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The SabreLine™ and SabreGuard™ Laser Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.

The Coloplast SabreGuard™ and SabreLine™ Laser Fibers are fiber optic laser delivery devices that transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures. The devices are 3.0 meters in length and are terminated with a SMA-905 connector on the proximal end. A laser fiber is made of silica inner core, with a primary and secondary cladding surrounded by a polymeric jacket. The laser fibers are compatible with laser systems operating in wavelengths between 500 nm - 2200 nm. The laser delivery devices are intended for use with any cleared surgical laser with a SMA-905 connector. Coloplast reference SUNXXX are equipped with a round tip, Coloplast reference SUEXXX are equipped with a radius tip; Coloplast reference SUDXXXX and RUSXXXX are equipped with a straight tip. Single use laser fibers are delivered sterile in a retail box of 3, with an instruction for use in paper version. Reusable laser fibers are delivered sterile in a retail box of 1, with an instruction for use in paper version.

This document describes the Coloplast SabreLine and SabreGuard Laser Fibers (K182831).

A table of acceptance criteria and the reported device performance is not explicitly provided in the given text. However, the document outlines the types of performance data (mechanical testing, biocompatibility, sterilization, and packaging) that were conducted to support the substantial equivalence determination. The conclusion states that the device is substantially equivalent to the predicate based on "non-clinical data provided, similar intended use, materials, design and construction, biocompatibility, and technological characteristics," implying that the performance data met unstated internal acceptance criteria for these characteristics.

Based on the provided information, I can extrapolate the types of tests done and their implied acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions "a comprehensive regimen of testing" and "mechanical testing was completed as follows to verify the product design performance," implying that sufficient samples were tested to achieve statistical significance or meet regulatory requirements for each test.
• Data Provenance: The document explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means all data is non-clinical performance data, likely derived from in vitro and benchtop testing. The origin of this data is Coloplast's internal testing.

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 information is not applicable as the device is a laser fiber and its substantial equivalence was determined through non-clinical performance data, not through expert-reviewed clinical data or diagnostic accuracy studies. There was no "ground truth" to be established by experts in a diagnostic context for these tests.

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

• This information is not applicable for the same reasons above. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) 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:

• This information is not applicable. The device is a medical instrument (laser fiber), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

• This information is not applicable as the device is a medical instrument, not an algorithm or AI system.

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

• For the non-clinical performance tests, the "ground truth" was established by engineering specifications, material standards, and validated test methods. For example, for tip diameter, the ground truth would be the design specification for the tip diameter. For biocompatibility, the ground truth would be the criteria for non-toxicity, non-sensitization, etc., as defined by ISO 10993-1.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• This information is not applicable for the same reasons above.

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The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.

The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient.

The provided text describes a 510(k) premarket notification for the SabreSource™ Drape. This is a medical device accessory and the submission focuses on its substantial equivalence to predicate devices, rather than establishing its performance through a study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.

Therefore, the requested information for acceptance criteria and a study proving performance cannot be fully provided in the format requested, as that type of study was not conducted or required for this device. The information provided outlines the technological characteristics and intended use that form the basis for its substantial equivalence, which is the primary "proof" for this type of device.

Here's how to address the request based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device revolves around its ability to function as a sterile barrier and allow laser transmission, thereby being substantially equivalent to existing devices.

Study Details (Not applicable for this type of submission)

The provided document describes a 510(k) submission for a medical device accessory (a drape). For such devices, the primary "proof" is demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting a controlled clinical study with specific acceptance criteria, sample sizes, and ground truth in the way one would for a diagnostic algorithm or a novel therapeutic device.

Therefore, the following information is not available or applicable from the provided text:

• Sample size used for the test set and the data provenance: No test set or clinical study was mentioned or required for this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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, as this is not an AI diagnostic device or one involving human reader performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context is established by the functional characteristics of the drape (sterility, optical clarity) and its equivalence to predicates.
• The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
• How the ground truth for the training set was established: Not applicable.

In summary: The K041846 submission for the SabreSource™ Drape is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. The "proof" is in showing that its technological characteristics and intended use are similar to already approved drapes, and any differences raise "no new issues of safety or effectiveness." This type of submission does not typically involve the detailed performance studies, ground truth establishment, and expert reviews that would be required for a novel diagnostic or AI-powered device.

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The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.

The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.

Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the SABRe Compac Auditory Brainstem Response Screener, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the text is missing:

• A table of acceptance criteria and reported device performance: There are no specific performance metrics or thresholds mentioned for the device.
• Sample size used for the test set and data provenance: The document does not describe any specific test set or the characteristics of the data used for testing.
• Number of experts used to establish ground truth and their qualifications: This information is not present.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no indication of such a study being conducted or its results.
• Standalone (algorithm-only) performance: The device is described as an "evoked potential device" and "Screener" for use by "trained professionals," suggesting it's generally a diagnostic tool, but no standalone algorithmic performance is detailed.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not mentioned as there's no description of an AI/ML algorithm being "trained" in the typical sense.
• How ground truth for the training set was established: Not applicable given the lack of training set information.

The core of the provided text is about the device's intended use and its substantial equivalence to a previously cleared device (SLE SABRE ABR Screener, K993177). This type of submission relies on demonstrating that the new device has similar technological characteristics and performs comparably to an already approved device, rather than presenting a full de novo study with detailed performance metrics against specific acceptance criteria.

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The SABRE Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the evaluation of hearing function.

The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.

The provided 510(k) summary for the SABRE Auditory Brainstem Response Screener does not contain information regarding detailed acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or comparative effectiveness with human readers. The document is primarily focused on establishing substantial equivalence to predicate devices based on intended use and technological characteristics.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size used for the test set and data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available.
6. Standalone (algorithm-only) performance: Not available.
7. Type of ground truth used: Not available.
8. Sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states that the SABRE ABR device is "similar in its intended use to predicate devices and existent methodologies," implying that its performance is expected to be comparable to these established devices, rather than being demonstrated through a detailed independent study described within this summary.

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The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.

The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.

Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.

The provided text describes a 510(k) premarket notification for a medical device, the ECI Sabre BT™ Blunt-Tip Surgical Trocar. It does not contain information about acceptance criteria, device performance, or a study report in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices, product description, indications for use, and biocompatibility testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only performance-related information provided is:

Biocompatibility:

• Cytotoxicity Test
• USP Intracutaneous Toxicity Test
• Guinea Pig Maximization (Kligman) Sensitization Test

Conclusion:
"Based on the indications for use, technological characteristics and performance testing, the ECI Sabre BT™ Blunt-Tip Surgical Trocar has been shown to be safe and effective for its intended use."

This conclusion is very general and does not provide specific acceptance criteria or quantitative performance metrics typically found in a study report for a diagnostic AI device.

It's important to note that this document is for a surgical trocar, which is a physical medical device, not an AI or software device. Therefore, the questions related to AI-specific metrics like "standalone algorithm performance," "MRMC comparative effectiveness study," "ground truth," "training set," and "test set" are not applicable to the information provided. The "performance testing" mentioned in the conclusion likely refers to mechanical, functional, and sterility testing typical for physical medical devices, which are not detailed in this summary.

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