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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 Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound

Wound retractors convert straight incisions into round openings that facilitate access to internal body cavities and spaces. APPLIED's wound retractors consist of a cylindrical flexible film sheath that has a semi-rigid polymer ring on each end. Retractors of this design are useful in open orthopaedic procedures that require unimpeded access while simultaneously protecting the wound.

Here's a breakdown of the acceptance criteria and study information for the Alexis Orthopaedic Wound Retractor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "These tests were performed on predicate and subject device."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document. The tests appear to be performance-based against objective criteria rather than subjective expert assessment.

4. Adjudication Method for the Test Set

This information is not provided as the tests described are non-clinical, functional and performance-based rather than involving human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical, functional, and performance testing of the device against a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical wound retractor, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.

7. The Type of Ground Truth Used

The ground truth was established through functional and performance testing of the device against predefined, objective laboratory established criteria related to its mechanical properties and intended function (wound retraction, tearing resistance, durability, incision size). The predicate device (Applied Medical Alexis Wound Retractor) served as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve a "training set" in the context of machine learning algorithms.

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

This is not applicable for the reasons stated in point 8.

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The Alexis Laparoscopic System 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. .
• Seal off the incision opening to permit insufflation of the peritoneum. Convert the . incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction during cardiac and general . surgical procedures through an atraumatically retracted incision.

Wound retractors convert straight incisions into semi round openings that facilitate access to internal body cavities and operative sites. These retractors are particularly useful in open or laparoscopic procedures that require removal of large quantities of tissue. The predicate and subject wound retractors share a common construction. Each consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. One ring (the inner ring) is positioned inside a body cavity while the other (outer ring) remains outside the patient. Rotating the outer ring inward - similar to rolling up a shirt sleeve - shortens the retractor and anchors the device in the patient. It also retracts the wound and converts the incision into a round opening. The flexible membrane that connects the rings protects the incised tissue throughout the procedure. The subject device has a snap-on silicone cap that closes and seals the wound opening. This allows the body cavity to be insufflated and the procedure to be completed under laparoscopic conditions. The center of the cap is designed to accommodate a 12mm trocar which effectively converts the wound retractor into a trocar port site.

The provided 510(k) summary for the Alexis Laparoscopic System describes a non-clinical comparison study against a predicate device (Applied Alexis Wound Retractor, K041711). The study aimed to demonstrate substantial equivalence or superiority of the new device.

Here's an breakdown of the information requested:

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

The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds, nor does it provide detailed quantitative "reported device performance" values for each criterion. Instead, it lists the types of tests performed and makes a general conclusion about substantial equivalence or superiority.

However, based on the Discussion of Nonclinical Tests Submitted, we can infer the performance aspects that were evaluated:

The conclusion states: "APPLIED's functional and performance testing has demonstrated that the subject device is substantially equivalent or superior to its predicate device and introduces no new safety and effectiveness issues when used as instructed." This implies that the device met or exceeded the performance of the predicate device for all evaluated criteria.

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

The document does not specify the sample size used for the test set or the data provenance. It only mentions that "Several of these tests were performed on both predicate and subject devices."

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 section is not applicable as the study described is a non-clinical functional and performance test of a wound retractor device, not a study involving diagnostic interpretation or human subject data requiring expert ground truth establishment.

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

This section is not applicable for the same reason as point 3. It's a non-clinical device performance test.

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

This section is not applicable. The study is a non-clinical evaluation of a physical medical device (wound retractor), not an AI-assisted diagnostic tool.

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

This section is not applicable. The study is a non-clinical evaluation of a physical medical device, not an algorithm.

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

This section is not applicable as the study is a non-clinical functional and performance test of a physical device. The "ground truth" would be the direct measurement of physical properties and performance characteristics against predefined engineering specifications or the performance of the predicate device.

8. The sample size for the training set

This section is not applicable. The study is a non-clinical evaluation of a physical medical device, not a machine learning model requiring a training set.

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

This section is not applicable for the same reason as point 8.

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The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries.

The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) :

• l Access the abdominal cavity during surgery through an atraumatically retracted incision.
• 피 Delivery maximum exposure of the abdominal cavity with minimum incision size.
• 트 Protect against wound contamination during laparoscopic and open surgery.
• . Seal off the incision opening to permit insufflating the peritoneum.
• 트 Convert the incision wound to an additional trocar port site.
• 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings.

To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material The Wound Retractor package also includes an incision template.

The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure.

The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.

The provided text is a 510(k) summary for the Alexis® Wound Retractor, a device used for surgical retraction and wound protection. It does not contain a study demonstrating that the device meets specific acceptance criteria in the way typically found for diagnostic algorithms or devices with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on substantial equivalence to a predicate device, and the "acceptance criteria" are related to biocompatibility, material properties, and sterility, which are standard for a medical device of this type.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• For the material and biocompatibility testing, specific sample sizes are not mentioned in the document. These tests are typically performed on a statistically relevant number of samples to demonstrate compliance with standards.
• Data provenance is not explicitly stated, but it can be inferred that these tests were conducted internally by Applied Medical Resources Corporation or by a qualified third-party testing facility under their direction, as part of the device development and regulatory submission process. These are laboratory-based tests of the device itself.

