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SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.

SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.

SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.

SagiPlan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input manually entered by the operator.

The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) remote afterloaders.

The main use of SagiPlan is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).

SaqiPlan can reconstruct one or more applicators.

Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device.

The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

The SagiPlan System comprises subjoined listed subsystems:

• . Personal Computer to execute the SagiPlan software.
• . Monitor to visualise the treatment planning process.
• . Keyboard to enter treatment data.
• . Mouse to select objects on the screen

The PC is used to execute the SagiPlan software and runs under Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the SagiPlan device.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics for a novel technology. Therefore, many of the requested details about specific performance outcomes and detailed study methodologies are not present in this document.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" table in the way one might expect for a new algorithmic device with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the substantial equivalence argument relies on the device having the same technological characteristics and same intended use as a legally marketed predicate device.

Table 1: Absence of Explicit Quantitative Acceptance Criteria and Performance

Study Information (Based on Available Text)

Given the nature of a 510(k) summary for a brachytherapy treatment planning system, the "study" described is primarily a comparison of technological characteristics and intended use against a predicate device, rather than a clinical trial or performance study against a ground truth.

2. Sample size 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 does not describe a "test set" in the context of evaluating an AI or algorithmic performance against real-world data. The evaluation is a comparison of design and intended function.

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: There is no mention of experts establishing a ground truth for an evaluation dataset.

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

• Not Applicable / Not Provided: No adjudication method is mentioned as there's no described test set or expert evaluation.

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 document does not describe an MRMC study. The SagiPlan is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study.

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

• Kind of, but not a "performance study" in the modern sense: The "study" here is a technical comparison by the manufacturer to demonstrate that the SagiPlan software (algorithm) functions in a manner substantially equivalent to the predicate device. This isn't a direct standalone performance validation against a ground truth dataset, but rather an assertion of functional equivalence. The software itself, without human input, calculates treatment plans based on user-entered data and images.

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

• Not Applicable / Not Provided: No explicit "ground truth" for a performance evaluation is mentioned. The "truth" in this context is implicitly the established and accepted functionality and outputs of the legally marketed predicate device, HDRplus. The SagiPlan is deemed "substantially equivalent" if its characteristics align with this predicate.

8. The sample size for the training set

• Not Applicable / Not Provided: The document does not describe an AI/ML model that undergoes a "training" phase with a dataset. It describes a software package that performs calculations.

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

• Not Applicable / Not Provided: As there's no described training set, there's no ground truth establishment for it.

Summary of the "Study" from the Document:

The "study" described is entirely focused on a Substantial Equivalence (SE) determination under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. For the SagiPlan device, this involves:

• Identification of a Predicate Device: HDRplus (K123263) from the same manufacturer.
• Comparison of Intended Use: SagiPlan and HDRplus have the "same intended use" (creation of treatment plans for remote afterloader based HDR brachytherapy).
• Comparison of Technological Characteristics: The document states SagiPlan has the "same technological characteristics" as the predicate, relying on a computer system, monitor, keyboard, mouse, and optionally a film scanner or frame grabber, running on Windows. It also states the differences "do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device."

Essentially, the "study" is a regulatory comparison showing that the design and stated function of SagiPlan are sufficiently similar to an already cleared device, implying that its performance and safety are also similar, without requiring new clinical performance data.

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SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.

The SagiNova "HDR afterloading systems are computer controlled medical devices that provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose.

The SagiNova HDR afterloading system includes the following models:

SagiNova®: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 25 channels
SagiNova® S: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 5 channels
SagiNova® Ir: Safe shielding suitable for a Ir 192 Source, Contains 25 channels
SagiNova® Ir-S: Safe shielding suitable for a Ir 192 Source, Contains 5 channels

These afterloading systems include the same treatment unit, applicators, and accessories. They differ in the type of radioactive source that can be accommodated within the shielded safe of the treatment unit and the number of allowed treatment channels.

