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The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:

· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.

· In-stent restenosis.

· Post-delivery expansion of balloon expandable coronary stents.

The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire NC ULTRA Coronary Dilatation Catheter. It outlines various performance tests conducted to establish substantial equivalence to a predicate device. However, it does not contain the specific level of detail required to fully answer all aspects of your request, particularly regarding clinical study design, expert qualifications, or detailed performance metrics against acceptance criteria.

Here's an attempt to answer your questions based on the available information:

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

The document states: "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use."

While it lists the types of tests performed, it does not provide a table with specific acceptance criteria or quantitative performance results for each test. For example, it lists "Balloon Rated Burst Pressure (in-stent)" as a test, but doesn't state what the accepted pressure was or what the device achieved.

Here's a generalized table based on the types of tests mentioned, but without specific numerical criteria or performance data:

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 describes in vitro performance tests and biocompatibility tests. This means the "test set" refers to material samples (e.g., catheter units, material extracts) used for these laboratory tests, not a clinical patient dataset.

• Sample Size: The document does not specify the sample size for the in vitro or biocompatibility tests.
• Data Provenance: Not applicable in the context of in vitro and biocompatibility testing. These are laboratory tests conducted on device components or finished products.

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 geared towards clinical studies involving human interpretation or pathology. Since the provided text only details in vitro and biocompatibility testing, there is no information about experts or their qualifications for establishing ground truth as would be required in a clinical setting. These tests typically follow standardized protocols and are evaluated by lab personnel, not medical experts establishing clinical ground truth.

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

Again, this question is relevant for clinical studies with human assessors. For the in vitro and biocompatibility testing described, adjudication methods like N+1 are not applicable. The results are typically quantitative measurements or observations against predefined pass/fail criteria according to established standards (e.g., ISO, FDA guidance).

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 does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an angioplasty catheter, not an AI software or a device that assists human readers in interpreting images. Therefore, this question is not applicable to the information provided.

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

This question is also not applicable. The Sapphire NC ULTRA Coronary Dilatation Catheter is a physical medical device, not an algorithm or software requiring standalone performance testing in that context.

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

For the in vitro performance tests, the "ground truth" is established by adherence to predefined engineering specifications, material properties, and performance benchmarks derived from industry standards (e.g., those in the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").

For biocompatibility testing, the "ground truth" is established by compliance with international standards like ISO 10993-1, which define acceptable biological responses and safety profiles for medical device materials.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical medical catheter and the testing described is primarily in vitro and biocompatibility, there is no concept of a "training set" in this context.

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

As there is no training set for a physical medical device, this question is not applicable.

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The Sapphire ULTRA Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion.

The Sapphire ULTRA Coronary Dilatation Catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in . patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

The Sapphire ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.0mm to 4.0mm. The balloon material is made of the semi-compliant material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube and an inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for Ø1.0-1.5mm configurations). The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm length each, located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire ULTRA Coronary Dilatation Catheter. It outlines the device's description, indications for use, technological characteristics, and performance tests conducted to demonstrate substantial equivalence to predicate devices.

However, the provided document DOES NOT contain information regarding:

• Acceptance criteria for an AI/ML device. This document describes a medical device (a catheter), not an AI/ML diagnostic or prognostic tool. Therefore, there are no AI/ML specific acceptance criteria, study designs (like MRMC), or details about ground truth establishment as would be typically required for such devices.
• Study that proves the device meets AI/ML acceptance criteria. The performance tests listed are for the physical properties and biocompatibility of a medical catheter, not for the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and proof of performance. The document focuses on the physical and biological safety and efficacy of a coronary dilatation catheter, which is a hardware medical device.

