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The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to:

• 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,
• Temporarily treat dry eye after ocular surgery, and
• Determine the potential effectiveness of permanent occlusion.

The Oasis Medical SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug is a mid-term duration device designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from degradable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and have a base diameter of 0.6mm with one end tapered to enable easier placement through the punctal opening.

This is a 510(k) summary for a medical device, the SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated clinical study with AI or human readers for device performance.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document, as they pertain to clinical studies or AI performance evaluation, which are not detailed here.

However, based on the provided information, I can offer the following:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for a primary clinical outcome. Instead, it relies on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. The "performance" described is primarily related to non-clinical testing confirming that the changes in the device (specifically the tapered geometry) do not negatively impact its fundamental characteristics compared to the predicate.

Relevant Study/Testing:

The study that "proves the device meets the acceptance criteria" (in the context of substantial equivalence) is comprised of non-clinical performance tests detailed in the "Summary of Non-clinical Testing" section. These tests were conducted to confirm that the modification (tapered end) did not alter the fundamental safety and performance characteristics from the predicate device.

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

This information is not provided in the document. The document describes non-clinical testing (biocompatibility, degradation, shipping) but does not specify sample sizes for these tests or their provenance. This type of information is typically not included in the public 510(k) summary but would be found in the full submission.

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)

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for diagnostic or interventional performance. The testing described is non-clinical.

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

This information is not applicable as the document does not describe a clinical study requiring adjudication of expert interpretations.

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

This information is not applicable. This document is for a physical medical device (canalicular plug) and does not involve AI or human readers for diagnostic or interventional tasks.

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

This information is not applicable. This document is for a physical medical device and does not involve an algorithm or AI.

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

This information is not applicable as the testing is non-clinical and relies on validated laboratory methods (e.g., ISO 10993-5 for cytotoxicity, ASTM F1635 for degradation, ISO 11607/ASTM D4169/ISTA 2A for shipping) rather than clinical ground truth types.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

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

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

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The Soft Plug® Extended Duration 180 Canalicular Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:

• 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,
• Temporarily treat dry eye after ocular surgery, and
• Determine the potential effectiveness of permanent occlusion.

The OASIS Medical SOFT PLUG® Extended Duration 180 Canalicular Plug is a mid-term implant designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from absorbable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and available in 0.2mm, 0.3mm, 0.4mm, and 0.5mm diameters.

The provided text is a 510(k) premarket notification for a medical device called "Soft Plug Extended Duration 180 Canalicular Plug." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a novel technology through a clinical study with defined endpoints like accuracy, sensitivity, or specificity.

Therefore, the information typically requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission.

This 510(k) summary primarily discusses:

• Device Description: What the device is (a mid-term absorbable plug for tear drainage), its material (polydioxanone monofilament), dimensions, and how it's used.
• Intended Use: The temporary treatment of dry eye, enhancement of topical medications, treatment of contact lens intolerance, treatment of dry eye after ocular surgery, and determination of potential effectiveness of permanent occlusion.
• Comparison to Predicate Device: It states "There are no differences in the material used for these devices," "There are no differences in the design of these devices," and "There are no differences in the function of these devices." This is the core of its claim for substantial equivalence.
• Non-Clinical Testing: This section details engineering and biocompatibility testing rather than clinical performance metrics. These tests include:
  • Shelf life testing: Demonstrated 9% loss of tensile strength after two years equivalent storage, noting a 20% loss would shorten absorption time by 10-15%.
  • Chemical characterization and biocompatibility testing: Performed according to ISO 10993-18:2005 and ISO 10993-1:2009, concluding that exposure levels of compounds are safe.
  • Product adoption study: For sterilization according to ANSI/AAMI/ISO 11135:2014, with ethylene oxide residuals reduced per ISO 10993-7:2008.
  • Bacterial endotoxin testing: Below 20 EU/device.
  • Shipping study: In accordance with ISO 11607:2016, ASTM D4169-13, and ISTA 2A 2011, showing no damage to pouched product despite minor carton damage.

In summary, the provided document does not contain the information required to fill out your requested table or answer most of your detailed questions because it's a 510(k) summary for a substantial equivalence claim, relying on non-clinical testing and direct comparison to a predicate device, not on a clinical performance study with AI or diagnostic accuracy metrics.

