Search Results

Meridian Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The Meridian System with NanoMetalene® surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian Interbody is intended for use with supplemental fixation.
No-Profile Interbody Implants with Screws:
The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The Meridian System 2-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
No-Profile Interbody Implants with Inline Fixation Anchors:
The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogenee bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
WaveForm A Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System Interbody is intended for use with supplemental fixation.
No-profile Interbody Implants with Screws:
The WaveForm A System 2-Hole No-profile Interbody, when used with Screws and with or without a Noprofile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiosraphic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 2-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
The WaveForm A System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
No-profile Interbody Implants with Inline Fixation Anchors:
The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Meridian Interbody System
The Meridian Interbody System featuring NanoMetalene® surface technology consists of anterior intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized.
The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
WaveForm A Interbody System
The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized.
The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

The provided text is a 510(k) summary for the SeaSpine Orthopedics Corporation's Meridian Interbody System and WaveForm A Interbody System. This document assesses the substantial equivalence of these spinal implants to existing predicate devices based on non-clinical testing (mechanical performance). It is not an AI/ML medical device submission. Therefore, it does not contain the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC)
• Sample size for the test set and data provenance (images, clinical data for AI/ML evaluation)
• Number of experts and their qualifications for establishing ground truth for an AI/ML test set
• Adjudication method for an AI/ML test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
• Standalone performance (algorithm only) for an AI/ML device
• Type of ground truth used (for AI/ML context)
• Sample size for the training set (for AI/ML)
• How ground truth for the training set was established (for AI/ML)

The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." and focuses on "Non-Clinical Testing" demonstrating "substantially equivalent mechanical performance".

Therefore, I cannot provide an answer that addresses the requested aspects of acceptance criteria and study design for an AI/ML medical device based on the given text.

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The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T) -L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Meridian Anterior Plate and Regatta Lateral Plate Systems each consist of varying sizes of plates and fixation options that accommodate either anterior or lateral surgical approaches in the thoracic, lumbar, and sacral spine (T1-S1). Each plate is manufactured from titanium alloy per ASTM F136 and is designed to provide additional support during spinal fusion procedures.

The provided text is an FDA 510(k) clearance letter and summary for a spinal plate system. It details the device's indications for use, its classification, and a comparison to predicate devices, including the non-clinical testing performed.

However, the document does not describe an AI medical device or a study proving an AI device meets acceptance criteria. It lacks any information regarding:

• Acceptance criteria for an AI device.
• Performance metrics (e.g., sensitivity, specificity, AUC) for an AI device.
• Sample sizes for test sets or training sets for an AI model.
• Data provenance for AI model development.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human-in-the-loop performance.
• Standalone AI performance.
• Ground truth types (pathology, outcomes data, etc.) for AI.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The document explicitly states the testing performed:

• Static Compression Bending (ASTM F1717)
• Static Torsion (ASTM F1717)
• Dynamic Compression Bending (ASTM F1717)

These are mechanical and physical performance tests for an orthopedic implant, not an AI diagnostic or assistance device. The conclusion states "Minor differences in non-clinical test results do not impact device performance when compared to the legally marketed predicate devices," which further confirms the focus on mechanical equivalence.

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The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.

The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.

This document is a 510(k) summary for the Meridian Vaginal Positioning System (VPS), a medical device. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

No acceptance criteria and device performance table can be generated from the provided text. The document lists the types of non-clinical performance tests performed (e.g., biocompatibility, sterilization validation, mechanical testing) but does not provide specific quantitative acceptance criteria values or the reported performance data for these tests. It only states that "The results of the performance testing described above demonstrate that the Meridian Vaginal Positioning System is as safe and effective as the predicate device and supports a determination of substantial equivalence."

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria as one might find in a clinical trial report for an AI/ML diagnostic device.

Here's what can be extracted regarding the study, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, this information is not present in the provided 510(k) summary. The document lists the types of tests performed (e.g., Cytotoxicity, Sensitization, Irritation, Functional testing, Maximum force for head, etc.) but does not provide numerical acceptance criteria or the specific results obtained for each test. The summary only states that the performance testing results "demonstrate that the Meridian Vaginal Positioning System is as safe and effective."

