The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. This is accomplished through 31 pairs of opposing tungsten leaves, which allow the MMLC to shape the x-ray beam according to a treatment plan generated by a planning system such as the RSA XPlan software.

The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' XPlan Conformal Treatment Planning Software or any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.

Device Description

The Mini Multi-Leaf Collimator (MMLC) is a complete system consisting of an independent device that attaches to a Siemens linear accelerator (LINAC) for small field conformal radiosurgery or radiotherapy. Along with XPlan Conformal Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns created by independently actuated leaves.

The subject of this submission, the software modifications for the MMLC VR1, is for use in an installation of a Siemens LINAC with the Lantis Verify and Record system and the PrimeView front end. This program coordinates MMLC settings with the Siemens software and hardware and assures that the MMLC is set correctly to the same field as the LINAC setting, and can abort treatment if the MMLC cannot be set correctly.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured as requested. It's important to note that the provided text is a 510(k) summary and approval letter, which typically focuses on substantial equivalence rather than detailed performance studies with quantified acceptance criteria in the manner often sought for AI/ML device evaluations. As such, some of the requested information may not be explicitly present.

Acceptance Criteria and Study for MMLC VR1

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a formalized table of acceptance criteria with corresponding performance metrics in the way one might find for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "performance" described relates to the system's functionality and its ability to correctly interface and coordinate with the Siemens LINAC.

Acceptance Criteria (Implied)	Reported Device Performance
Software readiness for clinical use (general safety & effectiveness)	"Radionics Software Applications' MMLC VR1 system testing verifies that the software is ready for clinical use."
Correct functionality of the MMLC-Siemens interface	"A rigorous test of the functionality of the MMLC-Siemens interface was conducted using a Siemens LINAC, equipped with PrimeView and Lantis. The LINAC was equipped with the Radionics MMLC interface hardware (BCI box)."
Coordination of MMLC settings with LINAC settings	The software "coordinates MMLC settings with the Siemens software and hardware and assures that the MMLC is set correctly to the same field as the LINAC setting, and can abort treatment if the MMLC cannot be set correctly." (This implies successful coordination and safety abort functionality as criteria).
Equivalence to predicate device function for beam shaping	"In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years." (This is a statement of functional equivalence to established methods, which is a core concept in 510(k)).

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

Test Set Sample Size: The document does not specify a numerical sample size for the test set. It mentions "a rigorous test of the functionality of the MMLC-Siemens interface was conducted using a Siemens LINAC." This implies physical testing with at least one LINAC setup.
Data Provenance: The testing was conducted using a "Siemens LINAC, equipped with PrimeView and Lantis" and "Radionics MMLC interface hardware (BCI box)." This suggests a controlled, prospective testing environment rather than retrospective data analysis from patient studies. There is no information about the country of origin of the data beyond the company's location (Burlington, MA, USA).

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

This type of information is not provided in a 510(k) summary for a device like the MMLC. The "ground truth" for this device is not based on expert interpretation of medical images or patient outcomes, but rather on the correct mechanical and software functioning of the radiotherapy equipment. The "experts" involved would likely be engineers, physicists, and radiotherapy professionals conducting the functional tests, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The testing described is functional verification of mechanical and software interfaces, not expert adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The MMLC is for beam shaping in radiotherapy, not for diagnostic interpretation by human readers. Its "effectiveness" is in its ability to accurately and safely shape radiation beams, not in improving human diagnostic performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The MMLC VR1's performance is inherently tied to its interaction with the LINAC and the treatment planning software, and ultimately, human operators oversee its use. The testing described is a standalone functional verification of the software and hardware integration, ensuring the algorithm (software modifications) correctly coordinates MMLC settings and safety functions. It's not a standalone diagnostic algorithm in the typical sense of AI/ML.

7. The Type of Ground Truth Used

The ground truth used for this device's validation is based on the correct and safe operational functionality and physical accuracy of the MMLC in shaping the X-ray beam as intended by the treatment plan and in coordination with the LINAC. This includes:

Accurate setting of the MMLC leaves.
Correct coordination between MMLC settings and LINAC settings.
Effective abortion of treatment if MMLC settings are incorrect.

This is a technical ground truth rather than a medical/clinical ground truth (like pathology, expert consensus, or outcomes data).

8. The Sample Size for the Training Set

The document is a 510(k) summary for a hardware/software device primarily focused on mechanical functionality and software integration, not an AI/ML algorithm that learns from a "training set" of medical data. Therefore, the concept of a training set sample size, as typically understood for machine learning, does not apply here. The software modifications likely underwent traditional software development and testing cycles rather than machine learning training.

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

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of device and its submission. The software was likely developed against functional specifications and tested against expected operational behaviors, not 'trained' on patient data.

Summary

{0}------------------------------------------------

Section 5: 510(k) Summary

K993594

MMLC 510(k) Summary

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

Submitter of Premarket Notification:

Nancy C. MacDonald Sr. Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Telephone: (781) 272-1233 Fax: (781) 238-0645

Establishment Registration Number:

1222895

Performance Standards:

No applicable performance standards have been issued under section 514 of the Food, Drug & Cosmetic Act.

Device Name: Mini Multi-Leaf Collimator (MMLC VR1)

Common Name: Radiotherapy beam shaping block

Safety Summary:

Radionics Software Applications' MMLC VR1 system testing verifies that the software is ready for clinical use. A rigorous test of the functionality of the MMLC-Siemens interface was conducted using a Siemens LINAC, equipped with PrimeView and Lantis. The LINAC was equipped with the Radionics MMLC interface hardware (BCI box).

Predicate Device:

Radionics MMLC: 510(k) # K982549, dated December 30, 1998.

{1}------------------------------------------------

Intended Use:

The intended use for the MMLC VR1 is:

Device Description:

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/3 description: The image shows the date "DEC 1 5 1999" in a simple, sans-serif font. The letters and numbers are printed in black ink against a white background. The date is formatted with the month abbreviated, followed by the day and year.

Nancy MacDonald Senior Regulatory Affairs Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516 Re:

K993594 Radionics ConforMAX MMLC VR1 Dated: November 23, 1999 Received: November 24, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. MacDonald:

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 (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 verily 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/cdch/dsma/dsmamain.html".

Sincerely yours,

CAPT 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

{3}------------------------------------------------

ODE Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MMLC VR1

Indications for Use:

The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' XPlan Conformal Treatment Planning Software or any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.

(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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993594

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.