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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.

The provided document describes the Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature. It is a medical device designed for peripheral transluminal angioplasty and for capturing embolic material during angioplasty in various peripheral arteries. The document is a 510(k) summary, demonstrating substantial equivalence to a predicate device (K133043).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table of non-clinical bench tests. All tests passed, indicating the device met its acceptance criteria. Below is a summarized version of the table provided in the document:

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

• Sample Size: "Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance... and the results of the risk analysis (DFMEA). The number of units utilized for each test depends on whether the data to be collected was variable data or attribute data, therefore the number of units tested varies from test to test. However, in all cases, the number utilized for testing met the required number of units based on the risk analysis, and the required confidence/reliability levels."
• Data Provenance: The studies are described as "In vitro bench testing" and "Design Verification and Validation," performed in accordance with Angioslide's Risk Analysis and applicable FDA Guidance documents and ISO standards. This indicates the testing was conducted in a laboratory setting, likely at the manufacturer's facility in Israel. The data is prospective, generated specifically for this submission.

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

This device is not an AI/imaging device requiring expert interpretation of medical images to establish ground truth. The acceptance criteria are based on objective, quantifiable physical and mechanical properties of the device, measured using standardized engineering and material science tests. Therefore, there are no "experts" in the traditional sense of medical image interpretation for a test set, nor are there qualifications of such experts relevant to the type of testing performed. The "ground truth" is established by the specifications defined in the design and validated through these bench tests against established industry standards (ISO, FDA guidance).

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

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests conducted are objective, measurable physical and mechanical tests of the device's components and functionality.

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 medical device (a balloon catheter), not an artificial intelligence (AI) or imaging diagnostic tool that would involve 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. This device is a physical medical device, not an algorithm. The testing described is for the physical and functional aspects of the catheter itself.

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

The "ground truth" for this device's performance is established by engineering specifications, industry standards (ISO), and FDA guidance documents. For example, the definition of "In Tolerance" for dimensions or "No leakage" for liquid leakage comes from predetermined, objective criteria. For the purpose of substantial equivalence, the performance is compared against these predefined physical and functional benchmarks, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set. The device is a physical medical instrument.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (S) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock ( 1 ) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.

The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature underwent non-clinical bench testing to demonstrate its performance and safety, particularly regarding its use within a stent environment.

1. Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states that "Sample sizes used for Design Verification and Validation testing were based on required confidence / reliability levels as a result of risk analysis performed for the PROTEUS™ PTA Balloon Catheter, or per recommendations within the FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." Specifically, the number of samples utilized for each test depended on whether the data to be collected was variable data or attribute data in nature." Specific numerical sample sizes for each test are not explicitly provided in the text.
• Data Provenance: The tests were non-clinical in vitro bench tests conducted by Angioslide, Ltd. No patient data (retrospective or prospective) from specific countries was used for these tests.

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

Not applicable. The study involved non-clinical bench testing, not human expert evaluation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The study involved non-clinical bench testing, not human expert review with adjudication.

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

No. This was a non-clinical bench test. No human readers or AI assistance were involved in evaluating efficacy.

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

Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used:

In a non-clinical bench study for a physical device, "ground truth" is established by the specifications and measurable outcomes of the device's physical performance against predefined engineering and regulatory standards (e.g., burst pressure, inflation/deflation times, absence of leakage, ability to pass through a tortuous model). The "ground truth" is essentially the expected physical behavior and integrity of the device under simulated conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device undergoing performance testing, not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.

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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9). One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure. The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock ( 1 l ) and pulling the pulling knob away from the handle (1). The embolic capture feature involves a single-use suction mechanism that works through inward folding of the balloon, which creates negative pressure within the capture cavity for debris capture and removal. The reduced pressure in the capture cavity causes some of the particles that are released during the procedure to flow into the cavity for containment and removal. The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.

