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The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.

The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.

The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
• Screw and Needle placement in the spine or pelvis.

The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.

The system is comprised of the Spine Guidance 5.0 Software, the Q Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.

The provided document is an FDA 510(k) summary for the Stryker Spine Guidance Software (version 5.0) and associated instruments. It details the device's characteristics, intended use, and comparison to predicate devices, as well as the non-clinical testing performed to establish 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

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The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.

This document describes a 510(k) premarket notification for a medical device called POWEReam Xia/Serrato, which is an attachment used with a Stryker battery-powered handpiece to facilitate the placement of pedicle screws. The submission seeks to demonstrate substantial equivalence to a predicate device, the Stryker POWEReam ¼” Drive (K233300).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not explicitly list the specific acceptance criteria or provide detailed performance data in a table format. It only broadly states that the device performs as intended.

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

The document does not specify the sample size used for the test set for any of the non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation). It also does not provide information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

Since this is a non-clinical submission for a mechanical instrument, the concept of "experts" establishing ground truth in the same way it would be for diagnostic AI is not directly applicable. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and potentially a team of engineers or quality assurance personnel. The document does not specify the number of individuals involved in establishing these engineering "truths" or their specific qualifications (e.g., "mechanical engineer with 15 years of experience in medical device design").

4. Adjudication Method for the Test Set

As this is a non-clinical device focused on mechanical performance and usability, traditional adjudication methods like 2+1 or 3+1 (common in AI diagnostic studies) are not mentioned or typically used. The "adjudication" of test results would likely involve review and approval by qualified engineers and quality personnel based on established test protocols and acceptance criteria. No specific adjudication method is detailed in the document.

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 performed. The document explicitly states: "Clinical testing was not required for this Traditional 510(k)." MRMC studies are typically clinical studies designed to compare diagnostic performance, especially with AI assistance. This device is a surgical instrument attachment, not a diagnostic tool.

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

This question is not applicable to the device described. The POWEReam Xia/Serrato is a mechanical attachment for a surgical power tool, not an algorithm, and it inherently requires human-in-the-loop operation. "Standalone performance" in the context of an algorithm does not apply here. The non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation) assessed the device's functional performance and usability.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Engineering Specifications: The design parameters, torque outputs, speed reductions, and material properties defined during the device's development.
• Validated Test Methods: Standardized procedures and instruments used to measure the device's performance against its specifications.
• Regulatory Standards: Adherence to relevant industry and regulatory standards for medical devices.

It does not involve expert consensus, pathology, or outcomes data in the manner of diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The POWEReam Xia/Serrato is a mechanical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for a mechanical device.

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Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).

The Face Patches, Model: MT-12MA and MT-12MC is an over-the-counter light emitting diode (LED) device.

Model: MT-12MA can emits 415nm and 630nm energy to treat mild to moderate acne. There is a total of 6 LEDs, providing a power intensity of approximately 30 mW/cm².

Model: MT-12MC has 3 modes (mode 1: 630+415nm, mode 2: 630+830nm, mode 3: 590nm), it can emit 630nm and 415 nm energy to treat mild to moderate acne and provide approximately 30 mW/cm²; 630nm and 830nm energy to treat full-face wrinkles and provide approximately 35 mW/cm²; and 590nm energy to treat wrinkles and provide approximately 35 mW/cm². There is a total of 18 LEDs.

The device components include the device containing two face patches, a controller, a charging cable, 120 Mini Dots, goggles and user manual. The user pastes the device on the treatment area, and the device will shut down automatically after a 3-minute after finishing treatment. Users should adjust the treatment time based on different modes and actual treatment situations. The device has one button, and delivery of therapy requires the operator to depress a physical switch on the device.

This FDA 510(k) summary for the Face Patches (MT-12MA, MT-12MC) indicates that no clinical studies were performed, and therefore, no acceptance criteria based on clinical performance are reported.

The submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, asserting that these tests are "sufficient to support that the device can be used safely and effectively."

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

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed, there are no acceptance criteria related to a device's clinical performance (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to compliance with recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, and software validation. The reported "performance" in this context is simply compliance with these standards.

