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The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.

The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.

The provided text describes the Insightra Freedom Ventral Hernia Repair System, a surgical mesh device. However, it does not include detailed "acceptance criteria" for the device's performance in terms of specific metrics (like sensitivity, specificity, accuracy, or recurrence rates with statistical targets) nor does it delineate a formal study with a methodology typically associated with establishing such criteria.

Instead, the document highlights biocompatibility testing and bench testing, as well as a "simulated use" animal study, to demonstrate safety and effectiveness in support of a 510(k) submission, confirming substantial equivalence to predicate devices.

Therefore, many of the requested sections regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, and adjudication methods cannot be fully answered from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

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:
  • For biocompatibility testing, the sample size is not specified.
  • For bench testing, the sample size is not specified.
  • For the in vivo simulated use animal test, the sample size (number of animals) is not specified.
• Data Provenance: Not specified, but the animal testing was performed "per GLP requirements."

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 as this is a medical device for surgical repair, not an AI/diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance and biological response of the mesh based on engineering and biological tests.

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

• Not applicable for this type of device and testing. The evaluation relies on standardized test methods and observations of physical and biological outcomes.

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 not an AI-assisted diagnostic device. The document does not describe any MRMC studies or AI assistance.

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

• Not applicable as this is a surgical mesh device, not an algorithm or AI system.

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

• The "ground truth" for this device's evaluation is primarily established through:
  • Biocompatibility Standards: Adherence to ISO 10993-1.
  • Engineering Specifications: Meeting predefined product specifications derived from design requirements.
  • Simulated Use Observations: Performance observed in in vivo simulated use experiments (animal study) to assess physical attributes like deployment, securement, and general surgical utility.
  • Comparative Analysis: Demonstrating substantial equivalence to predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' historical performance.
  • Clinical Observations (implied): Phrases like "effective in terms of recurrence rates, lack of migration and acute pain rates" suggest a general understanding of desired clinical outcomes, though no specific clinical study data is provided in this summary.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

• Not applicable.

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The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.

The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

The provided text describes a 510(k) summary for the Freedom Inguinal Hernia Implant, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a regulatory submission for a surgical mesh, which is a physical medical device, not a software-driven diagnostic or AI/ML product. The "Performance Data" section discusses:

• Biocompatibility testing: Previously conducted and applicable.
• Bench testing and in vivo simulated use experiments: Conducted in hernia simulators and fresh bovine meat.

These tests are designed to demonstrate the physical and material performance of the surgical mesh, ensuring it meets product specifications and intended use. They are not related to AI/ML performance metrics such as sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) because the document does not present an AI/ML device or its associated performance evaluation.

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The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exists.

The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manufactured from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the delivery device provided in the Freedom Inguinal Hernia Repair kit. The delivery device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. There are two different sizes of implants and corresponding delivery devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

The provided text describes a 510(k) premarket notification for the "Freedom Inguinal Hernia Implant." This document primarily focuses on establishing "substantial equivalence" to predicate devices rather than deeply detailing acceptance criteria of a standalone study for an AI/algorithm-based device.

However, I can extract information related to the device performance and acceptance criteria implied by the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a structured table of "acceptance criteria" and "reported device performance" in the way one would for an AI algorithm's metrics (e.g., sensitivity, specificity, AUC). Instead, it describes general desired outcomes for a hernia implant. Based on the objectives of the clinical studies, here's an attempt to structure the information:

