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The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

The provided document is an FDA 510(k) clearance letter for a medical device: "U Deliver Bolink ENFit Enteral Feeding Sets." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the document does not contain any information about an AI/ML-driven medical device. Specifically, it does not describe:

• An AI algorithm or its performance.
• Acceptance criteria for an AI model.
• A study that proves an AI device meets acceptance criteria, including details on sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details.

The "Performance Data" section explicitly states: "No new device testing was necessary as no changes have been been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use." This confirms that the critical study mentioned was a usability test for a physical device, not an AI performance study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI device based on this document.

The document pertains to the clearance of a physical medical device (enteral feeding sets) and its change in indications for use from prescription-only to over-the-counter, based on usability testing and substantial equivalence to a cleared predicate device.

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ANAX™ OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal Sytem and ANAX™ 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

The ANAX™ OCT Spinal System is manufactured by U&I corporation. The ANAX™ OCT Spinal System is for fixation the cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse (cross) links and occipital plate. Connectors are also provided for surgical convenience. The ANAX™ OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The single-use ANAXTM OCT Spinal System components are supplied as nonsterile and are fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAXTM OCT Spinal System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAXTM OCT Spinal System implants.

The provided text describes the ANAX™ OCT Spinal System, a spinal fusion device, and its 510(k) submission for substantial equivalence. The document does not contain information about a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it focuses on the substantial equivalence of the ANAX™ OCT Spinal System to a predicate device, based on mechanical performance and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/Machine Learning device, as this information is not present in the provided text.

The text explicitly states:
"Any mechanical test in non clinical setting (bench testing) was not conducted on the ANAX™ OCT Spinal System. However, the mechanical strength evaluation was conducted to compare data of proposed device of the ANAX™ OCT Spinal System(K150570) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The data met all acceptance criteria and that verifies performance of the ANAXIM OCT Spinal System is substantially equivalent to predicate devices."

This indicates that the "study" proving the device meets acceptance criteria was a comparison to existing data from the predicate device (ANAX™ OCT Spinal System K150570) regarding mechanical strength, rather than a de novo study with a new dataset for performance evaluation. The acceptance criteria themselves are simply that its mechanical performance "met the acceptance criteria which have been established from the predicate devices" and that its performance "is substantially equivalent to predicate devices." No specific numerical or qualitative acceptance criteria are provided in the text.

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SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications.

• Shoulder:
  Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair.

• Foot/Ankle:
  Medial or lateral stabilization, Achilles tendon repair.

• Elbow/Wrist/Hand:
  Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment.

• Knee:
  Extra-capsular repairs: Medial/lateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis Patellar realignment and tendon repairs : Vastus medialis obliquous advancement

The SECULOK™ Suture Anchor consists of two types, Suture Anchor and Knotless Anchor.

The Suture Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (ASTM F2026) and works with preloaded 1 ~ 3 USP#2 size sutures (Ultra High Molecular Weight Polyethylene(UHMWPE, ASTM F2848)). The Suture Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The Knotless Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (implant body) and Titanium alloy (tip, ASTM F136) and fixate the USP #2 sutures without knotting. The Knotless Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The SECULOK™ Suture Anchor comes preloaded on a disposable inserter made from surgical grade stainless steel and ABS plastic. The entire product is packaged in a box with a Tyvek® lid, and blister the finished product is sterilized by ethylene oxide. Both the implant, suture and inserter are designed for single use only and supplied non-pyrogenic.

Based on the provided text, the document describes a 510(k) premarket notification for the SECULOK™ Suture Anchor, demonstrating its substantial equivalence to predicate devices through performance testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria for performance testing were developed using data from the primary predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The reported device performance is that "The all tests met all acceptance criteria and that verifies performance of the SECULOK™ Suture Anchor is substantially equivalent to predicate devices."

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

The document refers to "non clinical setting (bench testing)" for performance testing. It does not explicitly state the sample size used for each specific test or the "test set" in terms of data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full test reports that support the 510(k) submission, but it's not present in this summary.

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 type of submission. The performance testing described is bench testing of the physical device's mechanical properties, not a clinical study involving human or animal subjects where expert ground truth would be established for diagnoses or assessments. The "ground truth" for these tests is based on established engineering standards (ASTM, USP) and mechanical properties of predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable. Since the testing is bench testing of mechanical properties, no adjudication by human experts is involved. The results are quantitative measurements against defined criteria.

