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The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture. It describes the device, its intended use, and states that performance testing was conducted. However, it does not provide specific details about the acceptance criteria, the study design, or the results of the performance testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only states that:

• Performance testing was conducted to verify that the Meniscal Repair Device with High Strength Suture is safe and effective and performs as intended. (Under "PERFORMANCE DATA")
• All components...are comprised of materials which are evaluated in accordance with ISO Standard 10993-1. (Under "MATERIALS")

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and materials, rather than providing detailed performance study results that would typically be associated with software or AI-driven diagnostic devices. For mechanical devices like this meniscal repair device, performance testing usually involves bench testing for mechanical properties (e.g., tensile strength, knot security) and biocompatibility testing, rather than studies involving human readers or expert consensus on diagnostic outcomes.

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The EEA™ Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.

The EEA™ Hemorrhoid stapler is designed for use as a stapling instrument for control of hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST™ staples. The EEA™ Hemorrhoid Stapler is offered in a 33mm diameter and with 3.5mm and 4.8mm staple sizes.

The accompanying accessories are comprised of a purse-string suture Anoscope, a Port, and a Dilator.

The provided text describes a 510(k) summary for the EEA™ Hemorrhoid Stapler and accessories, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not present acceptance criteria or detailed study results in the way typically found for diagnostic AI/ML devices. Therefore, I cannot construct a table of acceptance criteria vs. reported device performance, nor can I answer many of the specific questions regarding clinical study design, ground truth, or human-in-the-loop performance.

However, based on the information provided, I can infer some general aspects and state what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., success rates, complication rates, staple line integrity metrics) are not provided in this document.

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

• The document states "In-vitro, in-vivo and ex-vivo performance evaluations were completed".
• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This type of detail is not typically relevant for a surgical stapler's performance evaluation and is not provided. The "ground truth" for a stapler would be its mechanical performance and clinical outcome, not expert interpretation of an image or signal.

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

• Not applicable/not provided for this type of device.

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 study is not mentioned as this is a surgical device, not a diagnostic AI/ML system.

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

• Not applicable as this is a physical surgical device, not an algorithm.

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

• The document mentions "In-vitro, in-vivo and ex-vivo performance evaluations." For such a device, ground truth would likely involve:
  • In-vitro: Mechanical testing (e.g., staple formation, burst pressure of staple lines, force to fire, integrity checks).
  • Ex-vivo: Application on animal tissue or cadaveric human tissue to assess staple formation, tissue compression, and seal integrity.
  • In-vivo: Animal studies or possibly human clinical data (though not detailed here) to assess short-term safety and effectiveness, healing, and complication rates.
• Specific "ground truth" methods like pathology or expert consensus typically apply to diagnostic or AI devices, which this is not.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

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The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries

The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device. It describes the device, its intended use, and its substantial equivalence to predicate devices based on material and performance data. However, it does not contain acceptance criteria or a detailed description of any study that proves the device meets specific performance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No acceptance criteria: The document states "Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended," but it does not specify what those performance criteria were (e.g., tensile strength, knot security, deployment force).
• No detailed study information: While performance testing is mentioned, there are no details about the study design, sample sizes, data provenance, ground truth establishment, expert involvement, or any quantitative results.
• No direct comparison to acceptance criteria: Without specific acceptance criteria, a table showing reported device performance against those criteria cannot be created.

Therefore, most of the requested information cannot be provided based on the given document.

What can be extracted or inferred:

• Device Type: Meniscal Repair Device (surgical tool for soft tissue approximation).
• Intended Use: To approximate soft tissue, such as during the repair of meniscal tear injuries.
• Predicate Devices: Confirmed in the document (TiCron™ surgical suture, Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Stryker Mini-Mender Meniscal Repair System).
• Testing Conducted: Performance testing and material compliance testing (ISO Standard 10993-1 for biocompatibility).
• Regulatory Decision: The FDA found the device substantially equivalent to predicate devices, indicating that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.

In summary, the provided text from the 510(k) summary is a high-level overview and does not delve into the detailed technical specifications and study results required to answer your specific questions about acceptance criteria and study data.

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