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The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor.

The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:

• Localized
• Unresectable
• Low to Moderate Radiosensitivity

The tumors may be of the following type:

• Superficial
• Intrathoracic
• Intra-abdominal
• Lung, Pancreas, Prostate, Head and Neck
• Residual following external beam radiation or excision of primary tumor
• Recurrent

The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel

The provided text is a 510(k) Premarket Notification for the BEBIG Brachytherapy Strand Device. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than conducting a performance study with defined acceptance criteria and device performance evaluation as one might find for a diagnostic AI/ML device.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in this regulatory document.

However, I can extract the comparison to predicate device table which serves a similar purpose in this context: to show that the new device is comparable to existing, legally marketed devices.

Here's a breakdown of what can be extracted and what cannot:

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

This document does not present acceptance criteria in the format typically seen for a diagnostic or AI/ML device's performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison of characteristics.

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. This is a medical device for brachytherapy, and the submission is for substantial equivalence based on material and design comparison, not a clinical performance study with a test set of 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. Ground truth for a test set is not established for this type of regulatory submission.

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

Not applicable. Adjudication is not relevant for this type of regulatory submission.

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 medical device, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

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

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

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

Not applicable. Ground truth, in the context of a performance study for AI/ML or diagnostic devices, is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

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

Not applicable.

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RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized tumors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.

RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

RAPID Strand™ consists of 11 absorbable seeding spacers and 10 Model 6711 OncoSeed™ seeds (welded titanium capsule containing I-125 adsorbed onto a silver rod) spaced at a fixed distance within absorbable braided carrier. The absorbable braided carrier containing OncoSeeds and absorbable seeding spacer is stiffened and then sterilized by Ethylene Oxide. The seeds are housed in a plastic spacing jig within a stainless steel shielding tube which attenuates >99% of the I-125 photons. RAPID Strand™ is STERILE when shipped.

The Customized RAPID Strand allows the variable seed spacing to reflect individual patient prescriptions as specified by the treating physician. This Customized RAPID Strand will have less than ten (10) OncoSeed™ seeds and a variable number of Absorbable Seeding Spacers. The treating physician will determine the required dose and total number of active seeds for each Customized RAPID Strand.

The provided document is a 510(k) summary for the RAPID Strand™ device. It describes a medical device, its intended use, and claims substantial equivalence to predicate devices. However, this type of document, particularly from 2003, typically focuses on demonstrating equivalence based on technological characteristics and intended use, rather than rigorous performance studies with specific acceptance criteria, test sets, or ground truths as might be expected for modern AI/ML medical devices.

Therefore, much of the requested information (acceptance criteria, specific study details proving it meets criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sizes) is not present in the provided text.

Based on the available text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document describes technological characteristics and claims substantial equivalence to predicate devices, but does not present specific performance metrics with acceptance criteria for the new device.

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

This information is not provided. The document describes nonclinical test data focusing on infrared spectroscopy of the materials, but does not mention a "test set" in the context of clinical performance or a dataset for evaluating an algorithm's performance.

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)

This information is not provided. As there's no mention of a "test set" requiring ground truth establishment, this detail is absent.

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

This information is not 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

This information is not provided. The device described (RAPID Strand™) is a radionuclide brachytherapy source, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable to this device and is not mentioned.

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

This information is not provided. This device is a physical medical implant, not an algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. This device is a physical medical implant, not an AI algorithm that requires a training set.

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

This information is not provided.

Summary of available and missing information:

The provided document is a 510(k) summary for a physical medical device (brachytherapy source). It focuses on demonstrating substantial equivalence by comparing the device's technical specifications and intended use to previously cleared predicate devices. It includes:

• Device Description: RAPID Strand™ consists of absorbable seeding spacers and Model 6711 OncoSeed™ seeds embedded within a Polyglactin 910 Synthetic Absorbable Braided Carrier. The Customized RAPID Strand allows variable seed spacing.
• Intended Use/Indications for Use: Permanent interstitial implantation for selected localized tumors with low to moderate radiosensitivity, either as primary treatment (e.g., prostate cancer, unresectable tumors) or for residual disease after excision. It may be used concurrently with other treatment modalities like external beam radiation therapy or chemotherapy.
• Technological Characteristics Comparison (Subject vs. Predicate Device):
  • Absorbable Seeding Spacers: Subject device has 11 spacers, made of 90% Glycolide + 10% L-lactide with D&C Violet No.2 color, cleared under K013964. Predicate had none.
  • Coated VICRYL (Polyglactin 910) Braided Carrier Material: Both use Polyglactin 910 (90% Glycolide + 10% L-lactide coated with Polyglactin 370 and calcium stearate). The subject device's carrier is undyed (natural), cleared under K022269. The predicate's carrier was Coated Vicryl Violet (D&C Violet #2), cleared under K940632.
  • Sterilization: Both are sterile via Ethylene Oxide (EtO).
• Nonclinical Test Data: Infrared Spectroscopy FTIR Spectra of both the subject and predicate RAPID Strand were analyzed by Northview Laboratories, Inc. (reports provided in Section-G, but details of the reports are not given in this extract).
• Conclusion: The device is concluded to be substantially equivalent to the predicate RAPID Strand (K940632) based on intended use, indications for use, method of use, and other technological characteristics.

The specific details about acceptance criteria, performance studies involving test sets, ground truth establishment, expert involvement, and AI-related metrics (MRMC, standalone performance, training sets) are not applicable to this type of device or not present in this 510(k) summary from 2003.

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The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers are single-use, absorbable seeds comprised of spacer material used to provide a predetermined space between radionuclide seeds for brachytherapy procedures. CP Medical's synthetic absorbable seeding spacers, made of polydioxanone material, are indicated for use in brachytherapy, soft tissue, or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacer consists of absorbable spacer material, which is cut into a small cylindrical seed spacer utilized to provide space between the radionuclide seeds as they are implanted into the body.

The provided text describes a 510(k) premarket notification for a medical device (Polydioxanone Synthetic Absorbable Seeding Spacers) and its substantial equivalence determination. It does not contain information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, or specific study details relating to proving the device meets acceptance criteria.

The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the provided text.

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