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The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:

This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.

2. Sample Sizes and Data Provenance

• Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
• Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
• Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
  • Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
• Clinical Testing:
  • Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
  • Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."

3. Number of Experts and Qualifications for Ground Truth for Test Set

This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.

• For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.

4. Adjudication Method for the Test Set

Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.

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

No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.

6. Standalone Performance Study

This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).

7. Type of Ground Truth Used

• Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
• Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
• Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
• Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.

8. Sample Size for the Training Set

This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.

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Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.

Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.

The provided text describes a 510(k) summary for "Soothies Gel Pads," a nipple shield. The focus of the document is on establishing substantial equivalence to predicate devices, primarily through material composition and intended use, rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or interventional device.

Therefore, many of the requested elements for describing a study and acceptance criteria are not applicable (N/A) based on the provided text, as this is a regulatory submission for a Class I device and not a performance study report.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a dedicated study.

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

This information is not applicable as the document does not describe a performance study with a test set in the traditional sense. The safety evaluation mentioned a "residue of acrylamide gel" and its potential ingestion, but this is a risk assessment, not a performance study.

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

This information is not applicable. No test set or ground truth establishment by experts for performance measurement is described in the document.

4. Adjudication Method for the Test Set

This information is not applicable. No test set or adjudication method is described.

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

This information is not applicable. The document does not describe an MRMC comparative effectiveness study, nor does it quantify human reader improvement with or without AI assistance, as AI is not a component of this device.

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

This information is not applicable. The device is a physical nipple shield, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. Type of Ground Truth Used

This information is not applicable. No performance study with a defined ground truth is described. The "safety" section mentions an "evaluation" based on acrylamide monomer, but this is a risk assessment, not a ground truth for a performance metric.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as the device is a physical product and not an AI/algorithm-based system requiring training data.

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

This information is not applicable for the same reasons as #8.

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Over the Counter Use: To be worn inside the bra to:

• Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding .
• Absorb milk leakage .
• Protect the nipple from abrasion and friction damage caused by bra or clothing .
• Help alleviate discomfort .
• Protect clothing from milk leakage .

FERRIS PolyMem® STERILE BREAST PAD

This document is a 510(k) clearance letter from the FDA for a medical device called "Ferris PolyMem® STERILE BREAST PAD". It does not describe acceptance criteria, a study proving device performance, or any of the other information requested in the prompt related to an AI/algorithm-based device.

Therefore, I cannot provide the requested information from the given text.

The document is a regulatory approval for a physical medical device (breast pad), not a software or AI-driven device that would involve performance metrics like accuracy, sensitivity, specificity, or studies with test sets, ground truth, or expert adjudications.

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To relieve nipples that are sore and cracked from breastfeeding.

Not Found

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the "Soothing Gel Patch" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, rather than requiring a full clinical study with specific acceptance criteria and detailed performance metrics to be proven.

The letter focuses on regulatory compliance and categorization, not on the technical performance data of the device itself.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (i.e., algorithm only without human-in-the-loop) was done (This question is not relevant as it's a physical device, not an algorithm)
7. The type of ground truth used
8. The sample size for the training set (This question is not relevant as it's a physical device, not an AI/ML algorithm)
9. How the ground truth for the training set was established (This question is not relevant as it's a physical device, not an AI/ML algorithm)

To obtain this kind of information, you would typically need to review the full 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.

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