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The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic 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.

The Sovereign Posterior Cervical 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, the Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

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Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.

This document is a 510(k) Pre-Market Notification for a surgical mask, not an AI/ML device, so many of the requested categories (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable.

Here's the information based on the provided text, focusing on the acceptance criteria and performance of the Sovereign America Surgical Mask (Models 2000SM2 and 2000SM3):

1. Table of acceptance criteria and the reported device performance:

The device performance is compared against ASTM F2100-19 standards for Level 2 and Level 3 surgical masks, and against the predicate device (K160269).

Model 2000SM2 (Level 2 Performance)

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Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.

The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and the study information for the Sovereign America Surgical Mask (K201095), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Sovereign™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.

The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Sovereign™ Spinal System is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The subject devices in this submission add additional polyetheretherketone (PEEK) implant lordosis options with corresponding trials and PTC implant options with a Commercially Pure Titanium (CP Ti) coating, to the existing SOVEREIGN™ Spinal System.

The provided text describes a 510(k) summary for the Medtronic SOVEREIGN™ Spinal System, which is an intervertebral body fusion device. The submission focuses on adding new polyetheretherketone (PEEK) implant lordosis options and PTC implant options with a Commercially Pure Titanium (CP Ti) coating to the existing system. The document primarily discusses substantial equivalence to predicate devices based on mechanical testing and MRI compatibility. It does not describe an AI medical device or a study with clinical endpoints involving human readers or ground truth established by experts/pathology.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance metrics are not applicable to the information provided in the given text.

Based on the available information:

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

The acceptance criteria for the SOVEREIGN™ Spinal System are based on mechanical testing standards. The reported device performance indicates that the subject implants met these criteria.

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

This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device (intervertebral body fusion device), not a software or AI device with a test set of data.

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

This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device. Ground truth by experts is not established for this type of testing.

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

This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device. Adjudication methods are not used for this type of testing.

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

This information is not applicable. The document does not describe an AI medical device or any study involving human readers.

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

This information is not applicable. The document does not describe an AI medical device.

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

For the mechanical testing, the "ground truth" is defined by the performance requirements set forth in the referenced ASTM standards. For MRI testing, it's about meeting safety and compatibility guidelines outlined by the FDA for the MR environment. These are objective engineering and regulatory standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.

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The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of non-operative treatment. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.

The SOVEREIGN® Spinal System consists of interbody cages, screws, coverplates, instruments, and accessories. The subject instruments include:
• Trial Handle
• Trials
• Coverplate Inserter
• Interbody Inserters

This document, a 510(k) Pre-market Notification for the SOVEREIGN® Spinal System, focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting primary clinical study data for acceptance criteria. As such, it does not contain the detailed information typically found in studies designed to prove a device meets specific performance acceptance criteria related to diagnostic or treatment efficacy.

Therefore, many of the requested details, such as the specific acceptance criteria for device performance in terms of clinical outcomes, sample sizes for test and training sets, expert qualifications, ground truth methods, and results of comparative effectiveness studies (MRMC or standalone AI performance), are not present in this regulatory submission.

This submission primarily relies on:

1. Comparison of Technological Characteristics: It argues that the new device is substantially equivalent to existing predicate devices based on design, materials, sterilization, intended use, indications, and surgical technique.
2. Performance Data (Validation and Mechanical Testing): It states that a pre-clinical validation study demonstrated the proposed instruments could be used as intended, and mechanical testing was performed in accordance with FDA guidance to support substantial equivalence. It explicitly states that "testing is not warranted for the subject instruments as they do not present a new worst case when compared to the predicate instruments".

Given this context, here is a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" for clinical performance are not explicitly defined in the provided text, as the focus is on substantial equivalence to predicate devices through technical and manufacturing aspects. The "performance" reported is primarily related to the mechanical and functional aspects of the hardware, not clinical outcomes in human subjects.

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

• Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "pre-clinical validation study" was conducted in "spine models," which suggests bench testing or cadaveric testing, not a clinical test set from human data.
• Data Provenance: The nature of "spine models" doesn't allow for country of origin or retrospective/prospective classification in the typical sense of clinical data. It refers to laboratory or simulation environments.

