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The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.

The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.

The provided text is a 510(k) Premarket Notification for the Barkey S-Line blood/fluid warming system. This document is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a clinical study or a study proving the device meets acceptance criteria in the context of typical AI/ML medical device performance studies. Instead, it describes non-clinical testing (electrical/EMC and performance testing) to demonstrate the device's basic functionality and safety, and compares its specifications to a predicate device to establish substantial equivalence.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the type of device and submission described in this document. The Barkey S-Line device is a fluid warmer, not a diagnostic AI/ML system that would typically undergo such a rigorous performance validation involving human experts and clinical datasets.

However, I can extract the "acceptance criteria" in a broad sense from the non-clinical testing sections and the comparison to the predicate.

Non-Applicable Information for this Device/Submission Type:

• Sample sized used for the test set and the data provenance: Not a clinical study involving a test set of patient data.
• Number of experts used to establish the ground truth: Not applicable, no ground truth based on expert review of medical images/data.
• 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: No, this is not an AI/ML diagnostic device requiring an MRMC study.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no complex algorithm. The "electronics" section explicitly states "No microprocessor" and "The temperature regulation is realized by hardware comparator circuit."
• The type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" here is the physical measurement of temperature and electrical properties against specified ranges.
• The sample size for the training set: Not applicable; there is no machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Reported Device "Performance" (as per the non-clinical testing and comparison):

Based on the nature of this 510(k) submission for a fluid warmer, the "acceptance criteria" are derived from relevant electrical/safety standards and the device's ability to maintain a target temperature within specified limits, similar to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Sample Size: This document does not specify a "sample size" in the context of clinical data for an AI/ML device. The "testing" involves internal non-clinical validation of the device's physical and electrical properties. The number of units tested for electrical safety, temperature accuracy, or flow rate performance is not explicitly stated but would be part of a quality management system.
• Data Provenance: Not applicable in the context of clinical data. The performance claims are based on non-clinical testing performed internally by the manufacturer (Barkey GmbH & Co. KG), presumably in Germany given their address. The testing reports (e.g., electrical, performance testing) would be available internally.

3. Number of Experts and Qualifications:

• Not applicable. This device does not rely on expert interpretation of medical data for its function or validation for regulatory submission. The "experts" involved would be engineers and quality assurance personnel performing the non-clinical tests.

4. Adjudication Method:

• Not applicable.

5. MRMC Comparative Effectiveness Study:

• No. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a fluid warming device.

6. Standalone Performance:

• Yes, in a very literal sense. The device's performance in heating fluids and its safety features (e.g., overtemperature cutoff, alarms) are evaluated as a standalone product against engineering specifications and relevant standards. There is no AI/ML component or complex algorithm, it's a hardware-based direct warming device.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance relies on physical measurements against engineering specifications and regulatory standards. For example:
  • Temperature: Measured temperature must fall within a specified range (e.g., 39°C +/- tolerance) and safety cutoffs (e.g., 43°C +/- 1°C).
  • Electrical Safety: Electrical parameters (e.g., leakage current, insulation resistance) must meet the limits specified by IEC 60601-1.
  • Flow Rate vs. Temperature: Measured output fluid temperature at various input fluid temperatures and flow rates.
• This is not "expert consensus," "pathology," or "outcomes data."

8. Sample Size for the Training Set:

• Not applicable. There is no training set as there is no machine learning component. The device's temperature regulation is achieved through a "hardware comparator circuit" rather than a software algorithm.

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

• Not applicable.

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S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.

The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.

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

The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.

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

This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance:

Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.

7. Type of Ground Truth Used:

The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.

8. Sample Size for the Training Set:

This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."

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

This information is not applicable for the same reason as above.

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S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:
Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.
Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.

The provided 510(k) summary for the "S-line" Saline Bipolar Resectoscope does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a diagnostic AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and states that no performance standards are known and no clinical tests were performed for this specific submission.

However, based on the information provided, we can infer the overarching "acceptance criteria" through the lens of safety and effectiveness, and how the submitter "proved" this through substantial equivalence.

Here's an analysis based on your requested categories:

Acceptance Criteria and Device Performance

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" are implied to be that the device functions safely and effectively for its intended use, comparable to its predicate devices.

Study Details (or lack thereof, in an AI/ML context)

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

   • Test set size: Not applicable. No dedicated "test set" in the context of an AI/ML performance study was used. The submission relies on technical characteristics and substantial equivalence, not data from a specific test set.
   • Data provenance: Not applicable. No clinical data provided.

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

   • Not applicable. No ground truth establishment in the customary sense for evaluating a diagnostic device's performance.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication performed.

4. 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:

   • No. This device is a surgical instrument, not an AI/ML diagnostic aid for human readers.

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

   • Not applicable. This is a surgical resectoscope, not an algorithm.

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

   • Not applicable. Ground truth for performance metrics was not established as part of this submission. The "truth" is based on the design and intended function being safe and effective, similar to predicate devices.

7. The sample size for the training set:

   • Not applicable. This device is a hardware instrument, not a learned algorithm.

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

   • Not applicable.

Summary of the "Study" provided in Ko62720:

The submission for K062720 does not describe a "study" in the typical sense of a clinical trial or performance evaluation for an AI/ML device. Instead, it follows a 510(k) pathway for medical devices which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices.

The arguments made are:

• Technological Characteristics: The device has a similar design to traditional monopolar resectoscopes but includes an additional pin for the neutral pole, enabling bipolar functionality. It highlights the benefits of using saline over Purisole/Glycine solution (minimizing TUR-syndrome) and avoids intra-operative muscle tremor due to current localization.
• Safety and Effectiveness: The conclusion states that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This suggests manufacturing controls and design verification/validation (which are typically part of a Quality System) rather than a specific clinical performance study for regulatory submission.
• Predicate Devices: Substantial equivalence is claimed to several predicate devices, including resectoscopes from Richard Wolf (K980302, K042523), Olympus, ACMI (K031001, K022480), and a Gyrus system. The device's safety and effectiveness are considered to be comparable to these established devices, with the new technological characteristics not diminishing safety or effectiveness.
• No specific performance standards or clinical tests were performed for this submission.

In essence, the "proof" the device meets acceptance criteria is derived from its design, its intended function, and its demonstrated similarity (substantial equivalence) to devices already on the market where safety and effectiveness have been previously established.

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