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Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Phasor™ GREEN Drill is composed of 2 items: (1) a re-sterilizable, non-rechargeable battery-operated Phasor Green Driver (made of plastic housing, capable of drilling up to 10 total holes in one or more patients) in conjunction with (2) a separately packaged, single-use Phasor Green Drill Bit Assembly comprised of a steel bit (of 6.35-mm or less), plastic adapter, and polybag secured using latex-free bands. The device is for drilling cranial or orthopedic bone, by prescription only and used by qualified users, with (1) Drill Driver (provided non-sterile) for sterilization using vaporized hydrogen peroxide (VHP)prior to use at user facility and (2) Drill Bit Assembly provided gamma-sterilized for single-use respectively.

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UniBur is for single use only. This device is designed to be used with electric surgical instruments manufactured by Nakanishi INC. This device is intended for: cutting, drilling, removal, and shaping of bones in the fields of Neuro, Spine and ENT surgery.

The UniBur is a single-use, sterile medical device designed for cutting, drilling, removal, and shaping of bones, used with the Primado2 Total Surgical System (K132264) and used in the fields of neuro, spine, and ENT surgery.

The UniBur is designed to be connected to the slim motor handpiece of the Primado2 Total Surgical System.

The UniBur has 22 types of product variations based on differences in the length (3 types) and bending angle of the bur guard (3 types), the diameter of the bur for bone cutting (from φ0.6 mm to φ4.5 mm), and the grit size of the diamond embedded in the bur.

The UniBur consists of Diamond, Nickel, Stainless steel, Phosphor bronze, Stainless steel, FKM, Polyamide and PTFE.

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Phasor EZ-Fiducials is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging with the included screws placed using the included EZ-Driver (electric screwdriver) or manual screwdriver exclusively for each.

Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton):

1. Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver);

2. Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws;

3. EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws).

The provided FDA 510(k) clearance letter and summary for EZ-Fiducials focuses primarily on substantial equivalence to predicate devices based on technological characteristics and bench testing, rather than a clinical study with acceptance criteria based on human-in-the-loop performance or algorithm-only performance against a defined ground truth.

Therefore, for aspects related to "device performance," "acceptance criteria," "sample size," "expert ground truth," "adjudication methods," "MRMC studies," "standalone performance," and "ground truth for training/test sets," the available document does not provide this information. The submission relies on bench testing to demonstrate equivalence.

Here's an analysis of what information is provided and what explicitly is not provided based on your request:

Acceptance Criteria and Device Performance (Based on Available Information)

The document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical or AI/algorithm performance studies (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating compliance with an ASTM standard and general performance adequacy, often by comparison to predicate devices' known characteristics.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Proving Device Meets Acceptance Criteria

The study proving the device meets acceptance criteria is primarily bench testing. No clinical study data is presented.

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

• See table above. This is inferred from the discussion of performance testing. Explicit quantitative acceptance criteria (e.g., "deflection must be less than X mm") are not detailed, but compliance with ASTM F543-23 and "adequate performance" are stated.

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

• Sample Size: Not explicitly stated for bench testing. The testing refers to "bone simulant" but the quantity of fiducials, screws, or instances tested is not specified.
• Data Provenance: Not applicable in terms of patient data. The testing is bench testing using "bone simulant." There is no indication of retrospective or prospective data or country of origin, as it's not a clinical study.

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

• Not applicable. This was a bench study, not a study requiring expert ground truth for clinical cases. The "ground truth" for the bench testing would be physical measurements and compliance with engineering standards.

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

• Not applicable. There was no human interpretation or subjective assessment of clinical data that would require 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:

• No. An MRMC study was not done. The device is a physical fiducial system and an electric screwdriver, not an AI or software device that assists human readers.

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

• Not applicable. This is not an AI algorithm. The device performance here refers to the physical characteristics and functionality of the fiducials and screwdriver.

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

• Bench Testing Data/Engineering Standards. The ground truth for this submission's performance assessment is the physical performance and measurements of the device (deflection) and compliance with industry standards (ASTM F543-23).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. As above, no training set.

