Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Device Description

An "Innocure IMRT Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan and field identification. The Compensator device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block tray.

An "Innocure IMRT Radiation Blocking Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The Blocking device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.

An "Innocure Radiation Wound Protective Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.

AI/ML Overview

This document, K052383, is a 510(k) premarket notification for the "Innocure Intensity Modulating Radiation Therapy Compensators." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not explicitly available in this document. This is common for 510(k) submissions, which typically rely on comparison to a legally marketed predicate device rather than de novo clinical performance studies with detailed statistical analyses.

Here's a breakdown of what information can be extracted and what cannot:

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

Not explicitly provided. This document is a 510(k) summary, which asserts substantial equivalence based on intended use and technological characteristics to a predicate device. It doesn't present specific performance metrics or acceptance criteria that a new, de novo study would typically establish.

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

Not applicable/Not provided. This is not a clinical study on a test set of patients or medical images. The device is a physical compensator used in radiation therapy. The "test set" would implicitly be the technological characteristics and intended use compared against the predicate device.

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 "ground truth" establishment by experts in the context of a medical image or clinical outcome assessment is described, as this is a device for radiation beam shaping.

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

Not applicable/Not provided. There is no test set in the sense of a dataset requiring adjudication.

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

No. This device is an Intensity Modulating Radiation Therapy Compensator, a physical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

Not applicable/Not provided. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device (Southeastern Radiation Products, Inc., K040804). The new device asserts that its technological characteristics and intended use are sufficiently similar not to introduce new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable/Not provided.

Summary of available information relevant to "acceptance criteria" and "study":

The "study" presented is essentially the 510(k) submission process itself, which aims to demonstrate substantial equivalence to a predicate device rather than meeting specific performance criteria through a new clinical trial.

Predicate Device:

Name: ".Decimal Tissue Compensator/Intensity Modulator"
510(k) Number: K040804
Manufacturer: Southeastern Radiation Products, Inc.

Acceptance Criteria (Implicit via Substantial Equivalence):

The acceptance criteria, though not explicitly numerical targets, are implicitly the requirements for substantial equivalence as defined by the FDA. This means the device must:

Have the same intended use as the predicate device.
Have similar technological characteristics to the predicate device.
Not raise different questions of safety and effectiveness than the predicate device.

Reported Device Performance (Implicit via Comparative Analysis):

The document states:
"The subject devices...have the same intended use and similar characteristics as the predicate device and does not introduce new issues of safety or effectiveness."

This statement is the "reported device performance" in the context of a 510(k) submission – it asserts that the new device performs equivalently to the predicate device concerning safety and effectiveness, based on a comparison of its design, materials, and intended use. No specific quantifiable "performance" metrics for the Innocure compensators are provided beyond this assertion of similarity.

Summary

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Premarket Notification 510(k) Summary as required by 21 CFR 807.92

Date summary was prepared:

February 15, 2006

Manufacturer's Name:

Innocure, LLC 201 East Southern Avenue Suite 201 Tempe, AZ 85282-5133

Contact Person:

Donald W. Collins, Ph.D. Chairman and CTO 201 East Southern Avenue Suite 201 Tempe, AZ 85282-5133

Phone:	480-966-0980
Fax:	480-345-2850
Cell:	602-319-8620
Email:	Donald.collins@innocure.com

Trade Name:

Innocure Intensity Modulating Radiation Therapy Compensators including:

Innocure IMRT Filter™ Innocure IMRT Radiation Blocking Filter™ Innocure Radiation Wound Protective Blocking Filter™

Common Name:

Compensating Filters

Classification Name:

Radiation Therapy Beam Shaping Block (21 CFR §892.5710, Product Code: IXI)

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Predicate Device:

Southeastern Radiation Products, Inc., K040804, ".Decimal Tissue Compensator/Intensity Modulator".

Device Descriptions:

Intended Use:

Innocure Intensity Modulating Radiation Therapy Compensators are intended to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Technological Characteristics:

Innocure manufactures Intensity Modulated Radiation Therapy (IMRT) filters from a solid Aluminum (6061T6) block, solid Brass 360 block, and a reverse Styrofoam or Polystyrene Mold block to be filled with Molten Cerrobend or Tungsten Powdered Metal.

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Conclusions:

The subject devices, "Innocure "Innocure IMRT Fiiter™ (Compensators)", "Innocure IMRT Radiation Blocking Filters™ (Compensators)" and "Innocure Radiation Wound Protective Filters™ (Compensators)" for Radiation Therapy have the same intended use and similar characteristics as the predicate device and does not introduce new issues of safety or effectiveness.

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Public Health Service

MAR 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Donald W. Collins, Ph.D. Chairman and CTO Innocure, LLC 201 East Southern Avenue Suites 201 & 202 TEMPE AZ 85282-5133

Re: K052383

Trade/Device Name: Innocure Intensity Modulating Radiation Therapy Compensators including: Innocure IMRT Filter™, Innocure IMRT Radiation Bolcking Filter™, Innocure Radiation Wound Protective Blocking FilterTM Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: February 15, 2006 Received: February 21, 2006

Dear Dr. Collins:

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 either class II (Special Controls) or class 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality of your (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Higdon

Namey C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K052383 510(k) Number:

Innocure Intensity Modulating Radiation Therapy Device Name: Compensators including:

Innocure IMRT Filter™ Innocure IMRT Radiation Blocking Filter™ Innocure Radiation Wound Protective Blocking Filter™

Indications for Use: Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).

Prescription Use YES (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

Innocure, LLC

Tab 4

Regulation Number and Section

N/A