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The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP (L) and Cranial Loop (XL), are longterm implantable devices indicated for post-craniotomy bone flap fixation.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

The Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. They can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4mm to 24 mm.

The request cannot be fulfilled as no information regarding acceptance criteria, study details, sample sizes, expert involvement, or specific ground truth methods is provided for an AI/CADe device. The provided text is a 510(k) clearance letter for a cranial bone fixation system, which is a physical implant, not a software or AI device. The document explicitly states "No clinical testing was performed to support this submission." and focuses on "Biomechanical and functional testing" for a physical device.

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The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.

The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone.

The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use.

The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.

The provided text describes the regulatory clearance of a medical device, the "Absorbable Cranial Flap Fixation System," by the FDA. It includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not contain information about an AI-based device or a study involving AI with human readers.

Therefore, I cannot provide details on:

• Acceptance criteria specific to AI device performance.
• Sample sizes for test sets or training sets related to AI.
• Data provenance for AI studies.
• Number and qualifications of experts for AI ground truth.
• Adjudication methods for AI test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies with AI.
• Standalone algorithm performance for AI.
• Type and establishment of ground truth for AI training sets.

The document entirely focuses on the mechanical and biological performance of a physical medical implant.

Here's the information that is available in the document regarding the non-AI device's acceptance criteria and related studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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CirFIX® Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.

The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery.

The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by standard perforators or with spherical drills, can be covered.

The provided document is a 510(k) summary for the CirFIX Cranial Bone Fixation System. It details the device's technical characteristics, its intended use, and a comparison to predicate devices, along with summaries of non-clinical, mechanical, and performance testing. However, the document does not contain information about studies involving human readers, AI assistance, ground truth established by experts for a test set, or specific acceptance criteria with quantitative reported performance metrics for an AI/algorithm-based device.

The questions posed are typical for the evaluation of AI/Machine Learning-enabled medical devices, particularly those involving image analysis or diagnostic support, where performance is often measured by metrics like sensitivity, specificity, or reader agreement. The CirFIX system described is a physical medical device (bone fixation system), not an AI/ML software device. Therefore, the questions related to AI/ML device performance validation are not applicable to the content provided.

However, I can extract the information relevant to the device's performance testing and acceptance criteria for a physical device as described in the document.

Acceptance Criteria and Study for CirFIX Cranial Bone Fixation System:

The document describes pre-market testing to demonstrate substantial equivalence to predicate devices, focusing on functional, biomechanical, and cadaver testing. The "acceptance criteria" are implicitly met if the device performs as intended and is equivalent or better than predicate devices in specified mechanical tests, and demonstrates safe and effective implantation in simulated clinical use.

Since this is a physical device, the concept of "ground truth" and "expert consensus" for diagnostic accuracy (as would be for an AI model) does not directly apply in the same way. Instead, performance is assessed against physical and mechanical benchmarks and practical surgical considerations.

Here's a breakdown of the provided information, noting where the requested AI-specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with specific numerical targets and matching reported performance values. Instead, it describes tests and states that the criteria were met, or that results were adequate or equivalent to predicate devices.

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

• Manufacturing/Mechanical Testing: The document mentions "All tested samples" for functionality and biomechanical tests, but does not specify the exact numerical sample size for these tests.
• Cadaver Testing: "The test was performed on two cadaveric specimens with fully assembled devices."
• Data Provenance: The tests are reported as "Non-Clinical Testing" and "Mechanical and performance testing." Given they are laboratory and cadaver tests, the data provenance is prospective (generated for this submission). The origin is not explicitly stated as a country for the labs, but Ossaware Biotech Co., Ltd. is based in Taiwan.

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

N/A. As this is a physical medical device (bone fixation system), "ground truth" and "expert qualifications" in the context of diagnostic accuracy/AI model performance are not applicable. The cadaver testing described would involve the expertise of the individuals performing the simulated surgical procedures and evaluating the outcomes, but these are not referred to as "experts establishing ground truth" for a diagnostic test.

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

N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus "ground truth" in image interpretation or diagnostic studies, which is not relevant for this physical device's mechanical and functional testing.

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

N/A. This is a physical medical device, not an AI/ML-enabled diagnostic device. No MRMC study was conducted or is relevant.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

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

N/A. For this physical device, "ground truth" refers to established engineering principles, material properties, and surgical requirements for bone fixation. Performance is assessed against these physical and functional benchmarks rather than diagnostic accuracy.

8. The sample size for the training set

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

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

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

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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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OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSDSIGN Cranioplug.