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

• Not applicable in the context of this device and submission. The "ground truth" here is compliance with established physical, chemical, and biological safety standards (e.g., ISO, ASTM). These standards define the test methods and acceptance criteria, rather than requiring expert consensus on a diagnostic outcome. Experts involved would be those qualified to execute and interpret these standard tests (e.g., toxicologists for biocompatibility, materials scientists for mechanical properties, microbiologists for sterility validation).

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies comparing diagnostic interpretations, not for physical device property testing. Compliance is determined by whether the test results meet the predefined numerical or qualitative criteria of the respective standards.

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 a physical surgical device, not a diagnostic AI or imaging interpretation tool. Therefore, an MRMC study is not relevant.

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

• No. This is a physical surgical device. The concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable here. Its function is to be used by a human surgeon.

7. The type of ground truth used

• The "ground truth" for this device's acceptance is based on compliance with recognized international and national standards for:
  • Biocompatibility: ISO 10993 (biological safety).
  • Material Properties: ASTM D 412 (tensile strength, elongation) and ASTM D 624 (tear strength).
  • Sterility Validation: ANSI/AAMI/ISO 10993-7 (sterilant residues) and principles for achieving a 10⁻⁶ SAL (e.g., "three half-cycle validation runs").
  • Functional Adequacy: Demonstrated by "functional performance testing" (details not provided, but implies it mechanically performs its intended role).
• Ultimately, the overarching "ground truth" for regulatory clearance is substantial equivalence to an already legally marketed predicate device, demonstrating that it is as safe and effective.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

• Not applicable. No training set is involved.

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The Applied Alexis Wound 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.

The smaller two sizes of Alexis are also intended to be used to:

• Seal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, small and medium products will have two additional indications. These models have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may then be returned to fully laparoscopic and an additional trocar may be placed through the incision site. The Wound Retractor package also includes an incision template. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch.

This 510(k) summary for the Alexis™ Wound Retractors does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the format you've outlined for performance studies of AI/diagnostic devices.

Instead, this document describes a traditional medical device (wound retractor), and its clearance process is based on substantial equivalence to a predicate device, rather than a performance study with defined sensitivity/specificity metrics.

Here's a breakdown of what is provided and why it doesn't fit your requested format:

What's in the document that relates to device evaluation (though not in your requested format):

• Biological Evaluation: "The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices." This is a pass/fail criterion for biocompatibility, not a performance metric like sensitivity or AUC.
• Material Testing: "The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624)." These are material property tests, again with pass/fail criteria.
• Functional Performance Testing: "Functional performance testing has been completed and has passed the required testing." This is a very general statement, indicating the device performs its intended functions (retraction, protection). The specific acceptance criteria and results are not detailed here.
• Sterilization Validation: "Applied's 100% EO sterilization cycle provides a sterility assurance level of 10⁻⁶." This is a specific performance metric for sterility.

Why this document doesn't provide the requested information for an AI/diagnostic device performance study:

1. Nature of the Device: The Alexis™ Wound Retractor is a physical surgical tool, not an AI algorithm or a diagnostic test that generates quantitative results (like a score or a classification) requiring metrics such as sensitivity, specificity, or AUC.
2. Regulatory Pathway: This device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device (Heartport Soft Tissue Retractor). This means the FDA determined it is as safe and effective as a legally marketed device, circumventing the need for extensive clinical trials or complex performance studies generally associated with novel diagnostics or AI. The argument is that it "introduces no new safety or effectiveness issues."
3. Lack of AI/Diagnostic Metrics: The document doesn't discuss "ground truth," "expert consensus," "sample sizes for test/training sets," "MRMC studies," or "standalone performance" because these concepts are not applicable to the physical wound retractor's clearance.

Attempting to map the available information to your requested structure, acknowledging its limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

• This is not applicable as it's not a diagnostic/AI study. Testing for biological evaluation, material properties, and functional performance would have involved a sufficient number of device samples or components according to the respective standards, but a "test set" in the context of image data or patient outcomes is not relevant here.

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

• Not applicable. There is no "ground truth" to be established by experts in this context. Rather, compliance with engineering and biological standards is assessed.

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

• Not applicable.

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:

• Not applicable. This is not an AI/diagnostic device. The clearance is based on substantial equivalence to a predicate device, implying similar effectiveness without a comparative clinical study in this submission.

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

• Not applicable.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness is compliance with recognized standards (ISO, ASTM) and demonstrated equivalence to a predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

In summary, the provided document describes the regulatory clearance of a conventional medical device via the 510(k) pathway, focusing on substantial equivalence and compliance with established engineering and biocompatibility standards, rather than performance metrics typically associated with AI or diagnostic evaluations.

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