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The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT).

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT) as follows:

Gastroenterology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

• hemostasis of esophageal varices;
• palliation of malignant dysphagia;
• palliative ablation of obstructive neoplasms;
• hemostasis of colonoscopy.

Neurosurgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

• tumors adjacent to the spinal cord;
• tumors adjacent to the cortex.

General Surgery
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

• Laparoscopic
  • appendectomy;
  • cholecystectomy;
  • bowel resection.
• Open
  • mastectomy;
  • reduction mammoplasty;
  • breast biopsy;
  • rectal and anal hemorrhoidectomy;
  • bowel resection;
  • colectomy;
  • cholecystectomy;
  • liver resection;
  • condyloma;
  • thyroidectomy;
  • thoracotomy;
  • cavernous hemangioma.

Genitourinary (Urology)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

• Transurethral
  • transurethral incision of the prostate (TUIP);
  • bladder tumors;
  • bladder neck incisions;
  • urethral strictures;
  • exterior sphincterotomy.
• Laparoscopic
  • Lymphadenectomy.
• Open
  • condyloma;
  • circumcision
  • benign and malignant lesions of external genitalia.

Thoracic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

• pulmonary resection;
• coagulation of blebs and bullae;
• adhesiolysis;
• pericardiectomy
• mediastinal and thoracic lesions and abnormalities;
• mediastinal lymph node dissection;
• hemostasis;
• thoracotomy.

Gynecology (GYN)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

• Laparoscopic
  • excision/lysis of adhesions;
  • endometrial lesions, including ablation of endometriosis;
  • laparoscopic assisted hysterectomy (LAVH);
  • laser uterosacral nerve ablation (LUNA);
  • myomectomy;
  • ovarian cystectomy;
  • ovarian drilling;
  • tubal fimbrioplasty;
  • appendectomy.
• Open
  • conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN;
  • Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions.
• Intrauterine
  • Fibroids/polyps/adhesions;
  • Resection of septum.

Pulmonology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include:

• tracheal bronchial lesions.

Ophthalmology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

• Oculoplastics
  • open DCR;
  • endo-nasal DCR;
  • tumor excision and biopsy;
  • eyelid reconstruction;
  • blepharoplasty.

Orthopedics
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include:

• Open
  • Dissect and coagulate.

Otolaryngology (ENT)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

• Nasal/Sinus
  • turbinectomy and turbinate reduction/ablation;
  • polypectomy of nose and nasal passages;
  • ethmoidectomy;
  • meatal antrostomy;
• Laryngo-tracheal
  • removal of vocal cord/fold nodules, polyps and cysts;
  • arytenoidectomy;
  • tracheal stenosis;
• Oropharyngeal
  • uvulopalatoplasty (LAUP, laser UPPP);
  • tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil;
  • hemi glossectomy;
• Head & Neck
  • tumor resection on oral, subfacial and neck tissues;
  • parathyroidectomy;
  • thyroidectomy.

The PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810mm, 940mm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary. These devices have been cleared previously via K040294. Differences between the cleared and modified device are limited to:

• Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power).
• User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device).

The system is comprised of the following main components:

• A laser console/cabinet with fiber port to accept SMA-905 connectors.
• Display panel with soft-touch keypad control and separate Emergency Off button.
• Laser system microprocessor control electronics with operating software
• A detachable covered footswitch.

The provided document is a 510(k) Summary for the PhotoMedex LaserPro 810, 940 and 980 Systems Diode Laser Systems, submitted to the FDA for premarket notification. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove safety and effectiveness.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical study for several reasons:

• Substantial Equivalence: The submission is based on the concept of "substantial equivalence" to previously cleared devices (K040294, K023543, K954316, K952661). This means PhotoMedex is asserting that their modified devices (with increased maximum output power and user-adjustable aiming beam) are as safe and effective as the predicate devices, and perform similarly. They are not introducing "new clinical indications" that would necessitate new performance criteria or efficacy studies.
• Safety and Effectiveness Justification: Section 7, "SAFETY AND EFFECTIVENESS," explicitly states: "The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed... with both mandatory and voluntary and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be chisating when are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which havel previously demonstrated clinical effectiveness." This indicates that the safety and effectiveness are established by adherence to standards and the prior clearance of predicate devices for similar indications.
• No Clinical Study Details: The document makes no mention of any new human subject clinical trials, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance studies. These are typically associated with novel devices or significant changes requiring new performance validation.

