This is to certify that the BodyLoc™™ Whole Body Stereotactic Localizer System For Radiotherapy, as submitted under the above referenced 510(k) number, is indicated for use as a precision patient immobilization and positioning system for the purpose of performing diagnostic localization and fractionated stereotactic radiotherapy/ radiosurgery treatment. It is substantially equivalent to similar devices which are used to position the body during stereotactic radiotherapy of various body lesions. The decision and conditions under which the system is to be used is made by the patient's managing physician(s).

Device Description

The BodyLoc" is a body stereotactic localizer system which utilizes a coordinate reference system that can be used to reproducibly localize targets during diagnostic and treatment procedures. Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions. The BodyLoc" is supplied with a software program for calculation of BodyLoc" stereotactic coordinates from scanner images. Software is functional on IBM or IBM-compatible PC computers with Microsoft® Windows 95. Targets within the system can be aligned by use of the coordinate indicators on the sides of the frame and the moveable arc localizer. Immobilization is achieved by the use of a vacuum mold system or polyurethane foam mold for posterior (the part of the body nearest the frame base) areas and a thermoplastic body mold to cover large body surfaces in the ventral or anterior plane. The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations.

AI/ML Overview

The provided text describes the "BodyLoc™ Whole Body Stereotactic Localizer System For Radiotherapy" and presents a comparison to predicate devices, including performance data. However, it does not describe acceptance criteria in the traditional sense of pre-defined thresholds that the device must meet, nor does it detail a clinical study with a specified test set and ground truth. Instead, it demonstrates "substantial equivalence" to legally marketed predicate devices through a comparison of technological characteristics and performance metrics.

Here's an attempt to structure the information based on your request, highlighting what is implicitly or explicitly stated and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a comparison table where the performance of the BodyLoc™ is compared to predicate devices. The implicit acceptance criterion is that the BodyLoc™'s performance should be "substantially equivalent" or better than the predicate devices.

Feature / Metric	Predicate Device 1 (Elekta Stereotactic Body Frame)	Predicate Device 2 (Howmedica Extracranial Radiotherapy System)	BodyLoc™ (MIDCO®) Reported Performance	Implicit Acceptance Criteria / Conclusion (based on "substantially equivalent")
CT Localization error in the transversal plane (x-axis, y-axis)	Mean 3.1 mm	Mean 0.98 + 0.22 mm	Mean 0.5095 + 0.1058 mm	Better than both predicate devices.
CT localization error in the longitudinal plane (z-axis)	Range, 2-7 mm	Range, 0.9-3.5 mm	Range, 0.41-2.10 mm	Better than both predicate devices.
LINAC Set-up Error	Approximately 10 mm	Approximately 2.5 mm	Approximately 3.0 mm	Similar to Predicate 2, significantly better than Predicate 1.
Construction Material/Attenuation Coefficient (cm^-1)	Laminate of wood and plastic, 0.0467 cm^-1	Carbon fiber composite, Approximately 0.5 cm^-1	Polycarbonate, 0.029 cm^-1	Lower attenuation than both predicate devices (implies less interference with radiation).

Note: The document describes "an overall accuracy range substantially equivalent to that of predicate devices," which is a general statement. The specific numbers provided in the table indicate that the BodyLoc™ actually exceeds the performance of the predicate devices in terms of localization error, rather than just being "equivalent."

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

Test Set Sample Size: The document mentions "test calculations and measurements of multiple targets throughout the BodyLoc™ using various axial scan slice thicknesses." However, it does not specify a numerical sample size for the test set (e.g., number of targets, number of scan slices, or number of tests).
Data Provenance: The tests were "developed and performed by MIDCO®" for its BodyLoc System. The context suggests these were retrospective/benchtop tests conducted by the manufacturer, not clinical trials with human subjects. The country of origin of the data is not explicitly stated beyond MIDCO® being a US company.

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

The document does not mention the involvement of any experts (e.g., radiologists) in establishing ground truth for the performance tests. The ground truth for the localization and setup error measurements was likely established through precise physical measurements and pre-defined coordinates within the device itself:

"Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions."
"The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations."

This suggests the ground truth was based on the known physical locations of these fiducials and markers.

4. Adjudication Method for the Test Set

No adjudication method is described. The tests were likely objective measurements against known physical standards.

