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The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:

• Determine the potential effectiveness of permanent occlusion, .
• Temporarily treat dry eye syndrome, and the dry eye components of various ocular . surface diseases,
• . Temporarily enhance the efficacy of topical medications or ocular lubricants.
• . Temporarily treat contact lens intolerance secondary to dry eye, and
• Temporarily treat dry eye after ocular surgery.

Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO).
The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.

This document describes a 510(k) premarket notification for the Comfortear® Lacrisolve™ Absorbable Punctum Plug. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria in the clinical performance sense (e.g., diagnostic accuracy or treatment effectiveness).

The "acceptance criteria" discussed in the document are primarily related to safety, material biocompatibility, and manufacturing controls, aligning with the requirements for justifying substantial equivalence.

Here's an analysis of the provided text in relation to your questions:

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

The document doesn't present a table of quantitative acceptance criteria and device performance for clinical effectiveness per se. Instead, it outlines testing performed to ensure safety and manufacturing consistency. The "acceptance criteria" are implied by compliance with established international and FDA standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Efficacy/Effectiveness Test Set: No clinical efficacy test set is described. The submission relies on substantial equivalence to predicate devices for its intended use and general performance.
• Safety/Manufacturing Test Set (for EO Residuals and LAL):
  • EO Residuals: The document mentions "all lots tested" but does not specify the number of lots or individual devices. This likely refers to manufacturing validation data.
  • LAL Test: 3 pooled samples were used, with each pool consisting of 2 devices (Total 6 devices).
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission to the US FDA, the testing would typically be performed by laboratories compliant with US good manufacturing practice (GMP) regulations (21 CFR Parts 210, 211, and 820), implying a US or internationally accredited laboratory context. The data is retrospective in the sense that it represents completed validation and routine testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert-established ground truth for clinical diagnosis or assessment. The "ground truth" for the safety tests is defined by the international standards themselves (e.g., SAL of 10⁻⁶, endotoxin limits).

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

Not applicable, as there's no diagnostic or assessment test set requiring adjudication.

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 physical medical implant (punctum plug), not an AI diagnostic/imaging device.

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

Not applicable. This is a physical medical implant.

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

For the safety testing presented:

• The ground truth for sterility is defined by the requirements of EN ISO 11135-1:2007 (SAL of 10⁻⁶).
• The ground truth for ethylene oxide residuals is defined by ANSI/AAMI/ISO 10993-7:2008(R)2012.
• The ground truth for bacterial endotoxins is defined by ANSI/AAMI ST72:2011, USP <161>, USP <85>, EP 2.6.14, and JP 4.01 (e.g., <20.0 EU/device).

For the overall device, the "ground truth" for its safety and effectiveness for its intended use is established by its substantial equivalence to legally marketed predicate devices which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI model.

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

Not applicable. This is a physical medical implant, not an AI model.

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