• "Safe and effective for the treatment of inguinal hernias" (Group 1, n=61)
• No reports of unresolved post-operative complications (Group 1, n=61) |
  | Freedom from hernia recurrence (1, 6, 12, 24, 36 months) | - No recurrences after 3 years (Group 1, n=61)
• No long term complications or recurrences (Amato Study, n=30, mean 25.23 months follow-up)
• No recurrences (Petrella/Venditti Study, n=24, mean 4.5 months follow-up) |
  | Secondary Complications Objectives | |
  | No perioperative/postoperative complications (1, 6, 12, 24, 36 months) | - No reports of unresolved perioperative complications (Group 2, n=30)
• No reports of tissue injury or spermatic cord complications (Group 2, n=30)
• No long term complications (Amato Study, n=30) |
  | No bleeding, swelling, hematoma from dilation/delivery | - No reports of tissue tearing injury or spermatic cord injury (n=78 total with dilation technique) |
  | No seroma, infection/abscess, testicular/spermatic cord injury, wound complications, symptomatic pain, or chronic pain syndrome | - No reports of spermatic cord injury or compression complications due to device rotation/sizing (Group 2, n=27, 1 year+ follow-up)
• No chronic discomfort (Amato Study, n=30) |
  | Biocompatibility | Complies with requirements for device classification (Pre-Clinical Tests) |
  | In vitro Performance | Meets pre-determined acceptance criteria or specifications (Pre-Clinical Tests) |
  | In vivo Performance | Validated implantation procedure, demonstrated tissue incorporation (Pre-Clinical Tests) |
  | Delivery Device Performance | Successfully deployed implant in proper location (Cadaver studies), validated implantation technique (Cadaver studies) |

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

The document describes several clinical experiences and studies, rather than a single "test set" for an algorithm. It uses data from patient groups as clinical evidence for substantial equivalence.

• Group 1 (Retrospective Data):
  • Sample Size: n=61 patients
  • Data Provenance: Single center, single surgeon clinical experience. Likely unknown specific country, but general clinical practice data. Retrospective (patients followed for a minimum of 3 years after implantation with custom implants).
• Group 2 (Prospective/Retrospective Mixed):
  • Sample Size: n=30 patients (received Insightra manufactured implant). 27 followed for a year or more.
  • Data Provenance: Unspecified country, but clinical experience with Insightra's device. Follow-up ranged from perioperative to one year post-implantation, with a mean of 25 months for those followed longer. This suggests a prospective collection for at least part of the follow-up, but the initial collection might have been retrospective to some degree.
• Amato Study (Prospective):
  • Sample Size: n=30 patients (total implants n=34 due to bilateral hernias)
  • Data Provenance: Single center, single investigator. Country not specified. Prospective study enrollment June 2009 to August 2011.
• Petrella/Venditti Study (Prospective):
  • Sample Size: n=24 enrolled patients (target enrollment = 80)
  • Data Provenance: Single center, two investigators. Country not specified. Prospective study enrollment Dec 2011 to present (at time of filing).

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

For these clinical studies involving surgical implants, the "ground truth" is typically established by the implanting surgeon(s) and following clinicians who assess patient outcomes (recurrence, complications, comfort).

• Group 1: Single implanting surgeon (qualifications not specified beyond "surgeon").
• Group 2: Unspecified number of clinicians involved, likely the surgeons performing the implantations and follow-ups.
• Amato Study: 1 investigator (likely implanting surgeon). Qualifications not specified.
• Petrella/Venditti Study: 2 investigators (likely implanting surgeons). Qualifications not specified.

There is no mention of "experts" in the context of independent review or adjudication of study endpoints, as might be done for imaging-based diagnostic devices.

4. Adjudication Method for the Test Set

There is no explicit mention of an adjudication method (like 2+1, 3+1) for the clinical outcomes in any of the studies. The outcomes were likely recorded by the treating physicians/investigators. For surgical outcomes like hernia recurrence or complications, direct clinical examination and patient reporting, sometimes supplemented by imaging, serve as the basis for recorded outcomes.

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, an MRMC comparative effectiveness study was not performed. This document describes a medical device (hernia implant), not an AI algorithm for diagnosis or interpretation that would involve "human readers."

