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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

• 1.7 ml/min, 37°C
• 25 ml/min, 29°C
• 100 ml/min – N/A
  (Compared to predicate's performance at max 41°C: 1.7 ml/min, 37°C; 25 ml/min, 37.5°C; 100 ml/min, 36°C). Despite differences in specific performance values for flow rates, these are typically considered sufficient for the stated indications when compared for substantial equivalence. The document doesn't explicitly state the thresholds for "acceptable" performance for each flow rate but implied sufficiency. |
  | Ingress Protection (Water/Particulate): Adequate protection against ingress of foreign objects and water. | IPX2 (compared to predicate's IPX4). Deemed "adequate ingress protection" given the device's design and intended use. |
  | Protection Against Electric Shock: Classification of protection against electric shock. | Type BF (Similar to predicate). |
  | Alarm Functionality: Timely and appropriate audible/visual alerts for fault conditions (e.g., overtemperature). | Audible and Visual alarms for "Overtemperature" and "Fault" conditions. (Similar to predicate's Audible and Visual alarms for Low temp (42.0C)). |
  | Compatibility with Accessories: Proper function with specified IV sets. | "Used with user supplied FDA cleared IV sets" from Biegler (K954769), which are cleared for use with fluid warmers. (Similar to predicate). |
  | Dimensions: Appropriate physical size for intended use (implied, not a direct safety/performance criterion but part of equivalence). | 90 x 60 x 160 mm ("Dimensions not critical" compared to predicate's 228 x 278 x 132mm, as long as it functions). |
  | Operational Power Requirements: Compatibility with standard hospital power supply. | 100 - 240 VAC, 50/60 Hz (Similar to predicate's 110/220 VAC). |
  | Indications for Use, Patient Population, Environments of Use: Alignment with the predicate device and appropriate for intended context. | "Similar" in all these aspects to the predicate device. |
  | Fundamental Warming Methodology & Principle of Operation: Maintain a similar, safe approach to fluid warming. | "Similar technology of heat exchanger." The difference (heating within the controller vs. heating the line) "does not raise different risk concerns." |
  | Fluid Contact Materials: (Crucial for patient safety) Ensuring no hazardous materials in contact with fluids or that proper clearances exist for compatible accessories. | "The subject device has no fluid contacting materials" as it heats the IV line, which is an FDA-cleared accessory. (Predicate uses accessory extension sets that contact fluid). This is a design difference but deemed safe and equivalent. |

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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Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.

This document (K210080) describes the Dentis s-Clean s-Line Mini, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device requiring a study to prove meeting acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

The acceptance criteria described in this document are related to the physical, chemical, and mechanical properties, as well as the sterility and biocompatibility of the dental implant components, and their substantial equivalence to already marketed devices. The "study" proving acceptance is a series of non-clinical tests and comparisons to predicate devices.

Therefore, I cannot provide a table with "acceptance criteria and reported device performance" as typically found for AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, I will describe the non-clinical tests and their outcomes as presented in the document to demonstrate the device meets its acceptance criteria for safety and effectiveness as a physical medical device.

1. Table of Acceptance Criteria (for a physical dental implant) and Reported Device Performance

Since this is a physical dental implant, the "acceptance criteria" are based on meeting established standards and demonstrating substantial equivalence to predicate devices in terms of material, design, performance, and biocompatibility.

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

• Sample Size for Test Set: The document doesn't specify a "test set" in the context of an AI/ML diagnostic algorithm. For the physical device, fatigue testing per ISO 14801 would involve a specific number of samples, but the exact count is not provided. Other tests like biocompatibility, sterilization, and shelf-life are typically performed on a limited number of samples representative of the product. The document states a comparative fatigue test was conducted.
• Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the results of non-clinical bench testing and material characterization. The manufacturer is Dentis Co., Ltd. from South Korea. The testing was performed according to international standards (ISO, ASTM, USP) and FDA-recognized guidance. It's a "prospective" assessment in that the tests were done on the manufactured devices to demonstrate their properties.

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

• This is not applicable for a physical medical device submission like this one. "Ground truth" in this context refers to established standards (e.g., ISO for fatigue, ASTM for materials, ISO/AAMI for sterilization), which are derived from broad expert consensus in relevant fields (engineering, microbiology, toxicology, dentistry).

4. Adjudication Method for the Test Set:

• Not applicable as this is not an AI/ML diagnostic study with human readers. Test results are compared against defined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, this type of study is not relevant for a physical dental implant. MRMC studies are typically for evaluating the diagnostic performance of AI/ML systems, often with human readers.

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

• Not applicable. There is no algorithm or AI component in this dental implant.

7. The Type of Ground Truth Used:

• The "ground truth" for proving the device's acceptance is based on:
  • International Standards: Conformance to recognized standards such as ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 series (sterilization), ASTM F67, F136, F1980 (materials, shelf-life), and AAMI/USP guidelines for bacterial endotoxins.
  • Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device has the "same intended use and fundamental scientific technology" as legally marketed predicate devices, and any differences "do not raise different questions of safety and effectiveness."

8. The Sample Size for the Training Set:

• Not applicable. There is no AI/ML training set for this physical device.

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

• Not applicable. There is no AI/ML training set.

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Dentis s-Clean s-Line is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean s-Line is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). The device includes various abutments made from Ti-6A1-4V (ASTM F136) and Chrome-cobalt-molybdenum (CCM) alloy material (ASTM F1537). Some abutments have a TiN coating. Some components are provided sterile, while others are non-sterilized.

The provided text describes a 510(k) premarket notification for a dental implant system (Dentis s-Clean s-Line). This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not present a typical device performance study with specific acceptance criteria and reported numerical performance metrics.

Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various tests and comparisons, particularly in terms of:

• Indications for Use
• Design and dimensions
• Materials
• Surface treatments
• Sterilization methods
• Biocompatibility
• Dynamic fatigue and static strength

The "study that proves the device meets the acceptance criteria" is fundamentally the comparative analysis against the predicate and reference devices, along with performance testing (dynamic fatigue, static strength) and biological assessment (biocompatibility).

Here's an attempt to structure the information based on your request, acknowledging that the format of a 510(k) summary is different from a clinical study report.

Implied Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented is in comparison to these predicates rather than against pre-defined numerical thresholds for novel performance.

• Dynamic Fatigue Strength
• Static Strength | Tests conducted according to FDA guidance and ISO 14801:2016 for worst-case scenario. Results are implied to be equivalent to predicate (as no significant differences were cited to impact performance). |
  | Material Characteristics:
• Adherence to ASTM standards (F67, F136, F1537)
• Surface characteristics (SLA, TiN coating) | Fixtures made of CP Titanium Gr4 (ASTM F67). Abutments from Ti-6Al-4V (ASTM F136) and Chrome-cobalt-molybdenum (ASTM F1537).
  SLA surface identical to K153639. TiN coating identical to K171694. EDX, SEM, surface roughness, coating thickness, porosity, adhesion leveraged from predicates. |
  | Biocompatibility:
• Non-cytotoxic, non-sensitizing, non-irritating | Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance. Device has equivalent nature of body contact, duration, material formulation, and sterilization methods compared to predicates, thus no new issues raised. |
  | Sterilization:
• Sterility Assurance Level (SAL) of 10^-6
• Shelf Life Validation
• Pyrogenicity | Validated in accordance with ISO 11137-1:2006.
  Shelf life of 8 years for sterile devices, validated per ASTM F1980.
  LAL Endotoxin Analysis (testing limit 20 EU/device) meets pyrogen limit specifications. |
  | Dimensional Tolerance:
• Fixtures and Abutments | Stated tolerance of ± 1% range for dimensions. The dimensions of the subject device are stated to be "in range" or "similar" to the predicate devices and not to impact device performance. |

Detailed Information as Requested:

1. A table of acceptance criteria and the reported device performance: (See table above).

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 does not specify a "test set" in the context of a clinical study or human subject data. The samples for mechanical testing (dynamic fatigue, static strength) and biocompatibility are laboratory samples/implants, not patient data.
   • The document does not provide details on the number of samples used for these specific tests.
   • Data Provenance: The mechanical and surface characteristic data were leveraged from previous clearances (K153639, K171694, K082843, K150344, K171027), indicating prior existing test results. It is prospective testing for the elements that are different or new, but retrospective use of data for elements deemed identical to predicates. Country of origin for testing is not specified.

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 question is not applicable to a 510(k) submission based on mechanical and biocompatibility testing. There is no "ground truth" established by experts in the clinical sense for this type of submission. The "ground truth" for material properties and mechanical performance would be the universally accepted standards (ASTM, ISO) and the empirical results of the tests themselves, interpreted by qualified engineers/scientists.

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

   • Not applicable. This type of adjudication method is used in clinical trials or diagnostic accuracy studies involving expert panel reviews, which are not part of this 510(k) submission for mechanical equivalence.

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 pertains to AI/CAD devices, not dental implants. No MRMC study was conducted or relevant to this submission.

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

   • Not applicable. This pertains to AI/CAD devices, not dental implants.

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

   • For the mechanical and material aspects, the "ground truth" is defined by international standards (ISO, ASTM) and regulatory guidance (FDA Guidance Documents) for dental implants. The device components are compared against these established specifications and the validated characteristics of the predicate devices.
   • For biocompatibility, the ground truth is established by recognized biological evaluation standards (ISO 10993-1).

8. The sample size for the training set:

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

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

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

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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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The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

BEGO Semados® S-Line with TiPure"155 Surface is a dental implant system that can be placed subgingivally in both the upper and lower jaw using a one- or two-stage surgical procedure.

The provided text does not contain any information about acceptance criteria, device performance, specific studies with sample sizes, or expert adjudication for the BEGO Semados® S-Line.

The document is a 510(k) premarket notification summary, which primarily establishes substantial equivalence to a legally marketed predicate device (XIVE Dental Implant System® K032158) rather than detailing performance studies with specific metrics.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory approval based on equivalence and indications for use.

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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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The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system.

The provided text describes a 510(k) premarket notification for a line extension to the Array® Spinal System, a spinal fixation device.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify a "test set" in the context of clinical data or human subject studies. The performance testing was mechanical in nature. Therefore, information regarding sample size for a test set of patients and data provenance (country of origin, retrospective/prospective) is not applicable here as it appears to be a benchtop mechanical performance study.

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

This information is not applicable as the study described is mechanical performance testing comparing the new device to predicate devices, not a clinical study requiring expert ground truth for patient data.

4. Adjudication method for the test set

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

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

An MRMC study was not done. The study described is mechanical performance testing.

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

This concept is not applicable as the device is a spinal fixation system, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the mechanical performance testing would be the design specifications and performance characteristics of the predicate devices. The new device's performance was evaluated against these established benchmarks.

8. The sample size for the training set

The document does not refer to a "training set" in the context of machine learning or AI. For mechanical testing, the equivalent would be the number of components or assemblies tested, which is not specified in the provided text.

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

For mechanical testing, the "ground truth" (i.e., the acceptable performance levels) was established based on "requirements established in design specifications for its mechanical performance," which were "established based on those of the previously cleared predicate devices."

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