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The Sapphire X3 Anterior Cervical Plate System is intended fixation (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:

· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Trauma (including fracture or dislocation)
• · Spinal stenosis
• · Deformities or Curvatures (kyphosis, lordosis or scoliosis)
• Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The purpose of this submission is to seek clearance for additional implant sizes in the Sapphire X3 Anterior Cervical Plate System. The Spinal Elements' Sapphire X3 Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X3 plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameter allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This document, K231593, describes the 510(k) premarket notification for the "Sapphire X3 Anterior Cervical Plate System". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or AI/ML-driven performance.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's decision to clear the device for market.
• Device Description: Details about the physical components, materials, and design of the Sapphire X3 Anterior Cervical Plate System (plates and screws for spinal fixation).
• Indications for Use: The medical conditions for which the device is intended (e.g., Degenerative Disc Disease, Trauma, Spinal Stenosis).
• Predicate Devices: Identifying previously cleared devices that are similar and establish substantial equivalence.
• Performance Data (Mechanical Testing): Mentioning that mechanical performance testing (static compression bending, static torsion, dynamic compression bending) was performed according to ASTM F1717, which is a standard for spinal implant constructs.

There is no mention of any AI/ML component, software performance, or a study involving human readers or ground truth for diagnostic purposes. The device is a physical spinal implant system, not a diagnostic AI tool.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided document. The questions posed are relevant for AI/ML medical devices, which this product is not.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.

The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

The provided document is a 510(k) summary for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, detailing their substantial equivalence to a predicate device. It includes information on acceptance criteria and performance for various tests relevant to examination gloves, particularly concerning permeation by chemotherapy drugs and fentanyl.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Summary of Nonclinical Testing" table. This section outlines the tests performed, their purpose, acceptance criteria, and the results for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves.

Detailed Chemotherapy Drug Permeation Results (from "Indications for Use" section):

Note on Cytotoxicity: The device failed the cytotoxicity test ("Fail – Under the conditions of the study, the subject device is cytotoxic."). However, the conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device." The comparative table indicates the predicate device was also "cytotoxic," suggesting this is an anticipated characteristic for this type of nitrile glove and not a disqualifying factor for substantial equivalence in this context.

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

The document specifies the tests conducted according to various ASTM and ISO standards for medical gloves. While the standards imply established testing methodologies and sample sizes (e.g., AQL 2.5 for hole detection typically involves specific sample sizes), the exact numerical sample sizes used for each specific test (e.g., for biocompatibility, physical properties, or permeation tests) are not explicitly stated in this summary.

Data provenance: The tests were conducted according to internationally recognized standards (ASTM, ISO). The document does not specify the country of origin of the data collectors or if the data was retrospective or prospective. It is implied to be prospective testing carried out for the device's clearance.

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

This section is not applicable to this document. The "ground truth" for medical gloves like these is established through standardized laboratory testing procedures (e.g., ASTM D6978-05 for permeation, ASTM D6319-19 for physical dimensions, ISO 10993 series for biocompatibility). There are no human "experts" establishing a "ground truth" for classification or diagnosis in the way one would for an AI CAD system for medical imaging. The performance is measured against objective, measurable criteria defined by the standards.

4. Adjudication method for the test set

This concept is not applicable as the "test set" involves objective performance testing against established standards, not subjective expert reviews or diagnostic interpretations.

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 concept is not applicable as the device is a medical glove, not an AI-assisted diagnostic tool requiring human reader studies.

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 medical glove, not an AI algorithm. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used

The "ground truth" for the performance claims of these gloves is based on standardized laboratory test results defined by the relevant ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These include:

• Physical measurements (e.g., length, width, thickness).
• Mechanical properties (e.g., tensile strength, elongation).
• Barrier integrity (e.g., freedom from holes).
• Chemical resistance (e.g., breakthrough time for drugs).
• Biocompatibility (e.g., irritation, sensitization, cytotoxicity, systemic toxicity).

8. The sample size for the training set

This concept is not applicable as the device is a medical glove, not a machine learning model that requires a training set.

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

This concept is not applicable as the device is a medical glove, not a machine learning model.

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The Sapphire NC 24 Coronary Dilatation Catheter is indicated for:

• · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
• · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• · in-stent restenosis
• · post-delivery expansion of balloon expandable coronary stents

The Sapphire NC 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marker sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The Sapphire NC 24 Coronary Dilatation Catheter demonstrated substantial equivalence to its predicate devices through various performance tests. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual performance test. The tests were conducted on the "subject device," implying representative samples of the Sapphire NC 24 Coronary Dilatation Catheter.

