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The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Wound retraction device providing thoracic and abdominal access and protection from wound contamination.

This document is a 510(k) summary for the Covidien Surgisleeve™ Wound Protector, a medical device designed for surgical access and wound protection. It confirms that the device is substantially equivalent to a previously cleared predicate device (K140064). The document outlines the intended use, device description, materials, and performance data from in-vitro and in-vivo tests but does not present acceptance criteria or detailed study results for an AI/CADe device.

Therefore, the requested information cannot be extracted from the provided text. The document describes a traditional medical device (wound protector) and its regulatory clearance process, not a device involving AI or machine learning that would have acceptance criteria and a study design as typically requested for AI/CADe systems.

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The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Wound retraction device providing abdominal access and Protection from wound contamination

Here's an analysis of the provided information regarding the Surgisleeve™ Wound Protector XS, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample sizes used for the in-vitro or in-vivo testing. The data provenance (e.g., country of origin, retrospective/prospective) is also not explicitly stated. However, given the context of a 510(k) submission, the testing would typically be conducted by or for the manufacturer (Covidien) and would be considered prospective for the purpose of demonstrating device performance for regulatory submission.

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

This information is not provided in the given document. For a medical device like a wound protector, "ground truth" often relates to objective physical properties and functional performance rather than expert interpretation of images or clinical data. The "in-vivo use" testing would likely involve animal models or human cadavers/simulators, and the assessment would be based on direct observation of the device's function, potentially by engineers, surgeons, or trained personnel.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For the mechanical and functional tests described, it's unlikely that an adjudication process similar to clinical image interpretation (e.g., 2+1, 3+1) would be used. Performance would be assessed against predefined criteria and specifications.

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

No MRMC comparative effectiveness study was mentioned or conducted. The device is a physical wound protector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.

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

Not applicable. The Surgisleeve™ Wound Protector is a physical medical device, not an algorithm. Its performance is inherent in its design and materials, and it functions independent of any algorithm.

7. Type of Ground Truth Used

The ground truth used for this device would be primarily objective physical measurements and functional performance observations during in-vitro and in-vivo testing. For example:

• Film Penetration Resistance: Measured force required to penetrate the film.
• Strength of Attachment: Measured force required to detach components.
• Weld Seam Strength: Measured strength of the welded seams.
• In-Vivo Use: Direct observation and assessment of the device's ability to be inserted, retracted, allow instrument passage, and facilitate specimen removal without failure or adverse events in a simulated or actual surgical environment.
• Biocompatibility: Established by adherence to ISO 10993-1:2009, which involves various biological and chemical tests.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science.

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

Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth establishment process in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering standards, material specifications, and pre-clinical testing protocols.

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The Applied Wound Protector/Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision size.
• Protect against wound contamination during laparoscopic and open surgery.

Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm. The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.

The provided text describes the Alexis O Wound Protector/Retractor and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information of the acceptance criteria and study that proves the device meets the acceptance criteria is described.

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The Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically-retracted incision.

Wound retraction device providing access and protection from wound contamination. The Wound Protector Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The Interior and Exterior rings are flexible to aid insertion, film retraction, and removal.

The provided text describes a 510(k) summary for the Covidien Wound Protector, a sterile surgical drape. This document focuses on the device's technical characteristics and performance data related to its physical properties and usability, rather than clinical performance against specific metrics like accuracy or diagnostic efficacy that would require a study with human subjects, ground truth, and statistical analysis.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and the information provided. The "performance data" section in the document refers to a series of in-vitro and in-vivo tests designed to confirm the device's mechanical integrity and functionality, not a clinical study to prove efficacy or diagnostic capability.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists the tests performed, and the 510(k) clearance implies that the device met the acceptance criteria for all these tests. Specific numerical values for the performance are not provided in this summary.

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

• Sample Size: Not explicitly stated for each test. The performance data refers to in-vitro and in-vivo testing. For in-vivo tests, the sample size would typically refer to the number of animals or human subjects, but this is not provided. For in-vitro tests, the sample size would be the number of units tested.
• Data Provenance: The document does not specify the country of origin of the data. It mentions both in-vitro (laboratory) and in-vivo testing, but does not indicate if it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests are typically prospective tests conducted specifically for the submission.

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

• Not Applicable. This device is a physical surgical drape, not an AI or diagnostic device that relies on interpretation of data to establish ground truth with experts. The "tests" are about physical properties and usability, not diagnostic accuracy.

4. Adjudication method for the test set

• Not Applicable. As there's no diagnostic component requiring expert judgment or consensus, no adjudication method like 2+1 or 3+1 is relevant.

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 or imaging device. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.

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

• Not Applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

• For physical/mechanical tests (in-vitro): Ground truth is established by objective measurements against industry standards (e.g., ASTM D3787, ASTM D412) or established engineering specifications for strength, tear resistance, etc.
• For usability/in-vivo tests: Ground truth for "Ease of Use," "Incision Retraction," "Tissue Trauma," etc., would be established through observation, subjective assessment by trained personnel (possibly surgeons or medical professionals simulating use), and potentially histological examination for tissue trauma. However, the specific methodology for establishing this "ground truth" (or assessment criteria) is not detailed.
• For biocompatibility: Ground truth is established by adherence to the ISO 10993-1:2009 standard, which involves specific biological evaluation tests to ensure the materials are safe for patient contact.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

The Applied Wound Retractors come in-four sizes, small, medium-large and large and in two shapes, round and elliptical. The shape of a wound retractor is defined by its wound retracting ring. The Wound Retractor consists of a wound retractor ring and a wound protecting sheath. The wound retractor ring is molded from a plastic material. The wound protecting sheath is comprised of a cylindrical elastic sheath with a ring at one end. The Wound Retractor package also includes an incision template. The Wound Retractor is a disposable, single-use device and is packaged inside Tyvek/Mylar The would which is standard packaging material for medical products. The packaged product will then be packaged in an outer product carton in 1 to 10 pieces per carton.

This document is a 510(k) summary for a medical device called a "Wound Retractor." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in more detailed performance reports.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes, data provenance, number of experts, qualifications of experts, adjudication method,
• Multi-reader multi-case (MRMC) comparative effectiveness study results,
• Standalone algorithm performance, or
• Details about the ground truth for training or test sets.

The information provided is purely for regulatory clearance based on substantial equivalence, not a detailed technical performance study.

Here's what I can extract from the provided text based on your prompt, even though it doesn't contain the specific performance study details you're looking for:

The document does NOT contain information regarding:

• Acceptance criteria or reported device performance
• Sample sizes for test sets or their data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm (AI) performance (as this is a physical medical device, not an AI/software device)
• Sample size for training sets
• How ground truth for training sets was established

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. This 510(k) summary is focused on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting detailed performance study results against specific criteria.

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