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The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana.

The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.

AI/ML Overview

The provided text describes a 510(k) submission for the Synergetics Disposable Directional Endo Ocular Laser Probe. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, complex AI/software-driven device.

Therefore, much of the requested information regarding AI device testing (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for this conventional device are primarily based on demonstrating substantial equivalence to a predicate device (Gamp and Associates Disposable Endoocular Laser Probe, K954307) across key technical characteristics and intended use. The "reported device performance" is the direct comparison of these characteristics.

Criteria	Predicate Device - Gamp and Associates Disposable Endo Ocular Laser Probe - K954307	Synergetics Disposable Directional Endo Ocular Laser Probe	Assessment/Performance
Intended Use	Provides a mean for delivering endophotocoagulation during vitrectomy surgery.	Provides a mean for delivering endophotocoagulation during vitrectomy surgery.	Equivalent. The intended use is identical to the predicate device.
For Use With	HGM Laser, 905 SMA Connection	Lasers with 905 SMA Connection	Equivalent. Both devices are compatible with lasers using a 905 SMA connection.
Handle	Delrin	ABS with an ergonomic roller	Minor Difference. The material and design of the handle differ (Delrin vs. ABS with ergonomic roller). The submission implies this is a "slight difference" that "raises no new issues of safety and effectiveness," as supported by non-clinical testing.
Optical Fiber	Glass Optical Fiber - Silica Core	Glass Optical Fiber - Silica Core	Equivalent. Both use the same type of optical fiber.
Distal End	304 Stainless Steel Shaft	304 Stainless Steel Shaft with Nickel Titanium	Minor Difference. The Synergetics device includes Nickel Titanium in addition to 304 Stainless Steel for the distal end. Similar to the handle, this is presented as a "slight difference" that "raises no new issues of safety and effectiveness."
Jacket	PVC	PVC	Equivalent. Both use PVC for the jacket.
Coupling	SMA 905	SMA 905	Equivalent. Both use an SMA 905 coupling.
Single Use	Yes	Yes	Equivalent. Both are single-use devices.
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Equivalent. Both use Ethylene Oxide (EtO) sterilization.
Packaging	Double Tyvek Pouch	Double Tyvek Pouch	Equivalent. Both use a Double Tyvek Pouch. Synergetics' packaging validated to ISO 11607-1:2006.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission indicates "Bench testing, and comparative performance testing to the predicate device, was performed." This refers to physical, non-clinical tests on the device itself.

Sample Size: Not explicitly stated, but typically involves a number of manufactured units of the device. This is not patient or image data.
Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer, Synergetics, Inc., likely at their facilities or a contracted testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a diagnostic AI device requiring expert-established ground truth from medical images or patient data. The "ground truth" here would be the physical properties and performance measurements of the device itself (e.g., laser power output, sterility, packaging integrity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a diagnostic AI device or clinical study involving expert interpretation with adjudication.

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

Not applicable. This is a traditional surgical device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a traditional surgical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be established through a series of engineering and physical measurements against predefined specifications and industry standards, as well as comparison to the predicate device's known characteristics. Examples include:

Laser power transmission efficiency
Fiber integrity and durability
Sterility (validated to AAMI/ISO 11135)
Packaging integrity (validated to ISO 11607-1:2006)
Biocompatibility (if applicable, though not explicitly detailed here)
Mechanical strength and component integrity

8. The sample size for the training set

Not applicable. This is a traditional hardware medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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