The data provenance is not specified, but given that OrbusNeich Medical (Shenzhen) Co., Ltd is located in China, it is highly probable that the testing was conducted in laboratories within China. The study appears to be retrospective in the sense that these tests were performed on finished devices to demonstrate their compliance with pre-defined standards.

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

This information is not applicable to this type of device and study. The testing described is primarily physical, chemical, and biological performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria for these tests are typically based on engineering standards, regulatory guidelines (like FDA guidance and ISO standards), and internal design specifications, not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective performance testing against predefined criteria, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision support AI), but not for a physical medical device like a coronary dilatation catheter.

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

No, a standalone algorithm performance study was not done. This study is focused on the physical and biological performance of a medical catheter, not an algorithm.

7. The type of Ground Truth Used

The "ground truth" for this study is established through:

• Engineering and Design Specifications: The device is designed to meet specific physical dimensions, pressures, and other performance characteristics.
• Regulatory Guidance: Adherence to FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters") dictates many of the required performance tests and implied acceptance criteria.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) provides the framework and acceptance criteria for biological safety.
• Predicate Device Performance: The subject device's performance is compared against the known performance characteristics of the predicate device (Sapphire NC Plus Coronary Dilatation Catheter) and reference device (Sapphire II Pro Coronary Dilatation Catheter) to establish substantial equivalence.

8. The Sample Size for the Training Set

There is no training set for this study. This is not a machine learning or AI-driven device. The term "training set" is not applicable to the performance testing of a physical medical device.

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

As there is no training set, this question is not applicable.

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The Sapphire Infusion pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products.

The Sapphire Infusion pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

It is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home. The pump is intended to be used by both licensed health care professionals and by lay users.

The Sapphire and the administration sets are indicated for use by both adult and pediatric populations.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The SapphireInfusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals and lay users. The pump is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home use.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

Sapphire Infusion Pump accessories include the mini cradle with IPS, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

Updates included in this submission:

• 1. Addition of a new administration route Perineural Adding an administration route, Perineural, to the indications for use of the device. This update did not require any modification to the pump technology or design.
• 2. Additional updates (catchup changes) that did not change the basic functionality or technological characteristics of the pump or the administration sets
  • . Software (SW) - e.g., minor enhancements, back to spec corrections, cybersecurity enhancements including implementation of digital code signing, reorganization of alarm priorities and audio and visual alarm characteristics, addition of low battery alarm at 10 minutes, addition of air-in-line alarm off option.
  • Pump cradle (accessory) added ●
  • Administration sets, including sets with NRFit connectors. ●

This document is a 510(k) Summary for the Sapphire Infusion Pump and Sapphire administration sets. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

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

The document details various technological characteristics and their performance parameters, comparing the subject device to the predicate device. For many characteristics, the performance is stated as "Same," indicating it meets the established performance of the predicate. Where there are updates or new features, the testing confirms that safety and effectiveness are maintained.

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 sample sizes or data provenance for the individual bench tests or performance testing. It states that "Accuracy testing under anticipated environments of use and routes" was performed, and administration sets performance testing was done per ISO 80369-6:2016, but without details on sample size. Similarly, human factors studies were conducted with the "intended user population, use environment and use scenarios," but specific numbers are not provided. The testing is bench testing and human factors testing, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as the document discusses testing of a medical device (infusion pump and administration sets) for performance and safety characteristics, not a diagnostic algorithm where expert ground truth is typically required for image or data interpretation. The ground truth for performance testing is established by engineering specifications, regulatory standards (e.g., IEC, ISO), and risk analysis.

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

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among experts for establishing ground truth in diagnostic studies, which is not relevant to the performance and safety testing described for an infusion pump.

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 section is Not Applicable. The document describes a medical device (infusion pump) and its administration sets, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies or human reader improvement with AI are not relevant here.

