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Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time.

Neodent Instruments Kits are intended for sterilization of non-porous loads.

The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g

Neodent GM EasyGuide Kit Cases should not be stacked during sterilization

Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants:

Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry-time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time.

Neodent Instruments Kits are intended for sterilization of non-porous loads.

The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g.

Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices includes grommets manufactured from medical grade silicone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

Here's a summary of the acceptance criteria and study information for the Neodent EasyGuide Kit Cases, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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EasyGuide is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the EasyGuide treatment planning software.

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This FDA 510(k) clearance letter for the "EasyGuide" device, a software for pre-treatment planning of dental implants based on CT scans, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter is a notification of substantial equivalence to a predicate device, which means the FDA has determined it is as safe and effective as a legally marketed device. It does not typically include the in-depth technical performance characteristics or detailed study results that would satisfy your request for acceptance criteria and supporting study data.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance: This information is completely absent.
2. Sample size used for the test set and data provenance: No details on testing, sample sizes, or data origin are provided.
3. Number of experts used to establish ground truth and their qualifications: This is not mentioned.
4. Adjudication method for the test set: No information on this.
5. MRMC comparative effectiveness study details: This type of study is not mentioned or summarized.
6. Standalone (algorithm only) performance study details: Not present.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable, as this document is not about algorithm training or validation in that context.
9. How ground truth for the training set was established: Not applicable.

The letter focuses on the regulatory aspects of 510(k) clearance, such as product code, regulation number, substantial equivalence determination, and general controls. It refers to the "Indications for Use" for the device on the enclosed page, which is a high-level description of its intended use, but not performance specifications.

To obtain the information you're looking for, you would generally need to consult the actual 510(k) submission document itself, which contains the detailed testing and validation data provided by the manufacturer to the FDA. This summary letter does not include that level of detail.

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The Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as

• Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base tumor, Metastasis
• Treatment of vascular malformations, aneurysms
• Transnasal approaches

The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.

EasyGuide Spine is specially designed for spinal application areas such as:

• Stabilization techniques
• Tumor resection

The EasyGuide Spine option, which is the subject of this premarket notification, is an option for the EasyGuide Standard Workstation. The Spine option extends the functionality and application areas of the EasyGuide Standard Workstation to include pre-operative planning and intraoperative localizing and navigation during spinal surgical procedures.

The Spine option has the following features:

Hardware:

• Instrument Pointing
• Instrument Learner
• Instrument Switchbox
• Tracker
• Flexible camera pole
• Pedicle Awl

Software:

• 3D marker search
• Registration and tracking functions
• Planning and navigation functions
• Instrument learning

All instruments can be used in the surgical environments used in the sterile field can be autoclaved at 134° C. All other parts are easy to clean.

The provided document (K981480 for the Philips EasyGuide Spine option) is a 510(k) summary for a medical device and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical or performance study with metrics like sensitivity, specificity, or accuracy.

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, and compliance with general safety and regulatory standards.

Therefore, for aspects of your request that pertain to performance metrics, sample sizes, expert adjudication, or MRMC studies, the information is not present in this document.

Below is a response based only on the information available in the provided text.

Acceptance Criteria and Device Performance (Based on provided document)

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

• Not explicitly stated in the document. The document discusses compliance with safety and interoperability standards and substantial equivalence, but it does not describe a performance study with a test set of data or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable / Not stated. As no specific performance study utilizing a test set with ground truth is described, this information is not present.

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

• Not applicable / Not stated. No test set requiring adjudication is described.

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 study was not described. The document focuses on the device itself for surgical guidance, not on diagnostic interpretation or human reader performance improvement with AI assistance.

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

• No, a standalone performance study with specific metrics was not described. The submission is for a surgical guidance system that is inherently human-in-the-loop. The "performance" assessment is based on compliance with standards and substantial equivalence, not quantitative standalone algorithm performance.

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

• Not applicable / Not stated. No specific performance study requiring ground truth is described. The "ground truth" implicitly referred to would be established regulatory standards and the functional capabilities of predicate devices for the substantial equivalence claim.