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

No, this document describes an implanted medical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the effectiveness and safety of the hernia implant primarily relies on:

• Clinical Outcomes Data: Direct observation of procedural success, absence of recurrence or complications, patient-reported symptoms (pain, discomfort), and clinician assessment of tissue injury, seroma, infection, etc.
• Pathology/Histology (Implied): The in vivo survival study demonstrated "tissue incorporation," which would typically involve histological examination of explanted tissue.
• Imaging Data (Limited): Ultrasound findings were mentioned for a subset of patients in the Amato study ("Full and stable obliteration of twelve patients examined at 3, 6 and 12 months.") but not for the Petrella/Venditti study.

8. The Sample Size for the Training Set

This document does not describe an AI/ML algorithm, so there is no "training set." The "development" of the device involved:

• In vitro and In vivo (animal) tests: For material properties, mechanical performance, and biocompatibility.
• Cadaver studies: To validate implantation procedure and technique.
• Early clinical experience: The Group 1 patients (n=61) received "custom implants fabricated by the implanting surgeon," which can be seen as preceding the Insightra manufactured implant, providing early clinical insights that might conceptually relate to "training" in an operational sense, but not algorithmic.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. For the pre-clinical and early clinical development of the device, "ground truth" was established through standard laboratory testing, animal studies (pathology, tissue incorporation), and clinical follow-up by surgeons/investigators.

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The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.

The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors).

The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the hearbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.

The provided text describes the Insightra Ultra IABP Catheter Kit, a medical device for cardiac assist therapy. However, the documentation focuses primarily on demonstrating substantial equivalence to predicate devices through design and material comparison, and pre-clinical testing for safety and basic functionality. It does not include the details of a study that would typically be associated with AI/ML-based device performance evaluation, such as specific acceptance criteria for diagnostic accuracy, sample sizes for test/training sets in an AI context, expert ground truth establishment, or multi-reader multi-case studies.

Therefore, the response below will reflect the information that is available in the provided text, and explicitly state what information is not present given the nature of the device and the submission.

Acceptance Criteria and Study Details for the Insightra Ultra IABP Catheter Kit (K082746)

Based on the provided 510(k) summary, the device is an Intra-Aortic Balloon Pump (IABP) Catheter, a physical medical device designed to provide mechanical left heart assist. The assessment of its performance and acceptance criteria is centered on its physical and biological properties and its functional equivalence to existing, legally marketed predicate devices, rather than on the performance of a diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through pre-clinical in vitro tests and biocompatibility testing. The specific quantitative acceptance criteria are not detailed in the summary document but are stated to have been "pre-determined." The performance is reported as meeting these criteria.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of diagnostic accuracy, as this is a physical medical device. For the "in vitro" and "biocompatibility" tests, the sample size would refer to the number of catheters tested. This information is not provided in the summary.
• Data Provenance: The tests are described as "in vitro" and "biocompatibility" tests. This indicates laboratory-based testing, likely conducted within the manufacturer's facilities or by contracted testing laboratories. Information regarding country of origin of data or whether it's retrospective/prospective is not applicable in the same way it would be for clinical data or AI model evaluation.

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

• This information is not applicable to this type of device and submission. The ground truth for device performance in this context would be objective physical and biological measurements against pre-defined engineering and safety standards, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving discrepancies in expert interpretations of medical data, which is not relevant to the physical and biological testing described here.

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

• No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the function of the Insightra Ultra IABP Catheter Kit.

6. Standalone (Algorithm Only) Performance Study

• No standalone algorithm performance study was done. This device is a physical catheter, not an AI/ML algorithm.

7. Type of Ground Truth Used

• The ground truth used for assessing this device's performance is based on engineering specifications, established industry standards for material properties and device functionality (e.g., inflation/deflation characteristics, pressure handling), and regulatory requirements for biocompatibility (e.g., ISO 10993 standards). It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. Sample Size for the Training Set

• This information is not applicable as this is not an AI/ML device requiring a training set.

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

• This information is not applicable as this is not an AI/ML device requiring a training set.

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