Given the nature of a 510(k) for minor modifications to an existing device and the explicit statements in the document, it is not possible to extract the requested information. The "study that proves the device meets the acceptance criteria" in this context is implicitly the historical data and regulatory clearances of the predicate devices.

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The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

SLT Venous FDS products include the Venous Diffusing Fiber, the Venous Conical Fiber, and the Venous Flat Fiber.

SLT Venous Diffuser Fibers are flexible fibers with an active diffusing portion that diffuses the laser energy in a uniform pattern about its active diffusing length, resulting in a cylindrical or elongated spheroidal zone of coagulation.

SLT Venous Conical Fibers splay the laser energy radially at their distally conical portion, providing a much smaller and more focused coagulation zone than the Venous Diffuser Fiber.

SLT Venous Flat Fibers direct the laser energy forward from their distally flat end, providing the highest energy density of the three SLT Venous Fibers.

SLT Venous Fibers are available with SLT proprietary connectors (to fit SLT Contact Laser Systems) and SMA-905 connectors (to fit lasers with standard SMA-905 launch interfaces).

SLT Venous Diffuser Fibers are compatible for use only with lasers having wavelengths between 980nm and 1064nm.

SLT Venous Conical and Flat Fibers are compatible for use with lasers having wavelengths between 810nm and 1064nm.

SLT Venous Fibers are flexible and therefore, when used for endovascular applications, a catheter, cannula, or similar device should be used to insert the fiber into the vein.

SLT Venous Fiber products are sold sterile, and are intended for single use only.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for "SLT Venous Fiber Delivery Systems," which focuses on establishing substantial equivalence to previously marketed devices rather than detailing specific performance acceptance criteria and a study to meet them.

Here's what the document does provide:

• Device Description and Intended Use: The SLT Venous Fiber Delivery Systems are intended for endovascular coagulation of the greater saphenous vein in patients with superficial vein reflux.
• Predicate Devices: The document lists several predicate devices (e.g., Diomed 810nm Surgical Lasers and EVLT Procedure Kit, VNUS® Closure™ System, Ceralas D Diode Laser Systems) for comparison.
• Basis for Substantial Equivalence: The submission states that the intended use, method of tissue interaction, specifications, clinical technique, and animal study results are "the same or very similar" to the predicate devices.
• Safety and Effectiveness: Animal studies were performed to demonstrate "substantially equivalent safe and effective performance" to the predicate devices. Biocompatibility testing (USP Class VI and ISO 10993-1, including hemocompatibility per ISO 10993-4) was also successfully performed.

Missing Information:

The document does not include:

1. A table of specific acceptance criteria (e.g., specific quantitative metrics for coagulation effectiveness, safety endpoints).
2. Reported device performance against such criteria.
3. Details on the sample size used for any test set in the animal studies.
4. Data provenance (country of origin, retrospective/prospective).
5. Number of experts used or their qualifications.
6. Adjudication method.
7. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
8. Results from standalone (algorithm only) performance studies.
9. The specific type of ground truth used in the animal studies (beyond "animal studies").
10. Sample size for any training set.
11. How ground truth for a training set was established.

The document primarily focuses on asserting substantial equivalence based on general performance observations in animal studies and biocompatibility, rather than providing a detailed breakdown of acceptance criteria and a quantitative study proving adherence to them as would be expected for an AI/CADe device.

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The SLT bipolar sheath is indicated for use with currently marketed cutter systems used in Orthopedic Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.