Upon reviewing the provided FDA 510(k) summary, it's important to note that this document describes a medical device (a burr hole cover) and its non-clinical testing, not a diagnostic AI/ML device. Therefore, many of the requested categories, such as data provenance, expert adjudication, MRMC studies, standalone performance with ground truth for AI, etc., are not applicable as this is not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the "OSSDSIGN Cranioplug" (subject device) to a legally marketed predicate device ("OSSDSIGN Cranioplug") through bench and biological performance testing.

Acceptance Criteria and Device Performance for OSSDSIGN Cranioplug

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied based on establishing substantial equivalence to the predicate device. The goal is to demonstrate that the new device performs as safely and effectively as the predicate.

Regarding AI/ML Specific Questions (Not Applicable to this Device):

The following questions are not applicable to the OSSDSIGN Cranioplug as it is a physical medical implant (burr hole cover), not an AI/ML diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: Not applicable. This involves physical device testing, not data analysis.
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 an AI device involves expert annotations; for this physical device, "ground truth" is established by physical measurements and biological assays.
4. Adjudication method 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.
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.): For this physical device, "ground truth" is derived from standardized physical testing methods (e.g., universal testing machine, dynamic load simulation) and biological assays (cytotoxicity, in vivo implantation results/histology).
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Non-Clinical for a Physical Device):

The study described is a non-clinical evaluation to demonstrate the substantial equivalence of the OSSDSIGN Cranioplug (subject device) to its predicate device (an earlier version of the Cranioplug, K140309).

Key aspects of the study:

• Objective: To show that the subject device is as safe and effective as the predicate device, despite minor differences in materials (Titanium grade) and dimensions (titanium thickness, additional size).
• Methodology: Bench testing and biological performance testing.
  • Bench Testing:
    • Energy absorption, flap reattachment: Devices installed in an anatomical model and tested in a Universal Testing Machine to a 2mm displacement to determine deformation energy.
    • Flap Fixation Dynamic Load: Three Cranioplugs fixating a flap in an anatomical model, tested with an 8.5 kg head weight simulating 50 years of sleep with hourly repositioning.
  • Biological Performance:
    • Cytotoxicity: ISO elution method (ISO 10993-5) using extracts in IX MEM at 37°C for 24 hours.
    • In vivo implantation: A 52-week sheep implantation study, compliant with ISO 10993-6.
• Results: The subject device met the performance standards demonstrated by the predicate device in all tests.
  • Energy absorption was identical to the predicate (0.06 J).
  • No flap deformation observed under dynamic loading.
  • No evidence of cytotoxicity.
  • Biocompatibility, adequate resorption rate, and osteoconduction were observed in vivo.
• Conclusion: Nonclinical tests demonstrate that OSSDSIGN Cranioplug003 is as safe and effective as its legally marketed predicate device.

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The GuardianTM burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) burr hole cover for the skull. It can also be used to secure a lead with a 1.29-mm (0.051-in) or 1.39-mm (0.055-in) diameter

The GuardianTM burr hole cover system is used to close a cranial burr hole and secure an implanted, compatible lead, when applicable. The burr hole cover system is nonpyrogenic and has three main features: base, clip, and cover. The base is intended for burr holes with a 14-mm (0.55-in) diameter. It contains two grooved slots to hold a lead in place. The clip fits into the base to hold the lead. The locking mechanism temporarily holds a lead in place before the burr hole cover is secured. The cover snaps onto the base, closing the burr hole and locking a lead in place.

The document describes a 510(k) premarket notification for a modification to the Guardian™ Burr Hole Cover System to include an "MR Conditional" statement in the labeling. The acceptance criteria and the study that proves the device meets them are related to this MR Conditional status.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of medical imaging or diagnostic device performance evaluation. Instead, the testing was for the "MR Conditional" status. This typically involves physical testing of the device itself according to specific MR safety standards. Therefore, the "sample size" would refer to the number of physical devices tested to assess their behavior in an MR environment. The document does not specify the exact number of units tested.

• Data Provenance: The testing was conducted "following the FDA Guidance, 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment'." This implies a laboratory or testing facility setting, rather than clinical patient data. The country of origin of the data is not specified, but the submission is to the US FDA.

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

This question is not directly applicable to this type of submission. Establishing "MR Conditional" status for a passive implant primarily involves engineering and physics expertise for conducting MR safety tests and interpreting their results according to established international standards (e.g., ASTM F2052, F2119, F2182). It does not typically involve a panel of medical experts establishing "ground truth" on patient images or outcomes. The "ground truth" in this context is the objective measurement of MR-related effects (e.g., heating, artifact, force).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. MR safety testing data is typically objective and quantitative, and does not require adjudication by medical experts in the way clinical diagnostic study results might.

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 submission is for a burr hole cover system (a passive implant), not a diagnostic imaging AI algorithm.

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

Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's inherent physical properties and behavior in an MR environment.

