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The Indigo Prostate Seeding Needle Cartridge System is a single use, disposable system which is intended as a convenience and radiation safety device for the purpose of loading a radionuclide brachytherapy source into the Índigo Prostate Seeding Needles for prostate brachytherapy.

The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which are of low to moderate radiosensitivity.

The Indigo Prostate Seeding Needle Cartridge System consists of two main components, a single use, disposable seed magazine with a stainless steel shield and a Polyglactin 910 (PG910) absorbable spacer, which is a small cylindrical pellet utilized to provide space between the radionuclide seeds as they are implanted into the body. Both devices are intended to be used only in conjunction with Indigo Prostate Seeding Needles.

The provided text, K992262, is a 510(k) summary for the Indigo Prostate Seeding Needle Cartridge System. This document describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies.

The "Nonclinical Tests" section mentions functional testing and a time study, but these are engineering/design validation tests and not a clinical study proving performance against predefined acceptance criteria for diagnostic accuracy or clinical efficacy. The device is an accessory for brachytherapy source delivery, not a diagnostic or AI-powered device that would typically have the requested types of performance studies.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided document.

Here's a breakdown of what can be extracted from the document, though it doesn't align with the requested format:

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

• Not available in the provided document. The document describes non-clinical tests (functional testing of cartridge material, compression testing of spacers, time study, and radiation scanning) but does not provide specific acceptance criteria or an aggregated "reported device performance" table in the context of clinical outcomes or diagnostic accuracy.

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

• Not available in the provided document. The document describes non-clinical tests, not clinical studies with test sets.

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 and not available. This device is an accessory for delivering brachytherapy sources, not an AI or diagnostic device requiring expert-established ground truth for a test set.

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

• Not applicable and not available.

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 and not available. This is not an AI-powered diagnostic device.

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

• Not applicable and not available. This is not an AI algorithm.

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

• Not applicable and not available. The "Nonclinical Tests" relate to device durability, functionality, time efficiency, and radiation exposure, not clinical ground truth for diagnosis/prognosis.

8. The sample size for the training set

• Not applicable and not available. This device 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 and not available.

Summary of available non-clinical test information from the document:

• Nonclinical Tests Performed:

  • Functional testing of the cartridge material (post-autoclaving)
  • Compression testing of the spacers (post-autoclaving)
  • Time study (to ensure reduction in physicist's barriers for preloaded seed delivery)
  • Radiation scanning (to ensure reduction in physicist's barriers for preloaded seed delivery)

• Purpose of these tests: To ensure the durability and functionality of the devices and to demonstrate that the cartridge system reduces the physicist's barriers (time and radiation exposure) for the preloaded seed delivery technique.

Therefore, while non-clinical tests were performed to support the 510(k) clearance, the provided document does not contain the specific type of clinical performance study data requested for AI or diagnostic devices.

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The Indigo 830e LaserOptic ™ Treatment System is intended to be used in the contact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), and in the contact or non-contact mode for cutting, excision, incision, and coagulation of soft tissue in both open or closed surgical procedures.

The Índigo 830e LaserOptic™ Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

The Índigo Diffuser- Tip™ Fiberoptic is a sterile, single-use, disposable fiberoptic which is 3 meters in length with a light-diffusing section at the distal tip. The device is designed to deliver energy from the Indigo Model 830e diode laser only and bears a unique connector for coupling to the 830e laser at the proximal end. Modifications have been made to increase the resistance to breakage of the fiberoptic and improve the manufacturability of the device. None of the changes affect the function, intended use, or overall design of the fiberoptic or of the Indigo LaserOpticTM Treatment System.

The Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option is a modified device, and its acceptance criteria and performance are established through equivalence testing against a previously cleared predicate device (K963969). The study focuses on demonstrating that the modified device performs equivalently to the predicate and shows improved resistance to breakage.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the nonclinical tests. The tests were performed to compare the modified fiberoptic with the existing fiberoptic for equivalence. The data provenance is a non-clinical "testing" that was performed, implying laboratory or experimental settings rather than patient data. No country of origin for this data is specified, but it's part of a US FDA submission. The study is prospective in the sense of comparing a new modification.

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

Not applicable. The ground truth for this device's performance is based on direct physical measurements and comparisons to a predicate device, not expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. The testing involves direct physical measurements and comparisons, not subjective interpretations requiring adjudication.

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 not a diagnostic device involving human readers or AI.

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

Not applicable. This is a medical device (fiberoptic) for surgical procedures, not an algorithm.

7. The type of ground truth used

The ground truth used is based on direct physical measurements and comparisons to a legally marketed predicate device. This includes:

• Tissue temperature profiles
• Lesion size
• Internal heating of the fiber
• Time to reach operating temperature
• Fiber intensity profile
• Total energy delivered
• Resistance to breakage

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a diagnostic tool that learns from data.