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

This section is Not Applicable. The product is a physical device (infusion pump) with embedded software, not a standalone algorithm without human interaction. Performance testing was done on the device itself and its accessories.

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

The ground truth for the performance and safety testing of the Sapphire Infusion Pump and administration sets is based on several factors:

• Regulatory Standards: Compliance with established international standards such as IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarms), IEC 62133-2 (Battery Safety), ISO 10993-11 (Biocompatibility), ISO 80369-6 (Administration sets performance, specifically for NRFit connectors), ASTM F2503-13 (MR Safety).
• FDA Guidance Documents: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Infusion Pumps Total Product Life Cycle, Applying Human Factors and Usability Engineering to Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Reprocessing Medical Devices in Health Care Settings.
• Predicate Device Performance: The primary ground truth for many characteristics is the established safety and effectiveness of the previously cleared Sapphire Infusion Pump (K161667) and administration sets (K141389, K123049). The subject device demonstrates "Same" performance for a majority of parameters.
• Risk Analysis and Verification/Validation: For any new features or modifications (e.g., perineural route, 10-minute low battery alarm, option to disable air detection, mini cradle with IPS, NRFit connectors, sleeve removal, length/priming volume changes), the ground truth is established through internal risk analyses and subsequent verification and validation testing to confirm they do not introduce new questions of safety or effectiveness and meet their design requirements.

8. The sample size for the training set

This section is Not Applicable. The Sapphire Infusion Pump is a hardware device with controlling software, not an AI/ML model that undergoes a training phase with a specific dataset.

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

This section is Not Applicable for the same reasons as point 8.

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The Sapphire® Spinal System is intended for anterior (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

The Sapphire X Anterior Cervical Plate Spinal System is intended for anterior cervical fixation (C2-T1) in skettally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

Elements' Spinal System System and System and Sapphire Sapphire S X S Anterior Spinal Cervical Plate Spinal System are comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X Anterior Cervical Plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate. The same screws will be used for both the Sapphire® and Sapphire X Anterior Cervical Plate Systems.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameters allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This is a premarket notification for the Sapphire® Spinal System and Sapphire X Anterior Cervical Plate Spinal System. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results or acceptance criteria based on performance metrics like sensitivity, specificity, or F1-score for AI/ML devices.

Therefore, many of the requested fields cannot be answered directly from this document as they are not relevant to a 510(k) for a spinal fixation system. This document specifically covers mechanical performance testing, not AI/ML algorithm performance.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not applicable or not provided:

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

For a spinal fixation system, "acceptance criteria" are typically defined by recognized standards for mechanical testing to ensure the device's structural integrity and functionality. The document references ASTM F1717, which sets standards for such tests. The "reported device performance" is a qualitative statement of compliance.

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

This information is not provided in the document. For mechanical testing, sample size would refer to the number of devices tested. Data provenance is not typically specified in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a spinal fixation system undergoing mechanical performance testing, not an AI/ML diagnostic tool requiring expert-established ground truth.

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

This is not applicable as the device is a spinal fixation system undergoing mechanical performance testing.

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 is not applicable as the device is a spinal fixation system, not an AI-assisted diagnostic tool.

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

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

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

This is not applicable. For mechanical testing, the "ground truth" is adherence to the specified engineering standards and successful completion of the tests without failure.

8. The sample size for the training set

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm that requires a training set.

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

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

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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for:
• balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion
The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for:
• percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.

However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.

Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.

Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:

• Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:

  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Catheter Bond Strength
  • Tip Pull Strength
  • Radiopacity
  • Coating Integrity
  • Dimensional Verification
  • Shaft Burst
  • Balloon Inflation and Deflation Time
  • Flexibility and Kinking
  • Torque Strength
  • Particulate Evaluation
  • Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
  • Sterilization
  • Visual Inspection
  • Balloon Preparation, Deployment, and Retraction

• Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.

Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.

Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:

Table of Acceptance Criteria and Reported Device Performance:

(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)

Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):

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

   • Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
   • Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.

