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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.

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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.

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The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy.

The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. The indications and intended use for of the P.D. Access™ / SmartNeedle® Device are the same as predicate devices manufactured by CardioVascular Dynamics (the SmartNeedle").

The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices.

This 510(k) notification describes the P.D. Access™ / SmartNeedle® Device, a vascular access device intended for monitoring blood flow. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Testing of the P.D. Access™ / SmartNeedle® Device included dimensional, strength, ultrasonic performance and biocompatibility testing. These tests demonstrated that the all items tested were within specification tolerances. There were no failures during these tests."

However, the specific quantitative "acceptance criteria" and "reported device performance" are not detailed in this summary. The summary only provides a qualitative statement of compliance. For example, it doesn't list a specific "strength tolerance" in Newtons and then a "reported strength" of X Newtons.

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

The document does not specify the sample sizes used for the dimensional, strength, ultrasonic performance, or biocompatibility tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not applicable and not provided. The study described focuses on device performance against engineering specifications (dimensional, strength, ultrasonic, biocompatibility) rather than a diagnostic performance where expert ground truth would be required.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided, as the testing was against engineering specifications.

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

No. An MRMC comparative effectiveness study was not done. The device is a vascular access device with a monitoring function (audible blood flow). Its effectiveness is judged by meeting engineering specifications and being substantially equivalent to predicate devices, not by radiologists' diagnostic performance.

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

The concept of "standalone performance" as it applies to AI algorithms is not relevant here. This is a physical medical device. The "ultrasonic performance" testing would be considered the standalone performance of its monitoring capability. The document states this performance was within specification tolerances.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described would be the pre-defined engineering specifications for dimensions, strength, ultrasonic output characteristics, and biocompatibility standards. These are objective measures rather than expert consensus, pathology, or outcomes data in the typical sense of diagnostic performance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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