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

Not applicable, as there is no training set for this device.

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The Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85 cc and general surgery, general urological and for for gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. When used as a coagulating device, the Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation. The process of interstitial laser coagulation relies on quickly elevating tissue to a temperature range (Appox. 60 to 100°C) where tissue necrosis rapidly occurs, but below temperatures at which carbonization begins.

The provided text describes pre-market clearance for the "Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic" (K963969). The submission seeks to expand the indications for use, particularly for the treatment of Benign Prostate Hyperplasia (BPH).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The direct acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the submission relies on demonstrating equivalence to predicate devices in terms of safety and efficacy and characterizing performance.

Performance Characterization (Physical Parameters):

Clinical Performance (BPH):
The text states: "The results of a prospective, randomized study shows that the Indigo procedure is safe and effective for the treatment of Benign Prostate Hyperplasia."

Details of the Study to Meet Acceptance Criteria:

The document combines "invitro" and "human clinical testing" to establish equivalence and characterize performance.

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

• "Invitro" testing: The text specifies penetration depth measurements in porcine tissues (invitro). The sample size for this invitro testing (number of tissue samples or repetitions per setting) is not provided.
• Human Clinical Testing (for BPH): A prospective, randomized study was conducted. The specific sample size for this human study is not provided.
• Data Provenance:
  • Invitro: Porcine tissues, so likely laboratory-based data, origin not specified.
  • Human Clinical: Prospective, randomized human study. The geographic origin of the study participants is not specified.

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

Not applicable for the reported studies.

• For the invitro study, the "ground truth" is direct physical measurement (penetration depth).
• For the clinical study, the "ground truth" would be clinical outcomes related to BPH treatment (e.g., symptom improvement, safety endpoints), which are observed by clinicians, but no specific "expert panel" for establishing ground truth is mentioned in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This device is a surgical treatment system, not a diagnostic imaging device requiring interpretation adjudication.

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

No, an MRMC comparative effectiveness study was not done. The studies described are:

• An invitro characterization of the device's physical cutting/coagulation properties.
• A prospective, randomized clinical study evaluating the device as a treatment for BPH. This clinical study is for treatment efficacy and safety, not for diagnostic performance comparison.

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

This question is not applicable to this physical medical device. The device is a laser system and a fiberoptic, which is operated by a human surgeon. It does not involve an "algorithm only" performance.

7. Type of Ground Truth Used:

• Invitro: Direct physical measurement of penetration depth in porcine tissues.
• Clinical (BPH): Clinical outcomes (safety and effectiveness) as measured in a prospective, randomized human study. These outcomes would typically be objective clinical endpoints.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical surgical tool, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for the device would be the design, engineering, and manufacturing process.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues.

The Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the K963081 device, presented in the requested format:

Acceptance Criteria and Device Performance Study (K963081)

This submission describes the performance characteristics of a laser system as a general surgical instrument for cutting or coagulating tissues. The study focuses on quantifying penetration depth in various porcine tissues under different power and exposure settings.

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

The provided text does not explicitly state pre-defined acceptance criteria. Instead, it presents the reported device performance as measured penetration depths in different porcine tissues. If acceptance criteria were to be inferred, they would likely revolve around the laser's ability to consistently achieve specific penetration depths for cutting/coagulating, or to demonstrate comparable performance to predicate devices (though specific predicate performance isn't detailed here).

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: The sample size for each data point (e.g., number of tissue samples tested for each power/time setting) is not explicitly stated. The reported "mean ± standard deviation" implies multiple measurements were taken for each condition.
• Data Provenance:
  • Origin: Porcine tissues (animal origin).
  • Study Type: Invitro and exvivo testing. This means the tests were conducted on biological materials outside of their normal biological context (e.g., excised organs in a lab).
  • Retrospective/Prospective: The study described is inherently prospective as it involves controlled experimental conditions to characterize the device'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)

• Number of Experts: Not applicable. The "ground truth" (penetration depth) in this study is a direct physical measurement. It does not rely on expert interpretation or consensus.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. Penetration depth is a quantitative measurement, not subject to subjective adjudication. The standard deviation reported suggests variability in measurement or tissue properties, but not a need for expert adjudication.

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

• MRMC Study: No. This study is focused on the physical performance characteristics of a laser device, not on the interpretative performance of human readers or AI algorithms.

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

• Standalone Performance: Not applicable. This device is a laser system, not an algorithm. Its performance is measured directly, not through an algorithm.

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

• Type of Ground Truth: The ground truth is direct physical measurement of penetration depth in biological tissue samples.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI study that involves training data. The study describes experimental characterization of a physical device.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set mentioned or implied in this submission.

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Ask a specific question about this device