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The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated;
• Failure of anticoagulant therapy in thromboembolic diseases;
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved with the ALN Extraction and/or Repositioning Kit according to the Instructions For Use of these devices.

The ALN Optional Vena Cava Filter with Hook may be also retrieved with a Standard Gooseneck Snare according to the Instructions For Use of this medical device.

The ALN Extraction and/or Repositioning Kit is indicated for the removal of an implanted ALN Optional Vena Cava Filter and ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

The ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit consists of a 9 leg 316L stainless steel vena cava filter with or without a retrieval hook supplied with a delivery kit, and a retrieval kit with an 8 arm 316L stainless steel clamp. The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava of high risk patients. The filter design consists of legs with barbs that are intended to help stabilize the device inside the vein and prevent migration.

The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath. The insertion of the filter can be made by jugular, brachial or femoral approach with a 7F sheath. The retrieval can be made only by the jugular approach.

The provided document is a 510(k) summary for a medical device (ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit). This document focuses on modifications to the device's packaging and does not contain information about the device's clinical performance or the studies one would typically associate with proving a device meets acceptance criteria for its intended clinical use.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details, expert qualifications, ground truth, or MRMC studies. The document only mentions performance testing related to the packaging modification, not the fundamental function or safety of the Vena Cava Filter itself.

Here's what I can extract from the provided text regarding "Performance Testing," which in this context refers only to the change in device packaging:

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

Missing Information (Not Available in the Provided Text):

• Sample sized used for the test set and the data provenance: Not specified for packaging tests, and certainly not for clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for packaging tests, and not provided for clinical performance.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for packaging tests, and not provided for clinical performance.
• 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, as this is not an AI/imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/imaging device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for packaging tests, and not provided for clinical performance.
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary of the Document's Focus:

The core message of this 510(k) submission (K163699) is that a modification to the device packaging for the ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit does not raise new questions of safety and effectiveness, and therefore the device remains substantially equivalent to its predicate device (K113124). The "performance testing" mentioned is specifically limited to this packaging change (e.g., integrity of the sterile barrier, extractables from plastics). It is not a re-evaluation of the filter's clinical performance, efficacy in preventing pulmonary embolism, or retrieval success rates.

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The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated; -
• Failure of anticoagulant therapy in thromboembolic diseases; -
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit.

The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard GooseNeck Snare according to the instructions supplied in the Instruction For Use of this medical device.

Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter with or without a retrieval hook sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvel/film pouches and the extraction kit is packaged alone in the same type of pouches.

The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.

The provided document is a 510(k) Summary for the ALN Optional Vena Cava Filter and Extraction Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable or cannot be extracted from this document.

However, I can provide information on the non-clinical and clinical performances presented to support the device's safety and effectiveness, which serve a similar purpose to demonstrating acceptance criteria.

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

The document does not specify quantitative acceptance criteria in a table format. Instead, it describes general categories of non-clinical tests and highlights that the device "passed all the tests required to demonstrate its non clinical performances." For clinical performance, it discusses "low rates of complication" and successful retrieval.

Here's a summary of the reported performance categories:

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

For clinical performance, a study involving 220 patients was cited. The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions the study was published in "Chest in 2006."

For non-clinical performance, specific sample sizes are not provided for each test, but it states "passed all the tests required."

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 to this type of device and study. The clinical data involves patient outcomes and complications, which are typically established through medical records and clinical assessments by treating physicians, not by a panel of experts creating "ground truth" in the context of an AI/ML device.

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

This information is not applicable to the type of safety and effectiveness study described for this medical device. Clinical outcomes and complications are generally recorded by treating clinicians and are not subjected to a multi-reader adjudication process as would be common in an imaging-based AI/ML study.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed for this device, nor is there any mention of AI assistance. This document describes a traditional medical device, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical implant (vena cava filter) and extraction kit, not an algorithm.