• The SagiNova and SagiNova Sare capable of accommodating a Co-60 or Ir-192 radioactive . source due to the tungsten and lead safe that is incorporated within the treatment unit. These sources (Co-60 and Ir-192) are nearly identical in construction and clinical performance but differ in half life (Co-60 = 1953.2 days, Ir-192=73.4 days) and maximum activity (Co-60 = 2.2 Ci, Ir-192=13Ci).
• 0 The SagiNova Ir and SagiNova Ir-S can only accommodate an Ir-192, 13 Ci radioactive source within the lead safe that is incorporated in the treatment unit.

The number of treatment channels does not interfere with the performance of the device or the size of the implant that can be treated, but strictly limits the number of channels that can be connected at one time. This difference was designed to provide the user with a system that meets their specific clinical requirements. For standard HDR brachytherapy, e.g. GYN treatment, the 5 channel systems (SagiNova S and SagiNova Ir-S) are sufficient. While clinics that routinely perform more complex HDR brachytherapy implants, e.g. interstitial treatment, the 25 channel systems (SagiNova "Ir) are required.

The applicators and accessories are interchangeable between all SagiNova "models and are based on clinically accepted designs required for HDR remote afterloading brachytherapy treatment. The range of applicators includes:

• Intracavitary GYN applicators for the treatment of the vagina, cervix and endometrium including o tandem and ovoid, ring applicators and vaginal cylinders.
• . Interstitial applicators for the treatment of breast, prostate, and soft tissue including templates, needles and flexible catheters.
• 0 Intraluminal applicators for the treatment of esophagus, lung, nasopharynx including molds, catheters and bougie tubes
• o Intraoperative applicators for the treatment of tumor beds include needles, catheters, and molds
• 0 Surface applicators for the treatment of skin surface and mucosa including flexible molds.

The applicators are available for different imaging modalities including CT/MR and X-ray imaging. The applicators are securely connected to the SagiNova with specially designed transfer tubes or connectors. The transfer tube designs are based on the type of applicator to be connected to the treatment unit, e.g. "Easy Click" transfer tubes for plastic needles and catheters, Transfer Tubes for GYN applicators and metal needles and connectors for universal applicators.

The different components of the SagiNova HDR remote afterloading system work together to provide safe and effective HDR brachytherapy treatment to physician prescribed treatment areas.

The provided text describes the SagiNova® HDR Afterloading System, a medical device for brachytherapy treatment. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices through non-clinical testing. It explicitly states that clinical testing was not required.

Therefore, the following information regarding acceptance criteria and a study to prove the device meets these criteria can be extracted, with some items explicitly stated as not applicable or not performed:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-2-17 (Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment)
• IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-2 (Likely referring to a specific part of the IEC 60601- series, general safety for medical electrical equipment)
• IEC 60601-1-6 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability)
• IEC 60601-8 (Likely referring to a specific part of the IEC 60601- series) | "Confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met." |
  | Software Testing | Design and functionality testing in accordance with:
• Product specifications
• Risk control measures
• Usability requirements | "Confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met." |
  | Radioactive Sources | - Source integrity (Co-60 and Ir-192 sources)
• Weld connections for both sources
• Durability: 100,000 source transfers with Co-60 source (in SagiNova and SagiNova S)
• Durability: 25,000 source transfers with Ir-192 source (in SagiNova, SagiNova Ir, and SagiNova Ir-S)
• Compliance with ISO 2919 (Radiation protection - Sealed radioactive sources - General requirements and classification) | "Confirmed the source integrity and all weld connections for both sources, including 100,000 source transfers with the Co-60 source... and 25,000 source transfers with the Ir 192 source..." |
  | Applicators | - Design and functionality testing (in accordance with applicator specifications and risk control measures)
• Biocompatibility of materials (ISO 10993-5, ISO 10993-6, ISO 10993-9, ISO 10993-13, ISO 10993-7)
• MR Testing (ASTM 2052-6, F2213-06e1, F2119-07, F2182-11a, ASTM F2503-13)
• Sterilization testing for EtO (ISO 11135)
• Sterilization testing for steam sterilization (ISO 17665-1) | "Performed in accordance with the applicator specifications and risk control measures with additional testing performed for; biocompatibility... MR Testing... and sterilization testing..." |
  | Overall Performance | Meeting defined functional requirements, applicable recognized standards, and clinical expectations. Performance comparable to legally marketed predicate devices. | "Confirmed that the product meets the defined functional requirements, the applicable recognized standards and clinical expectations. These results were the same if not better than performed for the predicate devices and confirms that the device is safe and effective for clinical use." |

2. Sample size used for the test set and the data provenance
The document describes non-clinical testing rather than a study with a test set of data. The testing involved specific hardware components, software, radioactive sources, and applicators.

