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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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IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

The IPL sapphire cooling hair remove device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

This document describes the safety and performance testing for the "IPL sapphire cooling hair remove device" (Model: LB06) by Shenzhen Desida Technology Co., Ltd. for its 510(k) submission (K221635). The testing primarily focuses on safety rather than clinical efficacy for hair removal, as the device is determined to be substantially equivalent to previously cleared predicate devices for its intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility Safety:
   - ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity	Passed
   - ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization	Passed
   Electrical Safety:
   - IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility	Passed
   - IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance	Passed
   - IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment	Passed
   - IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment	Passed
   Eye Safety:
   - IEC 62471 Photobiological safety of lamps and lamp systems	Passed
   Software Verification and Validation:	All software requirement specifications met; all software hazards mitigated to acceptable risk levels.

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not explicitly state the sample size for any clinical test set, as the performance data provided focuses on laboratory and engineering safety tests (biocompatibility, electrical safety, eye safety, and software validation). No clinical study on human subjects is detailed for the subject device to prove its hair removal efficacy, likely due to substantial equivalence to predicate devices already cleared for that indication. The tests mentioned are likely conducted in a lab environment in China, given the manufacturer's location. The provenance is internal company testing to meet international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable (N/A) for the types of tests described. These are standardized engineering and biological safety tests, typically evaluated against established international standards rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:
   N/A. The evaluation methods for these standards are defined within the standards themselves, not through an adjudication process among experts in the context of this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
   No MRMC comparative effectiveness study was done or reported in this document. The submission relies on substantial equivalence to predicate devices for its intended use, rather than a direct clinical comparative effectiveness study against human readers or other devices for improved performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
   A standalone software validation was done, demonstrating that "all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This is a standalone assessment of the device's software function, not a standalone clinical performance study.

7. The Type of Ground Truth Used:
   For the safety tests (biocompatibility, electrical, eye), the "ground truth" is defined by the specific requirements and pass/fail criteria outlined in the referenced international standards (e.g., ISO 10993-5, ISO 10993-10, IEC 60601 series, IEC 62471). For software, the ground truth is the "software requirement specifications." There is no clinical "ground truth" (like pathology or outcomes data) mentioned for hair removal efficacy for this specific device in this document, as it relies on substantial equivalence for that claim.

8. The Sample Size for the Training Set:
   N/A. As this document describes evaluation for substantial equivalence through safety and engineering tests, there is no mention of a "training set" in the context of machine learning or AI models for clinical outcomes. The device is an IPL hair removal device, not an AI diagnostic tool.

9. How the Ground Truth for the Training Set Was Established:
   N/A for the same reasons as #8.

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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

• 1.5mm to 3.5mm balloons: 24 atmospheres
• 3.75mm to 4.0mm balloons: 22 atmospheres
• 4.5mm to 5.0mm balloons: 20 atmospheres | All acceptance criteria met. |
  | Balloon Fatigue | Not explicitly stated, but implied to withstand repeated inflations/deflations. | All acceptance criteria met. |
  | Balloon Compliance | Not explicitly stated, but implied to maintain precise control of balloon diameter and length under high pressure. | All acceptance criteria met. |
  | Balloon Inflation and Deflation Time | Not explicitly stated, but implied to be within acceptable clinical limits. | All acceptance criteria met. |
  | Catheter Bond Strength | Not explicitly stated, but implied to ensure structural integrity. | All acceptance criteria met. |
  | Tip Pull Strength | Not explicitly stated, but implied to ensure secure attachment of the tip. | All acceptance criteria met. |
  | Flexibility and Kink | Not explicitly stated, but implied to allow for smooth navigation through coronary arteries without kinking. | All acceptance criteria met. |
  | Torque Strength | Not explicitly stated, but implied to allow for effective manipulation by the user. | All acceptance criteria met. |
  | Marker Band Radiopacity | Not explicitly stated, but implied to allow for clear visualization under fluoroscopy. | All acceptance criteria met. |
  | Coating Integrity | Not explicitly stated, but implied to ensure smooth passage and minimize friction. | All acceptance criteria met. |
  | Particulate Evaluation | Not explicitly stated, but implied to be below harmful levels. | All acceptance criteria met. |
  | Balloon Rated Burst Pressure (in-stent) | Not explicitly stated, but implied to perform as expected within a stent. | All acceptance criteria met. |
  | Balloon Fatigue (in-stent) | Not explicitly stated, but implied to maintain integrity within a stent. | All acceptance criteria met. |
  | Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity) | Per ISO 10993-1 standards for biological evaluation of medical devices. | All acceptance criteria met. |
  | Packaging and Sterilization Validation | Not explicitly stated, but implied to maintain sterility and device integrity throughout shelf life. | All acceptance criteria met. |
  | Shelf Life | Not explicitly stated, but implied to maintain device performance over a specified period. | All acceptance criteria met. |