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

For clinical performance, the "ground truth" was based on outcomes data (e.g., complication rates, successful retrieval rates) from the 220-patient clinical investigation. These outcomes would have been observed and recorded by medical professionals.

8. The sample size for the training set

This information is not applicable as this isn't an AI/ML device requiring a training set. The clinical data referenced is to demonstrate the device's performance in real-world use.

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

This information is not applicable as this isn't an AI/ML device.

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The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated: -
• Failure of anticoagulant therapy in thromboembolic diseases; -
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The ALN optional filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit.

Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvek/film pouches and the extraction kit is packaged alone in the same type of pouches.

The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.

Here's an analysis of the provided text regarding the ALN Optional Vena Cava Filter and Extraction Kit, focusing on the acceptance criteria and the study used to demonstrate fulfillment:

I. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for the ALN Optional Vena Cava Filter and Extraction Kit. Instead, it describes a series of non-clinical tests and refers to clinical data. The acceptance is implied by successfully passing these tests and showing similar performance to predicate devices.

II. Study Details for Demonstrating Acceptance Criteria

The document references both non-clinical (bench) testing and clinical data.

Non-Clinical Performance Studies:

• Sample Size: Not explicitly stated for each non-clinical test (simulated deployment, introducer/sheath suitability, filter fracture, caval perforation/migration, thrombogenicity, MRI compatibility). For "clot trapping ability," it involved a bench test comparison, but the number of tests or samples is not specified.
• Data Provenance: Implied to be laboratory/bench testing. No country of origin is mentioned for these specific non-clinical tests.
• Ground Truth: The "ground truth" for these non-clinical tests would be the established engineering/materials standards and performance metrics for such devices. Not applicable for expert review.
• Adjudication Method: Not applicable for non-clinical tests described.
• MRMC Comparative Effectiveness Study: Not applicable for non-clinical tests.
• Standalone Performance: Yes, the non-clinical tests evaluate the device's inherent performance characteristics independently.
• Type of Ground Truth: Engineering specifications, material properties, and established test methodologies (e.g., ISO standards for medical devices, although not explicitly named).
• Training Set Sample Size & Ground Truth: Not applicable; these are performance validation tests, not machine learning model training.

Clinical Performance Study:

• Study Description: The document states, "The safety and effectiveness of the ALN Optional Vena Cava Filter and Extraction Kit have been demonstrated via clinical data collected for 14 years." It then specifically mentions: "The last clinical study about ALN Optional Vena Cava Filter and Extraction Kit was published in chest in 2006. It includes 220 patients who receive an ALN Optional Vena Cava Filter for prevention of venous thromboembolism."
• Sample Size (Test Set): 220 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the publication in "Chest" in 2006 suggests it was a published, likely prospective, clinical trial. The long data collection period (14 years) implies either a series of studies or long-term follow-up from a prospective study.
• Number of Experts & Qualifications (Ground Truth): Not specified in the provided text. Clinical studies typically involve physicians (e.g., interventional radiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the number and qualifications of those establishing study endpoints or ground truth directly are not detailed here.
• Adjudication Method: Not specified. Clinical trials often employ independent clinical event committees (CEC) or data safety monitoring boards (DSMB) for adjudication, but this detail is absent.
• MRMC Comparative Effectiveness Study: No, this was a study on the ALN filter itself, not a comparative effectiveness study involving human readers with/without AI assistance.
• Standalone Performance (Clinical): Yes, this clinical study assessed the standalone performance of the ALN Optional Vena Cava Filter in patients.
• Type of Ground Truth (Clinical): "Outcomes data." The study assessed clinical outcomes such as complication rates and successful retrieval. The fundamental "ground truth" for efficacy would be the absence of pulmonary embolism or the successful treatment of conditions leading to PE prevention.
• Training Set Sample Size & Ground Truth: Not applicable. This is a clinical trial evaluating device performance, not a machine learning model. The "training set" for the device's development would involve iterative design and bench testing, but not a dataset in the AI sense.

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