(116 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, which implies the device meets the safety and effectiveness standards demonstrated by those predicates. | Not explicitly reported for the KeraSys Bioengineered Lamellar Patch Graft in this 510(k) summary. The document states that 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 is a general statement about the material, not specific performance data for this particular device. |
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.
- Sample size used for the test set and the data provenance: N/A (No specific test set or study described for the KeraSys device).
- 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).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication described).
- 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).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm or software device).
- 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).
- The sample size for the training set: N/A (Not an AI/algorithm device requiring a training set).
- 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.
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.