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 gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for:

• · The preventive treatment of migraine headache in adolescent (aged 12 and older) and adult patients
• The acute treatment of pain associated with migraine headache in adolescents (aged 12 and older) and adult patients
• · Adjunctive use for the preventive treatment of cluster headache in adult patients
• · The acute treatment of pain associated with episodic cluster headache in adult patients
• · Treatment of hemicrania continua in adults
• · Treatment of paroxysmal hemicrania in adults

The gammaCore Sapphire (gammaCore) is a multi-use, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and -amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).

The gammaCore Sapphire:

• . Includes a charging station incorporated into the "clamshell" storage case connected to a power adapter for charging of the device as necessary by the end user.
• Provides visible (light and display) and audible (beep) feedback regarding device and stimulation . status.
• Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after . which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
• Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number . of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
• Indicates on the display the number of remaining doses available in a 24-hour period.

The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the health care provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her health care provider. The refill/reload RFID cards will be programmed by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy.

When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a health care provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The gammaCore RFID card-loading application uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication protocols.

The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with 1 to 6 additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "rd" and the "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload; upon completion of the device refill/reload, the card can be thrown away.

In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user; it is accessible only to the device manufacturer.

The subject device delivers the same energy and maintains the same operational characteristics as the gammaCore Sapphire device cleared in K203546. No changes in design or manufacturing process have been made that could affect device functionality. All functional aspects of the device remain the same as K203546, including the strength and nature of the device outputs.

The provided document is a 510(k) summary for the gammaCore Sapphire device, which is an external vagal nerve stimulator. It focuses on demonstrating substantial equivalence to a predicate device (gammaCore Sapphire, K203546) rather than detailing a study that proves the device meets specific acceptance criteria based on performance.

The submission is for an expanded labeling (additional indications for use), and the key argument for substantial equivalence is that the technology of the device itself is identical to the previously cleared predicate device. Therefore, no new performance testing or clinical studies were conducted to prove the device meets new acceptance criteria for its core technical performance. Instead, the "study" proving its acceptance is the demonstration that the expanded indications are supported by existing clinical data and that the device remains safe and effective for these new uses, given its proven performance characteristics.

Here's how to break down the information based on your request, focusing on the expanded indications rather than new hardware performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission based on substantial equivalence for expanded indications and not a new device with novel performance criteria, the "acceptance criteria" are implicitly tied to demonstrating that the device is as safe and effective as a legally marketed predicate for the new indications.

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

The "test set" in this context refers to the clinical data used to support the expanded indications, as no new hardware performance tests were conducted.

• Sample Size:
  • Hemicrania Continua: 19 patients across various clinical audits and case series/case reports.
  • Paroxysmal Hemicrania: 14 patients across various clinical audits and case series/case reports.
• Data Provenance: The document does not explicitly state the country of origin for the clinical audits and case series/reports. The references include publications in international journals (e.g., Cephalalgia, Headache, J Neurol Neurosurg Psychiatry, J Headache Pain, JAMA Neurol), suggesting a multi-national or at least broader clinical context. The data is presented as a combination of extrapolated data from randomized controlled trials (RCTs) (for cluster headache, DEN150048 and K182369) and retrospective clinical audits and case series/case reports.