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

The "ground truth" for determining MR Conditional status is based on objective, quantifiable measurements from MR safety testing protocols defined in recognized standards (e.g., SAR measurements, temperature rise, displacement force, torque, image artifact assessment). This is not derived from expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable, as there is no training set.

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The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.

The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.

Two different sizes are presented:

• . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
• . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.

The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.

The provided document is a 510(k) premarket notification for a medical device called "Cranial COVER". This type of document is and does not feature studies in the traditional sense you're asking about (e.g., studies for AI algorithms). The document instead reports on mechanical and performance testing to demonstrate substantial equivalence to predicate devices, which is a common regulatory pathway for medical devices.

Therefore, many of the requested categories for AI/clinical studies are not applicable to this document. I will extract the information that is present regarding the device's acceptance criteria and the engineering tests performed.

No information is available regarding:

• Sample sizes used for test set or data provenance in the context of an AI study.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Standalone (algorithm only) performance.
• Sample size for a training set.
• How ground truth for a training set was established.

Acceptance Criteria and Device Performance (Mechanical and Performance Testing)

The "Cranial COVER" is a physical medical device (burr hole cover), not an AI algorithm. Therefore, the "acceptance criteria" discussed are design specifications and performance metrics related to mechanical function, biomechanics, and biocompatibility, as opposed to diagnostic performance metrics like sensitivity, specificity, or AUC.

Here's a table summarizing the acceptance criteria (stated as "Goal" or implied by standard adherence) and the reported device performance from the "Discussion of mechanical and performance testing" section:

Additional Applicable Information from the Document:

The document states:

• No clinical testing was deemed necessary to support substantial equivalence to predicate devices.
• Biocompatibility: The implantable parts are made of PEEK, which is "well established as an implantable thermoplastic material." The non-implantable parts are made of "biocompatible polymers." This is a qualitative assessment of material suitability.
• Sterility: The sterilization method is identical to the predicate device, Cranial LOOP XL, and the results are comparable. This implies meeting ISO 11137-1/2, ISO 11737-1/2 standards for sterilization.
• Standards Applied: The device adheres to several ISO standards related to sterilization (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2006, ISO 11737-2:2009) and biological evaluation of medical devices (ISO 10993-1:2009). Adherence to these standards serves as a form of acceptance criteria.

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The Guardian™ Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter.

The GuardianTM burr hole cover system consists of three main features: base, clip, and cover. The GuardianTM burr hole cover system is used to close a cranial burr hole and can be used to secure an implanted compatible lead (1.29mm and 1.39mm). The burr hole cover is mated with the burr hole that is drilled in the patient's skull during the cranial surgery. The burr hole cover acts as a physical barrier protecting the exposed brain by covering the burr hole. The burr hole cover can also be used to provide temporary and permanent lead fixation.
There are ancillary components of the system (base holder with cranial screws, clip, insertion tool and screw driver) that aid in the placement of the burr hole cover system. The base holder is intended to align the base with the burr hole and to maintain the cranial screws in place in the package and during installation.
A clip insertion tool is intended to actuate the clip/insert and place it in the base. A screw driver is used to install the screws to the skull.

The provided text is a 510(k) summary for the Guardian™ Burr Hole Cover System, which is a medical device. This document details non-clinical bench testing and biocompatibility testing to establish substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets the acceptance criteria in the context of AI, multi-reader, or standalone algorithm performance.

However, I can extract the acceptance criteria and results for the non-clinical performance and biocompatibility testing of the Guardian™ Burr Hole Cover System.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing & Biocompatibility)

The document primarily focuses on verifying the device meets "pre-determined acceptance criteria" through a series of non-clinical tests. The "Testing Scope and Rationale" column often implies the acceptance criteria (e.g., "confirm actuation," "confirm does not rotate," "confirm no damage," "confirm ability to permanently remain fixated," "demonstrated compliance to ISO standards"). The "Results" column indicates whether these criteria were met.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document repeatedly uses the phrase "All SJM devices passed" or "All SJM and NeuroPace devices passed" for the performance bench tests. Biocompatibility tests also refer to "the SJM BHC system" being assessed. However, specific numerical sample sizes for each test are not provided in this document.
• Data Provenance: The nature of these tests (bench testing, in vitro, and in vivo animal biocompatibility studies) indicates the data provenance is from laboratory and animal studies, not human clinical data. There is no information regarding country of origin, or whether it's retrospective or prospective in the sense of human subject studies. These are pre-market device tests.

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

• This information is not applicable to this document. The tests described are objective, non-clinical performance and biocompatibility assessments, not studies requiring expert interpretation of results or ground truth establishment in the context of diagnoses or clinical assessments. Compliance with established ASTM, ISO, or internal St. Jude Medical test protocols would be the "ground truth."

