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The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.

The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass.

The K964571 submission for the SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and study particulars. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the format you've requested for a device that might be AI-driven.

However, based on the provided text, I can extract and infer some information, particularly regarding the performance comparison to predicate devices, which serves as the basis for demonstrating substantial equivalence.

Here's an attempt to answer your questions based on the available information, with caveats for missing details:

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

The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format, nor does it present device performance in a structured table against such criteria. Instead, it states that the device "showed similar rates" to the predicate, implying that performance comparable to the predicate device was considered acceptable.

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

The document mentions "comparative bench testing" but does not specify the sample size (e.g., number of devices tested, number of test runs) or the provenance (country of origin, retrospective/prospective) of the data. It appears to be bench testing rather than human subject data.

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)

This is not applicable as the device is a medical device for cardioplegia delivery, not an AI-powered diagnostic or image analysis tool requiring expert ground truth for a test set in the context of typical AI/ML studies. The evaluation was based on physical performance metrics.

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

Not applicable, as this was not an expert-driven adjudication of medical cases, but rather bench testing of device performance.

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 device is not an AI-assisted diagnostic tool or an imaging device involving human readers.

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

This question is framed for AI algorithms. For this physical medical device, the "standalone" performance is the bench testing described, which evaluated the device's operational characteristics independently.

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

For this device, the "ground truth" for performance comparison was the established performance characteristics of the legally marketed predicate devices (Sorin Biomedical Buckberg BCD Vanguard, Sorin Biomedical BCD Advanced Blood Cardioplegia System, Avecor Cardiovascular MYOtherm Cardioplegia System). The performance metrics (hemolysis, heat exchange, etc.) themselves are quantifiable physical parameters, not subjective expert interpretations or pathological diagnoses.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The device was developed and then tested against established physical performance criteria.

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

Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. The evaluation relies on comparative bench testing against predicate devices. The concepts of AI-specific acceptance criteria, test/training sets, expert ground truth, and MRMC studies are not relevant to this type of submission.

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The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.

The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of 805nm and a visible (aiming beam) 5 milliwatt Class Illa diode laser with a wavelength of 650nm.

The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas:

Labeling: The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser's power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device.

Power Output: Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged.

Indication For Use: The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications:

• · General Surgery
• · Ophthalmology/Oculoplastic
• · Urology
• · Gastroenterology
• · Gynecology
• · Otorhinolaryngology
• · Pulmonary/Thoracic
• · Dermatology/Plastic Surgery
• · Neurosurgery (coagulation only)
• · Orthopedic

This submission is for modifications to a medical device, specifically the Diomed Surgical Diode Laser, not a new AI/ML device. Therefore, the requested information tailored for AI/ML device studies (such as acceptance criteria tables, sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable or present in the provided text.

The document discusses modifications to a laser's power output and labeling, and the expansion of its indications for use. The focus is on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific acceptance criteria for an AI/ML algorithm.

Here's an analysis of the provided text based on the closest relevant interpretations:

1. Table of Acceptance Criteria and Reported Device Performance:
This type of table is not provided because the submission is not about an AI/ML device's performance against specific statistical metrics. Instead, it focuses on demonstrating that modifications to an existing laser product still result in a device that is safe and effective and substantially equivalent to its predicate.

However, the closest equivalent to "performance" and "acceptance criteria" can be inferred from the "Nonclinical Tests Used in Determination of Substantial Equivalence."

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified. The document mentions "canine tissue studies" but does not give a number of subjects or samples.
• Data Provenance: "Canine tissue studies." This implies prospective animal studies. The country of origin is not specified.

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

• This information is not provided as the study is a non-clinical, animal tissue study focused on physical effects of laser energy, not diagnostic interpretation by human experts.

4. Adjudication method for the test set:

• Not applicable. This is not an expert-driven adjudication study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This is not applicable to a physical medical device modification submission like this, which focuses on laser mechanics and tissue interaction rather than diagnostic interpretation.

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

• Not applicable. This device is a laser, not an algorithm.

7. The type of ground truth used:

• The "ground truth" here is the physical effect of the laser on canine tissue and comparison to "predicate laser systems" (specifically existing Nd: YAG lasers) in terms of tissue damage. This is empirical observation of biological effects.

8. The sample size for the training set:

• Not applicable. This device is a physical laser, not an AI/ML algorithm that requires a training set.

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

• Not applicable for the reasons stated above.

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