(83 days)
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:
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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.
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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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The MicroVision Scleral Buckling Components have the same intended use as the listed predicate products: for scleral buckling in retinal reattachment surgery. |
| Material Equivalence | All products are made of molded silicone, either in solid or sponge form, demonstrating equivalence in material composition to predicates. |
| Sterilization & Packaging Equivalence | All products are provided sterile for single use only, demonstrating equivalence in sterility and packaging. |
| Form/Availability Equivalence | All products are available in a wide variety of shapes and sizes, demonstrating equivalence in available forms. |
| Biocompatibility & Toxicity | Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic. All predicate products have also been demonstrated to be biocompatible and non-toxic. |
| Dimensional & Physical Properties | Bench testing was conducted to demonstrate that the MicroVision products are substantially equivalent to the predicates with respect to dimensional and physical properties. (Specific values or thresholds are not provided in this summary, but the conclusion of equivalence is stated.) |
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.
§ 886.3340 Extraocular orbital implant.
(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.