Therefore, I cannot provide the requested table or answer the specific questions about clinical performance, AI, or human reader studies. The document states that "No additional questions of safety and effectiveness are raised due to material, design, or function," and that non-clinical performance tests "demonstrate that the SOFT PLUG® Extended Duration 180 Canalicular Plug is as safe and effective as the predicate device, and is substantially equivalent to the predicate device." This is the "proof" provided within this type of regulatory submission.

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The OASIS N-PE Microkeratome Blades are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the comea.

The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 series low carbon stainless steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.

The acceptance criteria for the OASIS Disposable N-PE Microkeratome Blades and the study proving its performance are detailed below. It's important to note that this device is a Class I medical device (keratome blade) and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical studies typically associated with higher-risk devices or software.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size for the "test sets" of blades used in the dimensional equivalency, sharpness, and fit tests. It implies that these tests were performed on a sufficient number of OASIS blades to draw conclusions about their equivalence to the predicate.
• Data Provenance: The data provenance for the non-clinical testing is "non-clinical testing on porcine eyes." This indicates that the testing was performed on animal models. There is no mention of country of origin for this data specifically, nor is it specified if it was retrospective or prospective, though non-clinical tests are typically prospective for device validation.

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

This type of information (number and qualifications of experts for ground truth) is typically not applicable for a 510(k) submission of a Class I device focused on substantial equivalence to a predicate. The evaluation relies on direct material and performance comparisons, not expert interpretation of results that would require consensus for a "ground truth" in the way it's used in AI/diagnostic studies.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements (dimensions, sharpness, fit) or direct comparisons, not requiring expert adjudication for ambiguous results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a surgical blade, where performance is assessed through physical and functional equivalence.

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

Not applicable. This device is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established characteristics and performance of the predicate device (Nidek MK-2000 blade). The OASIS blades are directly compared against these known attributes through:

• Objective Measurements: Such as dimensional equivalency.
• Functional Demonstrations: Such as sharpness testing and fit into the microkeratome.
• Performance Equivalence in a Model: Confirmed by producing "corneal lamellar sections equivalent to the predicate devices" on porcine eyes.

8. The Sample Size for the Training Set

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

Not applicable, as there is no training set.

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The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

The OASIS Disposable M2-PE Microkeratome Blades are replacement stainless steel blades for the Moria M2 Microkeratome Blade. The Disposable M2-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable M2-PE Microkeratome Blades are single-use, disposable blades.

The provided document is a 510(k) Premarket Notification Summary for the OASIS Medical, Inc. Disposable M2-PE Microkeratome Blades. It focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with acceptance criteria in the typical sense of AI/ML device evaluations. Therefore, the information requested might not be fully present or will be interpreted based on the available data.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as would be defined for an AI/ML device comparing performance metrics (e.g., sensitivity, specificity thresholds) are not explicitly stated. Instead, the demonstration of substantial equivalence is based on the device having "the same" or "substantially equivalent" characteristics and performance compared to the predicate device.

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

• Sample Size for Test Set:
  • For Dimensional Equivalency, Sharpness, and Fit tests: The document does not specify the exact number of blades tested. It only states "physical measurements of the predicate device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc." and "sharpness tests show that the OASIS M2-PE blades (0415) perform as well as the predicate device."
  • For Non-clinical testing on porcine eyes: The document does not specify the number of porcine eyes used.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical device like a blade, the testing would typically be prospective laboratory and possibly animal testing conducted by the manufacturer, or a contract lab on their behalf.

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

There is no mention of "experts" in the context of establishing ground truth for a test set, as this is not a study evaluating human-interpretable output where expert consensus would be required (e.g., image reading). The "ground truth" for these performance tests would be objective measurements (dimensions, sharpness metrics) or outcomes from the animal model (quality of lamellar sections).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert readings, which is not relevant for the types of tests (dimensional, sharpness, fit, animal model) conducted for this mechanical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance, to measure the impact of AI on human reader performance. This document pertains to a surgical blade, not a diagnostic imaging or AI-assisted diagnostic device.

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

Yes, in a sense, the performance tests described (Dimensional Equivalency, Sharpness, Fit, Non-clinical testing on porcine eyes) can be considered "standalone" in that they assess the intrinsic characteristics and performance of the blade itself, without direct human-in-the-loop interpretation being the primary focus of the performance evaluation. However, this is not an "algorithm-only" study as described for AI/ML devices.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on:

• Objective Measurements: For dimensional equivalency, sharpness, and fit.
• Observed Outcomes: For non-clinical testing on porcine eyes, the "equivalence" of corneal lamellar sections to those produced by the predicate device would be the observed outcome. While not explicitly stated, this observation would likely be qualitative or semi-quantitative, assessed by experienced personnel.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for AI/ML models that learn from data. This document describes the evaluation of a physical medical device (a microkeratome blade), not an AI algorithm.