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

Not applicable. No clinical test set was used. The testing involved non-clinical validation against standards and device specifications.

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

Not applicable. No ground truth for a clinical test set was established as no clinical studies were conducted. The "ground truth" for the non-clinical tests is represented by the established specifications and requirements of the recognized standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was needed since no clinical studies were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. No MRMC comparative effectiveness study was done as no clinical efficacy or effectiveness studies were performed.

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

No. This device is a light-emitting device, not an algorithm, so the concept of standalone algorithmic performance is not relevant in the context of typical AI/software device studies.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is primarily defined by:

• Recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62471, IEC 62133-2).
• The device's own design specifications (e.g., for light output, power, irradiance, wavelengths, doses, etc.).
• FDA guidance documents (for software validation).

8. The Sample Size for the Training Set

Not applicable. No training set was used as this device is a hardware light-emitting device, not an AI/ML algorithm that requires training data.

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

Not applicable. No training set was used.

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The Peleton Surgical Single Use Power Tool System is a battery driven tool system for use in Trauma, Orthopaedic and Cardio related Surgical Procedures involving drilling, reaming, pin & wire placement and cutting of bone and hard tissue.

The Peleton Surgical Universal Power System is a battery powered tool for use in cardio-ortho related surgical procedures and is designed for the efficient cutting of bone and hard tissue. Due to the sterile barrier charging, the device is readily charged and available for immediate use in the surgical setting. The Peleton Surgical Universal Power System's lithium-ion polymer battery is always fully charged with more power than is needed for any surgery. Surgical attachments are easily interchangeable and cover every aspect of large bone surgical procedures, including, cutting reaming, sawing and surgical pin insertion and removal etc.

The Peleton Surgical Universal Power System is a double sterile barrier packaging system that includes internal and external electrical charging port features. This double sterile barrier packaging system consists of the device and its components being sealed inside an inner tray with a charging the device and the inner tray charging port. The sealed inner tray is then sealed inside an outer tray with a charging cable connecting the inner tray charging port to the outer tray charging port. The charging port includes various components to ensure a tight seal that maintains the proper sterile barrier.

The Peleton Surgical Universal Power System includes a variety of metallic attachments (ASTM F899) that are used in clinical procedures. The system is compatible with a Sternum Saw, Reciprocating Saw, Keyless Jacobs Chuck, Multi-Fit Hudson/Trinkle Reamer, Cannulated Pin and Wire Driver and Quick Release Drill Chuck. Each attachment is compatible with universal saws, drill bits and reamers from manufacturers of orthopedic accessories.

The single use Peleton Surgical Universal Power System was designed to instantly be ready to the surgical field, reducing operating room time, eliminating the need for multiple batteries/changes on extended cases, eliminating the risk of potential bioburden from improper cleaning from previous cases and reducing the amount of time needed to properly clean and re-sterilize the reusable system.

The provided document is a 510(k) summary for the Peleton Universal Single Use Power System and Attachments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with acceptance criteria for diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, human reader improvement with AI assistance, or standalone algorithm performance.

Specifically, the document primarily addresses:

1. Device Description and Intended Use: Clarifying what the device is and what it's used for (surgical procedures involving bone/hard tissue).
2. Technological Comparison: Highlighting similarities and differences with predicate devices, particularly the innovative sterile barrier charging.
3. Non-Clinical Testing: Detailing various engineering and safety tests performed to demonstrate the device's functional integrity, material compatibility, and safety (e.g., visual inspection, dimensional inspection, corrosion testing, attachment compatibility, mechanical testing, battery safety, packaging validation, EMC, biocompatibility).

The "Conclusions" section states that "Based on the intended use, indications for use, technological characteristics, and performance data, the subject Peleton Surgical Universal Power System is as safe and was concluded to be substantially equivalent to the applicable predicate devices." This is the core of a 510(k) submission, confirming equivalence for marketing, not diagnostic performance metrics against clinical ground truth.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided FDA 510(k) summary. The device described is a surgical instrument, not an AI/imaging device requiring diagnostic performance criteria.

