Search Results

The .decimal astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App serves as a tool which provides tested and validated calculation and design functions for use in other enduser applications. The Dosimetry App provides access to the functions that make up what is considered much of the core components of a typical proton treatment planning system. Through the use of these functions in user generated scripts or programs, users will be able to design and/or analyze proton treatment plans for regular fields using custom designed blocks and range compensators. Additionally, the functions provided by this device can also allow users to generate programs and scripts capable of performing treatment preparation and plan analysis tasks, such as structure/contour modification, image data analysis, and secondary dose calculation checks. Users should be experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes.

The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App device is not an interactive end user application. Users of the system will write scripts or fully interactive software programs that make calls to the functions provided by the Astroid Dosimetry App. In essence, this device serves a foundational proton dosimetry calculation library that greatly reduces the burden and time required to develop treatment planning and plan analysis software by making readily available much of the core functionality common to these types of applications. This core functionality includes various CT image processing tools, structure and contour modification operators, proton dose calculations, proton aperture and range compensator device design algorithms, and other low-level radiotherapy specific calculation functions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the .decimal Astroid Dosimetry App:

Important Note: The provided document is a 510(k) premarket notification summary. This type of FDA filing focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided will reflect this focus on non-clinical testing and comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it describes a validation approach aimed at demonstrating the device performs "as well as" predicate devices and is "safe and effective for clinical use" based on comparisons to experimental and analytical datasets.

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

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or specific datasets. The testing involved "experimental and analytical datasets" and "clinically oriented validation test cases."
• Data Provenance: Not explicitly stated. The document mentions "hospital-based testing partners" and "experimental and analytical datasets," suggesting a mix of simulated/laboratory data and potentially real-world clinical scenarios represented by the test cases. It does not provide country of origin or whether the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The testing involved ".decimal personnel and hospital-based testing partners." While it doesn't specify a number, the involvement of "hospital-based testing partners" implies the use of clinical experts in the validation process.
• Qualifications of Experts: Not explicitly stated. However, the target users of the app are described as "experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes." It is reasonable to infer that the "hospital-based testing partners" would possess similar qualifications.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "clinically oriented validation test cases" were "written and executed by .decimal personnel and hospital-based testing partners," suggesting a collaborative or independent validation approach rather than a formal adjudication process for establishing ground truth from multiple expert readings.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed as part of the development of this product." The focus was on non-clinical testing to demonstrate substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance. The device acts as a calculation library, not a direct AI assistant for human readers.

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

Yes, in essence, a standalone evaluation was performed. The device is described as a "foundational proton dosimetry calculation library" that provides "tested and validated calculation and design functions." The "Summary of Non-Clinical Testing" focuses on the performance of these functions against "experimental and analytical datasets" and "clinically oriented validation test cases." The device itself is not an interactive end-user application but rather a tool for developers to build upon, meaning its core functions are evaluated independently of human interaction in the context of the 510(k) submission.

7. The Type of Ground Truth Used

The ground truth used for testing appears to be based on:

• Experimental data: Comparisons to "experimental... datasets." This would typically involve physical measurements in a laboratory or clinical setting.
• Analytical data: Comparisons to "analytical datasets." This implies data derived from established physics models or theoretical calculations.
• Clinically oriented validation test cases: These would likely represent scenarios with known outcomes or established correct calculations, potentially based on expert consensus or established treatment planning principles.

8. The Sample Size for the Training Set

The document is a 510(k) summary for a software library, not a machine learning model. It does not mention a training set because it's not describing a system that learns from data in a typical machine learning sense. It's a set of pre-defined calculation and design functions.

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

As stated above, this is not applicable as the device is not described as involving a machine learning component requiring a training set. The functions within the Astroid Dosimetry App are based on established scientific and clinical principles of proton radiation therapy, rather than being "trained" on data.

Ask a specific question about this device

.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study that quantitatively measures the device's performance against such criteria.

The document states:

• "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the predicate device."
• The device is a ".decimal Proton Aperture," which is a physical device (a brass core encased in a steel ring) used to shape proton beams in radiation therapy. Its performance is related to its physical dimensions and ability to block radiation as designed by a treatment planning system.

Therefore, many of the requested categories of information are not present in the provided text, as this is a 510(k) summary for a physical medical device, not an AI/software-as-a-medical-device (SaMD) that typically relies on the detailed performance studies described in your query.

Here's an attempt to answer based on the available information, with many points noted as "Not applicable" or "Not provided":

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
Not provided. The text mentions "clinically oriented validation test cases" but does not specify the sample size or their provenance. Given it's a physical device, these "test cases" likely refer to physical prototypes or manufactured units rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/SaMD (e.g., radiologist consensus on images) is not relevant for this physical device. "Clinical use" and "safety and effectiveness" were "deemed" by ".decimal personnel."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for a test set.

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. This is a physical radiation therapy beam-shaping block, not an AI system or software. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of typical AI/SaMD studies. For this physical device, "ground truth" would relate to its manufacturing accuracy and material properties, ensuring it matches the design output from the TPS. The document states "clinically oriented validation test cases were written and executed in house by .decimal personnel." This implies internal testing against design specifications and functional requirements.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used.

