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The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.

The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.

The provided text describes the OPTIMUS 0.035" PTA Balloon Dilatation Catheter and its clearance. However, it does not include details about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical design verification/validation tests. It does not present a clinical study with detailed performance metrics as one might find for a novel device or AI-driven system.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on "substantial equivalence" to predicate devices.
• Reported Device Performance: The document states: "Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses. The device has been tested according to ISO 10993 Part 1 and was determined to be biocompatible."
  • Specific performance numbers (e.g., balloon burst pressure, inflation/deflation times, guidewire trackability, etc.) for non-clinical tests are not included in this summary.

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

• Not applicable / Not provided. The summary describes non-clinical design verification/validation tests, not a clinical study with a "test set" of patient data in the context of an AI/algorithm-driven device.

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

• Not applicable / Not provided. This information pertains to studies validating AI or diagnostic devices against expert consensus, which is not described here.

4. Adjudication method for the test set

• Not applicable / Not provided. This information pertains to studies validating AI or diagnostic devices against expert consensus, which is not described here.

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. This is a medical device (balloon catheter), not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a medical device, not an algorithm.

7. The type of ground truth used

• Not applicable / Not provided in the context of clinical "ground truth." The "ground truth" for this device's validation appears to be engineering specifications and standards for device performance, and biocompatibility testing against ISO standards.

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a "training set" in the machine learning sense.

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

• Not applicable / Not provided. This device does not involve a "training set."

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The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.

The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque markerbands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (OPTIMUS 0.035" PTA Balloon Dilatation Catheter) seeking "substantial equivalence" to a predicate device.

Here's an analysis of the provided information in relation to your request:

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

• Acceptance Criteria: The document does not list acceptance criteria in terms of specific performance metrics like sensitivity, specificity, or any quantitative targets that a diagnostic device would typically have.
• Reported Device Performance: The document states: "Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses." It also mentions "The device has been tested according to ISO 10993 Part 1 and has been determined to be biocompatible."
  • This indicates performance was evaluated against the predicate device and in terms of biocompatibility, but no specific numerical performance values are given.
  • The "performance data" section refers to non-clinical design verification/validation tests, which typically involve engineering tests (e.g., burst pressure, fatigue, trackability, etc.) to ensure the device functions as intended and safely, rather than clinical efficacy/diagnostic performance.

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

• The document does not provide details on sample size for any test set or the provenance of data. The "tests and analyses" mentioned are non-clinical, implying benchtop or in-vitro tests, not patient studies.

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 applicable and not provided in this document. Ground truth, experts, and their qualifications are relevant for studies determining accuracy or diagnostic performance, which is not the type of evaluation described here.

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

• This information is not applicable and not provided. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert assessment, which is not the subject of this 510(k) summary.

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

• An MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for AI-assisted diagnostic tools, which this device is not.

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

• A standalone performance assessment (algorithm only) was not done and is not mentioned. This is also relevant for AI/software devices. The OPTIMUS is a physical medical catheter.

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

• Ground truth as typically understood for diagnostic device evaluation (e.g., expert consensus, pathology) is not applicable and not discussed for this device. The "ground truth" for a catheter would be its physical specifications and functional performance in a simulated environment.

8. The sample size for the training set

• A "training set" is typically associated with machine learning or AI models. This document does not mention a training set as the device is a physical catheter, not an AI or software algorithm.

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

• This question is not applicable as there is no mention of a training set or ground truth for such a set.

Summary:

The provided document describes a 510(k) Pre-market Notification for a medical device, the OPTIMUS 0.035" PTA Balloon Dilatation Catheter. The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific diagnostic performance against quantitative acceptance criteria in a clinical setting.

The "performance data" mentioned refers to non-clinical design verification/validation tests (e.g., biocompatibility testing per ISO 10993 Part 1), which verify that the device meets its design specifications and safety requirements, and that it performs comparably to the predicate device in terms of engineering and functional characteristics. It does not involve patient data, expert interpretations, or diagnostic performance metrics like sensitivity or specificity.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System represents a line extension to the original Cordis premounted PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System (ref. 510(k) #K012590) with no change to the indication for use or to the fundamental scientific technology of the predecessor device.
Stent:
The PALMAZ GENESIS Transhepatic Biliary stent is a balloon expandable, laser cut stent mounted on a Cordis balloon catheter (OPTA PRO) and is currently provided in ten (10) nominal unexpanded stent lengths from 12mm to 79 mm. The stent is designed for expansion to diameters from 4mm to 10 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ Genesis stent is laser cut from a 316L stainless steel tube that meets the chemical analysis requirements of American Society for Testing Materials (ASTM) standard F138.
Delivery system:
The delivery system features the same OPTA PRO PTA balloon catheter, which was recently cleared by FDA via 510(k) #K032737, determined substantially equivalent on October 02, 2003), which incorporated this modified hub.
Accessory:
The delivery system features the same accessory (a 304 stainless steel Introducer Tube), which is packaged in the device packaging.

This is a 510(k) premarket notification for a medical device (a stent and its delivery system), not an AI/ML device. Therefore, the concepts of acceptance criteria, device performance, sample sizes for test and training sets, expert adjudication, MRMC studies, or standalone performance as they relate to AI/ML models are not applicable in this context.

The document discusses the substantial equivalence of the "Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System" to an existing predicate device. The "acceptance criteria" in this context are related to the device's physical and biological properties and its intended use, rather than a quantifiable performance metric for an AI algorithm.

Here's a breakdown of the relevant information provided, adapted to the context of a medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific numerical targets and results for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/ML device. Instead, it relies on demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

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

• Test Set/Clinical Data: The document explicitly states that the safety and effectiveness were demonstrated "via data collected from non-clinical design verification tests and analyses." This means there was no clinical test set in the sense of patient data. The "tests" here refer to in-vitro or ex-vivo engineering and material tests, not observations on human subjects.
• Data Provenance: Not applicable as it's non-clinical testing.

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 a medical device's physical performance is established through engineering and material science standards and testing protocols, not expert clinical interpretation of data.

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

• Not applicable. This is relevant for AI/ML performance evaluation where human experts might disagree. For device engineering tests, results are typically objective and measured against established specifications.

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 for AI/ML devices involving human readers.

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

• Not applicable. This is for AI/ML algorithms.

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

• For the non-clinical tests, the "ground truth" would be the engineering specifications, material standards (e.g., ASTM F138, ISO-10993), and predetermined test outcomes to ensure the device performs as intended (e.g., stent expansion diameter, material strength, biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI/ML model that undergoes a "training" phase with data.

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

• Not applicable for the same reason as above.

In summary: This 510(k) submission for the PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through non-clinical design verification tests and biocompatibility testing. It does not involve AI/ML technology, and therefore, the questions posed in the prompt regarding AI/ML performance evaluation are not applicable. The "study" proving it meets criteria refers to these non-clinical tests and the comparison to an already approved device.

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