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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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