The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

The provided text is a 510(k) summary for the SLT HemoSleeve Bipolar Sheath, which is a medical device. It does not contain information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document primarily focuses on:

• Indications for Use
• A general description of the device
• A statement of substantial equivalence to predicate devices based on intended use and technological features, supported by "performance data from device validation" (though the data itself is not presented).
• A formal FDA letter confirming substantial equivalence and market clearance.

Therefore, I cannot provide the requested information from the given text.

The document explicitly states:

"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used."

This indicates that performance data and validation were conducted, but the details of those studies are not included in this summary. This type of summary typically omits the detailed study results and focuses on the regulatory conclusion.

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The SLT Pneumatic Cutter System is indicated for use in Ear Nose and Throat Surgery primarily sinus endoscopy, and orthopedic procedures primarily arthroscopy. The cutter is intended to achieve the removal of tissue, both soft tissue and bone with the appropriate handpiece. It will also provide suction and irrigation to the operative site.

The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.

The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.

The provided text is a 510(k) summary for the SLT Pneumatic Cutter System. It describes the intended use of the device and states that it has been determined substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The text explicitly states: "Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used." This indicates that performance data was collected and used for the 510(k submission, but the actual data, acceptance criteria, and study details are not present in this summary.

Therefore, I cannot provide the requested information from the given input.

To answer your request, I would need a section of the document that outlines:

1. Specific quantitative or qualitative acceptance criteria (e.g., minimum cutting speed, maximum vibration, minimum suction rate, etc.).
2. Results of a study where these criteria were tested.
3. Details about the test setup, sample sizes, data provenance, ground truth establishment, or human-in-the-loop studies.

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The SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip.

The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

This document is a 510(k) summary for the SLT bipolar sheath and does not contain the information requested in your prompt. The provided text is a regulatory submission for a medical device that details its intended use, technological features, and substantial equivalence to legally marketed predicate devices. Key information such as acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment are not included.

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The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. This device is specifically intended for use in prostate procedures which treat the clinical condition of Benign Prostatic Hyperplasia. This device is currently cleared for market for multiple surgical indications.

The specific indication for use of the SLT® Contact Laser™ Fiber Delivery System is for the Incision, Excision, Coagulation and Vaporization of soft tissue for prostatectomy in treatment of Benign Prostatic Hyperplasia (BPH).

Vaporization of Prostatic Tissue - The Contact Laser Vaporization of the Prostate (CLVP) procedure vaporizes prostate lobe tissue as well as tissue obstructing the urinary channel. This procedure is indicated for prostates up to 45 grams in size.

Coagulation and Vaporization of Prostatic Tissue - The Coagulation and Hemostatic Resection of the Prostate (CHRP)™ coagulates the prostate lobe tissue and vaporizes tissue obstructing the urinary channel. This procedure is indicated for prostates up to 75 grams.

The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue.

The provided text describes a 510(k) submission for the SLT CL MD Laser System. The submission aims to establish substantial equivalence for the use of this laser system in prostate procedures for Benign Prostatic Hyperplasia (BPH) by demonstrating its safety and effectiveness are equivalent to the traditional electrosurgical procedure (TURP).

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or device performance in the typical format of metrics like sensitivity, specificity, or accuracy. Instead, the acceptance is based on demonstrating substantial equivalence in safety and effectiveness to existing legally marketed predicate devices, specifically the "current Gold Standard Electrosurgical Procedure (TURP)" for BPH.

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

• The document states: "This submission will establish, based on clinical data, that the laser procedure for treatment of BPH is equivalent in safety and effectiveness to the traditional electrosurgical procedure."
• However, the sample size for the clinical data (test set) is not specified in this summary.
• The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

• This information is not provided in the given text.

4. Adjudication Method for the Test Set:

• This information is not provided in the given text. The study describes a comparison to an established procedure (TURP), implying clinical outcomes would be the primary measure, rather than an expert consensus on individual cases in a traditional AI model evaluation.