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

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for:

-Blue LED 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.

• Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.

Microdermabrasion is intended for exfoliation of the skin.

Oxygen spray is intended to refresh the skin.

The subject device Oxylight 2.0 is a skin therapy system that was modified from the predicate device OxyLight cleared previously under K200104 for the LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray (General Wellness). The OxyLight 2.0 system includes two new LED handpieces called MyoLight. The MyoLight handpieces connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body.

This document is a 510(k) premarket notification for a medical device called OxyLight 2.0. It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (OxyLight, K200104) and thus does not contain the typical structure of a study proving a device meets specific clinical acceptance criteria for an AI/algorithm-based device.

The "acceptance criteria" and "device performance" in this context refer to the technical specifications and safety standards that the OxyLight 2.0 must meet to be considered substantially equivalent to its predicate. There is no AI or algorithm involved, and therefore, no performance metrics like accuracy, sensitivity, or specificity relative to a diagnostic task are presented.

Instead, the "study" proving the device meets acceptance criteria primarily involves non-clinical bench testing, electrical safety, electromagnetic compatibility, and biocompatibility.

Here's an analysis based on the provided document, addressing your points where applicable, and noting where the information is not relevant to this type of device submission:

1. A table of Acceptance Criteria and the Reported Device Performance

For this device (OxyLight 2.0), the "acceptance criteria" are not clinical performance metrics for an AI, but rather technical specifications and safety standards aligned with the predicate device. The "reported device performance" is the confirmation that the new device meets these technical specifications and passes the required non-clinical tests.

Note: This table reflects the comparison presented in the 510(k) summary, which is a key part of demonstrating substantial equivalence for physical devices.

Regarding AI/Algorithm-Specific Questions (Not applicable to this 510(k) submission):

This 510(k) submission is for a physical medical device (LED phototherapy and microdermabrasion system), not an AI/algorithm-based diagnostic or assistive software. Therefore, the following points are not applicable to this document:

2. Sample sizes used for the test set and data provenance: No test set of patient data (e.g., images for classification) was used for performance evaluation of an algorithm. The testing was physical device validation.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth established by experts for an algorithm's performance, as there is no algorithm.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. There is no human-in-the-loop AI assistance being evaluated.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the AI sense is not relevant here.
8. The sample size for the training set: Not applicable, as there is no AI algorithm being developed or trained.
9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being developed or trained.

Summary of the Study Proving Device Meets Criteria (Based on the document):

The "study" conducted for the OxyLight 2.0 to prove it meets acceptance criteria (i.e., is substantially equivalent and safe/effective for its intended use) is documented under "8. Non-Clinical Testing".

• Type of Study: Non-clinical validation and verification.
• Tests Conducted:
  • IEC 60601-1:2005/A1:2012: General Requirements for Basic Safety and Essential Performance (electrical safety).
  • IEC 60601-1-2:2014/EN 60601-1-2:2015: Electromagnetic Compatibility (EMC).
  • Biocompatibility Tests per ISO 10993 and FDA Guidance: To ensure materials in contact with skin are safe.
  • Software Validation & Verification Test: For the device's operational software.
  • Bench Testing: To verify the performance of the device's components and outputs (e.g., light wavelengths, energy/power outputs, and the function of the new handpieces).
• Assertions from the document: The applicant states these tests were "conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."
• Data Provenance (Implicit): The tests were performed in a controlled laboratory setting, adhering to international standards. The data is prospective as it was generated specifically for this submission. The origin is likely the manufacturer or accredited testing labs.
• Clinical Testing: The document explicitly states, "No clinical study is included in this submission." This indicates that substantial equivalence was demonstrated without new clinical trials, relying on the established safety and efficacy of the predicate device and the non-clinical testing of the modifications.

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are the established technical and safety specifications for similar devices, primarily the predicate. The "study" involves comprehensive non-clinical engineering and safety testing to demonstrate that the new device adheres to these specifications and introduces no new safety or efficacy concerns that would preclude a substantial equivalence determination.

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The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.

NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK.

