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The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

The provided document is a 510(k) Special submission for a medical device (BioLucent Applicator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Here's why and what information is available:

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

• Acceptance Criteria: Not explicitly stated in terms of diagnostic effectiveness. For a device like the BioLucent Applicator (a remote controlled radionuclide applicator system), the "acceptance criteria" would primarily revolve around its mechanical integrity, biocompatibility, sterilization efficacy, and functional specifications that ensure it can safely and effectively deliver radiation as intended, consistent with its predicate devices.
• Reported Device Performance: The document states:
  • "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
  • "The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics."
  • This implies that the device's performance (e.g., functionality, safety features) met standards consistent with the predicate devices, but specific quantitative metrics are not provided.

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

• This submission does not discuss a "test set" in the context of patient data or diagnostic performance. The "performance testing" mentioned would likely involve in vitro or engineering tests on device samples, not patient data. Therefore, this information is not applicable or available in this document.

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, as there is no "test set" for diagnostic performance described.

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

• Not applicable, as there is no "test set" for diagnostic performance described.

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 device is an applicator for radiation delivery, not a diagnostic imaging device involving human readers or AI assistance in interpretation.

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

• Not applicable, as this is a physical medical device for radiation delivery, not an algorithm.

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

• Not applicable, as there is no diagnostic or interpretive element described for this device's performance. The "ground truth" for the performance testing would likely be engineering specifications, material standards, and functional requirements for an applicator.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

Summary of available information related to performance and acceptance criteria from the document:

The BioLucent Applicator is a Class II device, specifically a "Remote Controlled Radionuclide Applicator System." This 510(k) submission is a "Special" submission, indicating minor changes to an already cleared device, allowing for reliance on substantial equivalence to predicate devices rather than new extensive clinical trials.

• Acceptance Criteria (Implied): The device's "integrity, suitability and substantial equivalence" to predicate devices (BioLucent Applicator (K062830, K061241), Wright Vaginal Cuff Applicator (K980601), Comfort Catheters (K032372), Shielded Rectal Applicator Set (K033371)). This would involve ensuring the device mechanically performs as intended, is biocompatible, sterile, and safe for its intended use in delivering radiation during brachytherapy.
• Study Proving Acceptance: "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." No specific details of these tests (e.g., number of units tested, types of tests like tensile strength, leakage, dose distribution verification) are provided in this summary, as they are typically detailed in a separate section of the full 510(k) submission not included here.
• Conclusion: Based on this performance testing, BioLucent, Inc. concluded that the device is "substantially equivalent to existing legally marketed devices" regarding its "intended use, principle of operation and overall technological characteristics." The FDA concurred with this determination, as indicated by the clearance letter.

Important Note: The FDA's clearance letter includes a specific warning required to be added to the device's labeling: "The safety and effectiveness of the BioLucent Applicator Kit for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This indicates a specific unmet acceptance criterion or an unproven extended indication, which the manufacturer must disclose. This is a crucial piece of information about limitations on the device's accepted use.

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The BioLucent Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

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The provided document is a 510(k) premarket notification letter from the FDA to BioLucent, Inc. for their BioLucent Applicator Kit. This type of document is a regulatory approval and does not contain details about acceptance criteria or specific study results proving device performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details from the text provided. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed, but does not include the technical data you are asking for.

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Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.

MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.

The provided text is a 510(k) summary for the MammoPad Radiolucent Cushion, which is a medical device intended to provide comfort and aid in positioning during breast imaging. This document describes the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/algorithm-based device.

The MammoPad is a physical accessory (a foam cushion) rather than an AI or algorithm. Therefore, the questions related to AI/algorithm performance (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable to this device submission.

The "Technological Characteristics/Performance Data Summary" section (excerpt {1}) explicitly states that "MammoPad is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics." The conclusion is that it is "substantially equivalent to an existing legally marketed device." This highlights that the approval pathway for this device was based on substantial equivalence, not on meeting specific performance metrics derived from a clinical study for a diagnostic algorithm.

Therefore, I cannot provide the requested table and study details because the provided document does not contain that type of information for this specific device.

For clarity, here's what the document does indicate about the device and its regulatory pathway:

• Device Name: MammoPad Radiolucent Cushion
• Intended Use: "Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology."
• Device Type: A physical, non-sterile, single-use foam cushion.
• Regulatory Pathway: 510(k) Pre-market Notification, approved based on substantial equivalence to predicate devices (MammoPad® (K003795), Scintimammography Pad Set, PineStar Technology, Scintimammography Pad, Cone Instruments).
• Performance Data: The submission relies on demonstrating that the device has "the same principles of operation and overall technological characteristics" as the predicate devices. There is no mention of a formal clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., as would be expected for an AI diagnostic device.

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The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

The provided text is a 510(k) summary for the BioLucent Applicator, a medical device for brachytherapy. It details the device's intended use, classification, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through quantitative metrics.

The relevant sections state:

• "Performance Data Summary: Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
• "Conclusion: Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioLucent Applicator is determined to be substantially equivalent to existing legally marketed devices."

This indicates that performance testing was done, but the specific acceptance criteria, reported performance statistics, and details of the study (like sample size, ground truth, expert qualifications, etc.) are not included in this summary. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria in a comprehensive clinical study as might be required for a PMA application or a de novo submission for a truly novel device.

Therefore, I cannot provide the requested table and study details from the given text.

However, based on the information provided, here's what can be inferred or explicitly stated regarding your questions:

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

• Information Not Provided: The specific acceptance criteria and detailed quantitative performance metrics are not included in this 510(k) summary. The summary only states that "Performance testing was conducted... to demonstrate the integrity, suitability and substantial equivalence of the device."

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

• Information Not Provided: Details on the sample size for any test set or the provenance of data are absent. The submission relies on "substantial equivalence" to predicate devices rather than a new clinical study.

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)

• Information Not Provided: This information is not relevant or included in a 510(k) submission focused on substantial equivalence. There is no mention of a "test set" in the context of expert ground truth for performance evaluation of a diagnostic or AI device.

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

• Information Not Provided: Not applicable to the content provided.

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

• Information Not Provided: This device is a physical applicator, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

• Information Not Provided: This is a physical medical device, not an algorithm.

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

• Information Not Provided: Not applicable, as the submission focuses on substantial equivalence of a physical device.

8. The sample size for the training set

• Information Not Provided: Not applicable, as this is not an AI or algorithm-based device that requires a training set.

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

• Information Not Provided: Not applicable.

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CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.

The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.

This 510(k) submission for the CuRay™ Custom Seed Array focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This submission is for a brachytherapy seed array, and the "performance data" refers to non-clinical, bench-top testing to demonstrate integrity and suitability (e.g., mechanical testing, sterility testing), not a clinical trial with a "test set" of patient data. The submission relies on demonstrating substantial equivalence to pre-existing predicate devices.

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

• Not Applicable. No ground truth established by experts for a patient test set in this type of submission.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical test set requiring adjudication in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not a software or imaging device that would typically involve a MRMC study for human reader improvement. The device is a physical medical implant.

6. Standalone Performance Study (Algorithm only):

• Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Not Applicable/Implicit from Predicate Devices. The "ground truth" for this type of submission is essentially the established safety and effectiveness of the predicate devices it is being compared to, which have already gone through their own regulatory pathways (PMA or prior 510(k) clearances, or were pre-amendments devices). The current submission focuses on demonstrating that the new device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.

8. Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.

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

• Not Applicable. As there is no training set, this is not applicable.

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