Here's a breakdown of the acceptance criteria and the study information for the PROTEUS™ PTA Catheter with Embolic Capture Feature, based on the provided text:

Acceptance Criteria and Device Performance

The device underwent extensive non-clinical bench testing, sterilization, packaging, and shelf-life testing to demonstrate conformance. The table below summarizes the acceptance criteria and reported device performance for these non-clinical tests.

Note: The provided document is a 510(k) summary for a submission that claims substantial equivalence to a predicate device (K111750), implying that the new device has identical technological characteristics for both PTA balloon function and embolic capture. Therefore, the "study" described here is a suite of design verification and validation tests rather than a comparative clinical trial.

Study Details for PROTEUS™ PTA Catheter

Based on the provided K120164 510(k) summary, the "study" refers to a series of non-clinical bench tests for design verification and validation, as well as tests for biocompatibility, sterilization, packaging, pyrogenicity, and shelf life. This is a 510(k) submission, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for effectiveness.

1. 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 sizes for Design Verification and Validation testing "were based on required confidence/reliability levels as a result of risk analysis performed for the PROTEUS™ PTA Balloon Catheter, or per recommendations within the FDA Guidance 'Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'" Specifically, the number of samples utilized varied depending on whether the data was variable or attribute.
     • For the "four corners" approach, at least four sizes (largest/smallest diameters and lengths) plus a middle catheter size were tested for robustness.
     • Many tests specify a confidence/reliability level (e.g., 90% Conf., 90% Rel. or 95% Conf., 90% Rel.), which dictates the minimum sample size for attribute or variable data.
   • Data Provenance: The tests were "in vitro bench testing" conducted by Angioslide, Ltd., an Israeli company. The data is prospective, generated specifically for this submission. The origin of the data itself is from laboratory bench tests.

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

   • This document describes bench testing of a medical device's physical and functional characteristics, not an AI or diagnostic device that requires expert ground truth. Therefore, no experts (e.g., radiologists) were used to establish ground truth in the traditional sense of medical image interpretation or diagnosis. The "ground truth" for these tests are the pre-defined engineering specifications and performance standards outlined in the acceptance criteria.

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

   • Not applicable. This is not a study requiring adjudication of clinical or image-based findings. The results of the bench tests (e.g., whether a dimension is "in tolerance" or if "no leakage" is observed) are direct physical measurements and observations against pre-defined criteria.

4. 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 (PTA Catheter) and not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance was involved.

5. 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 or AI system.

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

   • For the bench tests, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, FDA guidance documents), and internal design requirements. For example, "In Tolerance" for a dimension, "No Leakage" for a seal, "Force at Break ≥ 10N" for tensile strength. For pyrogenicity, it's a specific endotoxin limit (0.5 EU/ml).

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device that requires a training set. The "training" for this device would be its manufacturing process and design iterations, not data sets for an algorithm.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device.

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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angroplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

Acceptance Criteria and Device Performance for PROTEUS™ PTA Catheter with Embolic Capture Feature

This submission describes the non-clinical testing performed to demonstrate the substantial equivalence of the modified PROTEUS™ PTA Catheter with Embolic Capture Feature. The testing followed Angioslide's Risk Analysis, applicable FDA Guidance documents, and ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The sample sizes for testing varied depending on whether the data collected was variable or attribute data, which was determined by the risk analysis (DFMEA) performed for the PROTEUS™ PTA catheter and required confidence/reliability levels as per FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." The documentation does not specify the exact number of units tested for each individual test but states that the number met the required statistical confidence and reliability levels.

The data provenance is from in vitro bench testing conducted by Angioslide, Ltd. and is thus not from a specific country of origin in a clinical context (e.g., patient data). It is prospective in the sense that the tests were designed and conducted specifically for this submission.

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

Not applicable. The tests described are non-clinical (bench testing) of the physical and mechanical properties of the device, not an evaluation requiring expert interpretation of clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing, not an evaluation relying on expert consensus for clinical interpretations. The results are objective measurements against defined criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a device performance evaluation (bench testing) and not an AI-based diagnostic device.