Summary of the Study:

The "study" referenced in the 510(k) for EZ-Fiducials is a series of bench tests focusing on:

• Biocompatibility of materials.
• Sterility validation.
• Packaging integrity.
• Performance of the screws (e.g., deflection characteristics, compliance with ASTM F543-23 when inserted into bone simulant).
• Performance of the electric screwdriver (its ability to drive screws adequately).

The clearance is based on the argument that these bench tests demonstrate the device's substantial equivalence in terms of safety and effectiveness to the predicate device (Medtronic Navigus Unibody Fiducial Marker System) and a reference device (OsteoMed Pinnacle Driver), even with some technological differences (e.g., screwdriver speed, sterilization method). The document explicitly states: "No clinical testing was needed or performed otherwise." The predicate device was also "cleared based upon bench testing alone."

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Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and General Surgical procedures.

The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems. The Surgify Halo comprises: Shank, Locking Features, Burr Head, and Safety Mechanism (a self-centering ring and spring mechanism installed in the burr head). The moving ring, larger than the burr head, can adopt two positions: First Position (Hard Tissue Mode) where the ring protrudes, preventing cutting edges from engaging, and Second Position (Soft Tissue Mode) where the ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.

The Surgify Halo is a sterile surgical burr used for shaping and removing hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures. The company performed performance testing and design validation/summative evaluation to demonstrate substantial equivalence to its predicate device (K250380).

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text states that "All tests fulfilled Design input requirements" and "All tests fulfilled Design input and user requirements." It does not explicitly state numerical acceptance criteria for each parameter (e.g., "chatter rate < X dB"). The performance is reported as meeting these general design input requirements.

2. Sample Size and Data Provenance for the Test Set

• Sample Size:
  • For Functional Testing: Not explicitly stated as a number of devices or trials. The "Results" column simply indicates that "All tests fulfilled Design input requirements."
  • For Design Validation/Summative Usability Testing: Not explicitly stated as a number of participants or cases, only that "production equivalent Surgify Halo (4 mm)" was used.
• Data Provenance (Country of Origin and Retrospective/Prospective Data): Not specified in the provided document.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: For the Summative Usability Testing, it is mentioned that "Surgeons Summative Testing" was performed. Specific qualifications (e.g., years of experience, specialty beyond "Surgeons") are not provided.

4. Adjudication Method (Test Set)

• Adjudication Method: Not specified in the document. The usability testing was conducted as "Surgeons Summative Testing," implying direct user evaluation against scenarios, rather than an independent adjudication of results.

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

• MRMC Study Done? No, the document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a surgical burr, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance Done? N/A. The device is a physical surgical tool, not an algorithm. Its performance is intrinsically linked to its use by a human operator in a surgical setting.

7. Type of Ground Truth Used (Test Set)

• Ground Truth Type:
  • For Functional Testing: The "ground truth" was likely defined by engineering specifications and design input requirements for physical properties and operational performance (e.g., durability, cutting effectiveness, chatter, noise, thermal output).
  • For Summative Usability Testing: The "ground truth" was established by user requirements and validated through hazard-related use scenarios, assessing whether "user requirements were met" and "user errors" were minimized. This is a form of expert consensus/observation of appropriate use based on human factors principles.

8. Sample Size for the Training Set

• Sample Size: N/A. As a physical medical device (surgical burr) that is not an AI/ML algorithm requiring training data, the concept of a "training set" in the context of machine learning does not apply. The development would involve engineering design, material science, and iterative physical prototyping/testing.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: N/A, for the same reasons as #8.

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Phasor EVAC™ is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The EVAC system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Phasor EVAC™ subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.

This 510(k) clearance letter for the EVAC device (K243205) indicates that it is a central nervous system fluid shunt and components and it's regulated under 21 CFR 882.5550. While the letter confirms the device's substantial equivalence to predicate devices and states that various tests were conducted, it does not provide detailed information about specific acceptance criteria, study methodologies (like sample size, ground truth establishment, expert qualifications, or MRMC studies), or actual performance data in the format requested.

The document primarily focuses on explaining why the device is considered substantially equivalent to existing devices based on its intended use, indications for use, and technological characteristics. It mentions that "Various tests including for biocompatibility, packaging, sterility, safety, and performance were conducted and passed successfully," and that "testing for a closed system with firm purchase into bone was established and verified by testing." However, it does not disclose the specific data or criteria for these tests. It explicitly states, "No clinical testing was needed or performed otherwise."

