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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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