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510(k) Data Aggregation
(209 days)
The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.
Here's a breakdown of the acceptance criteria and study information for the iStent infinite Trabecular Micro-Bypass System, as presented in the provided FDA 510(k) summary, structured to answer your questions:
1. A table of acceptance criteria and the reported device performance
Please note that for the clinical effectiveness endpoints, explicit "acceptance criteria" are not stated as pass/fail thresholds in the provided text. Instead, the study reports the observed performance, and the FDA determined this performance supports substantial equivalence. For bench testing, direct pass/fail results against implicit or explicit criteria are mentioned.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | ||
| Effectiveness: | (Reported at 12 months for ITT Population/Worst Postoperative IOP & Last Available Medication Classes): | |
| Proportion of responders (>= 20% MDIOP reduction from baseline on same or fewer medications) | (Implicit criteria for substantial equivalence, not explicitly stated as a numerical threshold in the document, but assessed against predicate data for efficacy.) | 72.1% (44/61 participants) with a 95% CI of (59.2%, 82.9%). Other imputation methods yielded similar results (e.g., 73.4% with multiple imputation). |
| Change from baseline in MDIOP | (Implicit criteria for substantial equivalence, not explicitly stated as a numerical threshold in the document, but assessed against predicate data for efficacy.) | -5.5 ± 5.24 mm Hg (mean ± SD) with a 95% CI of (-6.9, -4.2). |
| Safety: | (Implicit criteria that adverse event rates and types should be comparable to or better than predicate devices and acceptable for the intended use.) | No intraoperative adverse events. Most common AEs included ocular surface disease (11.5%), substantial IOP increase vs. baseline (8.2%), and loss of BSCVA >= 2 lines (11.5%). Stent obstruction occurred in 3.3%. Stent migration in 1.6%. Secondary surgical intervention in 4.9%. No reports of: corneal decompensation, choroidal effusion/hemorrhage, hypotony maculopathy, deep stents not visible, stent explantation, stent dislocation (overall), or stent repositioning. |
| Bench Testing | ||
| Surface & Edge Quality | Stent had smooth edges and was free from surface defects. | Pass: SEM photos demonstrated smooth edges and no surface defects. |
| Dimensions | Production meets tolerances to appropriate statistical levels. | Pass: Validated that stent production meets tolerances. |
| Physical Stability | Dimensional measurements remain the same before and after incubation; surface finish maintained quality; coating intact after incubation. | Pass: Dimensional measurements and visual inspection confirmed stability after 14 days incubation. Coating remained intact. |
| Pressure/Flow Characteristics | Negligible flow resistance. | Pass: Numerical modeling and CFD showed negligible flow resistance. |
| Structural Integrity | Safety factors at lowest and highest implant velocities support structural integrity (e.g., 41x and 14x respectively). | Pass: FEA modeling showed safety factors of 41x and 14x, confirming structural integrity. |
| Insertion Testing | All specified requirements met (stent delivery, singulation, implantation, trocar penetration). | Pass: All tested injectors successfully passed predetermined acceptance criteria for stent delivery. |
| Stability of Coating | Coating stability demonstrated for shelf life. | Pass: Demonstrated for the shelf life period. |
| MRI Compatibility | MR Conditional. | Pass: Device is MR Conditional under specified conditions. |
| Corrosion Resistance | Acceptable corrosion resistance to pitting and crevice corrosion. | Pass: Test lab concluded acceptable corrosion resistance per ASTM F2129-15. |
| Sterilization SAL | 10^-6 sterility assurance level (SAL). | Pass: Gamma ray validation (25 kGy) substantiated 10^-6 SAL. |
| Bacterial Endotoxin | Meets recommendations for single-use intraocular ophthalmic devices. | Pass: LAL testing performed as recommended. |
| Packaging & Shelf Life | Functional performance of stent/injector, and packaging integrity maintained after simulated distribution and aging for 1 year. | Pass: Meets functional requirements and sterile barrier remains intact after simulated distribution and aging for 1 year. |