Therefore, based on the provided FDA 510(k) clearance letter, I cannot populate the detailed table and answer all the specific questions about acceptance criteria and study proving device performance as requested, because this information is typically contained in the actual 510(k) submission, not the clearance letter itself. The clearance letter summarizes the FDA's decision, but not the detailed technical data from the submission.

Here's what can be inferred or explicitly stated from the provided document, with notes where information is not present:

Acceptance Criteria and Device Performance (Based on Inferred Safety and Effectiveness)

The acceptance criteria for a 510(k) cleared device are implicitly that it demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective while having the same intended use. For this device, the "performance" described is its ability to meet the design intent and demonstrate equivalence through bench testing, rather than clinical efficacy.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Study Details (Based on Available Information)

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

   • The document states "No clinical testing was needed or performed otherwise." This indicates that the "test set" for demonstrating substantial equivalence was primarily based on bench testing and engineering evaluations of the device components and system.
   • Specific sample sizes for these bench tests are not provided in the clearance letter.
   • Data provenance (country of origin, retrospective/prospective): Not applicable or specified for bench testing.

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):

   • Given that "No clinical testing was needed or performed," there's no mention of expert panels establishing ground truth in a clinical context. The "ground truth" for the engineering tests would be derived from accepted engineering standards and specifications.

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

   • Not applicable, as no clinical study or human reader evaluation requiring adjudication was performed.

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:

   • No, an MRMC comparative effectiveness study was not done. The device is a surgical system (shunt and components), not an AI-assisted diagnostic tool.

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

   • This question is more pertinent to software/AI devices. The EVAC system is a mechanical device. Its "performance" refers to its physical functioning (e.g., maintaining a closed system, firm purchase into bone), not an algorithmic output. The "Phasor Drill" component is explicitly stated to have been previously cleared (K161704), indicating its standalone performance was established previously.

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

   • For this device, the "ground truth" for its functional performance was based on engineering specifications, material science standards, and mechanical testing requirements (e.g., ability to form a "closed system with firm purchase into bone"). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical study was performed.

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not an AI/machine learning algorithm requiring a "training set."

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

   • Not applicable for the same reason as above.

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Surgify Halo is a sterile surgical burr indciated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures

The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.

The Surgify Halo comprises:

• Shank: Transfers rotary motion from the drill motor to the burr head.
• Locking Features: Located at the distal end of the shank, these features securely attach the burr to the high-speed surgical drill.
• Burr Head: Shaped with two cutting edges for cutting of bone and hard tissue.
• Safety Mechanism: A self-centering ring and spring mechanism installed in the burr head. The moving ring, larger than the burr head, can adopt two positions:
  • First Position: (Hard Tissue Mode) The ring protrudes, preventing the cutting edges from engaging with the work material.
  • Second Position: (Soft Tissue Mode) The ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.

The provided text is a 510(k) summary for a medical device (Surgify Halo) and does not contain information about an AI/ML component or a study proving its performance against acceptance criteria in the context of AI/ML. The device is a surgical burr, which is a physical cutting tool, not a software or AI-driven diagnostic or therapeutic device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, or ground truth establishment related to AI/ML.

The "Performance Data" section describes functional testing for a physical device (durability, chattering, compatibility with drill systems) and sterilization/passivation validation, along with a table of "Design Verification Tests" and their result that "All tests fulfilled Design input requirements". This kind of performance data is standard for mechanical surgical tools and is not related to the performance of an AI/ML algorithm.

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The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/ Transnasal/ Transphenoidal, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

iBur™ Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic. Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

This document is a 510(k) premarket notification for a medical device, the Stryker iBur™ Hubs and Cutting Accessories. It outlines the modifications to an existing device, compares it to a legally marketed predicate device (K210377), and provides performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding numerical performance metrics for the iBur™ device. Instead, it makes a general statement about meeting acceptance criteria and demonstrating sufficiency for intended use.

