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The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.

The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.

The provided text is a 510(k) summary for the MicroVision Scleral Buckling Components. This document outlines the device's characteristics, intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way one might find for more complex diagnostic or therapeutic algorithms.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. Nature of the Device: Scleral buckling components are physical implants used in surgery. Their regulatory clearance relies heavily on material biocompatibility, physical properties, and equivalence to existing, established predicate devices, rather than clinical performance metrics in the same way a diagnostic AI would. There are no "performance metrics" in terms of sensitivity, specificity, accuracy, or reader improvement for this type of device.

2. Type of Regulatory Submission: A 510(k) submission generally focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves bench testing (physical and chemical properties), material characterization, and a comparison of intended use, rather than extensive clinical efficacy studies with ground truth established by experts.

Based on the provided text, here's what can be extracted and why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation for Missing Information: For devices like these, "acceptance criteria" are typically met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes (materials, intended use, performance, safety). The "reported device performance" here describes how it meets those equivalence criteria rather than numerical performance metrics like those for an AI algorithm.

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

• Not applicable/Not provided. This device is a physical implant, not a diagnostic algorithm that uses a "test set" of data. The "testing" involved bench testing for physical and material properties, and biocompatibility testing. The document does not specify sample sizes for these types of tests, or where their data originated from (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not provided. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where human assessment is the reference standard. For a medical device implant, ground truth regarding its material properties or biocompatibility is established through standardized laboratory tests (e.g., ISO 10993), not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. As there's no "test set" of clinical cases requiring expert interpretation, no adjudication method (like 2+1 or 3+1) was used.

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

• No. An MRMC study is designed to compare human reader performance, often with and without AI assistance, on a set of clinical cases. This is not relevant for a physical implant device designed for surgical treatment. Therefore, no effect size of human reader improvement with AI assistance is applicable or reported.

6. Standalone (Algorithm Only) Performance:

• Not applicable/Not provided. This is not an algorithm or AI device; it's a physical medical implant. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

• Regulatory/Bench Testing Standards: The "ground truth" for this device's acceptance is based on adherence to recognized standards for biocompatibility (ISO 10993) and demonstration of equivalent physical and dimensional properties through bench testing, compared to legally marketed predicate devices. It's not based on expert consensus on clinical cases, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. Sample Size for the Training Set:

• Not applicable/Not provided. This device is not an AI algorithm, so there is no concept of a "training set" for machine learning.

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

• Not applicable/Not provided. Since there's no training set, this question is not relevant.

In summary, the 510(k) summary for MicroVision Scleral Buckling Components demonstrates substantial equivalence primarily through bench testing and material characterization to established predicate devices, which aligns with the regulatory pathway for this type of device. The extensive clinical study details, expert consensus, and AI-specific metrics requested are not applicable or provided in this document given the nature of the device and the regulatory submission.

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Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.

Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.

The provided text describes a 510(k) summary for the Ocu-Guard Supple Orbital Implant Wrap, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way that might be seen for a new, complex algorithm or diagnostic device.

Therefore, many of the requested categories for acceptance criteria and study design are not directly applicable or extractable from this type of regulatory submission. The submission is primarily interested in showing that a modification to an existing product (adding a 1M NaOH treatment) does not negatively impact its safety or effectiveness compared to the previous version of the product.

Here's an attempt to answer as much as possible based on the provided text, with clarifications where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the "test" (NaOH-treated) and "control" (non-NaOH-treated) groups for the various tests (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical, biocompatibility, animal testing).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a manufacturing change, the data would typically be generated by the manufacturer (Bio-Vascular, Inc.) during product development and testing, implying a prospective and in-house provenance.

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

This concept is not applicable to the type of device and study described. The "ground truth" here is objective laboratory measurements (e.g., shrink, suture strength, pH values) and observations in animal models by scientists/technicians, not expert medical opinion on, for example, diagnostic images.

4. Adjudication method for the test set

Not applicable. This device's evaluation is based on objective measurements and animal studies, not subjective assessments requiring adjudication among experts.

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/imaging device.

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

Not applicable. This is not an AI/imaging device.

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

The "ground truth" for this evaluation was based on a combination of:

• Physical property measurements: Shrinkage, suture retention, thickness.
• Biochemical/Microbiological assays: Bioburden, sterility, pH, pyrogen, chemical analysis.
• Biological responses in animal models: Biocompatibility and inflammation, observed in animal testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets. The study described involves comparing two versions of a physical medical device.

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

Not applicable, as there is no training set mentioned for this product.

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Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

Not Found

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a device called "Retinal Detachment Implants." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about:

• Acceptance criteria for the device's performance.
• A study that proves the device meets specific performance criteria.
• Device performance data (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document is purely an administrative clearance letter, not a technical report detailing performance studies.

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The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.

Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.

This 510(k) summary describes a device, "Solid Silicone and Silicone Sponge Implants," used in retinal reattachment surgery. The submission focuses on a change in the silicone material used in the device, demonstrating that the new material is substantially equivalent to the previously cleared material. Therefore, the acceptance criteria and supporting studies are centered on establishing this equivalence, primarily through non-clinical testing.

Here's a breakdown of the requested information 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 a "test set" in the context of clinical performance or a specific sample size of devices. The testing described is primarily material-level and biocompatibility testing.

• Test Set Sample Size: Not specified for individual devices; testing was performed on the "new silicone material" and "sterilized finished devices manufactured with new silicone material."
• Data Provenance: The physical testing results were provided by the "material supplier." Biocompatibility testing was performed on finished devices. No country of origin is specified for the raw data or testing facilities. The studies appear to be retrospective in the sense that they are evaluating a material change for an existing device rather than a de novo clinical trial.

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

This information is not applicable to the provided document. The ground truth for this submission is established through material specifications and standardized biocompatibility testing protocols, rather than expert consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication is typically associated with human review of imaging or clinical data, which is not the nature of the testing described here.

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

No. An MRMC study is a clinical study involving human readers evaluating cases, often in radiology or pathology. The provided document describes non-clinical material and biocompatibility testing.

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

No. This device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Material Specifications: For the "material not substantially different" criterion, the ground truth would be the established physical and chemical properties of the previously cleared Dow Corning silicone material.
• Standardized Biocompatibility Endpoints: For biocompatibility, the ground truth is defined by the specific endpoints and acceptable limits set forth in the FDA "Tripartite Guidance" and "Table IV. Confirmatory Biological Testing" (e.g., non-cytotoxic, non-sensitizing, non-irritating).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable. There is no training set.

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