Here's an analysis of the acceptance criteria and study information for the P300 Attachment and NSK Sterile Cutting Accessories, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, but a surgical attachment. Therefore, most of the requested AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable.

Acceptance Criteria and Reported Device Performance

The device appears to be a traditional medical device (Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories), and the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than a clinical study with traditional acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

The acceptance criteria are implied by the successful completion of specific non-clinical tests and demonstrations of compliance with relevant standards. The "performance" section describes the results of these tests, which effectively serve as the reported device performance meeting the implicit acceptance criteria of the standards and internal specifications.

Study Information

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

   • Sample Size: Not applicable. The "test set" in this context refers to samples used for non-clinical bench testing (e.g., cell cultures, animal models for biocompatibility, physical device units for functional testing). Specific numbers for these types of samples are not provided in the summary. For example, for the "Acute Systemic Toxicity Test," it mentions "mice" but not the count. The biocompatibility testing selected "worst-case representative models" (Slim Attachment 300, specific bur/nozzle models) for evaluation.
   • Data Provenance: The manufacturing site for NAKANISHI INC. is listed as Kanuma, Tochigi 322-8666 Japan. The tests would likely have been conducted by or for the manufacturer. The FDA 510(k) summary does not specify the country of origin for the testing facilities, but it typically aligns with the manufacturer's region or accredited labs. All testing is prospective in nature, as it's conducted specifically for demonstrating the safety and effectiveness of the device being submitted.

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. This is a non-clinical submission for a surgical instrument. "Ground truth" in the context of expert consensus, as might be used for AI diagnostic devices, is not a concept applied here. The "truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for material safety, reprocessing, and sterilization, verified through laboratory testing.

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

   • Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed to establish ground truth for a diagnostic outcome. This submission relies on objective physical, chemical, and biological testing results.

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. This is a non-clinical submission for a mechanical surgical instrument. MRMC studies are used for evaluating the performance of AI/CADe diagnostic devices in conjunction with human readers.

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

   • No. This device does not have an algorithm or AI component.

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

   • For this device, the "ground truth" is defined by established scientific and engineering principles, as articulated in national and international standards (e.g., ISO 10993 for biocompatibility, ISO 17664/17665/ANSI/AAMI ST79 for reprocessing, ISO 11137-2 for sterilization). Compliance with these standards, demonstrated through specific laboratory tests (e.g., cytotoxicity assays, sensitization tests, pyrogenicity tests, material characterization), serves as the evidence that the device is safe and performs as intended.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The iBur hubs and cutting accessories are intended to be used with the Stryker Core Consolidated Operating Room (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, 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/Transsphenoidal, and Orthopedic Spine.

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

iBur™ Hubs and 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.

The Stryker iBur™ Hubs are available in straight and angled styles and in one length – 12.5cm.

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.

Here's a breakdown of the acceptance criteria and the study information for the Stryker iBur™ hubs and cutting accessories, based on the provided document:

This document does not include specific quantitative acceptance criteria or detailed study results for performance metrics like accuracy, sensitivity, or specificity. Instead, it describes a non-clinical performance study designed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or performance metrics for the device. The reported performance is a qualitative statement of efficacy in comparison to the predicate device.

"Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence." |
| Biocompatibility | Device materials must be biocompatible. | Confirmed "Biocompatibility testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Sterilization & Packaging | Device must be sterilizable and maintain sterility. | Confirmed "Sterilization and packaging testing" was conducted, and results supported substantial equivalence. No details on specific criteria or results are provided. |
| Shelf Life | Shelf life must be adequate. | Reported shelf lives: Diamond Cutting Accessories = 1 year, Fluted Cutting Accessories Tool Steel = 1 year. (Predicate had 5 years and 3 years respectively, but deemed "Similar"). Hubs are reusable, so not applicable. Deemed "Similar" to predicate. |
| Cleaning Methods | Cleaning methods must be effective. | Reported as "Manual and mechanical (automated)" for both proposed and predicate devices. Deemed "Same". |
| Sterility Assurance Level | Maintain a specified sterility assurance level. | Reported as 10^-6 for both attachments (hubs) and cutting accessories for both proposed and predicate devices. Deemed "Same". |
| Energy Source | Must operate within specified parameters (RPM, pressure). | Reported as 5000-75000 rpm and 120 psi pneumatic pressure for both proposed and predicate devices. Deemed "Same". |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "performance testing" that was conducted. It generally refers to "the proposed devices" and "the products."
• Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. Given it is a non-clinical performance test for a medical device, the data provenance likely refers to in-house laboratory testing at Stryker.

