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Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds:

• Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• Diabetic ulcers
• Chronic vascular ulcers
• Tunneled/undermined wounds
• Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
• Draining wounds

Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.

This document describes a 510(k) premarket notification for a wound dressing device, Corplex P/Theracor P/Allacor P. It focuses on demonstrating substantial equivalence to a predicate device, Myriad Particles, rather than proving the device meets specific performance criteria through a comparative effectiveness study in the context of an AI-powered medical device.

Therefore, many of the requested categories related to AI device performance, such as sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, are not applicable to the information provided in this 510(k) submission.

This submission is about a traditional medical device (wound dressing) aiming for clearance based on substantial equivalence, not a novel AI/ML device that requires extensive clinical validation of its algorithm's performance against human readers or a robust ground truth.

Here's an attempt to answer the applicable questions based on the provided text:

1. Acceptance Criteria and Device Performance

The submission does not outline specific, quantified performance "acceptance criteria" in the way one would for an AI algorithm's diagnostic accuracy (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various technological characteristics and presenting results of non-clinical (performance and biocompatibility) and clinical (human repeat insult patch test, skin prick test) testing to show that differences do not raise new safety or effectiveness concerns.

Table of Performance Testing (Non-Clinical):

Table of Biocompatibility Testing Results (All Met Requirements):

• Cytotoxicity: ISO 10993-5:2009
• Materials Mediated Pyrogenicity: ISO 10993-11:2017
• Sensitization: ISO 10993-10:2010
• Acute Systemic Toxicity: ISO 10993-11:2017
• Intracutaneous Reactivity: ISO 10993-10:2021
• Implantation: ISO 10993-6:2016
• Chemical Characterization and Toxicological Risk Assessment: ISO 10993-18:2020, ISO 10993-17:2002, ISO 21726:2019
• Genotoxicity: 10993-3:2014, ISO 10993-33:2015
• Viral Risk Assessment and Clearance Study
• Endotoxin: ANSI/AAMI/ST72
• Packaging System Cytotoxicity: ISO 10993-5:2009

Clinical Testing:

• Human Repeat Insult Patch Test
• Skin Prick Test

The text states that these tests were conducted to "demonstrate substantial equivalence... or to mitigate any potential performance risks" and that results "meet the requirements" (for biocompatibility). No specific numerical thresholds or performance metrics are provided for these tests, as the goal is conformance to standards and equivalence, not a quantitative measure of superior performance an AI device might exhibit.

2. Sample Size for the Test Set and Data Provenance

Not applicable in the context of an AI/ML device's test set. The clinical testing mentioned (Human Repeat Insult Patch Test, Skin Prick Test) would have used human subjects, but their sample sizes are not disclosed in this document. These are typical safety evaluations for skin-contacting devices, not performance evaluations like those for AI.

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 AI context of expert consensus, is not relevant here. The "ground truth" for this device's testing would be defined by the results of the specific ASTM, ISO, or other standardized tests performed (e.g., a certain level of endotoxin, or a negative cytotoxicity finding). These are objective measurements from laboratory tests, not subjective interpretations by human experts.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective interpretation requiring adjudication in the tests described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study. This is a submission for a wound dressing device, not an AI diagnostic tool.

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's clearance is a combination of:

• Conformance to established standards: e.g., ISO 10993 series for biocompatibility.
• Comparison to a predicate device: showing that the new device's characteristics and performance are "substantially equivalent" and do not raise new safety or effectiveness concerns compared to a legally marketed device.
• Laboratory test results: demonstrating properties like moisture content, dissolution, etc., meet internal specifications or are comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system

The provided text describes the SURGISIS Ocular Graft, an ophthalmic implant made from processed porcine small intestinal submucosa. It details the device's description, indications for use, and a summary that it is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility, viral inactivation, and mechanical testing. The text states that these outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.

However, the provided text does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria. The information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established is not present in the provided document.

The document focuses on establishing substantial equivalence to predicate devices, listing the predicate devices and their characteristics, rather than detailing the specifics of a study evaluating the performance against predefined acceptance criteria for the SURGISIS Ocular Graft itself in the manner requested. The "Summary of Testing" section is very high-level and does not provide quantitative results or detailed study methodology.

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