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

Not applicable. As the "test set" was in "spine models" for pre-clinical validation and mechanical testing, there would be no ground truth established by medical experts in the way it is done for clinical diagnostic or treatment studies. The "ground truth" for mechanical testing would be engineering specifications and successful functional operation within the models.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among experts on clinical ground truth. For mechanical and pre-clinical validation studies, conformity to specifications and successful operation are typically assessed by engineers and technicians.

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 spinal implant system (intervertebral body fusion device and associated instruments), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or performed for this type of device.

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

Not applicable. This is a physical medical device (spinal implant system) and its instruments, not an algorithm or AI product.

7. The type of ground truth used

For the pre-clinical validation and mechanical testing, the "ground truth" would be:

• Engineering Specifications: Adherence to design parameters, material properties, and dimensional tolerances.
• Functional Success in Spine Models: The ability of instruments to perform their intended surgical steps without failure or deviation.
• Compliance with Standards: Verification that mechanical properties meet or exceed requirements outlined in relevant FDA guidance (e.g., "Guidance for Industry and FDA Staff – Spinal System 510(k)'s").

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "design predicate" information refers to existing devices that serve as comparators for substantial equivalence, not a training set for an algorithm.

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

Not applicable, as no training set for an algorithm was used.

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Aesculap's Sovercign® mini system is indicated for use in adult and pediatric diagnostic and therapcutic general endoscopy and laparoscopy surgery.

Aesculap's Sovereign® mini system can be used in adult and pediatric laparoscopic general surgery. The system consists of modular forceps and scissors in lengths of 200 and 290 millimeters with interchangeable ratcheting and non-ratcheting handles. The system also includes reusable trocars and trocar pins. The trocars and trocar pins are available in 3.5 millimeter diameter and 60 and 110 millimeter lengths, and 5 millimeter and 60,110 and 150 millimeter lengths with or without a stopcock. The 3.5mm trocars are for use with the 3.5mm instruments, and the 5mm trocars accommodate 4 and 5mm endoscopes. The instruments and trocars are composed of stainless steel and PEEK materials.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance data.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No Performance Data or Acceptance Criteria: The document explicitly states under the "PERFORMANCE DATA" section that "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, quantitative performance criteria or studies for this device outlined in this submission.
• Focus on Substantial Equivalence: The primary purpose of this 510(k) submission is to demonstrate "Substantial Equivalence" to a predicate device (Aesculap Needlescopic Instrument System K982623). The comparison focuses on "TECHNOLOGICAL CHARACTERISTICS" such as design, size, materials, and monopolar capabilities, rather than on new performance data against set acceptance criteria.

Therefore, the following information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: No test set or performance data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review is discussed for performance.
4. Adjudication method for the test set: No test set is mentioned.
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 device is a surgical instrument, not an AI-assisted diagnostic tool, so such a study would not be applicable and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical instrument.
7. The type of ground truth used: Not applicable, as performance data against a ground truth is not provided.
8. The sample size for the training set: Not applicable, as this is not a learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary from the provided documents:

The submission focuses on the Sovereign® mini system being substantially equivalent to the Aesculap Needlescopic Instrument System (K982623).

• The device is a Laparoscope, General and Plastic Surgery instrument (Endoscope and Accessories).
• It is intended for adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
• The modified instruments are stated to have the same technological characteristics as the predicate devices, being similar in design, size, manufacturing materials, and monopolar capabilities.
• No specific performance standards or performance data are provided in this regulatory submission for the modified device.

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The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws. then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

The SOVEREIGN® Spinal System is an intervertebral body fusion device with integrated screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN® Spinal System interbody device is manufactured from PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The SOVEREIGN® Spinal System includes instrumentation that enables the surgeon to implant the devices via a laparoscopic or an open anterior approach. The purpose of this Special 510(k) submission is to make modifications to the inserter sleeve that is part of SOVEREIGN® Spinal System. The inserter sleeve is a cylindrical stainless steel sleeve, incorporating a polymer bushing, which is used in conjunction with the inserter knob and one of three inserter shafts to securely hold a SOVEREIGN® interbody implant during insertion and impaction into the vertebral disc space.