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

Not applicable, as there is no training set for a physical device.

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The OASIS Disposable N-PE (Precision Edge) Microkeratome Blade (Catalog #0412) is a replacement blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.

The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.

The OASIS Disposable N-PE Microkeratome Blades are replacement blades for the Nidek MK-2000 Microkeratome, intended for lamellar resection of the cornea. The study aimed to demonstrate substantial equivalence to the legally marketed Nidek MK-2000 microkeratome blades (K990900).

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided document describes a 510(k) Premarket Notification Summary which aims to demonstrate substantial equivalence of the OASIS Disposable N-PE Microkeratome Blades to a predicate device. This is primarily a comparative study against a legally marketed device rather than a standalone study with defined acceptance criteria for de novo clinical performance. The "acceptance criteria" are effectively the characteristics and performance of the predicate device that the new device must match or be equivalent to.

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

The document explicitly mentions non-clinical testing on porcine eyes. It does not specify the exact number of porcine eyes used, making the sample size for this part of the testing unknown from the provided text. The data provenance for this specific test would be non-human (animal model), likely conducted in a laboratory setting. No country of origin is specified. The study is retrospective in the sense that it aims to demonstrate equivalence to a pre-existing medical device.

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

The document does not mention the use of human experts to establish ground truth for the test set. The evaluations appear to be based on objective physical measurements (dimensional equivalency), biomechanical tests (sharpness, fit), and direct comparison of lamellar sections from porcine eyes.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the evaluation methods are primarily quantitative and comparative against the predicate rather than involving subjective interpretation by multiple experts.

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

No MRMC comparative effectiveness study was mentioned. The device is a surgical blade, and the assessment focuses on its physical and functional equivalence, not on human reader performance with or without AI assistance.

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

This question is not applicable. The device is a physical surgical tool and does not involve an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for the equivalence demonstration is primarily established through:

• Physical measurements and specifications of the predicate device.
• Performance characteristics (sharpness, fit) as demonstrated by the predicate device.
• Resulting tissue sections (corneal lamellar sections) obtained using the predicate device.

Specifically for the OASIS blade, the "ground truth" for its performance is its ability to produce measurements, sharpness, fit, and lamellar sections equivalent to those of the predicate device.

8. Sample Size for the Training Set:

This question is not applicable. The device is a physical product and does not involve machine learning algorithms or a "training set" in the computational sense. The "training" for the manufacturing process would be part of Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), not a data-driven training set.

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

This question is not applicable for the reasons stated above.

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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.

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The OASIS® Medical Silicone Punctal Plug is intended for 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 punctum

Silicone Punctal Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pyterygium, blepharitis, keratitis, red lid margins, recurrent chalazions, recurrent corneal erosion, filamentry keratitis and other external eye diseases.

Other patients that may benefit are: cataract patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.

The OASIS Medical Silicone Punctal Plug is designed to be inserted into the punctal opening in order to block tear drainage through the canaliculus. Each Punctal Plug is molded from medical grade silicone and comes premounted on an inserter. The plugs are available in the following sizes: Micro, Mini, Petite, Small, Medium.

The provided text is a 510(k) summary for the OASIS Medical Silicone Punctal Plug. It describes the device, its intended use, and its substantial equivalence to a previously marketed device. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics and performance to the predicate, rather than establishing specific acceptance criteria and performing a new clinical study to meet those criteria from scratch.

Therefore, I cannot fulfill your request for the structured table and detailed answers concerning acceptance criteria and a study to prove they are met because the necessary information is not present in the provided text.

Specifically, the document states:

• "The OASIS Medical Silicone Punctal Plug is substantially equivalent to the OASIS Medical Silicone Punctal Plug (K945906)." This indicates that the regulatory pathway was based on equivalence, not on fulfilling novel acceptance criteria with a new clinical study.
• "The OASIS Medical Silicone Punctal Plug is identical to the predicate device except for its physical design and a modifieed inserter." This further emphasizes the focus on design comparison rather than a new performance study.

Without information detailing a specific study performed to demonstrate achievement of defined acceptance criteria, I cannot complete the requested output.

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