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The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.

The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm

The provided document, K090078, is a 510(k) summary for a medical device called the KeraSys Bioengineered Lamellar Patch Graft. It does not contain details about acceptance criteria, device performance from a study, or the methodology of such a study.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is claiming their new device is as safe and effective as a device already legally marketed, rather than presenting new performance data from a clinical or analytical study.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's how to interpret the document based on your request:

Acceptance Criteria and Study Details (Not Applicable as per 510(k) Summary)

The K090078 submission focuses on demonstrating substantial equivalence, not on providing a new study with acceptance criteria and measured device performance. As such, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this 510(k) summary.

The summary states: "The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing. Outcomes demonstrate safety and efficacy for soft tissue reconstruction." This refers to general testing on the material (porcine SIS) used in the device and its predicate devices, rather than a specific performance study of the KeraSys Bioengineered Lamellar Patch Graft itself against predefined acceptance criteria for its intended use.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Not Applicable for this 510(k) Summary)

Most of the following categories are not applicable (N/A) because the provided 510(k) summary does not describe a new performance study that would generate this type of data.

1. Sample size used for the test set and the data provenance: N/A (No specific test set or study described for the KeraSys device).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No test set or ground truth established for this device's performance in this document).
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication described).
4. 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: N/A (This device is a physical implant, not an AI diagnostic tool. No MRMC study is relevant or mentioned).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm or software device).
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No specific ground truth for performance evaluation described for this device).
7. The sample size for the training set: N/A (Not an AI/algorithm device requiring a training set).
8. How the ground truth for the training set was established: N/A (Not an AI/algorithm device).

Summary of 510(k) K090078 Content:

• Device Name: KeraSys Bioengineered Lamellar Patch Graft
• Intended Use: Implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
• Material: Four layers of laminated porcine small intestinal submucosa (SIS).
• Sterilization: Ethylene Oxide.
• Substantial Equivalence Claim: The device claims substantial equivalence to predicate devices based on similar intended use, materials, and technical characteristics. The predicate devices listed are SURGISIS Ocular Graft (K053622) and SIS Facial Implant (K050246).
• Testing Mentioned (General): "The Surgisis family of devices has undergone extensive biocompatibility testing, viral inactivation testing and mechanical testing." This refers to the core material, not a specific performance study of the KeraSys device itself.

This 510(k) provides evidence for market clearance primarily through a demonstration of similarity to already-approved devices, rather than through presenting novel performance study results against detailed acceptance criteria.

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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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The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system

The provided text describes the SURGISIS Ocular Graft, an ophthalmic implant made from processed porcine small intestinal submucosa. It details the device's description, indications for use, and a summary that it is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility, viral inactivation, and mechanical testing. The text states that these outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.

However, the provided text does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria. The information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established is not present in the provided document.

The document focuses on establishing substantial equivalence to predicate devices, listing the predicate devices and their characteristics, rather than detailing the specifics of a study evaluating the performance against predefined acceptance criteria for the SURGISIS Ocular Graft itself in the manner requested. The "Summary of Testing" section is very high-level and does not provide quantitative results or detailed study methodology.

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SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) clearance letter for the "Suture Groove™ Gold Eyelid Weight Implant," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls, and indications for use.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, details on MRMC studies, standalone performance, training set information, or ground truth establishment. This information is typically found in a clinical study report or a premarket submission summary, which is not present in the given text.

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Hydroxyapitate orbital implants are indicated for post enucleation patients. This product is intended to establish a platform to affix an artificial eye that becomes integrated with the patients tissues.

Moa Bone™ - Hydroxyapitate Orbital Implant

This document is a 510(k) premarket notification letter from the FDA for a medical device called "Moa Bone™ - Hydroxyapatite Orbital Implant." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily addresses the substantial equivalence determination for marketing the device.

Therefore, I cannot provide the requested information based on the provided text.

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