7. The sample size for the training set:

• Not applicable / Not stated. No machine learning or AI training set is mentioned or described in the context of this 510(k) submission.

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

• Not applicable / Not stated. As no training set is mentioned, this information is not available.

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The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as:

• Frameless stereotactic procedures .
• Intra-operative resection of brain tumors .
• Biopsies .
• Endoscopic procedures .

The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation.

The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position during a surgical procedure when used with the EasyGuide Standard Workstation.

The EasyGuide Neuro (Release 1) Image Guided Surgery Workstation was cleared for marketing via 510(k) 961834. Since then the product structure for EasyGuide has been reconfigured into a basic version known as EasyGuide Standard and options to this version. EasyGuide Standard has also been called EasyGuide Neuro Basic. The EasyGuide Standard Workstation is the same as the EasyGuide Neuro Image Guided Surgery Workstation which was cleared for marketing as noted above. A Neuro (Release 2) option and an EasyTaxis option, which are the subjects of this premarket notification, are options for the Philips EasyGuide Standard Workstation. The Neuro (Release 2) option and the EasyTaxis option extend the functionality and application areas of the EasyGuide Standard Workstation.

The provided document is a 510(k) summary for the Philips EasyGuide Neuro (Release 2) and EasyTaxis options, which are enhancements to an existing Image Guided Surgery System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, the document does not contain the specific information requested regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies.

The document primarily states that the device complies with electrical safety standards (UL-2601), electromagnetic compatibility standards (IEC-601-1-2), and digital imaging communication standards (ACR/NEMA DICOM Version 3). These are not performance metrics in the way you might expect for diagnostic or AI-driven devices but rather safety and interoperability compliance.

Here's a summary of what is available in the document, framed against your request, and why other information is absent:

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

   • Acceptance Criteria (Compliance Statements):
     • Compliance with UL-2601 (electrical safety)
     • Compliance with IEC-601-1-2 (electromagnetic compatibility)
     • Compliance with ACR/NEMA DICOM Version 3 (digital imaging communication)
     • Compliance with Title 21 CFR Part 1040.10 (position digitizer laser)
   • Reported Device Performance: No quantitative performance metrics are provided in the context of clinical accuracy or efficacy studies. The "performance" described is its adherence to the aforementioned safety and communication standards. This is typical for a 510(k) focused on substantial equivalence for a surgical navigation system, where the efficacy is largely tied to predicate devices and the system's ability to accurately track instruments.

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

   • Not applicable / Not provided. The document describes a substantial equivalence submission, which doesn't typically require such detailed clinical study data for device clearance unless significant new claims or technologies are involved that differ substantially from predicates.

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

   • Not applicable / Not provided. No test set or related ground truth establishment is described.

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

   • Not applicable / Not provided.

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 / Not provided. This device is a surgical navigation system, not an AI diagnostic tool involving "human readers" in the typical sense.

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

   • Not applicable / Not provided. The device is inherently-human-in-the-loop as it assists surgeons.

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

   • Not applicable / Not provided.

8. The sample size for the training set:

   • Not applicable / Not provided.

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

   • Not applicable / Not provided.

In conclusion, this 510(k) document establishes substantial equivalence based on safety, interoperability, and functional similarity to predicate devices, rather than detailed performance studies with acceptance criteria based on clinical outcomes or accuracy metrics for a new, novel technology.

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The EasyGuide is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The EasyGuide facilitates image-supported decisions that may lead to more effective craniotomies, fewer unforeseen complications and shorter surgery times. As an interactive lightbox, Philips EasyGuide Neuro can facilitate image-based decision making. Anatomical structures can be visualized and surgical paths precisely determined before surgery. Decisions on the location and size of a tumor, or an arteriovenous malformation can be made with confidence. Critical areas can be identified and avoided for better access to pathology.