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

   • Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.

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

   • N/A. This refers to adjudication in human reader studies for diagnostic accuracy.

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:

   • N/A. This device is a physical balloon catheter, not an AI-assisted diagnostic tool.

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

   • N/A. This is a physical device, not an algorithm.

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

   • For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.

7. The sample size for the training set:

   • N/A. This device is not an AI model requiring a training set.

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

   • N/A. No training set is used for this type of device.

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The Sapphire NC Plus Coronary Dilatation Catheter is indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion

• · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• · in-stent restenosis
  · post-delivery expansion of balloon expandable coronary stents

The Sapphire NC Plus coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0- 5.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F (6F for Ø4.5-5.0mm) or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. This Special 510(k) describes the addition of the Ø4.5- 5.0mm balloon configurations to the Sapphire NC Plus PTCA catheter family.

The provided text is a 510(k) Summary for a medical device, the "Sapphire NC Plus Coronary Dilatation Catheter." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device for regulatory clearance. It does not describe an AI/ML-based medical device.

Therefore, the information requested in the prompt, which pertains to AI/ML device validation (e.g., acceptance criteria for diagnostic accuracy, sample sizes for AI model training/testing, expert adjudication, MRMC studies, ground truth establishment methods), is not present in the provided text.

The document discusses performance data related to the physical properties and functionality of the balloon catheter, such as:

• Shelf-Life Performance Testing
• Visual Inspection
• Dimension Inspection
• Balloon Preparation, Deployment, and Retraction
• Balloon Rated Burst Pressure
• Balloon Fatigue
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Tip Pull Strength
• Particulate Evaluation
• Balloon Rated Burst Pressure (within stent)
• Balloon Fatigue (within stent)

The "Performance Data" section states, "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a table of these acceptance criteria or the specific numerical results. It only generically states that testing was performed and met criteria.

To answer your request, here's what can be extracted based on the provided text, and what cannot:

What Can Be Inferred/Stated from the Text (within the context of a physical medical device, not AI):

• Acceptance Criteria and Reported Device Performance: The document states that "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a specific table of these criteria or the numerical performance results of the catheter (e.g., specific burst pressure values, inflation times, etc.). These would typically be detailed in a separate test report referenced by the 510(k) but not included in this summary.
• Sample sizes used for the test set and the data provenance: Not explicitly stated. The tests are for the physical device properties and would involve a sample of manufactured catheters. The provenance would be the manufacturing site.
• Training/Test Set Information (for AI): Not applicable, as this is a physical medical device, not an AI/ML diagnostic.
• Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a physical device is established through engineering and scientific testing standards.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: The performance data listed (e.g., burst pressure, fatigue) represent the standalone performance of the device itself. No human interaction for "reading" or "interpreting" is involved in these specific tests.
• Type of ground truth used: Engineering specifications, material properties, and established test standards for medical devices (e.g., ISO standards, ASTM standards).
• Sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (coronary dilatation catheter) and does not contain the information requested about AI/ML device acceptance criteria or validation studies.

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The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The provided text describes a 510(k) premarket notification for the Sapphire Dorsal Comfort Fit Appliance. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, and adjudication methods for evaluating an AI-powered device is largely not applicable in this context.

Here's an breakdown based on the information available:

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

This document does not establish new acceptance criteria as it's a 510(k) submission seeking substantial equivalence. The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, showing that the new device is as safe and effective as existing ones.

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

• Sample Size: Not applicable. No clinical test set involving human patients was used for performance evaluation in the context of an "AI software" or "diagnostic" device. The testing described is for material properties and device integrity.
• Data Provenance: Not applicable. The testing was conducted on material samples and a prototype device "assembly."

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

Not applicable. No expert review for ground truth was established as this is not an AI/diagnostic device.

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

Not applicable.

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 diagnostic device.

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

Not applicable. This is a physical medical device (intraoral appliance), not an algorithm or software.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established by demonstrating its material properties, design features, and intended use are substantially equivalent to already cleared predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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