The provided text is a 510(k) summary for a medical device called the SOVEREIGN® Spinal System. It describes modifications to an inserter sleeve, intended use, and substantial equivalence to predicate devices, supported by non-clinical tests. However, it does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria in a manner relevant to artificial intelligence or diagnostic performance.

Specifically, the document discusses:

• Device Description: The SOVEREIGN® Spinal System is an intervertebral body fusion device with integrated screw fixation. The current submission focuses on modifications to an inserter sleeve.
• Indications for Use: For degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with autogenous bone graft, for skeletally mature patients who have had six months of non-operative treatment. It can be used as a stand-alone device with screws or with supplemental fixation.
• Technological Characteristics: The subject device is largely identical to the predicate SOVEREIGN® Spinal System, with the primary modification being the material of a bushing in the inserter sleeve (Radel polyphenylsulfone vs. Delrin polyoxymethylene).
• Predicate Devices: SOVEREIGN® Spinal System (K091813, K110063) as primary predicates, and CAPSTONE CONTROL™, PERIMETER®, and TELAMON® PEEK Spinal System for sterilization and cleaning rationale.
• Non-Clinical Tests: Mechanical (axial pull) testing, tolerance analyses, and user validation were performed to confirm the modified instrument functions as intended. Cleaning and sterilization assessments were also conducted in accordance with various ISO and AAMI standards.
• Conclusions: The sponsor concludes substantial equivalence to predicate devices based on a risk analysis and verification/validation testing of the instrument modifications.

The document does not include:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or efficacy studies. The "performance" discussed is related to the mechanical function of the inserter sleeve and its cleaning/sterilization.
2. Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, or type of ground truth for a diagnostic test set. These concepts are not applicable to the type of device and submission described (a modification to a surgical instrument, not an AI, diagnostic, or imaging device).
3. Sample size or ground truth establishment for a training set. Again, this is not relevant to a surgical instrument modification.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets these criteria in the context of AI, diagnostic performance, or similar efficacy studies because the provided text is about a hardware modification to a surgical intervertebral fusion device, not a diagnostic or AI-powered system.

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The Sovereign Compact Phacoemulsification System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."

The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.

This document describes the regulatory submission for the "Sovereign Compact Phacoemulsification System," which is an upgrade to an existing medical device. As such, the submission focuses on proving substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this regulatory submission for the "Sovereign Compact Phacoemulsification System." This is typical for submissions focused on substantial equivalence to existing, already cleared devices, especially when the changes are primarily software or minor hardware enhancements.

Instead of defining new "acceptance criteria," the submission argues that the device meets the safety and effectiveness profile of its predicate devices through non-clinical testing. The "reported device performance" is implicitly that it performs "equivalently" to the predicate devices in the described modes of surgery.

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

The document does not specify a "test set" in the context of clinical trials or AI/algorithm validation for performance metrics. The evaluation relies on non-clinical testing. Therefore, information regarding sample size and data provenance in this context is not applicable. The "test" here refers to engineering and functional verification and validation.

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

This is not applicable as the submission did not involve clinical studies requiring expert ground truth establishment for a test set of data. The "ground truth" for the device's functionality and safety is based on engineering specifications, regulatory standards, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication for performance measurement.

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

No MRMC study was done. This device is a surgical system, not an AI or imaging diagnostic tool where MRMC studies are typically performed. The comparison is against predicate devices in terms of function and safety, not an evaluation of human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a medical device, a phacoemulsification system, which by its nature is used with a human surgeon (human-in-the-loop). There is no "algorithm only" performance study in the context of diagnostic or AI systems for this type of device.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering specifications and regulatory standards: The device was tested to ensure it met its defined functional and safety requirements, which are derived from engineering principles and relevant standards.
• Performance of predicate devices: The primary ground truth for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices (Mojave Cataract Extraction System (K003638), AMO Ophthalmic Surgical System (K060366), and Sovereign Phaco Handpiece (K981116)). The new device is asserted to perform "equivalently" in the same surgical modes.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical system, not an AI or machine learning algorithm that requires a "training set" of data in the conventional sense. The "development" or "training" involves engineering design, prototyping, and testing.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The "ground truth" for the device's development and validation came from established engineering principles, design specifications, and the performance characteristics of previously cleared predicate devices.