The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. The system includes a mobile workstation (based on the Easyvision workstation platform K925950), position digitizer, and dedicated instruments. The workstation is a combination of a Sun SPARC for running the EasyGuide software and a computer for processing the data from the position digitizer. The optical position digitizer uses two infrared CCD cameras mounted on a titanium alloy sub-frame and has a laser for easy positioning of the cameras. The instruments (pointers) are equipped with infrared light emitting diodes (LED). Signals from the LEDs are received by the CCD cameras. The computer processes this information and calculates the position, direction, and rotation of the pointer tip in space. The point of space is then shown on the monitor, overlaid on the image generated from the pre-operative scans.

The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. While the input document provides details on the system description, performance standards, safety information, and intended use, it does not contain specific acceptance criteria tables or detailed study designs that definitively "prove" the device meets such criteria in a statistically rigorous manner.

However, based on the provided text, we can infer a key performance metric and a qualitative assessment of the device's benefits.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with predefined thresholds. The "reported device performance" is derived from the results of the clinical evaluation described.

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

• Sample Size: The document refers to "the patient population in the study" for which the mean RMSE was calculated. A specific number for this patient population/test set is not provided.
• Data Provenance: The system "has been extensively investigated during clinical trials in the United States and Europe." This indicates a prospective nature for at least part of the data collection in a clinical setting across multiple geographies.

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

• The document describes a comparative planning study where "two plannings for neurosurgery were made: a planning using conventional means... and a planning using EasyGuide Neuro interactively." These were performed by neurosurgeons or medical professionals involved in neurosurgical planning.
• The comparison involved "Both incision lines and planned craniotomy were compared in term of size. Shape and location (centering)."
• Number of Experts: Not explicitly stated. It implies at least one neurosurgeon or planning expert for each planning method ("a planning... was performed prior to using EasyGuide Neuro," and "a planning using EasyGuide Neuro interactively... led to a second incision line.").
• Qualifications of Experts: Implied to be neurosurgeons or professionals involved in neurosurgical planning. No specific years of experience or board certifications are mentioned.

4. Adjudication Method for the Test Set

• The document describes a comparison between two planning methods (conventional vs. EasyGuide Neuro). The comparison was made "in term of size. Shape and location (centering)" of incision lines and planned craniotomy.
• Adjudication Method: The text does not describe a formal adjudication process (e.g., 2+1, 3+1). It appears to be a direct comparison of the outputs of the two planning methods, likely assessed by the involved surgeons or study investigators.

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

• No, an MRMC comparative effectiveness study is not explicitly described. The study focused on comparing two planning methods (conventional vs. EasyGuide Neuro) rather than comparing multiple human readers' performance with and without AI assistance. The "assistance" itself is the EasyGuide Neuro system.
• Effect Size: Therefore, no effect size of how much human readers improve with AI vs. without AI assistance is reported. The benefit is framed as the system's ability to achieve "significantly smaller craniotomies" and offering other clinical advantages compared to conventional methods.

6. Standalone (Algorithm Only) Performance

• Yes, in part. The "mean RMSE = 4.1 mm" for neuronavigation accuracy is a standalone performance metric of the system's ability to correlate a point in space with pre-operative images, distinct from comparing human decision-making. The system's interactive nature means the "algorithm only" aspect is integrated with human review, but the RMSE is a measurement of the system's intrinsic accuracy.

7. Type of Ground Truth Used

• Inferred based on the study design:
  • For the "mean RMSE = 4.1 mm," the ground truth for navigation accuracy would likely involve physical phantom measurements and/or intraoperative verification (e.g., comparing the system's indicated position with known anatomical landmarks or actual surgical targets). The document states the "interactive portion (the optical position digitizer) has been tested in both laboratory and clinical environments," supporting this inference.
  • For the craniotomy size and clinical benefits, the ground truth was based on the outcome and assessment of surgical planning by medical professionals in a clinical setting compared to conventional methods. This can be considered a form of expert assessment/consensus on clinical utility and efficacy.

8. Sample Size for the Training Set

• Not provided. The document describes a study to evaluate benefits and effectiveness, implying a test or evaluation cohort. There is no information about a separate training set or the process of training the system (as it predates modern deep learning paradigms for most medical devices of this era).

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

• Not applicable/Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned. The system appears to rely on established engineering principles for image processing, digitization, and anatomical correlation rather than a machine learning model requiring a distinct training phase in the modern sense.

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