable. This device is a manual cranial drill. It does not employ machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set for this device, this question is not relevant.

In summary, the K122456 submission for the MRII Cranial Drill relies on demonstrating "substantial equivalence" to a predicate device through a comparison of technological characteristics and general statements about "bench testing" that yielded "acceptable results." It does not specify detailed acceptance criteria or present quantitative study data to prove the device meets pre-defined performance thresholds, which is common for 510(k) submissions for devices considered low-risk and similar to existing predicate devices.

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The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.

The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.

This document is a 510(k) Premarket Notification for a Hand Drill (Catalog # 11-9901-7) manufactured by Medical Designs, LLC. The primary goal of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a predicate device that is already legally marketed in the U.S. This type of submission generally does not include a formal study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) or De Novo submission, especially for a Class II manual surgical instrument.

Therefore, the requested information elements related to specific performance acceptance criteria, clinical study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), and training set information are not applicable or present in this 510(k) summary.

Instead, the demonstration of safety and effectiveness relies on comparison to a predicate device and similarities in design, materials, and intended use.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission does not include a formal clinical study with pre-defined acceptance criteria and reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The criteria for acceptance in a 510(k) are based on demonstrating substantial equivalence to a predicate device, primarily through comparison of intended use, technological characteristics, and safety/effectiveness profiles.

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

Not applicable. No formal test set or clinical data is presented for performance evaluation in this 510(k) submission.

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

Not applicable. Ground truth for a test set is not established as no performance study is detailed.

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

Not applicable. No test set requiring adjudication is 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

Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

Not applicable. Ground truth for a performance study is not relevant for this 510(k) submission.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a learning algorithm that requires a training set.

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

Not applicable. Ground truth for a training set is not relevant for this 510(k) submission.

Summary of the 510(k) Approach for this Device:

The 510(k) submission for the Medical Designs Hand Drill establishes substantial equivalence to the Integra NeuroSciences Camino Hand Drill - Model 030 (K862160) by demonstrating:

• Identical Intended Use: Both devices are intended for use in Neurosurgical procedures. The Medical Designs Hand Drill also specifies use with their Subdural Evacuating Port System Kit (S.E.P.S.), which is a further specific application within neurosurgery.
• Similar Technological Characteristics: The submission states that the Medical Designs hand drill is made of "the same materials and components as the predicate device" (ABS plastic housing, glass filled nylon handle, ABS plastic handle knob, lubricated aluminum gears, ¼" spring-loaded, chrome-plated steel, 3-jaw chuck assembly). The device is also a single-use disposable and sterilized using gamma radiation.
• Biocompatibility: The materials are stated to be identical to the predicate device, and neither device comes into direct contact with the body or bodily fluids when used as intended. This addresses biocompatibility concerns by similarity.
• No new issues of safety or effectiveness: By using identical materials and having the same intended use, the submission argues that the device does not raise any new safety or effectiveness concerns compared to the predicate.

The FDA's review and clearance (NOV 12 2002) indicate their agreement that substantial equivalence was demonstrated, allowing the device to be marketed. This regulatory pathway does not typically require an extensive performance study with quantitative acceptance criteria as would be needed for novel or higher-risk devices.

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The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

The LandmarX™ FrameLock™ kit is an optional accessory of the LandmarX Image Guided Surgical System, previously cleared in K992927. The LandmarX™ FrameLock™ kit is designed to provide a safe, reliable, compact, and minimally invasive means of direct and rigid fixation to the patient's skull for the LandmarX™ reference arc (REF # 960-632). The FrameLock™ mounts using a titanium screw entering a pilot hole drilled with stainless steel manual drill and accessories. A small percutaneous incision is adequate to install the device. The FrameLock also permits navigation using the sterile drape technique.

The provided document is a 510(k) premarket notification for a medical device (FrameLock Kit) and does not describe a study involving acceptance criteria for an AI/algorithm. Instead, it details the device's classification, description, indications for use, and a statement of substantial equivalence to previously marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in the provided text. This document is focused on regulatory clearance based on substantial equivalence, not the performance evaluation of an AI-powered device against specific acceptance criteria.

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The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.

Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.

This document describes the marketing authorization for a medical device and, as such, does not contain information about the device's acceptance criteria, study design, or performance metrics in a way that aligns with your request for AI/algorithm performance. The information provided is for a cranial drill, which is a physical surgical tool, not an AI or software-based device.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The "Test Data" section in the input only shows that standard medical device tests (Sterility, Performance, Cytotoxicity, Comparative Evaluation) were performed and found "Acceptable" for regulatory approval, but it does not detail performance metrics, sample sizes, ground truth establishment, or human reader studies relevant to an AI/algorithm.

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