6. Standalone Performance Study

This document details standalone performance testing of the device itself (hardware), not an algorithm or AI without human interaction. The results demonstrate the device's ability to meet its specifications.

7. Type of Ground Truth Used

The "ground truth" for these tests was established by engineering specifications, regulatory standards (ISO), and defined acceptance criteria for the physical and mechanical properties of the device, such as dimensions, tensile strength, burst pressure, and flow characteristics.

8. Sample Size for the Training Set

Not applicable. This is a medical device (catheter) and not an AI/Machine Learning algorithm, therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture is an over the wire coaxial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature consists of a foldable balloon with radiopaque markers which aid in positioning the balloon in the artery during the angioplasty procedure, the co-axial shaft comprising the inner shaft and the outer shaft, and the handle comprising the handle enclosure, the T-connector, the inflation port, the pulling rod with the guidewire port, and the pulling rod locks.

Following embolic capture, the user can opt to use the PROTEUS™ Particle Visualization Kit (PVK) to facilitate the visualization of the embolic material captured by the PROTEUS™ PTA Balloon Catheter.

The provided text describes a Special 510(k) submission for the PROTEUS™ PTA Catheter with Embolic Capture Feature. This submission is for modifications to an already cleared device, specifically the addition of a Particle Visualization Kit (PVK) accessory.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria or provide a table of reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc. This is common for Special 510(k) submissions focusing on modifications, especially when the modification is an accessory and the core function (embolic capture) of the device remains identical to a predicate.

The primary "acceptance criterion" implied throughout is substantial equivalence to the predicate device (Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature K090364) in terms of indications for use, technological characteristics, and performance characteristics.

The document states:

• "The balloon technological characteristics of the modified version of PROTEUS™ PTA Balloon Catheter are substantially equivalent to those of the unmodified version of the device."
• "The modified PROTEUSTM PTA Balloon Catheter overall length, catheter sheath sizing, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are identical to the unmodified version of the device."
• "The embolic capture technological characteristics of the modified PROTEUSTM PTA Balloon Catheter are identical to those of the unmodified version of the device."

The only specific testing mentioned relates to the new accessory:

• "Verification and validation testing of the PROTEUS™ Particle Visualization Kit included simulated use testing."

Without specific metrics or quantitative data from this simulated use testing, a formal table cannot be constructed.

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

• Test Set Sample Size: The document mentions "simulated use testing" for the Particle Visualization Kit but does not specify the sample size (e.g., number of simulated procedures, number of particles visualized).
• Data Provenance: The testing was "simulated," implying in-house lab testing, not patient data from a specific country, nor retrospective or prospective in a clinical sense.

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

• The document does not mention the use of experts to establish ground truth for any test set. The nature of the device (a catheter and a visualization kit) and the type of testing described (simulated use for an accessory) likely did not necessitate independent expert ground truth establishment in the way a diagnostic AI algorithm would.

4. Adjudication Method for the Test Set:

• Since there's no mention of experts establishing a ground truth for a test set, no adjudication method was needed or described.

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

• No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically done for diagnostic imaging devices or AI algorithms where human interpretation is involved. This submission is for a medical device (catheter) and an accessory, not a diagnostic imaging AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

• Not applicable. The device is a physical catheter and a visualization kit, not an algorithm. Therefore, no standalone algorithm performance study was mentioned.

7. Type of Ground Truth Used:

• For the simulated use testing of the Particle Visualization Kit, the "ground truth" would likely be engineer-defined criteria and observations of whether the kit successfully facilitated the visualization of deliberately introduced embolic material. This is based on the functional description of the PVK. No mention of expert consensus, pathology, or outcomes data for this specific testing.

8. Sample Size for the Training Set:

• Not applicable. This device is hardware (catheter and accessory), not a machine learning or AI algorithm, so there is no "training set."