However, it does indicate the types of performance tests conducted and their qualitative outcomes:

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

The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "performance testing was conducted on the proposed devices" but does not specify the number of devices or units tested.

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 information is not applicable to this document. The device is a surgical cutting accessory, not an AI/diagnostic device that requires expert-established ground truth from a test set. The validation focuses on the device's physical performance characteristics.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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. The device is a surgical tool, not an AI system.

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

This information is not applicable. The device is a surgical cutting accessory, not an AI algorithm.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI or diagnostic device. For this type of device (surgical cutting accessory), the "ground truth" for performance is established through engineering and material science testing, ensuring the device meets predefined technical specifications for cutting efficacy, safety (e.g., temperature), and structural integrity. This is indicated by the mention of "all acceptance criteria were met for the performance testing."

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable. The device is a physical product, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a modified medical device. It focuses on demonstrating that the device's modifications do not alter its fundamental scientific technology or intended use and that its performance remains substantially equivalent to a predicate device through non-clinical performance testing. The questions regarding AI, expert ground truth, and training data are not relevant to this type of device submission.

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The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures.

The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.

The hekaDrill device primarily consists of various components for surgical procedures involving cutting, drilling, and sawing of soft and hard tissues. The performance assessment focused on comparing the device's cutting performance, electrical safety, electromagnetic compatibility, and biocompatibility with predicate devices and relevant standards.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each performance test (e.g., number of cutting trials, number of biological samples). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance tests described. The assessment relied on objective measurements and comparisons against established standards and predicate device performance. For the biocompatibility tests, the "ground truth" is determined by the specific reaction observed (e.g., cytotoxicity, sensitization), not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable in this context. The performance tests involve objective measurements and comparisons to standards, not subjective interpretations requiring adjudication among experts.

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. The hekaDrill is a surgical drill system, not an AI-powered diagnostic or assistive device that would involve human readers or image interpretation.

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

Not applicable, as this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

For the performance tests:

• General Performance: The "ground truth" was established by comparing direct measurements of performance characteristics (vibration, noise, control, cutting effectiveness) against those same characteristics of a predicate device.
• Electrical Performance: The "ground truth" was the adherence to established international safety standards (IEC 60601-1:2005 and IEC 60601-1-2:2014).
• Biocompatibility: The "ground truth" was dictated by the specific biological responses observed in standardized tests, such as the absence of biological reactivity in cytotoxicity assays or no significant reaction in sensitization tests.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. The concept of a "training set" is typically associated with machine learning or artificial intelligence models.

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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Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.

The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems. The Surgify Halo comprises: A shank, which transfers rotary movement of the drill motor to the head. Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill. A head that is shaped to have two cutting edges to cut bone and hard tissue. A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions: In the first position, the ring protrudes to a level higher than cutting edges and prevents the cutting edges from cutting into the work material. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material

The provided text describes the Surgify Halo, a sterile surgical burr, and its performance evaluation to demonstrate substantial equivalence to a predicate device (Adeor HiCut Highspeed Instrument).

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

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

The document does not explicitly present a table of formal acceptance criteria with specific numerical thresholds. Instead, it states that "All tests fulfilled Design input requirements" and that the "performance of the Surgify Halo burr was comparable to that of the conventional diamond and fluted burrs." This implies that the acceptance criteria were defined by the product's design input requirements and the performance of established devices.

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

The document does not specify the sample sizes used for any of the individual tests. Similarly, there is no information provided regarding the provenance of the data (e.g., country of origin, retrospective or prospective nature). The testing appears to be primarily laboratory-based "Design Verification Test" and "Design Validation Testing." The "Performance Testing Animal" section suggests an animal model was used, but details are not provided.

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

The document mentions "Nurses Summative Testing" and "Surgeons Summative Testing" for Design Validation/Usability. These tests involved a "series of tests based on hazard-related use scenario, user interface." However, the number of nurses and surgeons involved, their specific qualifications, or how their input established a "ground truth" (beyond fulfilling design input requirements for usability) is not detailed.

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

No information is provided regarding an adjudication method. The testing seems to be based on meeting predefined design input requirements and comparative performance, rather than a system requiring expert adjudication of ambiguous cases.