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

• Number of Experts: Not applicable. This was a non-clinical performance test of a surgical tool, not a diagnostic device requiring expert interpretation of results to establish ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a non-clinical performance test.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)."
• Effect Size: Not applicable.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone (algorithm only without human-in-the-loop performance) non-clinical performance study was done for the device itself, separate from human interaction. This is described as "Functional / Performance Testing, Biocompatibility testing, Sterilization and packaging testing." This type of testing aims to confirm the physical and mechanical properties and safety aspects of the device in isolation, or with simulated use, rather than involving human operators for performance evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "Performance Data (Non-Clinical Tests)," the ground truth would be based on engineering specifications, material science standards, and established test methodologies to assess functionality, integrity, biocompatibility, and sterilization effectiveness. It's not based on expert consensus, pathology, or outcomes data in the traditional sense, as it's a hardware device rather than a diagnostic or interpretive tool.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a mechanical/surgical device, not an AI/Machine Learning algorithm that requires a "training set." The development process for such a device would involve design, prototyping, and iterative testing, not a "training set" in the computational sense.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of device.

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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 and bone. The system is specifically intended for use in Neurologic 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 provided text describes a 510(k) submission for the hekaDrill System. It includes details about performance testing, but it does not provide acceptance criteria in a quantitative format or a detailed study section with specific sample sizes, ground truth procedures, or expert involvement as requested.

However, based on the limited information available in the "Discussion of the Performance Testing" table, I can extract and infer some aspects related to acceptance criteria and reported device performance.

Here's an attempt to structure the answer based on the given information, with caveats about missing details:

Acceptance Criteria and Supporting Study for hekaDrill System

The K193630 submission for the hekaDrill System included performance testing to demonstrate the functionality and safety of the device compared to predicate devices. The following table summarizes the reported performance relative to general criteria.

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

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

• Sample Size: The document does not specify the sample sizes used for any of the performance tests. For instance, for "Cutting performance," it does not state how many devices were tested or how many cutting tasks were performed. For biocompatibility tests, the number of samples or specimens analyzed is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab-based performance tests for a new device submission, they would typically be prospective studies conducted in a controlled lab environment by Zethon Ltd (a UK company) or its contracted testing facilities.

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

• This information is not provided in the document. The performance tests described (cutting performance comparison, electrical safety, EMC, biocompatibility) are primarily objective, quantitative measurements against established standards or predicate device performance, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• This information is not applicable/provided. The tests are objective measurements against standards or predicate performance, not subjective readings requiring adjudication for ground truth.

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, hekaDrill System, is an electric cranial drill motor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance would not be relevant to this device.

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

• This information is not applicable. As stated above, the hekaDrill System is a surgical instrument, not an algorithm.

7. The type of ground truth used:

• For the General Performance (Cutting performance), the ground truth was based on a comparison to a predicate drill system (Midas Rex Drill Systems), implying the predicate's performance served as a benchmark for "equivalent or better."
• For Electrical Performance and Electromagnetic Compatibility, the ground truth was adherence to international consensus standards (IEC 60601-1:2005 and IEC 60601-1-2:2014, respectively).
• For Biocompatibility, the ground truth was established by recognized biocompatibility testing methods (e.g., L929 MEM Elution for cytotoxicity, Kligman Maximization for sensitization, etc.) where specific biological responses or lack thereof (e.g., "Non-cytotoxic," "Non-sensitizer") define compliance.

8. The sample size for the training set:

• This information is not applicable/provided. The device is a surgical instrument, not a machine learning algorithm that requires a training set.

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

• This information is not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

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