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For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The Innovatech Straight Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber with PVC jacket, a Delrin handpiece and a 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

The Innovatech Straight Laser Probe is an ophthalmic laser delivery device, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided text, primarily through a substantial equivalence comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innovatech Straight Laser Probe are implicitly defined by its substantial equivalence to predicate devices, meaning its performance characteristics are comparable to those already legally marketed. The table below summarizes the key features and their performance (or characteristics) for the Innovatech device and its primary predicate, the Peregrine Straight Laser Probe (Product: PD600.00, 510(k): K024061).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not contain information about a specific "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI evaluation. The substantial equivalence claim is based on a comparison of device specifications and intended use against existing predicate devices. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since there is no mention of a "test set" in the context of clinical performance or AI evaluation, there is no information provided on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no described test set involving expert review, there is no adjudication method mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical ophthalmic laser probe, not an artificial intelligence algorithm. Therefore, no standalone (algorithm only) performance study was conducted or is relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications and functional characteristics being substantially equivalent to legally marketed predicate devices. This is a technical and regulatory comparison, not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" as understood in machine learning.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation and illumination during ophthalmic surgery. This Indications for Use: r or photoougaliation, as well as laser energy, to target tissue causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The Innovatech Illuminating Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

The provided text does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) premarket notification summary for the "Innovatech Illuminating Laser Probe," primarily focused on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.

Here's what can be extracted and what is not available based on your request:

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

• Not available. The document does not specify quantitative acceptance criteria or provide performance data from a study. It focuses on comparing physical and functional specifications to predicate devices.

2. Sample sized used for the test set and the data provenance

• Not available. No test set or study data is presented. The submission relies on a comparison to predicate devices rather than a performance study of the Innovatech device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not available. Since no test set or performance evaluation study is described, there's no mention of experts establishing ground truth.

4. Adjudication method for the test set

• Not available. No adjudication method is mentioned as there is no test set described.

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/Not available. This device is an ophthalmic laser probe, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable/Not available. This is a hardware device for surgical procedures, not an algorithm.

7. The type of ground truth used

• Not available. No ground truth is mentioned because no performance study is detailed. The "ground truth" for this submission is effectively the established performance and safety of its predicate devices, implying that if the new device is sufficiently similar, it should perform equivalently.

8. The sample size for the training set

• Not applicable/Not available. This is a physical device, not a machine learning model, so there is no training set in the context of AI.

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

• Not applicable/Not available. As above, this is not an AI/ML device.

Summary of available information related to equivalence, which is a form of "acceptance" for 510(k):

The submission demonstrates "Substantial Equivalence" by comparing the Innovatech Illuminating Laser Probe to three predicate devices: Peregrine Illuminated Laser Probe (PD600.10, K031023), HGM Illuminating Laser Probe (K931784), and Peregrine Straight Laser Probe (PD600.00, K024061).

Table of Comparison (from the document):

"Study" Proving Acceptance (Substantial Equivalence):

The "study" here is a design and materials comparison between the Innovatech device and multiple legally marketed predicate devices. The acceptance is based on the argument that because the Innovatech Illuminating Laser Probe shares the same indications for use, fundamental technological characteristics, and similar materials and design specifications (e.g., fiber type, diameter, maximum power output, connector, handpiece, needle material and gauge) with its predicates, it is substantially equivalent and therefore presumably as safe and effective. The minor differences (like jacket material from Teflon to PVC in one comparison, and the inclusion of illumination compared to a non-illuminating predicate) are implied to not raise new questions of safety or effectiveness.

Sterilization: The device will be ETO Sterilized, and the method used to validate the sterilization cycle is the AAMI Overkill Method, which is a standard method. This is a crucial aspect of safety and effectiveness that is mentioned.

In summary, for a 510(k) submission like this, "acceptance criteria" are generally met by demonstrating that the new device does not raise new questions of safety and effectiveness compared to predicate devices, rather than through a direct performance study with quantitative metrics against predefined thresholds.

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