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 section is not applicable. The Surgify Halo is a physical surgical burr, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This section is not applicable. The Surgify Halo is a physical surgical burr. Its performance is inherent to the device itself (e.g., cutting efficiency, durability), not a standalone algorithm.

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

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

• Design Input Requirements: The device was tested against its own design specifications (e.g., durability, cutting efficiency, noise levels, geometrical features).
• Predicate Device Comparability: The performance of the Surgify Halo was compared to that of "conventional diamond and fluted burrs," implying these established devices served as a benchmark for acceptable performance.
• Biocompatibility Standards: Compliance with ISO 10993-1:2018.
• Sterilization Standards: Compliance with EN/ISO 11137-1/2 (2015).
• Usability Feedback: Input from nurses and surgeons during summative testing to ensure the device meets intended use and user needs.
• Animal Performance: Comparison to conventional burrs in an animal model.

8. The sample size for the training set

This section is not applicable. The Surgify Halo is a physical surgical burr, not a machine learning or AI model that requires a training set.

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

This section is not applicable, as there is no training set for this device.

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The Hubly Electric Drill is a single-use, sterile, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Hubly Electric Drill is a battery powered cranial drill. It is single-use disposable and provided ethylene oxide sterilized. The drill is designed to create optimal burr holes, in the emergency room, at the bedside, or in the operating room. The system is designed to streamline bedside intracranial access and facilitate the treatment of emergent conditions in adult patients.

The device is a battery-powered hand drill which can be used one-handed using either hand. The drill is trigger-activated after removal of the battery pull tab. The drill has a single speed and turns off when the trigger is released. The drill bit has depth indicators at 5 and 10mm depth, which the physician may use to visually gauge depth of penetration while drilling.

The drill also has an auto-stop feature which detects when the bit breaks through the inner table of the skull and immediately stops the drill. The device has an LED indicator which indicates to the user (green) when they are applying enough force and (red) when the drill stops.

The drill features mechanical plunge prevention with a tapered stainless steel drill may be reactivated any number of times using the trigger if the physician desires.

The provided text describes performance testing for the Hubly Electric Drill. However, it does not contain specific numerical acceptance criteria or numerical reported device performance in a table format, nor does it detail a study proving the device meets specific acceptance criteria in the way requested.

Instead, the document outlines various tests conducted to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness.

Here's an attempt to extract and synthesize the information based on the request, noting where information is not explicitly provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "meets all design specifications and requirements" for bench tests and "all in vivo requirements were met" for the animal study.

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

• Test Set Sample Size: The document does not specify a numerical sample size for any of the performance tests (bench testing, animal study).
• Data Provenance:
  • Bench Testing: Conducted by Hubly Inc. (implied, as they are the applicant).
  • Animal Study: Conducted in a GLP (Good Laboratory Practice) compliant setting using a sheep model. The location/country is not specified.
  • Retrospective/Prospective: The tests described (bench, animal) are prospective studies conducted to support the 510(k) submission.

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

• This information is not provided in the document. The studies described are performance tests and an animal study, not studies relying on expert review for ground truth establishment.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The described tests are instrumental/procedural performance tests and an animal study, not studies involving human reader interpretation requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed on human subjects." The studies focused on bench performance and an animal model.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The Hubly Electric Drill is a physical medical device (a drill), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The "software verification testing" was conducted on firmware responsible for the automatic stopping feature, but this is an embedded system, not a standalone AI application. The software implements "additional safety features" and has a "Moderate" level of concern.

7. Type of Ground Truth Used

• Bench Testing: Ground truth was implicitly based on engineering design specifications and requirements (e.g., battery life, depth of penetration, trigger performance).
• Animal Study: Ground truth was based on observational outcomes in the sheep model, specifically demonstrating that "Users (Test Device Evaluators) could safely use the Hubly Electric Drill for intracranial access without damaging the dura or brain tissue."

8. Sample Size for the Training Set

• This information is not applicable/provided. The device is a physical drill with embedded firmware, not a machine learning model that requires a training set in the conventional sense. The "software" mentioned is firmware, which is typically developed through traditional software engineering processes, not trained on data.

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

• This information is not applicable/provided for the reasons stated in point 8.

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