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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 CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.

The CorNeat EverPatch is a synthetic, tissue-integrating surgical matrix made of non-degradable polymer fibers. The EverPatch includes 6 bio-stitching holes which are intended to anchor the device by facilitating direct conjunctival adhesion to the sclera thus supporting its bio-integration. The holes at each corner can also be used to suture the device to the sclera.

The FDA 510(k) summary for the CorNeat EverPatch focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results in the manner typically seen for novel efficacy claims. Therefore, some information, such as precise quantitative acceptance criteria or detailed effect sizes from MRMC studies, is not explicitly provided in this document because it's not required for a 510(k) submission based on substantial equivalence for this type of device.

However, I can extract the relevant information concerning characterization and performance testing that was performed to support the device's safety and bio-compatibility.

Here's a breakdown of the available information:

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

The document does not provide specific quantitative acceptance criteria or a performance table as usually understood for diagnostic or interventional devices with quantifiable efficacy metrics. Instead, the performance is demonstrated through various bench testing and biocompatibility assessments, with the implicit "acceptance criterion" being that the results are acceptable for safe and effective use, and comparable to the predicate device where relevant.

Reported Device Performance (from "PERFORMANCE DATA" section):

• Biocompatibility: Evaluated per ISO 10993 Biological Evaluation of Medical Devices Part 1, for externally communicating, blood contacting, permanent devices, and FDA Guidance. All listed tests (Cytotoxicity, Maximization Sensitization, Ocular Irritation, Acute Systemic Toxicity, Pyrogenicity, Implantation 13 weeks, Chemical Characterization, Subacute/Sub-chronic Toxicity, Subacute/Chronic Toxicity, Genotoxicity) were performed and presumably met their respective acceptance limits according to the standards.
• Verification and Validation Tests: Performed in accordance with Design Controls (21 CFR §820.30).
  • Dimensional Analysis: Performed.
  • Cheese-wiring: Performed.
  • Mechanical properties: Performed.
  • Sterilization: Performed.
  • Packaging Validation: Performed.
  • Shelf-life: Performed.
  • Pyrogenicity - Bacterial Endotoxin Test (LAL): Performed.
  • Ocular implantation animal study: Performed.

The document implicitly states that these tests demonstrate the device "demonstrates the requirements and is substantially equivalent to the predicate."

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

• The document mentions an "Ocular implantation animal study" as part of the performance data. However, the specific sample size (number of animals) for this study is not provided.
• The provenance for the animal study (e.g., type of animal) is not specified.
• For the other bench tests, "sample size" typically refers to the number of units tested, which is not specified in this summary.
• Clinical data was not required to demonstrate substantial equivalence, so there is no human test set or data provenance from human subjects for this submission.

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

• Not applicable. Since clinical data was not required and the performance evaluation focused on bench and animal studies (for biocompatibility and physical characteristics), there was no "ground truth" establishment by human experts in the context of clinical interpretation or diagnosis.

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

• Not applicable. As no human expert evaluation or clinical test set for diagnostic accuracy was part of this submission, there was no need for an adjudication method.

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 device is a passive implantable medical device (prosthesis, eyelid spacer/graft, polymer) not an AI-driven diagnostic or interpretative tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this device.

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

• Not applicable. As mentioned above, this device is not an algorithm or AI system.

7. The type of ground truth used

• For biocompatibility, the "ground truth" is established by relevant ISO standards (ISO 10993) and FDA guidance, which define acceptable biological responses and material properties.
• For mechanical properties and physical dimensions, the "ground truth" is defined by engineering specifications and design requirements for the device, and assessed through standard engineering testing methodologies.
• For the ocular implantation animal study, the ground truth would be based on histopathological examination and clinical observations derived from the animal models, interpreted by veterinary pathologists or researchers.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

• Not applicable. As there is no training set for this device.

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The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.

The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm

The provided document, K090078, is a 510(k) summary for a medical device called the KeraSys Bioengineered Lamellar Patch Graft. It does not contain details about acceptance criteria, device performance from a study, or the methodology of such a study.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is claiming their new device is as safe and effective as a device already legally marketed, rather than presenting new performance data from a clinical or analytical study.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's how to interpret the document based on your request:

Acceptance Criteria and Study Details (Not Applicable as per 510(k) Summary)

The K090078 submission focuses on demonstrating substantial equivalence, not on providing a new study with acceptance criteria and measured device performance. As such, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this 510(k) summary.

The summary states: "The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction." This refers to general testing on the material (porcine SIS) used in the device and its predicate devices, rather than a specific performance study of the KeraSys Bioengineered Lamellar Patch Graft itself against predefined acceptance criteria for its intended use.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Not Applicable for this 510(k) Summary)

Most of the following categories are not applicable (N/A) because the provided 510(k) summary does not describe a new performance study that would generate this type of data.