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 SECULOK™ Suture Anchor is a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This section is not applicable. As explained above, the SECULOK™ Suture Anchor is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• Established engineering standards: ASTM F543-17 for torsional properties and driving torque, USP 29 <881> for suture tensile strength.
• FDA guidance documents: Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017) for axial pullout strength and fatigue tests.
• Mechanical performance data of legally marketed predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The acceptance criteria were specifically "developed using the data of the primary predicate."

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" in the context of this device and the described performance testing. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.

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 U Deliver Bolink ENFit Enteral Feeding Sets are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. . BK-1085)
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) .
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO/DIS 18250-3. 'Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

This document is a 510(k) premarket notification for the U Deliver Bolink ENFit Enteral Feeding Sets, establishing substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with human subjects or medical imaging analysis.

Instead, the document focuses on bench testing to demonstrate physical and functional equivalence of the U Deliver Bolink ENFit Enteral Feeding Sets to the predicate device and compliance with recognized standards.

Here's an analysis of the information provided, addressing the requested points where applicable, and noting where the information is not present in this type of submission:

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

The document does not provide a formal table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it lists the types of bench tests conducted, implying that the acceptance criteria for these tests are met by conforming to recognized standards (ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, ISO 10993) or by demonstrating equivalence to the predicate device.

Bench Tests Performed (Implied performance met as per standards/equivalence):

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each bench test. It generally states that "Bench tests have been carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets."
• Data Provenance: The document implies that the testing was performed by or for the manufacturer (Cedic S.r.l., Italy, a contract manufacturer). The submission itself is from U Deliver Medical, LLC (USA). The testing is prospective (conducted specifically for this submission).

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

This question is not applicable to this type of device and submission. This is a medical device for delivering nutritional formulas, not an imaging or diagnostic device that requires expert interpretation to establish a 'ground truth'. The "ground truth" here is compliance with technical standards and functional performance metrics, verified through engineering bench tests.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions. This submission relies on objective engineering measurements and compliance with recognized standards.

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 a software device, an AI-powered diagnostic tool, or a device that involves "human readers." It's a physical enteral feeding set.

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

Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

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

The "ground truth" for this device is established by:

• Technical Standards: Compliance with FDA-recognized international standards such as ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, and ISO 10993. These standards define the required physical dimensions, mechanical properties, and biocompatibility.
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly to or better than the legally marketed predicate device (Metrixcare Enteral Feeding Sets, K132424) in relevant functional aspects (e.g., flow rate).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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The U&U Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The U&U Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap, Spike, Drip chamber, Back check valve, Pinch clamp, Slide clamp, Stopcock, Micron filter, Needleless Y-site, Male luer lock, Luer lock cap.

This document is a 510(k) premarket notification for a medical device called the "U&U Intravascular Administration Set." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Zyno Medical Administration Set" (K120685). The information provided focuses on the non-clinical testing performed.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document provides a table comparing the technological characteristics of the submission device (U&U Intravascular Administration Set) and the predicate device (Zyno Medical Administration Set). It also includes a summary of non-clinical test results for the submission device, which effectively acts as a table of acceptance criteria and reported performance.

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

The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific sample sizes used for each test (e.g., for particulate contamination, leakage, flow rate, tensile strength) are not detailed in this document.

The data provenance is from non-clinical bench testing performed by U&U Medical Technology Co., Ltd. and its contract manufacturer. The document doesn't specify the country of origin of the raw data, but the submitting company is based in China, and the contract manufacturer is also in China. The data is prospective as it involves tests conducted on the newly manufactured U&U Intravascular Administration Set.

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

This is not applicable as this study is not evaluating a diagnostic algorithm or a clinical scenario requiring expert interpretation to establish "ground truth." The "ground truth" here is objective physical and chemical properties measured against established engineering standards and specifications.

4. Adjudication method for the test set:

This is not applicable for the same reason as point 3. The testing involves objective measurements rather than subjective assessments 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:

This is not applicable. This document is for a physical medical device (intravascular administration set), not an AI-powered diagnostic tool, and therefore no MRMC study was performed.

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

This is not applicable as there is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is established by objective engineering standards and specifications, specifically those outlined in ISO 8536-4 (Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed), as well as general expectations for such devices (e.g., "No Leakage," "Normal" principle of operation). The predicate device's characteristics also serve as a benchmark for substantial equivalence.