• Sample size for hardware/software/applicator testing: Not explicitly stated as a "sample size" in the conventional statistical sense, but rather a comprehensive suite of tests on the device and its components.
• Sample size for source durability: 100,000 source transfers for Co-60 and 25,000 for Ir-192.
• Data provenance: Internal testing by Eckert & Ziegler BEBIG GmbH and external test laboratories. Country of origin for the testing is primarily Germany, as the company is based in Berlin, Germany. The testing described is prospective, in that it was conducted specifically to validate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is a non-clinical device validation study, not a study evaluating expert performance or diagnostic accuracy. "Ground truth" in this context refers to the defined engineering specifications and regulatory standards.

4. Adjudication method for the test set
Not applicable. The testing involved verifying compliance with established engineering specifications and international standards, not subjective evaluation 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 MRMC comparative effectiveness study was performed. The device is an HDR afterloading system, not an AI-powered diagnostic or decision support tool for human readers. Clinical testing was explicitly stated as not required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a device that autonomously performs brachytherapy based on physician-prescribed dose plans. The "standalone" performance was verified through comprehensive hardware and software testing to ensure it operates according to specifications without human intervention during the treatment delivery phase. There is no "algorithm only" performance reported in the context of diagnostic accuracy, but the device's functional algorithms were tested.

7. The type of ground truth used
The "ground truth" for this device validation (non-clinical testing) was based on:

• Engineering specifications and product requirements.
• Established international standards (e.g., IEC 60601 series, ISO 2919, ISO 10993 series, ISO 11135, ISO 17665-1, ASTM standards for MR compatibility).
• Risk management processes.
• "Clinical expectations," although clinical trials were not performed.

8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI algorithm development study.

9. How the ground truth for the training set was established
Not applicable, as there was no training set.

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IsoSeed I25.S17plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.

IsoSeed I25.S17plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation as temporary implants. IsoSeed 125.S17plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed I25.S17plus.

IsoSeed I25.S17plus is a radioactive brachytherapy source intended for permanent as well as temporary implantation. IsoSeed 125.S17plus is a cylindrical sealed source containing radioactive lodine-125. The source is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. The radioactive iodine 1-125 is deposited as silver iodide (Agl) on the surface of a silver bar. The silver bar also serves as an X-ray marker.

lodine-125 has a half-life of 59.41 days. It decays with 100% to Te-125 as a result of electron capture by the radiation of X-rays and y-radiation in the energy range up to 35 keV. The most commonly used activities used for implants are up to 1.045 mCi. Other source strengths for temporary applications are available up to 25 mCi.

IsoSeed I25.S17plus is delivered non-sterile and must be steam sterilized by the user. The device is intended for single use, unless it is used as temporary implant without direct tissue contact.

The provided text describes a medical device, the IsoSeed I25.S17plus brachytherapy iodine-125 source, and its regulatory submission (K140849) for substantial equivalence to existing predicate devices. However, the document does not contain any information regarding acceptance criteria for a device's performance, nor does it describe a study to prove such performance criteria were met.

The document pertains to the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence with respect to safety and effectiveness, not a performance study with acceptance criteria.

Therefore, for the information requested I must state that none of the requested information (points 1-9) can be extracted from the provided text as it does not describe a performance study or acceptance criteria for the device.