1. Sample size used for the test set and the data provenance: N/A (No specific test set or study described for the KeraSys device).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No test set or ground truth established for this device's performance in this document).
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication described).
4. 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: N/A (This device is a physical implant, not an AI diagnostic tool. No MRMC study is relevant or mentioned).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm or software device).
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No specific ground truth for performance evaluation described for this device).
7. The sample size for the training set: N/A (Not an AI/algorithm device requiring a training set).
8. How the ground truth for the training set was established: N/A (Not an AI/algorithm device).

Summary of 510(k) K090078 Content:

• Device Name: KeraSys Bioengineered Lamellar Patch Graft
• Intended Use: Implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
• Material: Four layers of laminated porcine small intestinal submucosa (SIS).
• Sterilization: Ethylene Oxide.
• Substantial Equivalence Claim: The device claims substantial equivalence to predicate devices based on similar intended use, materials, and technical characteristics. The predicate devices listed are SURGISIS Ocular Graft (K053622) and SIS Facial Implant (K050246).
• Testing Mentioned (General): "The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing." This refers to the core material, not a specific performance study of the KeraSys device itself.

This 510(k) provides evidence for market clearance primarily through a demonstration of similarity to already-approved devices, rather than through presenting novel performance study results against detailed acceptance criteria.

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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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The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.

The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.

The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.

The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure on adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.

The provided text describes the ProKera™ device and its 510(k) submission, focusing on performance data related to its physical integrity and the amniotic membrane attachment, rather than clinical performance for diagnostic or treatment effectiveness. Therefore, many standard metrics for AI/ML performance (e.g., sensitivity, specificity, AUC) and associated study details (e.g., ground truth establishment, MRMC studies) are not applicable to this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section has been adapted as the 510(k) summary focuses on physical performance and integrity rather than diagnostic accuracy.

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

The document does not specify the sample size for the mechanical integrity and cryopreservation tests (e.g., how many devices were tested). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned; however, the testing appears to be laboratory-based physical performance testing rather than clinical data from human subjects.

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

Not applicable for this type of device submission. The "ground truth" here relates to the physical and material properties of the device (e.g., strength of attachment, integrity after freezing), which are determined by engineering and material science testing, not expert clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical interpretations of diagnostic images or data where human consensus is needed. For physical performance testing, the results are typically quantitative measurements or direct observations (e.g., visible cracks).

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a physical medical device like the ProKera™ ophthalmic conformer.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance claims would be the objective results of the physical and material property tests. For example:

• Mechanical Integrity: Measured force required to dislodge the membrane or the outcome of drop tests (e.g., membrane remained attached, no damage).
• Cryopreservation Stability: Quantitative measurements of fastening strength before and after freezing, and qualitative/microscopic observations for cracks or chipping.
• Sterility/Bioburden: Laboratory results from established microbiological testing protocols.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML 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 this device.

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The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.
The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used.
The Conformer is indicated in all cases in which an orbital implant is used.

Both the Motility Orbital Implant and the Bio-eye Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile.
The technological characteristics of the Ocular Implant are the same as the predicate: Both Implants are manufactured of porous hydroxyapatite. It is a synthetic hydroxyapatite which is similar in composition to the mineral content of human bone. The implant material has a unique interconnected porous matrix derived from specific marine corals. A patented manufacturing process preserves the porous structure of the coral while the calcium carbonate skeleton undergoes a hydrothermal chemical conversion to hydroxyapatite. The Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.
The Interpore 200 Porous Hydroxyapatite is identical to the Motility Orbital Implant described above. Interpore is the manufacturer and supplier of the Motility Orbital Implant. The Interpore 200 Porous Hydroxyapatite is sterilized by gamma radiation and is supplied sterile.
The Ophthalmic Conformer, which is now 510(k) exempt (Federal Register 1-21-98), will now be supplied sterile.

The provided document is a 510(k) premarket notification for the Bio-eye® Hydroxyapatite Ocular Implant and Conformer. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through comprehensive studies as one might find for a novel device.

Therefore, the document explicitly states:

• SUMMARY OF PERFORMANCE DATA: Not applicable.
• CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS: Not applicable.

This means the 510(k) submission does not include performance data or studies that would allow for the completion of the requested table and detailed information about acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The basis for clearance is the demonstration of substantial equivalence to existing predicate devices (Motility Orbital Implant K891137, Ophthalmic Conformer K945110, and Interpore 200 Porous Hydroxyapatite K860983), primarily based on technological characteristics (both are manufactured of porous hydroxyapatite, similar in composition to human bone, derived from marine corals with a patented manufacturing process preserving porous structure, and converting to hydroxyapatite). The primary "change" noted is that the Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.

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