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

The document describes non-clinical performance testing (e.g., biocompatibility, mechanical testing, sterilization validation). It does not involve a "test set" in the context of patient data or clinical images. Therefore:

• Sample size for the test set: Not applicable, as this was non-clinical testing of the device itself, not a clinical study involving patient data. The document would typically refer to the number of devices or test units used for each test (e.g., n=5 for bend testing), but these specific numbers are not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable for non-clinical device testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This was non-clinical performance testing of a physical medical device (Vaginal Positioning System), not a study involving the interpretation of data where expert ground truth would be established (e.g., image annotation for an AI algorithm).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No. This document describes the non-clinical performance testing of a physical surgical instrument. An MRMC study is typically performed for diagnostic devices (especially AI/ML-driven ones) to assess the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical surgical instrument, not an algorithm. Standalone performance is relevant to AI/ML algorithms that provide an output without human intervention.

7. Type of Ground Truth Used:

• Not applicable. For physical device testing, "ground truth" refers to established material properties, mechanical specifications, and biological safety limits, as defined by standards like ISO 10993-1. The "ground truth" for these tests would be the established limits and specifications against which the device's performance is measured. The document states that tests were performed "per the special controls listed in 21 CFR 884.4910" and according to standards like ISO 10993-1.

8. Sample Size for the Training Set:

• Not applicable. This document is not describing an AI/ML device that requires a training set. The "device" is a physical instrument.

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

• Not applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, the Meridian Vaginal Positioning System (VPS). It details non-clinical performance testing to establish substantial equivalence. It does not contain information about acceptance criteria values, reported performance data, clinical study sample sizes, expert adjudication, or AI/ML-specific testing methodologies (like MRMC studies or training set details). The "proof" of meeting safety and effectiveness criteria relies on demonstrating compliance with recognized standards and pre-defined specifications through the listed non-clinical tests, which include biocompatibility, sterilization validation, package integrity, dimensional analysis, and various mechanical tests.

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The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).

The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).

The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.

The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.

The provided text describes the submission for K170053, a 510(k) premarket notification for the Meridian PM device, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The submission focuses heavily on demonstrating substantial equivalence to predicate devices (SICAT OptiSleep and TheraSom-CAST) rather than presenting a standalone study of the device's clinical performance against specific acceptance criteria for efficacy in reducing snoring or OSA.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not present in the provided document. The performance data presented is entirely non-clinical and relates to the device's material properties and biocompatibility.

Here's a breakdown of the available information:

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

• Clinical Performance/Efficacy: The document does not provide specific acceptance criteria or reported performance for clinical outcomes such as reduction in AHI (Apnea-Hypopnea Index) or snoring intensity. The "acceptance criteria" discussed are for non-clinical tests.

• Non-Clinical Performance:

  Test Category	Test Method	Acceptance Criteria	Reported Performance
  Material Properties		"internal requirements, applied national standards, and applied international standards"	Passed
  Flexural Properties	ISO 178:2010/Amd.1:2013(E) Method A	(Not specified directly, but implied by "passed")	Passed
  Plane-Strain Fracture Toughness	ASTM D5045 -14 (modified notch geometry)	(Not specified directly, but implied by "passed")	Passed
  Tensile Properties	ASTM D638-14 - Modified specimen length, test speed and grip separation	(Not specified directly, but implied by "passed")	Passed
  Biocompatibility	ISO 10993-1:2009 and FDA guidance document	(Not specified directly, but implied by "passed")	Passed
  Cytotoxicity	ISO 10993-5	(Not specified directly, but implied by "passed")	Passed
  Irritation and Skin Sensitization	ISO 10993-10	(Not specified directly, but implied by "passed")	Passed
  Chemical Characterization	ISO 10993-18	(Not specified directly, but implied by "passed")	Passed
  Risk Analysis	ISO 14971	"outcomes of these risks are considered acceptable...all potential risks have been mitigated"	Passed

Regarding the clinical study details, the document does not contain the requested information:

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

• Not Provided. There is no mention of a human test set for clinical efficacy.

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)

• Not Provided. Not applicable as no clinical test set is described.

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

• Not Provided. Not applicable as no clinical test set is described.