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

• The document does not specify the number of experts or their qualifications involved in establishing the "ground truth" for the case series/audits. It refers to published literature (references 5-10) which would inherently involve clinical diagnoses made by medical professionals (neurologists, headache specialists). The diagnoses of hemicrania continua and paroxysmal hemicrania themselves serve as the "ground truth" for these conditions, and their treatment response to nVNS is observed.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical data from the case series/audits. These are real-world observational data and published case series, where patient outcomes are typically evaluated by the treating clinician(s) and potentially reviewed by the authors of the respective papers. The RCT data (for cluster headache) would have had their own internal adjudication processes, but these details are not provided here as the data is "extrapolated."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a direct treatment device, not an AI-assisted diagnostic tool for human readers. Therefore, this type of study is not applicable.

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

• This is a medical device for direct patient treatment, not a diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable. The device itself performs the function (nerve stimulation).

7. The Type of Ground Truth Used

• The ground truth for the expanded indications (hemicrania continua and paroxysmal hemicrania) is based on clinical diagnoses of these conditions and patient-reported (or clinician-observed) outcomes reflecting "clinically meaningful benefits" from nVNS therapy (e.g., decreases in pain severity, reductions in frequency/severity/duration of attacks). This is essentially outcomes data from real-world clinical experience and existing published literature.

8. The Sample Size for the Training Set

• This submission describes a medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable to this 510(k) submission. The device's design and functionality were established through prior development and clearance (K203546).

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

• As explained above, there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's original design and safety/effectiveness (as detailed in the predicate K203546) would have been established through a combination of engineering validation, non-clinical testing, and clinical studies for the original indications. The current submission simply leverages that established ground truth and applies it to new, similar indications based on existing clinical evidence.

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gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

• · The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
• · The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
• · Adjunctive use for the preventive treatment of cluster headache in adult patients.
• · The acute treatment of pain associated with episodic cluster headache in adult patients.

The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:

• . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
• Provides visible (light and display) and audible (beep) feedback regarding device and stimulation . status.
• . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
• . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
• Indicates on the display the number of remaining doses available in a 24-hour period. .

The provided text describes a 510(k) summary for the gammaCore Sapphire device, which is an external vagal nerve stimulator for headache. This submission seeks to expand the indications for use to include the adolescent population for the preventive and acute treatment of migraine headache.

Based on the information provided, here's a breakdown regarding acceptance criteria and supporting studies:

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

   The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) because this is a 510(k) submission for an expanded indication of an already cleared physical medical device, not a new AI/ML-driven diagnostic or prognostic device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and safety and effectiveness in the new population. The substantial equivalence comparison table (Table 1) acts as the primary "performance" comparison.

   Acceptance Criteria (Implied)	Reported Device Performance (Subject Device vs. Predicate)
   Intended Use	Same
   Indication for Use	Expanded to adolescents (age 12+) for preventive and acute migraine treatment. Supported by extrapolation from adult data and a small adolescent study.
   Rx vs OTC	No change (Prescription use)
   Treatment Protocol for Migraine (Acute & Preventive)	No change compared to adults (same 120-second stimulation cycle, number of stimulations, and daily schedule)
   Patient-Contacting Materials	No change (SS, ABS-PC, SignaGel electrode gel)
   Electrical Classification	No change (UL 60601-1 Class III Type BF Applied Part)
   Waveform/Frequency	No change (Sinusoidal wave, symmetrical biphasic 5000-Hz pulses at 25 Hz)
   Maximum Output	No change (30V, 60 mA peak)
   Load Impedance	No change (450-550 ohms)
   Power Supply	No change (3V LiFePo4 battery)
   Service Life	No change (3 Years from date of manufacture)
   Controls	No change (Control slide)
   Output Regulation	No change (Device software and control slide)
   Device Status Display	Differences in user interface that do not impact safety or effectiveness.
   Battery Charger	No change (Qi-compatible wireless charger in clam shell storage case)
   RFID Refill/Reload Capability	No change (Allows refilling/reloading)
   Device Diagnostics (Bluetooth)	No change (Provides diagnostics for manufacturer)
   Alarm Signals	No change (Start-up, Session complete, Errors/depleted battery, No doses left, Expired/no days left, Low battery, Reloading error, Card error)
   Display/Message	No change to core output display, minor user interface differences considered not to impact safety/effectiveness.

