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Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.

The Best® device is a single catheter brachytherapy device consisting of an inflatable distal spherical balloon for anchoring and/or stabilizing and a series of inflatable balloons for centering the treatment catheter within the lumen. The catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into the catheter lumen. A removable flexible guide cable is positioned in the central treatment catheter for initial placement in the existing body lumen. Proximal ports are also provided with Luer-lock type connectors for inflation of the distal anchoring/stabilizing balloon inflation/deflation and for inflation of the series of centering balloons, either simultaneously or individually.

The Best® Intraluminal Balloon Applicator for Brachytherapy underwent non-clinical performance testing to evaluate its functionality. No clinical performance data was collected or reviewed in support of this premarket notification.

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

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

The document does not specify the sample size used for the performance tests. The data provenance is not explicitly stated, but as it's part of a 510(k) summary for a US FDA submission, it can be inferred to be from the manufacturer's testing (likely in the US). The tests are non-clinical, implying prospective testing specific to this device.

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. This device underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic or clinical evaluation.

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

Not applicable, as no expert-based ground truth was established.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device (applicator), not an AI diagnostic tool. No AI assistance is mentioned or involved.

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

Not applicable. This is a physical medical device.

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

Not applicable. For non-clinical performance tests, "ground truth" typically refers to engineering specifications and measurements rather than clinical ground truth derived from expert consensus, pathology, or outcomes data. The performance was evaluated against internal design specifications and functional requirements.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This is a physical medical device.

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"Best® Multi-Lumen Balloon Applicator for Brachytherapy" is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.

The Best® device is a multi-catheter brachytherapy device consisting of an inflatable outer spherical balloon and an inner inflatable balloon for treatment catheter positioning. Each catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into each of the catheter lumens. Five treatment lumens are provided, one central lumen located along the long axis of the applicator and four moveable lumens, which are symmetrically offset from the central lumen by inflation of an inner balloon, which positions the treatment lumens at a location greater than or equal to 50% of the outer balloon diameter. A removable stiffening stylet is positioned in the central treatment lumen for initial placement into the resection cavity, as well for repositioning of the device as needed. Three proximal ports are also provided with Luer-locktype connectors for inner and outer balloon inflation/deflation and for application of intracavitary vacuum for removal of air and/or fluid.

The document provided is a 510(k) Summary for a medical device called the "Best® Multi-Lumen Balloon Applicator for Brachytherapy." This device is a physical medical instrument, not a software-based AI/ML device. Therefore, the typical acceptance criteria and study designs applicable to AI/ML devices, such as those related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or provided in this submission.

The acceptance criteria and "study" described in this document are focused on the physical and functional performance of the device, primarily by demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, framed within the context of a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for a diagnostic accuracy study. Instead, it demonstrates performance through functional testing and comparison to a predicate device. The implicit acceptance criteria are that the device performs its intended mechanical functions reliably and safely, similar to the predicate device.

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

• Test Set Sample Size: Not applicable in the context of human data or AI model evaluation. The "tests" performed were engineering and functional assessments of the physical device. The sample size would refer to the number of physical devices tested, which is not specified but is typically a small number for design verification.
• Data Provenance: Not applicable. This is not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth in this context relates to the physical and mechanical properties and functionality of the device, which are established through engineering measurements and design specifications, not expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication" in the sense of reconciling divergent expert opinions on medical diagnoses. Performance is assessed against engineering specifications and functional requirements.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the function of this physical brachytherapy applicator.
• Effect Size of Human Readers with/without AI assistance: Not applicable.

6. If a Standalone (Algorithm Only without Human-in-the-Loop Performance) was done:

• Not applicable. This device is a physical instrument used by a human physician, not a standalone algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on engineering specifications, manufacturing tolerances, and the demonstrated functional behavior of the device (e.g., successful balloon inflation, unimpeded source wire movement, acceptable imaging properties) when subjected to defined tests. The comparison to the predicate device's established safety and effectiveness also serves as a benchmark for "ground truth" regarding substantial equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML model development.

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

• Not applicable for the same reason as above.

In summary: The provided document is a 510(k) submission for a physical medical device. It demonstrates safety and effectiveness through mechanical performance testing and a detailed comparison to a legally marketed predicate device, rather than through clinical trials or performance studies relevant to AI/ML diagnostic tools. The "study" here is a series of engineering and functional tests to confirm the device operates as intended and meets design specifications, ensuring it is substantially equivalent to the predicate.

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The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.

The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.

The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer matcrial, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

The provided text is related to a 510(k) premarket notification for the "Best Strand" device by Best Medical International, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study with detailed statistical analysis.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

The document primarily states:

• Device Name: Best Strand (and Best Spacer)
• Intended Use: Accessory in brachytherapy procedures, used to orient, hold, carry, and maintain spacing of radionuclide seeds and spacer components. Indicated for use in soft tissue or organ tissue (not cardiovascular or neurological).
• Predicate Device: CP Medical CARRJER SLEEVE (K034062) and I-125 Rapid Strand's accessory Sleeve (K940632 and K010821).
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications.

The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details on sample sizes used for a test set, data provenance.
3. Information on the number or qualifications of experts or adjudication methods.
4. Multi-reader multi-case (MRMC) comparative effectiveness study.
5. Standalone algorithm performance.
6. The type of ground truth used (as it's not an AI/diagnostic device).
7. Sample size for a training set.
8. How ground truth for a training set was established.

This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and intended use, rather than conducting new clinical performance studies with specific acceptance criteria as one might see for novel AI/diagnostic devices.

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The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile.

The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile.

