This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.

Device Description

The Aktina Pinpoint Head and Neck Stereotactic Localizer, Part Number 50-100, is used for the localization and fixation of patients undergoing stereotactic radiotherapy and radiosurgery of the cranial area, as well as radiotherapy of the head and neck area. Fixation is accomplished via two components: a customized Dental Tray that with the aid of slight vacuum suction fixes to the roof of the patient's mouth, and a customized head and neck support. Localization is accomplished via two components: a hardware component which comprises of a Stereotactic Fiducial Frame that is positioned over the patient's treatment area while being accurately interfaced to the Dental Tray, and a software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.

AI/ML Overview

The K103616 510(k) submission for the "Pinpoint Stereotactic Head and Neck Localizer" does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for submissions involving AI/software with performance metrics.

This submission is for a physical medical device (a head and neck fixation system with stereotactic localization hardware and software). The emphasis is on proving substantial equivalence to a predicate device, as opposed to demonstrating specific diagnostic or predictive performance metrics.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative performance benchmarks.	The device is deemed substantially equivalent to its predicate device (Aktina Medical Corporation's Stereotactic Head and Neck Localizer, K081935). The key reported performance is that "Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met." This is a general statement, not a specific performance metric.

Reasoning for Absence: The submission focuses on proving substantial equivalence to a predicate device, which had previously demonstrated its safety and effectiveness. The modifications to the device (new mouthpiece design with external vacuum port) are described as not altering its fundamental form, fit, or function, thus not requiring new performance studies with specific acceptance criteria in the context of diagnostic accuracy.

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

Sample Size: Not applicable/not provided. This is a hardware device with localization software, not a diagnostic AI system evaluated on a dataset of patient images.
Data Provenance: Not applicable/not provided.

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

Not applicable. Ground truth establishment by experts for a test set of data is not relevant for this type of device submission.

4. Adjudication Method for the Test Set:

Not applicable.

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

No. This is not an AI-assisted diagnostic or interpretation system. The "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame" is a localization algorithm, not a system for human reader interpretation improvement.

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

The submission mentions a "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame." While this is an algorithm, the 510(k) does not describe a standalone performance study with metrics like accuracy, sensitivity, or specificity for this software component. The focus is on the overall system's equivalence. Hardware specification testing is mentioned, which would include verification of the integrated system's function.

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

Not applicable in the context of evaluating a diagnostic or predictive algorithm. For the localization software, the "ground truth" would likely involve precise physical measurements of the fiducial frame and geometric validation against CT scans, rather than clinical ground truth from patient data.

8. The sample size for the training set:

Not applicable. There is no mention of a machine learning training set for an AI model in this submission. The software component described is likely based on deterministic algorithms for coordinate system determination, rather than a learned model.

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

Not applicable.

Summary of the Study per the 510(k):

The "study" presented in this 510(k) is primarily a substantial equivalence comparison to a predicate device, rather than a detailed performance study with quantitative acceptance criteria for a new AI or diagnostic algorithm.

The core of the "study" is outlined in Section 7, "Performance Standards and Data," and Section 9, "Summary of Substantial Equivalence":

Performance Data: "Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met." This suggests internal testing against engineering specifications, but specific metrics are not disclosed in this summary.
Biocompatibility: The new mouthpiece components were evaluated against ISO-10993-1, demonstrating biocompatibility for surface contact of less than 24 hours.

The FDA's decision to clear the device K103616 relies on its similarity in design and intended use to the predicate device (K081935), with the conclusion that "No new issues of safety or effectiveness are introduced by using this device." This implies that the predicate device's established safety and performance profile is leveraged for the current device due to their high degree of similarity and the minor nature of the changes.

Summary

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K103616

JAN 2 5 2011

510(k) Summary

In Compliance with 21 CFR Section 807.92(c)

1. General Provisions

Device Trade Name:	Pinpoint Stereotactic Head and Neck Localizer
Common Name:	Head and Neck Fixation System
Owner Nameand Address:	Aktina Medical Corporation360 North Route 9 WCongers, New York, 10920Phone: 845-268-0101Fax: 845-268-1700Registration Number: 2436865
Contact Person:	Tony Spaccarotella
Date:	December 3 2010

2. Classification

This device is classified as class II according to 21 CFR 892.5050, "Medical charged-particle radiation therapy system." The product code is IYE.

3. Predicate Device

Stereotactic Head and Neck Localizer, K081935, manufactured by Aktina Medical Corporation, 360 North Route 9 W, Congers, New York, 10920

4. Description

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the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.

5. . Intended Use

6. Technological Characteristics

The Aktina Medical Pinpoint Stereotactic Head and Neck Localizer is identical to the predicate device, except that an additional source has been added for both the mouthpiece and its materials and the mouthpiece vacuum port is external to the patient rather than inside the mouth. The new mouthpiece and the original mouthpiece are otherwise identical in form, fit and function.

7. Performance Standards and Data

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product

Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met.

8. Biocompatibility

The Aktina Medical Corporation Pinpoint Stereotactic Head and Neck Localizer and its associated components, including the new mouthpiece, have been shown to be biocompatible per the requirements of the FDA's Blue Book Memorandum #G95-1, entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for surface devices in contact with the skin or a mucosal membrane with a contact duration of less than 24 hours.

9. Summary of Substantial Equivalence

This device is similar to the predicate device in design and intended use, as well as technological, physical, and performance characteristics. No new issues of safety or effectiveness are introduced by using this device.

.. .

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tony Spaccarotella Director Quality Assurance/Regulatory Affairs Aktina Medical Corporation 360 North Route 9W CONGERS NY 10920

JAN 2 5 201

Re: K103616

Trade/Device Name: Pinpoint Stereotactic Head and Neck Localizer Regulation Number: 21 CFR 892,5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 8, 2010 Received: December 10, 2010

Dear Mr. Spaccarotella:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Spatola

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 4

Indications for Use

510(k) Number (if known):

Device Name: __ Pinpoint Stereotactic Head and Neck Localizer

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

510K. K103616

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.