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

Ask a specific question about this device

.decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

Photon Blocks are intended for use by healthcare professionals.

In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.

The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.

The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The block fits into a customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, the radiation will pass through targeted area defined by the radiation therapy professional.

The provided document describes the .decimal Photon Block, a device used in radiation therapy to shape and focus photon beams. It details the device's description, intended use, and indications for use, and also includes a 510(k) summary for regulatory approval.

However, the document explicitly states: "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk."

Instead, the document mentions: "Clinically oriented validation test cases were written and excelled in house by .decimal personnel including a Board Certified Medical Physicist where Photon Blocks were deemed safe and effective for clinical medical. The tests show that .decimal Photon Blocks performed as well as the predicate device."

This indicates that the manufacturer performed non-clinical testing to demonstrate substantial equivalence to a predicate device (.decimal Electron Aperture K111759) rather than a study with acceptance criteria and a detailed performance report in the manner expected for a device proving its efficacy via clinical trials.

Therefore, most of the requested information regarding acceptance criteria, study details involving human subjects, ground truth, expert involvement, and sample sizes for test and training sets cannot be extracted from this document because such a study was explicitly not performed.

Here's what can be inferred or extracted based on the provided text, acknowledging the absence of a typical clinical study:

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

Since no specified acceptance criteria or detailed performance metrics from a formal clinical study are provided, this section cannot be completed as requested. The document only broadly states that the device "performed as well as the predicate device."

No specific acceptance criteria or performance metrics were detailed in the provided document, as no clinical study was performed.

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

• Sample size for test set: Not applicable, as no clinical test set was used. "Clinically oriented validation test cases" were performed in-house, but the sample size of these test cases is not specified, nor is their provenance.
• Data provenance: Not applicable. The validation was described as "in house."

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)

• Number of experts: The document mentions "in house by .decimal personnel including a Board Certified Medical Physicist." It doesn't specify if multiple experts were involved or just one for establishing ground truth for the validation test cases.
• Qualifications of experts: "Board Certified Medical Physicist." No years of experience are specified.

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

• Not applicable. The in-house validation did not describe a formal adjudication method.

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 done. The device described (Photon Block) is a physical beam-shaping device, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

• Not applicable in the context of an algorithm. The device is a physical component. Its "performance" was likely assessed against physical specifications and its ability to shape the beam accurately, which would be a standalone evaluation of the physical device. The document mentions "validation test cases," suggesting a standalone performance evaluation of the device's manufacturing and function.

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

• For the "clinically oriented validation test cases," the ground truth was established by ".decimal personnel including a Board Certified Medical Physicist." This suggests an expert-driven assessment of whether the Photon Blocks met their design specifications and functioned correctly to achieve the intended beam shaping, likely comparing actual block dimensions and beam profiles against design specifications.

8. The sample size for the training set

• Not applicable, as this is a physical device and no machine learning model requiring a training set is described.

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

• Not applicable, as no machine learning model requiring a training set is described.

Ask a specific question about this device

Ask a specific question about this device

Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.

.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

This document is a 510(k) Premarket Notification summary for a device called "Bolus Compensator". The key information related to acceptance criteria and supporting studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics using an established format. Instead, it states that "Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use." This implies that the acceptance criteria were met by these in-house validation tests. The "intended use" section suggests the implicit performance criteria:

• Manufactures solid Bolus Compensators for intensity modulation of external beam radiation therapy.
• Designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue.
• Guides radiation to the targeted area.
• Must be validated and approved by the radiation therapy professional prior to use on a patient.

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

• Sample Size for Test Set: The document mentions "Clinically oriented validation test cases were written and executed in house." It does not specify the number of test cases (i.e., sample size).
• Data Provenance: The tests were "executed in house" by .decimal personnel. This indicates the data is retrospective and generated internally for validation purposes. The country of origin would be the United States, given the company's address is in Sanford, Florida, and the submission is to the FDA.

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

• Number of Experts: The document states "including Board Certified Medical Physicists." It does not specify the exact number of medical physicists involved.
• Qualifications of Experts: The experts were "Board Certified Medical Physicists." No further details on their experience (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set

The document simply states that the Bolus Compensators "was deemed fit for clinical use" based on the in-house validation. It does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The "Board Certified Medical Physicists" were involved in deeming the product fit, implying their expertise formed the basis of the determination, but not a specific multi-reader adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk." This implies that no study comparing human readers with and without AI assistance was conducted.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device is a "Bolus Compensator manufacturing service" and the physical bolus compensator itself. It is a physical device, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only) performance" study does not apply here. The validation focused on the physical characteristics and functional performance of the manufactured compensators.

7. The Type of Ground Truth Used

The ground truth was established by "Board Certified Medical Physicists" deeming the manufactured Bolus Compensators "fit for clinical use." This suggests a form of expert judgment/consensus on the functional suitability and accuracy of the manufactured devices based on the "clinically oriented validation test cases." It is not based on pathology, outcomes data, or patient-level clinical results, as no clinical testing with human subjects was performed.