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The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN™ Interbody System may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.

The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK Optima® (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The provided document is a 510(k) summary for the SOVEREIGN™ Spinal System, specifically addressing an update to include modified screws. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the testing was performed "in accordance with ASTM Standard F2077-03 'Test Methods for Intervertebral Body Fusion Devices'" and "ASTM Standard F2267-04 'Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression'." The acceptance criterion can be inferred to be meeting the performance requirements or demonstrating comparable performance to the predicate device as outlined by these ASTM standards.

The reported device performance is summarized as: "Based on the non-clinical testing conducted in accordance with ASTM F2077 and ASTM F2267 and additional supporting documentation provided in this premarket notification, the subject device demonstrated substantial equivalence to the predicate SOVEREIGN™ Spinal System (K091813 - S.E. 11/17/2009) in terms of design, intended use, indications for use and fundamental technology."

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of implants, screws tested). It simply lists the types of tests performed.

Regarding data provenance, this is a pre-market notification (510(k)) for a medical device, which involves bench testing (non-clinical) of the physical device. Therefore, the data provenance is from laboratory testing, not human subjects. There is no information on country of origin for the data as it pertains to clinical studies, nor is it retrospective or prospective in a clinical sense.

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 the provided document. The "ground truth" for these types of mechanical tests is established by adherence to specified ASTM standard test methods and the resulting physical measurements (e.g., load, displacement). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads). For mechanical bench testing, results are objective measurements.

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 question is not applicable. The SOVEREIGN™ Spinal System is a physical intervertebral fusion device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.

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

This question is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As mentioned, for this type of submission, the "ground truth" is defined by the objective physical measurements obtained during controlled laboratory testing following established ASTM standards. The goal is to demonstrate that the device performs mechanically as intended and is comparable to a predicate device.

8. The Sample Size for the Training Set

This question is not applicable. The SOVEREIGN™ Spinal System is not an AI algorithm, so there is no concept of a "training set" in this context.

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

This question is not applicable, as there is no training set for a physical medical implant.

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The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN® phacoemulsification machine. The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

The SOVEREIGN® High Vacuum Pack and the SOVEREIGN® Compact High Vacuum Pack are accessory kits indicated for use with the SOVEREIGN® phacoemulsification machine and the SOVEREIGN® Compact phacoemulsification machine, respectively, to perform an irrigation/aspiration (I/A) procedure or a phacoemulsification procedure during cataract surgery. The tubing assembly component of the kit incorporates a flow restriction feature for preventing/neutralizing post occlusion surge following an occlusion break at the distal end of a phaco tip. The materials, basic scientific concepts, physical properties and intended use of the device kits are similar to those of the identified predicate devices.

The provided text describes a 510(k) summary for the SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack, which are accessory kits for phacoemulsification machines used in cataract surgery. The summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a diagnostic medical device.

However, based on the information provided, we can infer some "acceptance criteria" and the nature of the "study" conducted for this type of submission. The primary goal was to prove substantial equivalence to existing legally marketed devices.

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a "sample size" in the context of clinical patient data. The evaluation was primarily bench testing. For bench testing, the sample size would refer to the number of units tested. This information is not provided in the document.
• Data Provenance: The data provenance is nonclinical bench testing. The country of origin for the testing is not explicitly stated. It is considered retrospective in the sense that it compares performance to established predicate devices.

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

• Number of Experts: Not applicable. This was bench testing, not an expert-driven clinical evaluation requiring ground truth establishment in that manner.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve direct measurement and comparison to predefined engineering specifications or predicate device performance, not expert adjudication in the clinical sense.

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

• MRMC Study: No, an MRMC study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical accessory used with a phacoemulsification machine, hence inherently "human-in-the-loop" in its application during surgery. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the bench testing was derived from established performance characteristics of the predicate devices (e.g., their known flow resistance and chamber maintenance capabilities). This is a form of engineering specification/benchmark comparison, rather than expert consensus, pathology, or outcomes data in a clinical trial.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification were based on engineering principles and comparisons to existing predicate designs.

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

• Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of machine learning.

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