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:

• The document describes a clinical study comparing a laser procedure to an electrosurgical procedure (TURP). This is a comparative effectiveness study, but it's not an MRMC study comparing human readers with and without AI assistance. The device is a surgical tool, not an AI diagnostic aid.
• Therefore, an MRMC study and effect size in human reader improvement with AI are not applicable in this context.

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

• The device is a surgical laser system, intended for use by a surgeon. It is not an algorithm that performs autonomously.
• Therefore, a standalone algorithm-only performance assessment is not applicable.

7. The Type of Ground Truth Used:

• The ground truth in this context would be clinical outcomes data from patients treated with the laser procedure for BPH, compared against clinical outcomes data from patients treated with the traditional electrosurgical procedure (TURP).
• The effectiveness is assessed by the ability of the laser to achieve the intended tissue effects and clinical improvements in BPH patients, equivalent to TURP.

8. The Sample Size for the Training Set:

• This device is a surgical tool, not an AI model that relies on a "training set" in the machine learning sense. The concept of a training set is not applicable.
• The device's design, safety, and initial effectiveness were developed and tested through engineering principles, performance testing, and prior 510(k) clearances.

9. How the Ground Truth for the Training Set was Established:

• As the device is a surgical tool and not an AI model, the concept of "ground truth for the training set" is not applicable.
• The "ground truth" for the device's development and validation would stem from established medical and engineering principles, preclinical testing, and clinical experience/literature forming the basis for the predicate devices.

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The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements:

Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector.

Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.

This device is a prescription device.

The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.

This document, K980156, is a 510(k) summary for the SLT Select Fiber Delivery Systems and Contact Tips, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance criteria or clinical study results as would be expected for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for AI models is not applicable or cannot be extracted from this particular document.

Here's an analysis based on the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed performance metrics in the way a modern AI/software device submission would. The basis for approval is "substantial equivalence" to existing devices. The document states:

"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use."

This implies that some form of validation was conducted to show the device performed comparably to predicate devices in achieving specific "tissue effects of incision, excision, vaporization and coagulation of tissue." However, the specific criteria for these effects (e.g., depth of incision, degree of coagulation, rate of vaporization) and the results of this validation are not provided in this summary.

The "acceptance criteria" can be inferred as the device successfully demonstrating the intended tissue effects when used with compatible laser systems, comparable to how predicate devices perform these actions.

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

Not applicable. This is a medical device for surgical procedures, not an AI/software device that uses test sets of data for algorithm evaluation. The "validation results" mentioned are likely related to engineering testing, material compatibility, and demonstration of functional performance in controlled environments or potentially animal/benchtop models, not human data sets. The document does not provide details on the specific validation tests or the sample sizes used in them.

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

Not applicable. There is no mention of "ground truth" or expert review in the context of a test set, as this is not an AI/software device being evaluated for diagnostic or predictive accuracy.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described for this type of medical device submission.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

Not applicable. As this is not an AI/software device, the concept of "ground truth" in terms of clinical outcomes or expert consensus on data is not relevant to this submission. The "validation results" would likely be based on physical measurements and observations of the fiber's ability to transmit laser energy and create the desired tissue effects.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model, so there is no training set.

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

Not applicable. There is no training set or associated ground truth for this medical device.

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The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.

The provided text describes a medical device called the "SLT Fumich Probe Guide" and its intended use, but it does not contain any information about acceptance criteria, performance studies, or clinical (or even non-clinical) data proving its effectiveness or meeting specific criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is completely absent from the provided 510(k) summary.

The document is a 510(k) summary, which typically focuses on describing the device and establishing substantial equivalence to a predicate device, rather than presenting detailed performance study results like those you've requested. For information regarding acceptance criteria and performance data, one would typically need access to the full 510(k) submission, clinical study reports, or design verification and validation documents, none of which are included here.

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