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The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.

The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.

The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.

The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.

The provided text describes the Molteno3 S-Series Glaucoma Implant and its comparison to the predicate Molteno3 G-Series implant for 510(k) clearance. The document focuses on demonstrating substantial equivalence rather than defining and proving acceptance criteria with specific performance metrics against a predetermined threshold for a novel device.

Therefore, the acceptance criteria are implicitly defined by the demonstrated substantial equivalence to the predicate device, meaning the new device performs "as safe and effective" as the predicate device. The study aims to show that there is "no clinically significant difference in outcome" between the new and predicate device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details, particularly specific performance acceptance criteria with numerical thresholds, are not explicitly stated in this type of substantial equivalence document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds defined for the new device's performance but rather the demonstration that its performance is equivalent to the predicate device. The "reported device performance" refers to the outcomes observed in the clinical study for the S-Series device and the comparison to the predicate.

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

• Sample Size for Test Set: Data from 70 patients receiving the S-Series implant.
• Data Provenance:
  • S-Series Data: Clinical data developed in the United States.
  • Predicate (G-Series) Data: Published historical data from the Otago Glaucoma Surgery Outcome study (country not explicitly stated, but Otago is in New Zealand) and a Finnish study, along with additional unpublished data from the Otago study.
• Retrospective or Prospective: Not explicitly stated for either dataset. The S-Series data "developed using both the G-Series implants" then specifying "clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data" suggests the S-Series data might be prospective or a compiled registry, while the predicate data is explicitly historical.

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

The text does not describe a ground truth established by experts in the context of interpreting data for the study. Instead, the "ground truth" (or reference for comparison) for the S-Series device's performance is the clinical outcome data (IOP, visual acuity, adverse events) reported for both the S-Series patients and the historical predicate device cohorts. The assessment of "no clinically significant difference" would likely have been performed by clinical researchers or statisticians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical outcome data. This type of method is more common in studies where subjective assessments (e.g., image interpretation) need consensus. Here, the outcomes are objective clinical measurements (IOP, visual acuity, adverse events).

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

An MRMC study was not performed. The study described compares clinical outcomes of a medical device in patients, not the performance of human readers with or without AI assistance. The device itself is an implant, not an AI diagnostic tool.

6. Standalone Performance Study

This is not applicable as the Molteno3 S-Series Glaucoma Implant is a medical device for implantation, not an algorithm. Its "performance" is measured by its clinical effect in vivo (reduce intraocular pressure, maintain visual acuity, safety profile), as opposed to an algorithm's standalone diagnostic accuracy. The clinical study described in Section VII.B is effectively the standalone performance study for the device's clinical impact.

7. Type of Ground Truth Used

The "ground truth" used for assessing the device's performance comprises clinical outcome data including:

• Intraocular Pressure (IOP) measurements
• Visual acuity measurements
• Post-operative reductions (other unspecified clinical parameters)
• Adverse event rates

This outcome data is used to determine if the device is "safe and effective."

8. Sample Size for the Training Set

The document describes a clinical comparison study, not the training of an algorithm or AI model. Therefore, there is no training set in the context of machine learning. The clinical data serves as evidence for device performance.

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

As there is no training set for an algorithm, this question is not applicable.

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The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular The Molten.> Elawoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

The Molteno3 Glaucoma implant consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. This third generation design is intended to maximize single quadrant bleb performance and simplify insertion and postoperative management.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Molteno3 Glaucoma Implant:

Limitations of the Provided Information:

It's crucial to note that the provided documents (a 510(k) summary and the FDA's clearance letter) are extremely limited in their detail about the study and acceptance criteria. They are focused on establishing substantial equivalence for regulatory purposes, not on providing a comprehensive scientific publication of a study. As such, many of the requested details are not present in the given text.

Acceptance Criteria and Study Details for the Molteno3 Glaucoma Implant

Based on the provided K062252 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion/Performance Metric (Implied)	Reported Device Performance
   Clinical Equivalence (Overall Patient Outcomes)	"The outcomes through 22 months are substantially equivalent" to the original Double Plate Molteno Implant.
   Safety Profile	(Not explicitly stated as a separate metric, but implied by "substantially equivalent clinical performance").
   Intraocular Pressure (IOP) Reduction	(Not numerically stated, but the primary function for which it's compared).
   Device Material Composition	"Identical in material composition to predicate Molteno Implant devices."

   Note: The 510(k) process for substantial equivalence does not typically require predefined, specific numerical acceptance criteria in the same way a PMA or clinical trial for a novel device would. The "acceptance criterion" here is largely demonstrating equivalence to a predicate device.

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

   • Sample Size: "Current data of 44 patients receiving the GS-175mm2".
   • Data Provenance: Not specified (e.g., country of origin, specific clinics). The data is described as "current data," implying it's new data collected for this submission, which typically aligns with a prospective or concurrently collected retrospective study. However, without more information, it's impossible to definitively state if it was purely prospective. It's compared to "historical data," which by definition is retrospective.

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

   • Not mentioned. The document does not provide any information about "ground truth" establishment by experts for the clinical outcomes data. Clinical outcomes in this context (IOP reduction, success/failure of the implant) are usually objective physiological measurements or predefined clinical endpoints (e.g., meeting target IOP, avoiding reoperation).

4. Adjudication Method for the Test Set:

   • Not mentioned. There is no indication of an adjudication method in the provided text.

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

   • No. This type of study is specifically relevant to image-based diagnostic devices where multiple readers interpret cases. The Molteno3 Glaucoma Implant is a therapeutic device, so an MRMC study is not applicable here.

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

   • N/A. The Molteno3 Glaucoma Implant is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

   • Clinical Outcomes/Patient Data: The "ground truth" implicitly refers to the actual clinical performance and outcomes in patients who received the Molteno3 Glaucoma Implant, particularly regarding its ability to reduce intraocular pressure and control disease progression. This is measured directly from patient follow-up. It's compared against the "historical data" of the predicate device for equivalence.

8. Sample Size for the Training Set:

   • Not applicable/Not mentioned. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set." The Molteno3 is a "third generation design" based on prior engineering and clinical experience with earlier Molteno implants, so fundamental design principles would have been "trained" by years of experience, but not in the computational sense.

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

   • Not applicable/Not mentioned. As there is no training set in the computational sense, this question is not relevant. The device design would have evolved based on clinical feedback and performance of previous generations of the implant.

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