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 Provided. This is not relevant for this type of device (intraoral snore/OSA device) and no MRMC study or AI component is mentioned.

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

• Not Provided. This is not relevant for this type of device and no algorithm is mentioned for performance assessment.

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

• Not Provided. Not applicable as no clinical ground truth is described. The "ground truth" for the non-clinical tests would be the established chemical, physical, and biological properties as per the standards.

8. The sample size for the training set

• Not Provided. Not applicable as no clinical training set or machine learning model is described.

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

• Not Provided. Not applicable as no clinical training set is described.

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The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

The Meridian M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.

The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the Meridian M110 Fetal Monitoring System. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It outlines regulatory requirements but does not include performance acceptance criteria or study results.

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Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.

Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.

The provided text describes a 510(k) submission for a dental composite material named Meridian. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against specific acceptance criteria using clinical studies with complex statistical methodologies often seen for other types of medical devices.

Therefore, many of the requested sections are not applicable to this type of device and submission. Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are defined by the performance standards outlined in ISO 4049:2009 for polymer-based dental restorative materials, and the "reported device performance" demonstrates that Meridian meets these standards and is substantially equivalent to the predicate device (Tetric EvoCeram, K042819).

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

The document does not specify the sample sizes used for the in vitro tests conducted according to ISO 4049:2009 and ISO 10993. These are laboratory-based material tests, not clinical studies involving patient data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" are not applicable.

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

Not applicable. The ground truth for this device is based on standardized laboratory testing protocols (ISO 4049:2009, ISO 10993), not on expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results, typically involving human readers. This device underwent in vitro material 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

Not applicable. This is a dental composite material, not an AI-powered diagnostic device. No MRMC studies were performed.

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

Not applicable. This is a material, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is the physical and chemical properties of the material as measured by standardized, objective laboratory tests defined by international standards (ISO 4049:2009 for performance, ISO 10993 for biocompatibility). The comparison is against the predicate device, showing "substantial equivalence" based on these measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device involved meeting established material standards.

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

Not applicable. As above, this is not an AI/ML device.

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The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.

The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.

The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.

The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.

The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).

The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )

The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.

The Adeor Meridian™ Cranial Perforator is a sterile, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery. Its primary function is to automatically release and stop perforating once a specific cranial bone thickness is reached, preventing plunging into underlying tissue.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Meridian™ Cranial Perforator are primarily centered around its ability to automatically release and stop perforation at specified bone thicknesses, and its general mechanical functionality.

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

The document mentions that "Samples of each model were used to drill holes in wood and animal bone." It also states "On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed..."

• Test Set Sample Size: The exact number of "samples of each model" is not specified. For the animal cadaver testing, it refers to "animal cadavers (pig head and calf shoulder)," implying at least one of each, but the total number of perforators tested on them is not given.
• Data Provenance: The animal cadaver testing used biological material (pig head and calf shoulder) which would be considered an in vitro/ex vivo study environment. The country of origin for this testing is not explicitly stated in the provided text. The company is based in Germany. The sterilization validation refers to international standards recognized by FDA.

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

No explicit mention of experts establishing ground truth for the mechanical performance testing is provided in the document. The performance bench testing appears to be objective measurements/observations rather than subjective expert assessments requiring a "ground truth" establishment in the traditional sense of clinical studies (e.g., for diagnostic accuracy). The "satisfactory" remarks and observations like "no friction," "no skidding," "firm axial rotation," and "plain and even surface" would likely be criteria directly observed and measured/assessed by the testing personnel (e.g., engineers, technicians).

4. Adjudication Method for the Test Set

Not applicable. There is no indication of subjective assessments by multiple individuals requiring an adjudication method. The performance bench testing focuses on objective, measurable mechanical functionality and observation of device behavior.

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

No. This type of study is not relevant for the evaluation of a mechanical surgical device like a cranial perforator. MRMC studies are typically used to assess diagnostic accuracy or the impact of AI assistance on human interpretation of medical images.

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

Not applicable. The device is a mechanical surgical tool, not an AI algorithm. Its performance is inherent to its design and mechanical function, with human operation being an integral part of its use.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is the objective physical behavior of the device (e.g., whether it stops perforating at the correct depth, whether it exhibits friction, skidding, or wobbling, and the quality of the cut). This is established through direct observation and measurement during the bench testing on wood, animal bone, and animal cadavers.