4. Adjudication Method for the Test Set

• This information is not applicable to this document, as the tests are objective mechanical and biological assessments, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable to this document. The device is a physical medical implant (burr hole cover system), not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant here.

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

• No, this information is not applicable to this document. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For Performance Bench Testing: The "ground truth" is defined by the pre-determined acceptance criteria and established engineering/physical principles applied in the test protocols (e.g., proper actuation, no rotation, no damage, consistent fixation, etc.).
• For Biocompatibility Testing: The "ground truth" is defined by compliance with internationally recognized standards, specifically referenced ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 14708-3, ISO 10993-18, ISO 10993-17, ISO 11135:2007, ISO 10993-7:2008).

8. The Sample Size for the Training Set

• This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

• This information is not applicable. Since there is no training set, there is no ground truth to be established for it.

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OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.

Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.

The document does not describe acceptance criteria for an AI/ML powered device, but rather for a Burr Hole Cover (OssDsign Cranioplug). The sections of the document describing testing (pages 4 and 5) outline bench performance characteristics and material composition tests for the OssDsign Cranioplug and its predicates.

Therefore, many of the requested fields are not applicable (N/A) as they relate to software performance evaluation, not a physical medical device.

Here's an interpretation based on the provided document for the OssDsign Cranioplug:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample sizes for each test. For the physical properties (compressive strength, falling load, 12-hour load), small sample sizes of devices are typical. For the biological tests (dissolution, cytotoxicity, sensitivity), multiple samples would be tested to ensure consistency.

• Data Provenance: Not explicitly stated, but these are laboratory bench and animal (rabbit) tests conducted for a medical device. It is generally understood to be prospective data generated specifically for the 510(k) submission.

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

N/A - The "ground truth" for these tests is based on objective measurements and established scientific standards (e.g., ISO standards, material properties, biological responses) rather than expert consensus on interpretive tasks. The "experts" would be the scientists and engineers conducting and analyzing these tests.

4. Adjudication Method for the Test Set

N/A - Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical images or diagnoses, not for objective physical or biological bench tests.

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

N/A - This type of study is for evaluating the performance of diagnostic or screening devices, often involving human readers interpreting outputs (e.g., images). The OssDsign Cranioplug is a physical implantable device, not an interpretive one.

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

N/A - This concept applies to AI/ML algorithms. The OssDsign Cranioplug is a physical medical device.

7. The Type of Ground Truth Used

• Bench Performance Tests (Compressive Strength, Falling Load, 12 Hour Load): Objective physical measurements against established engineering principles and comparison to predicate device performance.
• Biological Tests (Dissolution, Cytotoxicity, Sensitivity): Objective biological responses measured against established ISO standards and comparison to control articles.

8. The Sample Size for the Training Set

N/A - "Training set" refers to data used to train AI/ML algorithms. The OssDsign Cranioplug is a physical device and does not involve AI/ML.

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

N/A - As above, this is not applicable to a physical medical device.

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The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm bur hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling Jead.

The NeuroPace® Burr Hole Cover (model 8110) includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm). The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic. The NeuroPace® Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant. The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The base is made from a synthetic polymer and the cap is made from silicone. The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO). The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.

The provided document, K141368, is a 510(k) premarket notification for the NeuroPace® Burr Hole Cover, Model 8110. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data or detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, the information regarding acceptance criteria, specific study design elements (like sample sizes, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), is not explicitly present in this summary document. The document primarily relies on non-clinical testing and comparison to the predicate device to establish substantial equivalence.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is not available:

Acceptance Criteria and Device Performance

The document doesn't explicitly list numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/software device evaluation. Instead, it states that the modified device was subjected to various non-clinical tests to demonstrate functional equivalence and safety.

Study Details (Not Applicable/Available for this submission type)

Since this is a 510(k) submission for a physical medical device (burr hole cover) and not a software or AI/ML-based device, most of the requested details related to performance evaluation against ground truth, expert consensus, and sample sizes for diagnostic accuracy are not applicable or not provided in this type of regulatory document. The focus is on non-clinical testing demonstrating physical and material properties, and functionality consistent with its intended use and predicate device.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a diagnostic dataset. The "test set" here refers to physical devices undergoing engineering and material testing. No specific sample sizes for these tests are detailed in this summary, nor is data provenance in the sense of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be established engineering specifications and material properties, against which the physical device is tested.
7. The sample size for the training set: Not applicable, as no algorithm is being "trained."
8. How the ground truth for the training set was established: Not applicable.

In summary, the K141368 document demonstrates substantial equivalence through non-clinical testing of the physical, material, and functional characteristics of the NeuroPace® Burr Hole Cover, Model 8110, compared to its predicate device. It does not involve AI/ML components, clinical studies for diagnostic accuracy, or associated performance metrics and ground truth evaluations often seen in software as a medical device (SaMD) submissions.

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