8. The sample size for the training set:

This is not applicable as this is a physical medical device and does not involve machine learning algorithms requiring a training set.

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

This is not applicable for the same reason as point 8.

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Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.

This document is a 510(k) premarket notification for the Benefix™ Interspinous Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for acceptance criteria based on diagnostic accuracy or clinical outcomes.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study design are not applicable to this document. The "acceptance criteria" here refer to "performance criteria" derived from bench testing to demonstrate mechanical equivalence to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but the tests were performed "in a non-clinical setting (bench testing)." This implies a sufficient number of devices were tested to statistically support the conclusions of substantial equivalence to the predicate.
• Data Provenance: The data is from bench testing conducted by U & I Corporation. The country of origin of the data is not specified beyond the manufacturer's location in South Korea. It is prospective data for the device, as it was generated specifically for this submission.

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

• Not applicable. This device is a physical implant, not an AI/algorithm. Ground truth in this context would refer to mechanical properties and performance, not expert-derived labels from medical images or clinical observations. The "ground truth" for the bench tests are the established standards and expected mechanical properties, determined through engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As this is bench testing for mechanical properties, there is no need for human expert adjudication of results in the traditional sense. The 'adjudication' is based on whether the measured mechanical properties meet the engineering specifications and are comparable to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This document describes a medical device (spinal fixation system), not an AI algorithm. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant here.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance testing is mechanical performance data measured through standardized bench tests (modified ASTM F1717, spike pull-off, locking mechanism strength). The targets for this "ground truth" are derived from the established performance characteristics and safety profiles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. As there is no training set for an AI algorithm, this question is irrelevant.

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The L'DISQ® is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs.

The L'DISQ® is a plasma electrode which is 1.0 mm(PD01, PD02, PD03, PD04, PD05, PD07 and PC01) or 0.7 mm(PC02) thickness based on the high frequency electrosurgical system. L'DISQ® removes the disc lesions that are causing pain by a plasma based radiofrequency device. L'DISQ® is a single use device and there are 3-type of designs (L'DISQ, L'DISQ C, L'DISQ C.7) according to the level of spine treated.

The provided document describes the L’DISQ® electrosurgical device for treating herniated discs and its substantial equivalence to the predicate device, Perc™DC/DLR SpineWand™ (ArthroCare). The study focuses on performance testing to support this claim.

Here's an analysis of the requested information based on the provided text:

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

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

• Sample Size: Not specified. The document only states "we conducted following tests" without providing details on the number of samples or devices tested for either the removal or durability tests.
• Data Provenance: Not specified. The country of origin of the data (where the tests were conducted) is not mentioned, nor is whether the study was retrospective or prospective.

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

• This information is not applicable as the studies described are performance tests (e.g., removal, durability) for an electrosurgical device, not diagnostic studies that require expert interpretation or ground truth establishment by medical professionals.

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

• This information is not applicable as the studies described are performance tests, not diagnostic studies requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

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

• This information is not applicable. The L'DISQ® is a physical medical device, not a standalone algorithm. Its performance is inherent to its design and function, not an algorithm that can operate without human interaction.

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

• For the "Removal test for nucleus pulposus" and "Durability test for electrode," the ground truth would be based on objective physical measurements or predefined criteria for effective tissue removal and electrode integrity after use, respectively. The document does not specify the exact metrics or methods used to establish this "ground truth" (e.g., amount of tissue removed, structural integrity checks).

8. The sample size for the training set

• This information is not applicable. The L'DISQ® is a physical electrosurgical device, not a machine learning model, so there is no "training set."

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

• This information is not applicable as there is no training set for this type of device.

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The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis .
• Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
• Pelvic obliquity ●
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.

The U&I Corporation's Perfix™ Iliac Screw System underwent non-clinical (bench) testing to demonstrate its performance and establish substantial equivalence to predicate devices. The study aimed to show that the device met established acceptance criteria, indicating no new safety or efficiency issues compared to existing, legally marketed spinal fixation systems.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the mechanical performance of the Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices. However, the exact numerical acceptance criteria for each test and the specific reported performance values for the Perfix™ system are not detailed in the provided text. The document generally confirms that the tests were performed and the device met the criteria.

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

• Sample Size: The document does not specify the exact number of devices or constructs tested for the "test set" in the performance testing.
• Data Provenance: The study was a non-clinical setting (bench testing). Data provenance is not geographical in this context, but rather refers to the type of experimental setup. It is retrospective in the sense that the acceptance criteria were established from existing predicate devices.