For sterility, the ground truth is established by scientific validation against recognized international standards (ISO 11137 series) that define a Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

Not applicable. The Meridian™ Cranial Perforator is a mechanical device, not a machine learning or AI model 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 this mechanical device.

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The MERIDIAN™ Filter System - Femoral Delivery Kit is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated. .
• Failure of anticoagulant therapy for thromboembolic disease. .
• . Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
  MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

The MERIDIAN™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the six legs provide the lower level of filtration and the six arms provide the upper level of filtration. The legs contain hooks and the arms contain anchors to resist filter movement. The MERIDIAN™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The MERIDIAN™ Filter System - Femoral Delivery Kit consists of a 8 French inner diameter (I.D.) introducer sheath and dilator set, a storage tube preloaded with the MERIDIAN™ Filter and pusher system. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The storage tube and pusher system attach to the introducer and allow for delivery and deployment of the MERIDIAN™ Filter.

Here's a breakdown of the acceptance criteria and study information for the MERIDIAN™ Filter System - Femoral Delivery Kit, based on the provided text:

Important Note: The provided document is a 510(k) Summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be the case for a novel device. Therefore, the "study" described here is primarily a series of in vitro and in vivo performance tests designed to show that the modified device performs comparably to the predicate. It does not involve human subjects as a traditional clinical trial would for evaluating primary outcomes.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative thresholds against which "reported device performance" is directly compared for each test. Instead, it states that the results from the performance tests "demonstrate that the technological characteristics and performance of the MERIDIAN™ Filter System – Femoral Delivery Kit is comparable to the predicate devices and that the subject device can perform in a manner substantially equivalent to the predicates devices with the same intended use."

The document lists the following performance tests conducted:

In Vitro Delivery System Testing:

• Dimensional and Visual Inspection
• Tensile
• Torque
• Flushability
• Component compatibility
• Attachment/Detachment
• Filter Dislodgement
• Pushability
• Trackability
• Removability
• Filter Centering (Tilt)
• Arm and Leg Entanglement (Filter Configuration)
• Deployment Force
• Deployment Accuracy
• Liquid Leakage
• Leakage during power injection
• Burst
• Air Aspiration
• Biocompatibility per ISO 10993-1

In Vivo Delivery System Testing:

• Delivery System Trackability and Pushability
• Dilator and Introducer Sheath Trackability and Pushability
• Ease of Deployment (Deployment Force)
• Deployment Accuracy
• Filter Centering (Tilt)
• Arm and Leg Entanglement (Filter Configuration)
• Dilator Marker Band Visibility Under Fluoroscopy
• Introducer Sheath Tip Visibility Under Fluoroscopy

Summary of Reported Performance: The overall reported performance is that the device is "comparable to the predicate devices" and "substantially equivalent." Specific quantitative metrics for each test and their relation to defined acceptance criteria are not provided in this 510(k) summary. The FDA's clearance implies that the provided data (which likely included specific test reports and data that are not part of this public summary) met the agency's requirements for demonstrating substantial equivalence.

Study Details

Given this is a 510(k) summary focused on demonstrating substantial equivalence through performance testing of a modified device, many of the typical "study" parameters for clinical trials (like sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies) are not applicable or described in the same way.

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

   • Sample Size: Not specified in the provided summary. Performance tests typically involve a defined number of devices or components.
   • Data Provenance: The tests were conducted "in vitro and in vivo." The "in vivo" testing would likely refer to animal models, not human subjects, given that this is a 510(k) for a modification (delivery kit components). The country of origin for the data is not specified but would typically be conducted by or for the manufacturer (Bard Peripheral Vascular, Inc. in Tempe, Arizona, USA). The study is prospective in the sense that these tests were performed specifically to support this 510(k) submission.

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

   • Not applicable in the context of device performance testing. Ground truth here is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and comparison to the predicate device's established performance under those specifications.

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

   • Not applicable as this is not a study requiring human expert assessment or consensus on clinical outcomes. Device performance tests are typically objective measurements.