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

• Not applicable, as there is no training set.

In summary, the provided document focuses on establishing substantial equivalence for a non-AI physical medical device and an accessory. It describes the device's characteristics and notes that non-clinical simulated use testing was performed for the new accessory, but it does not delve into detailed quantitative acceptance criteria or elaborate on study designs typical of AI/diagnostic device submissions. The core argument is that the modified device is identical or substantially equivalent in its critical features to an already cleared predicate.

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The Angioslide eXtraTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral translyminal angioplasty and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is a single-use disposable over-the-wire co-axial dual lumen catheter with a foldable balloon near the distal tip. The balloon catheter consists of the balloon located near the distal atraumatic soft tip, the telescopic shaft and the handle.

One lumen is used for inflation of the balloon and is accessed via the inflation port. The other lumen, starting at the quidewire port. allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopague markers for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft comprises the outer shaft and the inner shaft. The distal end of the balloon is connected to the inner shaft and the proximal end of the balloon is connected to the outer shaft. The inner shaft is connected to the pulling rod and the outer shaft is connected to the handle body. The pulling rod lock locks the handle body and the pulling rod together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by unlocking the pulling rod lock counter-clockwise and retracting the pulling rod. The inward-folding of the balloon forms a cavity and allows for collection of embolic material.

Here's an analysis of the Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature based on the provided 510(k) summary, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly lay out a table of acceptance criteria with corresponding performance metrics from the studies for the device itself in a quantitative manner. Instead, the document describes the types of tests performed and states that the "results of the MC-LEADER and MC-LEADER Supplemental Studies met performance goals derived from historical literature describing PTA performance." For the animal study, it states: "The results of this study demonstrated that the safety and performance of the Angioslide eXtra™ PTA Balloon Catheter was substantially equivalent to that of the control article when used in an in vivo model."

However, based on the identified endpoints from the clinical studies, we can infer the performance goals the device aimed to meet:

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

The raw sample sizes for the clinical studies are not explicitly stated. However, the document mentions:

• MC-LEADER Study: Unspecified number of patients, conducted at three centers outside of the US.
• MC-LEADER Supplemental Study: Unspecified number of patients, conducted at two centers outside of the US.

Both clinical studies were described as:

• Prospective
• Multi-center
• Non-randomized
• Single-arm

The animal study:

• Chronic GLP study
• Used an "in vivo porcine model." The exact number of animals is not specified.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical studies. For the animal study, it mentions:

• Study pathologist: Assessed safety via gross and microscopic evaluation post-procedure.
• Investigators: Assessed functional performance during PTA and post-stent dilation.
  No further details on the qualifications or number of these individuals are given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for the clinical or animal studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The clinical studies were single-arm studies focused on the performance of the Angioslide eXtra™ device itself, and the animal study compared it to a control device in an in vivo model. There is no mention of human readers or AI assistance in the context of effectiveness studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a physical medical device (balloon catheter), not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable.

7. The Type of Ground Truth Used

• Clinical Studies: The ground truth for the clinical studies involved a combination of:
  • Clinical Outcomes Data: Acute device success, acute procedural success (<50% residual stenosis), adverse event rates, clinical success at 30 days (ABI and RB improvement), target vessel revascularization at 12 months, serious adverse event rate, acute distal embolization rate. These are directly observed and measured clinical endpoints.
• Animal Study: The ground truth for the animal study involved:
  • Pathology: Gross and microscopic evaluation post-procedure by a study pathologist.
  • Functional Performance Assessment: By investigators during PTA and post-stent dilation.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a physical medical device and not an AI/ML algorithm. The document describes pre-clinical (bench and animal) testing and clinical studies to evaluate the safety and performance of the device.

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

As stated above, a training set is not applicable for this type of device. The ground truth for the evaluations (bench, animal, clinical) was established through the various testing methodologies and clinical endpoints outlined.

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