(157 days)
The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.
The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.
The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure on adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
The provided text describes the ProKera™ device and its 510(k) submission, focusing on performance data related to its physical integrity and the amniotic membrane attachment, rather than clinical performance for diagnostic or treatment effectiveness. Therefore, many standard metrics for AI/ML performance (e.g., sensitivity, specificity, AUC) and associated study details (e.g., ground truth establishment, MRMC studies) are not applicable to this submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This section has been adapted as the 510(k) summary focuses on physical performance and integrity rather than diagnostic accuracy.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Integrity (Amniotic Membrane Attachment) | |
| - Conformer holds amniotic membrane firmly. | - Tested by dropping stainless steel balls (12.138 g or 16.567 g) onto the attached membrane. |
| - Device does not pose a risk of coming loose. | - (Implicitly met by successful drop tests, though specific passing criteria are not detailed). |
| Cryopreservation Stability | |
| - Cryopreservation does not negatively affect rings. | - Conformer ring placed in -80°C for up to three weeks. |
| - Cryopreservation does not negatively affect amniotic membrane. | - (Implicitly met through cryopreservation testing, though specific membrane integrity tests are not detailed beyond "no negative effects"). |
| - No change in fastening strength after cryopreservation. | - Tested after -80°C storage for up to three weeks, showing "no change in the fastening strength." |
| - No change in integrity of skirt or inner ring after cryopreservation. | - Tested after -80°C storage for up to three weeks, showing "no change in... the integrity of the skirt or the inner ring." |
| - No cracks or chipping after cryopreservation. | - Microscopic evaluation revealed "no cracks or chipping" after -80°C storage for up to three weeks. |
| Regulatory Compliance (Implicit) | |
| - Conforms to human tissue processing regulations. | - Conforms to 21 C.F.R. § 1270 and 1271 (human tissue processing). |
| - Conforms to AATB standards. | - Conforms to the standards of the American Association of Tissue Banks (AATB). |
| - Conforms to sterility and bioburden standards. | - Conforms to ISO 11737.1, EN 11743-3, USP XXV (Validation of Microbial Recovery), USP XXIV (Microbial Limits), USP XXIV (Sterility Tests), and PDA Technical Report No. 21 (Bioburden Recovery Validation). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the mechanical integrity and cryopreservation tests (e.g., how many devices were tested). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned; however, the testing appears to be laboratory-based physical performance testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device submission. The "ground truth" here relates to the physical and material properties of the device (e.g., strength of attachment, integrity after freezing), which are determined by engineering and material science testing, not expert clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical interpretations of diagnostic images or data where human consensus is needed. For physical performance testing, the results are typically quantitative measurements or direct observations (e.g., visible cracks).
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 assesses the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a physical medical device like the ProKera™ ophthalmic conformer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims would be the objective results of the physical and material property tests. For example:
- Mechanical Integrity: Measured force required to dislodge the membrane or the outcome of drop tests (e.g., membrane remained attached, no damage).
- Cryopreservation Stability: Quantitative measurements of fastening strength before and after freezing, and qualitative/microscopic observations for cracks or chipping.
- Sterility/Bioburden: Laboratory results from established microbiological testing protocols.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.