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Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.

This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.

However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.

2. Sample Size for Test Set and Data Provenance

• MRI Safety: The testing was conducted using the largest sizes available in the market (2.8g) for both Gold and Platinum Eyelid Weight Implants. While the specific number of individual implants tested for each condition (force, heating, artifact) is not explicitly stated, it implies at least one sample of each type and weight was used for the respective tests. The provenance of the data is from non-clinical laboratory testing specific to the device.
• Biocompatibility: Not directly referenced as a "test set" in the traditional sense for diagnostic performance. It involved chemical characterization and cytotoxicity testing. The sample size for these tests (e.g., number of replicates, specimens) is not specified but would follow the requirements of the ISO 10993 standards. Data provenance is from laboratory testing.
• Sterility and Shelf-Life: The testing involved validation protocols based on standards like ISO 11135-1 and ASTM standards for package integrity. The sample sizes for these validation activities are not explicitly detailed but are typically defined by the respective standards (e.g., for bioburden, sterility validation, accelerated aging studies). Data provenance is from laboratory testing (in-house or contract sterilizer).

3. Number of Experts and Qualifications for Ground Truth

This document does not pertain to the diagnostic performance of an AI/ML device or a device requiring expert interpretation for its primary function. Therefore, there were no "experts used to establish ground truth" in the context of clinical outcomes or diagnostic accuracy. The ground truth for the non-clinical tests is based on objective measurements and adherence to established engineering and material science standards and protocols.

4. Adjudication Method

Not applicable, as this is not a study requiring human adjudication of clinical or diagnostic outcomes.

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

Not applicable, as this is not a study assessing human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical implant, not an AI/ML algorithm.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests described is based on:

• Objective Measurements: For MRI safety (deflection angles, temperature changes, artifact dimensions), sterility (SAL, residual levels), and shelf-life (dimensional stability, package integrity).
• Established Standards and Protocols: Adherence to international standards (ISO, ASTM) for methods, acceptance criteria, and measurement techniques.
• Material Characterization: For biocompatibility, the ground truth is based on the chemical composition of the materials and their known biological responses, validated by specific in-vitro tests (cytotoxicity, leachable tests).

8. Sample Size for Training Set

Not applicable, as this is not an AI/ML algorithm requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as this is not an AI/ML algorithm requiring a training set.

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RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm.

The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.

The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.

The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.

This document describes a 510(k) submission for the RadioMed™ Soft Tissue Marker, which is a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against acceptance criteria in a comprehensive study.

Based on the provided text, there is no specific acceptance criteria table or a study proving the device meets distinct performance criteria in terms of accuracy, sensitivity, specificity, etc. This is because 510(k) submissions for devices like markers often rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance testing mentioned is related to manufacturing standards and visibility, not a clinical effectiveness study with defined performance metrics.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Missing Information (Not Applicable to this 510(k) submission):

• 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices and manufacturing quality, not a comparison against specific clinical performance metrics.
• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of a clinical performance study as described in the prompt.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical marker, not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information that is present or can be inferred:

Overview of Evidence Presented:

The submission focuses on comparing the RadioMed™ Soft Tissue Marker to existing predicate devices (RadioMed™ Marker, Implanter/Adjustable/Anderson's Marker, Extracranial Marker) to demonstrate substantial equivalence. The key aspects of this comparison are:

• Intended Use: The intended use and indications for use have not changed from the predicate device.
  • Intended Use: "RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures."
• Technological Characteristics: The fundamental scientific technology of the modified device has not changed.
  • Material: The material (metallic gold) is identical to the Anderson Marker (K940121) and Extracranial Marker, and is widely used in other approved medical devices with a "safe history of use." This obviates the need for additional biocompatibility testing.
  • Design: The design is identical to the predicate RadioMed™ Marker (K022326) except for the outside diameter (OD) and material (gold vs. unspecified material in K022326). The new marker ranges in OD between 0.75mm and 1.2mm.
• Performance Testing (Non-Clinical):
  • Summary of standards achieved:
    • FDA QSR 21 CFR Part 820 Good Manufacturing Practices
    • AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
  • Visibility Studies: "Visibility Studies (see section H - Performance Testing)" are mentioned, implying that the marker's visibility under radiographic imaging was assessed. However, no specific data, acceptance criteria, or experimental setup for these visibility studies are provided in this summary.

Conclusion from a 510(k) Perspective:

The FDA's letter (K031206) confirms that they have "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the information provided in the 510(k) submission, primarily focusing on the safety and effectiveness as demonstrated through comparison to predicates and adherence to manufacturing and sterilization standards, rather than direct clinical performance against novel acceptance criteria.

In summary, for this specific 510(k) submission, the "acceptance criteria" and "study" are intrinsically linked to demonstrating substantial equivalence through comparison with predicate devices and adherence to established manufacturing and safety standards, rather than a clinical trial proving specific performance metrics of an AI algorithm.

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