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

No MRMC comparative effectiveness study was conducted or reported. The device is a physical immobilization and localization system, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The reported performance metrics (CT localization error, LINAC Set-up Error) are "algorithm only" or "device only" metrics, demonstrating the accuracy of the BodyLoc™ system and its associated software for calculating stereotactic coordinates. The studies evaluated:

"the accuracy of the fiducial system."
"the axial imaging localization algorithm used with the fiducial system."
"the fiducial localization system in relation to quality assurance reference markers embedded in the base of the localizer at known stereotactic frame z-axis levels."
"The imaging fiducial localization algorithm was then tested against a scanner screen measurement method."

7. Type of Ground Truth Used

The ground truth used was based on known physical coordinates of fiducials and quality assurance markers embedded within the BodyLoc™ frame. This is effectively a physical standard or engineered ground truth, rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive AI.

8. Sample Size for the Training Set

No training set is mentioned. This device is a physical system with an associated software for coordinate calculation, not a machine learning or AI model trained on data. Therefore, the concept of a "training set" is not applicable here.

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

As there is no training set, this question is not applicable.

Summary of Missing Information:

Explicit, pre-defined "acceptance criteria" thresholds.
Specific numerical sample size for the tests (e.g., how many "multiple targets" were used).
Details on the methodology of the "Monte Carlo tests and test calculations."
Involvement of human experts in establishing ground truth for device performance.
Any form of clinical study or MRMC study.
Information related to machine learning/AI (training set, validation set, etc.) as the device does not appear to be an AI-driven diagnostic system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Medical Instrumentation and Diagnostics Corporation. The logo features a stylized "M" with a person climbing on it, along with the text "INCO" to the right of the M. Below the logo, the full name of the company, "Medical Instrumentation and Diagnostics Corporation," is written in a smaller font.

K991336

510(k) Summary

As required by section 807.92(c)

Trade Name:

BodyLoc™ Whole Body Stereotactic Localizer System For Radiotherapy

Common Name: Body Stereotactic Frame and Immobilizer Classification Name: X-ray Radiation Therapy System (accessory) Reference: Per 21 CFR Section 892.550 Proposed Regulatory Class: II

Submitter: MIDCO® 5995 Mira Mesa Blvd., Suite B San Diego, CA 92121 TEL. (619) 558-5880 FAX. (619) 558-5883 Contact: Tyrone L. Hardy, M.D. Date of Preparation: April 13, 1999

000392

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ldentification of Predicate Devices

a) Elekta Instrument AB

18140 Smokesignal Drive San Diego, CA 92127 Product Name: Stereotactic Body Frame 510(k) Number: K960338

b) Elekta Instrument AB St. Larsgatan 8 Linkoping, SW S-582 24 Product Name: Accessories to the Stereotactic Body Frame 510(k) Number: K970291

c) Howmedica Inc. (Leibinger) 359 Veteran Blvd. Rutherford, NH 07070-2584 Product Name: Extracranial Radiotherapy System 510(k) Number: K982463

Device Description

The BodyLoc" is a body stereotactic localizer system which utilizes a coordinate reference system that can be used to reproducibly localize targets during diagnostic and treatment procedures. Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions. The BodyLoc" is supplied with
a software program for calculation of BodyLoc" stereotactic coordinates from scanner images. Software is functional on IBM or IBM-compatible PC computers with Microsoft® Windows 95. Targets within the system can be aligned by use of the coordinate indicators on the sides of the frame and the moveable arc localizer. Immobilization is achieved by the use of a vacuum mold system or polyurethane foam mold for posterior (the part of the body nearest the frame base) areas and a thermoplastic body mold to cover large body surfaces in the ventral or anterior plane. The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations.

Intended Use

The BodyLoc™ is a body stereotactic frame device designed for stereotactic diagnostic localization and stereotactic radiotherapy of localized targets.

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Summary of Substantial Equivalence

MIDCO®'s body localizer (the BodyLoc™) is substantially equivalent in function, use, and performance to the stereotactic body frame predicate devices manufactured by Elekta Instruments AB and Howmedica (Leibinger). The dimensions of the BodyLoc™ are similar and it can be used with CT and MR imaging systems. The differences in the design of the BodyLoc " to predicate devices include the following:

Body localization with an uninterrupted fiducial indicator and coordinate a) localization system that extends continuously from the head to the pelvis/mid-thigh; and means for both,
Anterior and posterior immobilization over wide body areas for reliable b) repositioning and immobilization.