The placement of the markers and marker strand in soft tissue, prior to therapeutic procedures, allows better dosimety coverage of the targeted site due to clearer identification of the anatomic regions.

The provided text is a 510(k) summary for the Best Radiopaque Strand and Best Radiopaque Marker. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain explicit acceptance criteria or a study demonstrating that the device meets specific performance criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device might.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, which implies that the performance is at least similar to the predicate, but specific quantitative acceptance criteria are not given.
• Reported Device Performance: The document describes the characteristics and intended use of the device, primarily that it is a radiopaque marker or strand for brachytherapy and soft tissue/organ localization. It does not provide quantitative performance metrics (e.g., visibility in specific imaging modalities, migration rates, etc.) that would typically be associated with a "reported device performance" in the context of acceptance criteria.

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

• Not provided. The document does not describe any specific test set or clinical study with patient data.

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. Since no specific test set or ground truth establishment process is described, this information is not available.

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

• Not applicable/Not provided. No test set or adjudication process is mentioned.

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 a physical radiopaque marker, not an AI or software device. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.

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

• Not applicable. This device is a physical radiopaque marker, not an algorithm or software.

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

• Not applicable/Not provided. No specific ground truth for performance evaluation is mentioned, as the submission focuses on substantial equivalence to predicate devices rather than a detailed performance study with a defined ground truth.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set in that context. If "training set" refers to any pre-clinical testing or validation work on the materials or design, that information is not detailed in this summary.

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

• Not applicable/Not provided.

In summary:

This 510(k) summary focuses on the administrative process of demonstrating substantial equivalence of the Best Radiopaque Strand and Best Radiopaque Marker to existing predicate devices. It provides device descriptions, intended use, and classification information. It does not include detailed studies with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a performance study report for a novel or more complex device, especially those involving AI or diagnostic interpretation. The FDA's letter confirms that substantial equivalence was found based on the provided information, allowing the device to be marketed.

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The BEST Model No. 81-01 Series Sources are intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments (e.g., interstitial, intracavitary, intralumen, or topical radiation therapy).

BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources. These sources are pure Ir-192 sources.

Acceptance Criteria and Study for BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 Sources

This document describes the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 sources.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are based on substantial equivalence to the BEST Model No. 81-01 source, which is documented in the AAPM's TG-43 report, and compliance with FDA recognized standards for Photon-emitting Brachytherapy Sources.

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

The document does not explicitly state a "test set" in the traditional sense of a clinical or image-based AI study. Instead, the "testing data" refers to physical measurements and characterizations of the sources themselves.

• Sample Size: The study involved measurements on at least one representative model: the BEST Model No. 81-01-17 intermediate downsize source. The text implies that the other two models (81-01-11 and 81-01-14) were considered to have the "same pure Ir-192 gamma ray spectrum" as the 81-01-17, suggesting that detailed individual measurements might have been carried out for 81-01-17 which then was extrapolated. The specific number of physical sources tested or measurements taken is not detailed beyond "measurements" for 81-01-17.
• Data Provenance:
  • Air kerma measurements: Conducted at NIST (National Institute of Standards and Technology), an institution located in the USA.
  • TG-43 parameter measurements: Conducted at the University of Kentucky, an institution located in the USA.
  • Compliance testing for FDA recognized standards: Data provided to the NRC (Nuclear Regulatory Commission) for source registration. The location where these tests were performed is not explicitly stated, but given the context of NRC registration in the USA, it's highly probable the testing was conducted in the USA or at facilities complying with US regulatory standards.
• Retrospective or Prospective: This type of testing is inherently prospective as it involves the physical characterization of newly manufactured devices under controlled conditions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The concept of "experts" for establishing ground truth in this context differs from an AI study involving human interpretation of clinical data. Here, "ground truth" is established by:

• Scientific consensus/standards: The AAPM's TG-43 document provides the established dosimetry parameters for Ir-192 sources, representing a consensus among medical physicists.
• National metrology institutes: NIST performs highly calibrated physical measurements, establishing a reference "ground truth" for physical quantities like air kerma.
• Academic institutions: The University of Kentucky performed TG-43 parameter measurements, implying expertise in medical physics and dosimetry.

The document does not specify the number or specific qualifications of individual experts at NIST or the University of Kentucky explicitly, but their departmental and institutional affiliations imply:

• Qualifications: Experts would be highly qualified medical physicists with expertise in brachytherapy dosimetry, radiation measurement, and knowledge of the TG-43 formalism and relevant ANSI/ISO standards. Their experience would be implicit in their roles at these institutions.

4. Adjudication Method for the Test Set

Not applicable in this context. The "test set" consists of physical measurements and characterizations against established standards (TG-43, ANSI, ISO), not subjective interpretations requiring adjudication. Agreement is based on meeting numerical parameters and qualitative characteristics (e.g., pure Ir-192 spectrum).

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

Not applicable. This is a pre-market notification for a medical device (brachytherapy source), not an AI algorithm intended for interpretation or diagnostic assistance. Therefore, no MRMC study involving human readers or AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no AI algorithm involved in the function or evaluation of these brachytherapy sources. The devices are physical radioactive sources.

7. Type of Ground Truth Used

The ground truth used is a combination of:

• Established scientific consensus and guidelines: The AAPM TG-43 document defines the expected dosimetric properties of Ir-192 sources.
• Metrological standards: NIST provides a gold standard for physical measurements (e.g., air kerma).
• Recognized industry standards: ANSI N43.6-1977 and ISO 2919 define safety and classification requirements for sealed radioactive sources.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm being trained for this device. The "training set" concept is not relevant here.

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

Not applicable, as no training set was used.

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