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

   For the expansion of indications to adolescents, the primary "test set" for safety and effectiveness relied heavily on:

   • Extrapolation from adult clinical data: This is clearly stated, meaning the adult data from prior studies (PRESTO, PREMIUM, EVENT) served as a large part of the basis.
   • Small adolescent study: "a small study was performed evaluating the use of gamma Core Sapphire in the acute treatment of migraine in adolescent population. As described in Grazzi et al¹, in nine (9) adolescents, 46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
   • Sample size for adolescent study: 9 adolescents.
   • Data provenance: The Grazzi et al. study is a published peer-reviewed paper (Neurol Sci. 2017 May). The document does not specify the country of origin for the Grazzi study, but typically these are international clinical trials. It is a prospective study as it evaluates the use in a group of adolescents.

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

   This information is not provided in the 510(k) summary. For a device like nVNS, the efficacy is typically self-reported by patients (e.g., pain reduction, headache freedom) and assessed by clinicians based on established diagnostic criteria for migraine. The Grazzi et al. paper would contain specifics on patient selection and outcome assessment, but that detail is not within this 510(k) summary. Given it's a treatment device, "ground truth" would be clinical outcomes (e.g., headache resolution) rather than an expert-adjudicated label on an image.

4. Adjudication method for the test set

   Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are common in image-based AI studies where expert consensus is needed to establish a definitive diagnosis for a test image. Here, clinical outcomes are measured after device use.

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 MRMC comparative effectiveness study was done, as this is not an AI-assisted diagnostic device. It is a physical neuromodulation device. Therefore, no information on human reader improvement with AI assistance is applicable or provided.

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

   Not applicable. The gammaCore Sapphire is a physical device that delivers therapy and is used by a human patient. It does not operate as a standalone algorithm or AI.

7. The type of ground truth used

   The ground truth for the effectiveness of the device in the expanded indication (adolescents) is based on:

   • Clinical Outcomes Data: Self-reported pain relief and resolution of migraine symptoms, as well as the absence of requiring rescue medication. The Grazzi et al. study reported "46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
   • Adult Clinical Trial Results: The prior 510(k)s (K173442, K191830) relied on outcomes from multi-center, randomized, double-blind, sham-controlled clinical studies (PRESTO, PREMIUM, EVENT) for adults.

8. The sample size for the training set

   Not explicitly applicable in the context of this device because it's not an AI/ML algorithm that is "trained" on data in the traditional sense. The device's technological characteristics are fixed. The clinical studies (PRESTO, PREMIUM, EVENT, and the Grazzi et al. study) provide the evidence base that informed the safety and effectiveness, rather than a "training set" for an algorithm. The total sample sizes for these studies are not fully detailed in this 510(k) summary but would be found in the referenced prior 510(k) documents and publications. The adult studies would have had considerably larger sample sizes than the 9 adolescents mentioned.

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

   Again, "training set" and "ground truth" establishment in the AI/ML sense are not directly applicable. The "ground truth" for the effectiveness shown in the supporting clinical studies (for both adults and adolescents) was established through clinical trial methodology:

   • Randomized, double-blind, sham-controlled study designs comparing the device to a sham control.
   • Measurement of defined clinical endpoints, such as pain reduction, headache freedom, and reduction in headache frequency.
   • Reporting of adverse events to assess safety.

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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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