Technological Characteristics

The technological characteristics of the BodyLoc™ in comparison to predicate and legally marketed devices is provided in the following table entitled "Substantially Equivalent Devices Comparison Table".

Summary of Performance Data and Conclusions

MIDCO® developed tests to evaluate the functionality of its BodyLoc System as a stereotactic localization device. Since the BodyLoc" is a stereotactic immobilization system with an internal imaging fiducial localization system, it was necessary to test the accuracy of the fiducial system. Additional tests were developed to test the axial imaging localization algorithm used with the fiducial system. Tests were also developed to evaluate the fiducial localization system in relation to quality assurance reference markers embedded in the base of the localizer at known stereotactic frame z-axis levels. The imaging fiducial localization algorithm was then tested against a scanner screen measurement method. The latter screen coordinate measurement method can also be used as an additional target quality assurance method.

A series of Monte Carlo tests and test calculations and measurements of multiple targets throughout the BodyLoc" using various axial scan slice thicknesses resulted in an overall accuracy range substantially equivalent to that of predicate devices. The material used to manufacture the frame was evaluated under normal use, and the frame material was evaluated for radiation attenuation when irradiated with different MeV LINACs. These studies also demonstrated that the BodyLoc™ was safe and accurate in positioning a patient in relation to the coordinate reference system.

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SUBSTANTIALLY EQUIVALENT DEVICES COMPARISON TABLE
Features	Stereotactic Body Frame®(Elekta)K960338,K970291	Extracranial RadiotherapySystem (Howmedica/Fischer)K982463	TMBodyLoc(MIDCO®)
1.Anterior body form(immobilization)	No	No	Yes
2.Posterior body form(immobilization)	Yes	Yes	Yes
3.Dimensions	1000cm L x 50cm W x 20cm H	2000cm L x 50cm W x 18cm H	1125cm L x 55cm W x 19cm H
4.ConstructionMaterial/AttenuationCoefficient (cm")	Laminate of wood and plastic0.0467 cm™	Carbon fiber compositeApproximately 0.5 cm7	Polycarbonate0.029 cm™
5.Method of suppressingdiaphragmatic movements	Breastplate	Breastplate	Thermoplastic mold over chest andabdomen
દ.Stereotactic fiducialmarkers built into frame	Yes	Yes	Yes
7.Fixation	Vacuum pillow	Skeletal and/or Vacuum pillow	Vacuum pillow or foam mold andThermoplastic Mold
8.Imaging studies	CT scan before each treatmentAlso MR	Single CT scan before treatmentAlso MR	CT and/or MR scan before eachtreatment
Treatment modality9.	Photon linear accelerator	Photon linear accelerator	Photon linear accelerator
10. Radiation delivery	Usually 8-10 noncoplanar fixedbeams	Usually 4-6 noncoplanar fixed beams	Usually 4-10 noncoplanar fixed beams
11. CT Localization error in thetransversal plane.(x-axis, y-axis)	Mean 3.1 mm	Mean 0.98 + 0.22 mm	Mean 0.5095 + 0.1058 mm
12. CT localization error in thelongitudinal plane (z-axis)	Range, 2-7 mm	Range, 0.9-3.5 mm	Range, 0.41-2.10 mm
13. LINAC Set-up Error	Approximately 10 mm	Approximately 2.5 mm	Approximately 3.0 mm
14. Proposed clinicalapplications	Intraabdominal, intrathoracictherapeutic targets	Spinal, paraspinal and otherextracranial therapeutic targets	Head, neck, thoracic, pelvis, abdominaltherapeutic targets
15. Immobilization	Non-Invasive	Invasive/Non-Invasive	Non-Invasive

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, with flowing lines representing movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1.2 1999

Tyrone L. Hardy Medical Instrumentation and Diagnostics Corp. 5995 Mira Mesa Blvd, Suite B San Diego, California Suite B

RE:

K991336 BodyLoc Whole Body Stereotactic Localizer System for Radiotherapy Dated: April 15, 1999 Received: April 19, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Hardy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 either class III (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Dan Setiz

APT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications For Use

510(k) Number: _ K 99/336

Device name: BodyLoc"* Whole Body Stereotactic Localizer System For Radiotherapy

Indications For Use:

This form submitted by:

MIDCO® 5995 Mira Mesa Blvd., Suite B San Diego, CA 92121 TEL. (619) 558-5880 FAX. (619) 558-5883

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use

Colin m. Pillard

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number

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.