The document details:

• Device Name: IsoSeed I25.S17plus brachytherapy iodine-125 source
• Classification: Class II, 21 CFR 892.5730 Radionuclide brachytherapy source, Product code KXK
• Predicate Devices: Nucletron SelectSeed I-125 (K002429), Eckert & Ziegler BEBIG IsoSeed I-125 (K033781), Medi-Physics OncoSeed 6711 (K914281)
• Device Description: Cylindrical sealed source, 4.5 mm long, 0.8 mm diameter, titanium capsule, radioactive Iodine-125 deposited as silver iodide on a silver bar. Half-life of 59.41 days.
• Intended Use/Indications for Use: For permanent interstitial implantation of selected localized tumors (low to moderate radiosensitivity), either as primary treatment or for residual disease. Specific activity ranges are detailed for different applications (0.189 to 1.045 mCi for permanent implants; > 1.045 mCi for temporary implants or tumors requiring higher activity).
• Nonclinical Testing: Tests according to ISO 2919 (classified C 63X11), MR compatibility tests (ASTM F2503, ASTM 2052, ASTM 2213, ASTM 2182, ASTM 2119), and Biocompatibility tests (ISO 10993-1, ISO 10993-5, ISO 10993-18). These were performed to support safety claims, not a substantial equivalence determination based on performance.
• Clinical Testing: "Not applicable"

Conclusion: The provided text is a 510(k) summary for a medical device seeking clearance through substantial equivalence. It confirms the physical characteristics, indications, and safety testing (non-clinical) to show it's similar to already approved devices. It explicitly states "Summary of Clinical Testing: Not applicable," which means no clinical performance study was conducted or presented in this document for the purpose of establishing acceptance criteria or proving device performance in that context.

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HDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.

HDRplus is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input entered by the operator. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR). HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

The HDRplus System comprises subjoined listed subsystems:

• Personal Computer . It executes the HDRplus software.
• Monitor . To visualise the treatment planning process.
• Keyboard . To enter treatment data.
• Mouse . To select objects on the screen

The PC is used to execute the HDRplus software and runs under Windows XP Professional or Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

Accessory: Film Scanner
The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.

Accessory: Pen Tablet
The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

Accessory: Touch Panel
The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.

The provided document is a 510(k) summary for a medical device called HDRplus, a Brachytherapy Treatment Planning System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for specific performance metrics is not available in the provided text.

The document discusses the device's intended use, technological characteristics, and comparison to a predicate device, concluding that it is substantially equivalent. However, it does not detail a study designed to explicitly test and report on acceptance criteria for device accuracy or clinical performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Available. The document does not provide a table of acceptance criteria or specific, quantifiable performance metrics for the HDRplus treatment planning system. The focus is on substantial equivalence to a predicate device, implying that its performance is expected to be comparable, but no direct performance data or acceptance targets are listed.

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

• Not Available. The document does not mention any specific test sets, sample sizes, or data provenance from a study evaluating the HDRplus system against acceptance criteria.

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 Available. Since no specific test set or ground truth establishment process is described for performance evaluation, information about experts is not provided.

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

• Not Available. No adjudication method is mentioned as there is no description of a formal test set evaluation process.

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 Available. The HDRplus is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study. It aids in calculating optimal dose distribution. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not described or relevant for this type of device based on the provided information.

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

• Partially Applicable / Not Explicitly Detailed as a "Study": The device, HDRplus, is a software package that "calculates a proposed treatment course" and "calculates the optimal dose distribution." This implies a "standalone" algorithmic function. However, the document does not present this as a separate "study" with specific performance metrics and acceptance criteria for "algorithm-only performance." It's integrated into the description of the device's function. The system is intended to be used by "medical professionals," indicating human oversight and input.

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

• Not Available. No specific ground truth type is mentioned for validating the device's performance against acceptance criteria. The calculations performed by the device are based on "imported clinical images and other user entered data," and it "evaluates clinical images in calculating the local and global doses." The accuracy of these calculations would likely be verified against established physics models and clinical standards, but the document does not detail how this was done for a formal "ground truth" study.

8. The sample size for the training set

• Not Applicable / Not Available. The HDRplus device is described as a software package for calculating radiation therapy plans. There is no mention of machine learning or AI models that would require a "training set" in the context of deep learning. It's a deterministic calculation system based on physics models and user input.

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

• Not Applicable / Not Available. As there's no mention of a training set for machine learning, this question is not applicable.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the HDRplus Brachytherapy Treatment Planning System to an existing legally marketed device. This type of submission typically relies on comparing intended use, technological characteristics, and safety/effectiveness profiles rather than presenting a detailed study with explicit acceptance criteria and performance data for the new device. Therefore, the document does not contain the specific experimental data and statistical analyses requested.

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