| Biocompatibility (Stent) | Non-toxic, non-mutagenic, non-irritating, non-sensitizing, no significant reaction after implantation, non-pyrogenic. | Pass for all tests: Cytotoxicity (Cell growth inhibition < 30%, No cell lysis or toxicity), Genotoxicity (No mutagenic changes, No toxicity or mutagenic effects, No chromosomal aberrations induced), Intraocular Irritation (No evidence of irritation), Sensitization (No evidence of sensitization), Implantation (No significant reaction), Systemic Toxicity (No evidence of systemic toxicity), Pyrogenicity (Non-pyrogenic). |
| Biocompatibility (Injector) | Non-toxic, non-irritating, non-sensitizing, non-pyrogenic. | Pass for all tests: Cytotoxicity (No cell lysis or toxicity), Intraocular Irritation (No evidence of irritation), Sensitization (No evidence of sensitization), Irritation (Non-irritating), Systemic Toxicity (No evidence of systemic toxicity), Pyrogenicity (Non-pyrogenic). |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Test Set): 61 participants (implanted with iStent infinite).
- Data Provenance:
- Country of Origin: 14 sites in the US and one OUS site.
- Retrospective/Prospective: Prospective, multi-center, single-arm, open-label clinical trial.
- Follow-up: 12 months post-operatively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document describes a clinical trial for an implantable medical device, not an AI or diagnostic imaging device where "experts" would be establishing a ground truth for a test set of images or readings. The "ground truth" here is the clinical outcomes (IOP reduction, adverse events) observed directly in patients treated with the device, which are objective measurements or clinically assessed by the participating investigators. Therefore, this question is not directly applicable in the context of this device's clinical performance study, as 'ground truth' in this case refers to direct patient data and outcomes rather than expert labeled data for AI model validation. The study was conducted by medical professionals at clinical sites, implicitly assuming their expertise in ophthalmology and glaucoma management.
4. Adjudication method for the test set
Similarly to question 3, this question pertains more to diagnostic studies where readings or classifications need to be adjudicated. For an interventional device clinical trial like this, adjudication methods would typically apply to subjective endpoints (e.g., adverse event classification or severity), usually by an independent Clinical Events Committee (CEC) or Data Monitoring Committee (DMC). The document does not explicitly state an independent adjudication method for clinical outcomes or adverse events in the manner of "2+1" or "3+1" for image interpretation. However:
- The study design was "open-label," meaning participants and investigators knew the treatment.
- The safety section mentions that "participants with hypotony (IOP < 6 mmHg) associated with clinically significant findings, loss of light perception, IOP-related SSIs, cyclodialysis cleft, and/or no stents visible were treated as non-responders," which implies predefined rules for classifying certain safety events as failures or non-responders in the effectiveness analysis. This is a form of pre-specified adjudication criterion regarding outcomes but not expert consensus on ground truth data.
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
No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, human readers or AI assistance in reading cases are not relevant to this study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. Again, this device is a physical implant, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this study is primarily clinical outcomes data directly measured from human patients after the device implantation. This includes:
- Intraocular Pressure (IOP) measurements (mean diurnal IOP, reduction percentages).
- Medication usage.
- Adverse events (ocular and systemic).
- Visual acuity (BSCVA) measurements.
- Ocular findings from various examinations (slit-lamp, fundus, gonioscopy, pachymetry, visual field).
For the bench testing, the "ground truth" (or acceptance criteria) was based on established engineering standards, material science principles, and functional requirements verified through laboratory tests.
8. The sample size for the training set
This question is not applicable. The study describes a clinical trial and bench testing for an implantable medical device, not the development or training of an AI algorithm on a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there was no "training set" in the context of AI algorithm development for this device. The clinical study collected real-world patient data post-implantation to assess safety and effectiveness.
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