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The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

The ALATUS Vaginal Balloon Packing System is designed as an immobilizer to assist in positioning and displacing the vaginal wall in a more predictable and reproducible location during computed tomography (CT) exams and radiation treatment (RT) therapy. The proposed device is a latex free balloon made from Polyurethane consisting of the following components:

1. Balloon
2. Catheter tubing
3. Connector
4. Flex tubing
5. 1-way stopcock, 90° turn handle

The provided text is a 510(k) summary for the ALATUS Vaginal Balloon Packing System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific performance studies with sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.

Therefore, I cannot fulfill your request for the tables and sections regarding acceptance criteria and performance study details. The document primarily addresses regulatory clearance based on substantial equivalence, rather than a detailed performance study as would be expected for an AI/ML device.

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InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum

The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.

The provided text describes a 510(k) submission for a rectal suppository applicator called "InsertEase™". The core of the submission revolves around demonstrating substantial equivalence to already legally marketed predicate devices, primarily vaginal applicators.

Here's an analysis of the acceptance criteria and the study as described in the document, keeping in mind that the primary "study" is a comparison to predicate devices rather than a traditional clinical trial:

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, the acceptance criteria are met if the device demonstrates equivalent:

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) based on substantial equivalence to a physical device. There wasn't a "test set" of performance data generated, but rather a comparison of technical characteristics and intended use.
• Data Provenance: The "data" primarily comes from the established regulatory classifications and descriptions of existing predicate devices marketed in the United States (implied by FDA regulation). This is retrospective in the sense that it relies on the known characteristics and regulatory history of pre-existing devices.

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

Not applicable. Ground truth, in the sense of expert review of performance, was not established for InsertEase™ using a test set. The "ground truth" for the substantial equivalence claim relies on the established regulatory framework and common understanding of how such applicators function, and their safety/effectiveness as previously determined by the FDA for similar devices.

4. Adjudication method for the test set

Not applicable, as there was no test set or expert adjudication process described for performance evaluation.

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 a medical device for physical application, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study was conducted or relevant to this submission.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Predicate Device Characteristics: The established design, materials, intended use, and functional principles of legally marketed vaginal applicators (Product Code: 884.4520(7)) and other relevant devices like Enema Kits (876.5210) and Rectal Dilators (876.5450), and the precedent set by the FDA regarding the Rectal Speculum vs. Vaginal Speculum.
• Regulatory Precedent: The FDA's prior determination of substantial equivalence for devices with similar function but different anatomical sites (e.g., vaginal vs. rectal speculums).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

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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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EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure.

V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use.

V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.

The EpiStat & V-Stat Vaginal Tamponade Balloon is a Class I and Class II medical device, respectively, and its premarket notification 510(k) summary does not contain the level of detail typically found in studies for AI/ML-powered devices. The provided document concerns a traditional medical device (tamponade balloons) seeking substantial equivalence to existing predicate devices, rather than a novel AI/ML application. Therefore, many of the requested categories related to AI/ML device studies, such as ground truth, expert adjudication, MRMC studies, and training set details, are not applicable or cannot be extracted from this document.

However, based on the provided text, here's what can be gathered regarding acceptance criteria and performance for the EpiStat & V-Stat Vaginal Tamponade Balloon:

1. Table of Acceptance Criteria and 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)

• The document does not specify sample sizes for the performance tests (burst strength, tensile strength, leak testing, etc.).
• The data provenance is not specified. The tests are described as "Performance Testing" which implies an in-house or contracted laboratory setting, rather than clinical data from human subjects.

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 information is not applicable and not provided in the document. The "ground truth" for a mechanical device is typically established by engineering specifications and objective physical measurements rather than expert human interpretation.

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

• This information is not applicable and not provided in the document. Adjudication methods are relevant for subjective assessments, particularly in clinical studies or image interpretation, which are not described here.

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 information is not applicable and not provided. An MRMC study is relevant for AI/ML image interpretation or diagnostic tools, which this device is not.

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

• This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.

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

• For the performance tests, the "ground truth" is based on objective engineering and manufacturing specifications and established industry standards (e.g., ISO 10993-1 for biocompatibility). There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's physical and biological performance attributes.

8. The sample size for the training set

• This information is not applicable and not provided. The device is a physical tamponade balloon, not an AI/ML system requiring a training set.

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

• This information is not applicable and not provided for the reasons stated above.

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Common Name: Circumcision Clamp

Circumcision Clamp

The provided text is a 510(k) summary for a medical device called EZ-CIRC, a circumcision clamp. It explicitly states that the safety and effectiveness determination is based on a predicate device, the Mogan clamp, which was legally marketed prior to May 28, 1976.

This summary does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement for the EZ-CIRC device itself. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed performance metrics as would be expected for novel AI-powered diagnostic devices.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text. The document is solely focused on identifying the device, its classification, and its predicate.

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