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

This question is not applicable to this study. The "ground truth" for this type of mechanical performance testing is defined by established engineering standards (ASTM F1717) and the performance of predicate devices, not by expert medical opinion on individual cases.

4. Adjudication Method for the Test Set

This question is not applicable to this study. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple observers. This study involved mechanical testing against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the mechanical performance of a medical device, not on the interpretative performance of human readers, with or without AI assistance.

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

N/A. This device is a physical spinal implant system, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The performance testing was for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

• Established industry standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
• Performance of predicate devices: The Perfix™ Iliac Screw System was compared directly against the mechanical performance of the Synergy™ Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096), and Global Spinal Fixation System™ (K001668). The acceptance criteria were derived from these predicate devices.

8. The Sample Size for the Training Set

This question is not applicable to this study. There is no concept of a "training set" in a mechanical bench testing study for a physical device.

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

This question is not applicable as there was no training set.

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The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological . impairment
• Trauma (i.e., fracture or dislocation) .
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
• Tumor .
• Pseudoarthrosis
• Failed previous fusion

The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobait-chromium-molybdenum alloy (ASTM F1537).

The provided text describes a medical device, the ANAX™ 5.5 Spinal System, and its substantial equivalence to predicate devices, focusing on mechanical performance. This document pertains to a 510(k) submission to the FDA, which is primarily concerned with establishing substantial equivalence for medical devices based on predicate devices. It does not contain information about studies involving AI, human readers, or image-based diagnostics.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present:

ANAX™ 5.5 Spinal System - Acceptance Criteria and Performance

The ANAX™ 5.5 Spinal System is a mechanical spinal fixation system designed to provide immobilization and stabilization of spinal segments. The provided document details its substantial equivalence to predicate devices based on mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The testing was "bench testing" on the device itself.
• Data Provenance: Not applicable in the context of clinical data/patient data. The testing was non-clinical bench testing.

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

• This is not applicable. The ground truth for mechanical performance testing is based on established engineering standards (ASTM F1717) and comparison to predicate devices, not expert human interpretation for diagnostics.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic interpretations, not for mechanical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

• This is not applicable. The device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or system designed to be read by human readers. Therefore, an MRMC study and AI improvement effect size is irrelevant to this submission.

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

• This is not applicable. The device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: Established engineering standards (ASTM F1717 for mechanical testing) and the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of a mechanical device's 510(k) submission. This term applies to machine learning models.

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

• This is not applicable. There is no training set for this type of device.

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The ASPIRON™ ACP System is intended for anterior inter-vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• · Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
• · Spondylolisthesis
• · Trauma (including fractures, dislocation)
• · Spinal stenosis
• · Tumors
• · Deformity (defined as scoliosis, kyphosis, or lordosis)
• · Pseudoarthrosis
• · Failed previous fusion

WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

ASPIRON™ ACP System consists of a variety of shapes and size of bone plates, screws and associated instruments. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. ASPIRON ™ ACP System is intended to provide stabilization of the cervical vertebra for various indications. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

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

Acceptance Criteria and Device Performance Study (K131200)

The ASPIRON™ ACP System, an anterior cervical plate system, established substantial equivalence by demonstrating mechanical performance equivalent to its predicate devices. The study involved non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size for each performance test. It refers to these as non-clinical "bench testing." Typically, these tests involve multiple samples to ensure statistical validity, but the exact number is not provided in this summary.
• Data Provenance: The tests were conducted in a non-clinical setting (bench testing). No country of origin for the data is specified beyond the manufacturer being in Korea. This was a retrospective study in the sense that the device was tested against established performance criteria derived from existing predicate devices.

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

Not applicable. This was a bench test evaluating mechanical performance against engineering standards and predicate device performance, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Ground truth was established by adherence to ASTM standards and comparison to predicate device performance, not through expert adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This was a bench testing study for mechanical performance, not a clinical study involving human readers or cases.

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

Not applicable. This device is a physical medical implant (anterior cervical plate system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The device's performance was evaluated inherently "standalone" in its mechanical properties.

7. The Type of Ground Truth Used

The ground truth used was:

• Adherence to recognized consensus standards (specifically ASTM F1717 for construct testing).
• Performance data from legally marketed predicate devices (Maxima™ K061002, Blackstone™ III° K012184, ZEPHIR™ K994239) as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as there is no "training set."

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