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

   • This is not an AI-assisted diagnostic device, but rather a medical implant delivery system. Therefore, an MRMC comparative effectiveness study is not applicable.

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

   • This is not an algorithm or AI device. The performance tests are of the physical device and its components.

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

   • The "ground truth" (or standard of comparison) for these performance tests is based on:
     • Engineering specifications: Ensuring the components meet design tolerances and functional requirements (e.g., deployment force, trackability).
     • Material standards: Conformance to established standards, such as ISO 10993-1 for biocompatibility.
     • Predicate device performance: Demonstrating that the modified device performs comparably to the previously cleared predicate device in all relevant aspects.

7. The sample size for the training set:

   • This is not an AI/machine learning device; hence, there is no "training set." The device is evaluated based on its physical and mechanical properties.

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

   • Not applicable as there is no training set for an AI/ML model.

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The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Meridian Guidewire is a stainless steel guidewire with a radiopaque, distal coil. The distal portion of the guidewire is hydrophilically coated. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

This 510(k) summary describes a guidewire, which generally undergo non-clinical (bench) testing rather than clinical studies with human participants. Therefore, many of the typical clinical study parameters (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable in the same way they would be for AI/ML-based diagnostic devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating substantial equivalence to a predicate device, not necessarily meeting specific numerical performance metrics in a clinical study. The "acceptance criteria" are implied by the similarity to the predicate and the successful completion of non-clinical tests.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" would be the guidewire itself and its components, subjected to various bench and in vitro tests. The provenance is the manufacturer (Micro Therapeutics dba ev3 Neurovascular, Irvine, CA, USA). All testing would have been conducted in a controlled laboratory environment.

2. 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): Not applicable for this type of device and submission. "Ground truth" for guidewires is typically established by engineering specifications, material standards, and validated testing protocols, not expert clinical consensus on individual cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against engineering standards and established testing methodologies.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a medical device (guidewire), not an AI/ML diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a guidewire, the "ground truth" for performance is based on adherence to design specifications, material properties, biomechanical test results (e.g., tensile strength, torqueability, lubricity), sterility standards, and biocompatibility requirements, all of which are scientifically measured and compared against established benchmarks or the predicate device.

7. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.

8. How the ground truth for the training set was established: Not applicable.

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The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian machine is designed to operate in the chronic and acute dialysis environment.

The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.

The provided document is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed studies proving performance against acceptance criteria in the manner of an AI/ML medical device or diagnostic test.

The core of a 510(k) for a device like a hemodialysis machine relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical metrics.

Therefore, the requested information elements related to AI/ML performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies are not applicable to this type of device and submission.

Here's a breakdown based on the provided text, highlighting what is available and explaining why other elements are not:

Acceptance Criteria and Device Performance

Non-Applicable Information for this 510(k) Submission:

The following information points are typically associated with performance studies for software/AI devices or clinical trials, which are not detailed in this 510(k) summary for a hemodialysis machine where substantial equivalence is based on technological characteristics.

1. Sample size used for the test set and the data provenance: Not applicable. Performance is demonstrated through comparison of engineering and functional specifications to the predicate, rather than a clinical "test set" in the diagnostic sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to ground truth for diagnostic accuracy, which is not the focus here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a treatment machine, not an interpretive diagnostic tool that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to engineering validation and verification that the machine performs its mechanical and electronic functions correctly and safely, rather than a diagnostic 'truth'.
7. The sample size for the training set: Not applicable. There is no mention of an "algorithm" or "training set" in the context of this device.
8. How the ground truth for the training set was established: Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for a hemodialysis machine. This type of device is classified as a physical medical device (Class II) that performs a therapeutic function. The regulatory pathway for such a device, a 510(k), focuses heavily on demonstrating substantial equivalence to an already legally marketed predicate device. In this case, the Baxter Meridian Hemodialysis Machine is stated to be "technologically the same" as its predicate (K992894).

This means the submission relies on comparing design specifications, materials, operational principles, and intended use to the predicate. It is not an AI/ML-driven diagnostic device that would require extensive performance studies involving test sets, training sets, ground truth established by experts, or MRMC studies to evaluate algorithmic performance or human-AI interaction. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is as safe and effective as the predicate device.

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