8. The Sample Size for the Training Set

This device is a physical product (.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators), not an AI algorithm trained on data. Therefore, the concept of a "training set" is not applicable in the context of machine learning.

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

As stated above, this is not an AI/machine learning device, so there is no training set or ground truth for a training set in the conventional sense. The "ground truth" equivalent would be the engineering specifications and performance expectations for the manufactured bolus compensators, which were assessed by medical physicists during an in-house validation process.

Ask a specific question about this device

The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format.

Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.

The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format.

Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.

This document is related to a 510(k) premarket notification for the ".decimal p.d" software, which assists in radiation therapy. The provided text does not contain acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria using statistical metrics like sensitivity, specificity, or accuracy.

The document states:

• "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of this device." This explicitly indicates that a clinical study, as typically understood for evaluating device performance against acceptance criteria using patient data, was not performed.
• Instead, "Clinically oriented validation test cases were written and executed by in house .decimal customer support personnel including Board Certified Medical Physicists." This suggests an internal validation process focused on functional and technical correctness, rather than a statistical evaluation of clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of a clinical performance study. The provided text does not support such an analysis.

Ask a specific question about this device

In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensator and an aperture.

The range compensator is made out of acrylic or wax. The custom shape/design specifications for range compensators are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.

.decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy. The Range Compensator are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

This appears to be a 510(k) premarket notification summary for a medical device called the ".decimal Range Compensator." It describes the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on regulatory information for market clearance, not on a detailed scientific study.

Ask a specific question about this device

In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensators and apertures.

The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. The aperture is a brass plate with a 2D pattern/hole cut out of it, which defines the area that is to be treated with the proton beam. Apertures are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.

.decimal's Aperture manufacturing service manufactures the solid apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

The provided text describes a 510(k) premarket notification for a medical device called ".decimal Aperture." However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document primarily focuses on:

• Identifying the submitter, contact person, and device name.
• Classifying the device and identifying a predicate device.
• Stating the intended use of the device: manufacturing solid apertures for intensity modulation in external beam proton radiation therapy to block radiation from hitting critical structures and healthy tissue while guiding it to the targeted area.
• Outlining the summary of technological characteristics, noting its similarity to the predicate device.
• Confirmation from the FDA of substantial equivalence to a legally marketed predicate device.
• Detailed indications for use, explaining how the aperture is used in proton therapy for cancer treatment.

Therefore, I cannot provide the requested information in the table or the detailed study description, as none of it is present in the provided text.

Ask a specific question about this device

The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.

.decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface.

The provided text, K061440, describes a software translator called "p.d" designed to smooth out unmachinable areas in radiation therapy compensating filters. The document is a 510(k) summary for a premarket notification to the FDA in 2006.

However, the K061440 document does not contain the detailed acceptance criteria or a study that addresses the specific points requested in the prompt. It provides general information about the device, its intended use, and substantial equivalence to a predicate device, but lacks the specific performance data, sample sizes, expert qualifications, or study methodologies that would typically be found in a comprehensive validation or clinical study report.

Here's an analysis of what is and is not present in the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

• Not present. The document states that "p.d Software Validation" (PD-11) is attached in Section 11 and "Summary of Clinical Testing" is in Section 12, but these sections are not included in the provided text. Therefore, specific acceptance criteria (e.g., maximum deviation from original design, smoothing parameters, processing time) and quantitative performance metrics are not available.

2. Sample size used for the test set and the data provenance:

• Not present. The document mentions "clinical testing" but does not provide any details about the test set size, data origin (country), or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not present. There is no mention of experts, ground truth establishment, or their qualifications. The intended use states the customer verifies the filters, but this is an operational process, not a ground truth methodology for a study.

4. Adjudication method for the test set:

• Not present. Without details of a test set or ground truth establishment, an adjudication method is not mentioned.

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:

• Not present. This type of study is not mentioned. The device is a software translator for manufacturing, not an AI-assisted diagnostic tool that human readers would interpret.

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

• Implicitly yes, but no details of the study. The device is a "software translator" that takes a TPS design and smoothes it out. Its function is inherently standalone in that it performs an automated transformation of a digital design. However, there is no study described that evaluates its standalone performance against specific metrics. The "clinical testing" summary is referenced but not provided.

7. The type of ground truth used:

• Not explicitly stated, but inferred to be a comparison against the original "steep, narrow, and unmachinable areas" and the requirement for a "machinable surface." For this type of device, ground truth would likely involve geometric accuracy, smoothness criteria, and mechanical machinability assessments. However, the document does not specify how this ground truth was established for study purposes.

8. The sample size for the training set:

• Not present. As this is from 2006 and the device is described as a "software translator" to smooth designs, it's less likely to be a deep learning model requiring a large training set in the modern sense. It's more likely rule-based or algorithmic. Regardless, no training set size is mentioned.

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

• Not present.

In summary, the provided document K061440 primarily focuses on the regulatory submission for substantial equivalence. It points to validation and clinical testing summaries (Sections 11 and 12) which are not included in the provided text. Therefore, the specific details regarding acceptance criteria and study methodologies, as requested, cannot be extracted from this document alone.

Ask a specific question about this device