Search Results

The OASIS Medical Soft Plug® Absorbable Plug - SA is intended for temporary use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the canaliculus. It may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the OASIS Medical Soft Plug® Absorbable Plug - SA may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye.

The proposed device, the Soft Plug® Absorbable Plugs - SA, is substantially equivalent in intended use and operation to the various collagen intracanalicular plugs in the market today. These include the Soft Plug Collagen Intracanalicular Plug by OASIS Medical (K946357), the Temporary Intracanalicular Plug by Eagle Vision (K890919), and the Collagen Implants For Use in the Lacrimal Efficiency Test™ by Lacrimedics (K895342). All of these plugs are 2 mm long and are cut from non-sterile suture material. The implants are intended to be inserted into the canaliculus to block fluid flow for a temporary period of time (less than 3 months based on results obtained in an animal study) until they are absorbed. The only difference is the type of absorbable suture they are cut from, polyglyconate versus collagen, and the length of time they will take to absorb, less than 3 months versus several days.

The proposed device, the Soft Plug® Absorbable Plugs - SA, is also similar in intended use and operation to the Herrick Lacrimal Plug™ by Lacrimedics (K896175). This is a silicone intracanalicular plug intended for insertion into the canaliculus to permanently block fluid flow. It approximates the size of the absorbable plugs mentioned above.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for the Soft Plug® Absorbable Plugs - SA. However, I can extract the available information and highlight what is missing.

Available Information and Missing Details:

Here's a breakdown based on the provided text, addressing each requested point as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance:

   The text does not explicitly state formal "acceptance criteria" in a tabular format with quantitative targets for the device's performance. Instead, it describes the results of a human clinical study in qualitative terms and compares absorption time to predicate devices.

   Acceptance Criterion (Inferred)	Reported Device Performance
   Biocompatibility	No evidence of antigenicity, systemic toxicity, carcinogenicity, mutagenicity, tetratogenicity, or adverse effects on reproductive performance (pre-clinical testing).
   Retention Time	Remained in place for two months in rabbit canaliculus. All gone by third month (animal study).
   Comfort Level	Most patients unable to differentiate between Soft Plug® Absorbable Plugs - SA and collagen plug; reported same comfort level for both eyes.
   Efficacy (Subjective Relief)	All patients showed signs of improvement as a result of the treatment. Subjective relief persisted for at least one month.
   Complications/Adverse Events	None reported in the clinical study.

   Missing: Specific quantitative thresholds for comfort, efficacy, or retention time that would constitute "acceptance."

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

   • Sample Size: 40 dry-eye patients for the double-blind clinical study.
   • Data Provenance: The text does not explicitly state the country of origin. It indicates a "double-blind study involving 40 dry-eye patients." It is a prospective clinical study.
   • Animal Study: The pre-clinical testing involved "polyglyconate plugs inserted into the rabbit canaliculus," indicating an animal model. No specific number of rabbits is given.

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

   This information is not provided in the text. The study describes patient-reported comfort and "signs of improvement," likely assessed by the investigating clinicians, but there's no mention of a ground truth established by a panel of experts.

4. Adjudication Method for the Test Set:

   This information is not provided in the text. Given the nature of this device (intracanalicular plug), it's unlikely that a formal adjudication method (like 2+1 or 3+1 for imaging studies) would be directly applicable for assessing subjective patient relief or comfort.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

   This is not applicable. The device is an intracanalicular plug, not an AI software/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

   This is not applicable. The device is a physical medical device (an absorbable plug), not an algorithm or AI software. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used:

   • For the human clinical study: The "ground truth" seems to be based on patient-reported comfort and subjective relief, along with clinical observation of complications/adverse events by the treating clinicians.
   • For the animal study: The ground truth for retention time was likely direct observation of the plugs in the rabbit canaliculus over time. Biocompatibility was assessed through various tests (antigenicity, toxicity, etc.).

8. The Sample Size for the Training Set:

   This is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

   This is not applicable for the same reason as point 8.

Summary of Study Details:

• Study Type: Double-blind clinical study (human patients), pre-clinical animal study.
• Human Study Design: Compared Soft Plug® Absorbable Plugs - SA (in one eye) to a collagen plug (in the other eye) in the same patient.
• Human Study Duration: Evaluated monthly over a period of four months.
• Key Findings (Human Study):
  • No complications or adverse events.
  • All patients showed signs of improvement.
  • Most patients could not differentiate between the two types of plugs and reported similar comfort levels.
  • Subjective relief persisted for at least one month.
• Key Findings (Animal Study - Rabbit):
  • Polyglyconate suture produced no evidence of antigenicity, systemic toxicity, carcinogenicity, mutagenicity, tetratogenicity, or adverse effects on reproductive performance.
  • Plugs remained in place for two months, and all were gone by the third month, indicating absorption. This residency time was between short-term collagen plugs and permanent silicone plugs.

Ask a specific question about this device