(194 days)
When the TxCell Scanning Laser Delivery System is connected to the IQ 532 (532 nm), the IQ 577 (577 nm) or the IQ 810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye.
532 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: Retinal photocoagulation (RPC) for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy; Retinal tears and detachments; Lattice degeneration; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma.
577 nm: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy; Choroidal neovascularization; Branch retinal vein occlusion; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Retinal tears and detachments; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma.
810 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including: Retinal photocoagulation for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy; Retinal tears, detachments and hole; Lattice degeneration; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma.
The TxCell™ Scanning Laser Delivery System is a slit lamp adapter laser delivery system which is installed by the customer on existing slit lamps in their office or clinic and is used by ophthalmologists to deliver laser energy to various ocular targets. The TxCell™ delivery system delivers laser applications in both single spot mode and multi-spot mode. The TxCell™ Scanning Laser Delivery System adds the use of multi-spot pattern scanning technology when coupling with commercially available IRIDEX laser systems. This offers existing IRIDEX laser systems the ability to deliver, in addition to standard single spot applications, a full spectrum of multi-spot pattern scanning options through a variety of customer owned slit lamps. The TxCell™ Scanning Laser Delivery System consists of the following system components: TxCell™ Scanning Slit Lamp Adapter (SSLA) that may be coupled to Zeiss-style or Haag Streit-style slit lamps or the IRIDEX Laser Workstations. TxCell™ Control Box with power supply, scanner controller, drive electronics and electrical connections. The Control Box is paired with an SSLA. Cables to connect the SSLA to the Control Box and the Control Box to the laser console. The TxCell Scanning Laser Delivery System requires connection to a TxCell compatible Laser Console from the IRIDEX Family of IQ Laser Systems (IQ 532, IQ 577, IQ 810). The touchscreen on the TxCell compatible IQ Family Laser Console accesses a Pattern Selection Screen and the knobs on the Laser Console set the pattern parameters. All other user interface screens and menus are unchanged and operate the same as on the standard IQ Family Laser Console.
The provided 510(k) summary for the TxCell™ Scanning Laser Delivery System focuses on bench testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to human subject studies (e.g., sample size for test set, experts for ground truth, MRMC study, training set details) are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|
| Control pulse-to-pulse power variations (single and multi-spot) | Better than 0.5% |
| Control duration variability (single and multi-spot) | Less than 0.25% |
| Consistency of output energy (single and multi-spot, CW & MicroPulse) | Consistently delivered |
| Spatial positioning independence of pulse-to-pulse variations | Pulse to pulse variations are controlled by the laser console and are independent of spatial positioning due to changes in spot location by the scanner. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of a clinical study. The test involved measurements of laser output power and duration.
- Data Provenance: Bench testing, performed by IRIDEX Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for this engineering bench test is the precise measurements taken by calibrated instruments. No human experts were involved in establishing a "ground truth" in the diagnostic sense.
4. Adjudication method for the test set:
- Not Applicable. No human adjudication was involved. The evaluation was based on direct instrumental measurements.
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. This device is a laser delivery system, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, in essence. The testing performed was standalone for the device's physical performance characteristics (laser output). There is no "algorithm" in the AI sense for this device. The device's performance was evaluated independently without human intervention during the measurement process.
7. The type of ground truth used:
- Instrumental measurements/engineering specifications. The ground truth was established by direct measurement of physical parameters (power, duration).
8. The sample size for the training set:
- Not Applicable. This device is hardware for laser delivery, not an AI or machine learning system that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.