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The Integral Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.

Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.

It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.

The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.

The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.

Basic parameters/use conditions/power supply specifications is as follows:

◆Noise ＜70 dBA

◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: <90µm
Air filter hole diameter: <25µm

◆Saliva ejector Weak saliva:

• vacuum degree >15 kPa;
• water pumping rate＞80 mL/min

Strong saliva:

• vacuum degree >25 kPa;
• water pumping rate＞1000 mL/min

◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: <5 Kg

◆Film viewer Power supply: 24 V ac Inside power supply
Power input: 80 VA

◆Operating light Power supply: 12 V ac Inside power supply
Power input: 50 VA
Illuminance: 5 000~20 000 Lx
Radiant heat: <200 W/m² @ max. illuminance
Color rendering index: >85 Ra

◆Foot switch Tripping force: >10N and <30N
Degree of protection against harmful ingress of water: IPX4(foot switch)
Service life: >25 000 repeats

◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm

Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions

◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm

◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa

The provided FDA 510(k) clearance letter pertains to the Integral Dental Unit, a Class I medical device. This device is an "Operative Dental Unit and Accessories" and is intended to supply power to and serve as a base for other dental devices and accessories, including a dental chair, for use by trained dental professionals in a dental clinic environment.

The document states that clinical performance testing was not performed for this device. As such, information regarding acceptance criteria derived from a clinical study, sample size for test sets (including data provenance, ground truth establishment, expert qualifications, and adjudication methods), MRMC studies, or standalone algorithm performance, and training set details are not provided in this submission.

Instead, the device's acceptance criteria are based on conformance to established international standards for electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, software life cycle processes, and general performance for stationary dental units and dental patient chairs.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. Clinical performance testing was not performed. The testing conducted was primarily engineering and bench testing against recognized standards.

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

Not applicable. Ground truth as typically understood for clinical studies (e.g., expert interpretation of medical images) was not established. Performance was assessed against engineering specifications and international standards by relevant testing laboratories.

4. Adjudication method for the test set

Not applicable. No expert review or adjudication method was described as clinical performance testing was not performed.

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. No MRMC study was conducted as this device is an Integral Dental Unit, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on conformance to international engineering and safety standards (e.g., IEC, ISO) and the device's adherence to its own design specifications and functional parameters. There is no clinical "ground truth" derived from patient outcomes or expert consensus in this submission.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

Not applicable. This is not an AI/Machine Learning device.

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The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.

This document is a 510(k) clearance letter for "Integral Dental Units" (K242611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and safety data, rather than clinical accuracy or AI performance.

Therefore, many of the requested sections related to acceptance criteria, MRMC studies, standalone AI performance, and AI-specific ground truth establishment cannot be fulfilled from this document as it does not describe AI-powered functionality or clinical accuracy testing for a diagnostic or AI-assisted system.

The "device" in this context is a dental operative unit, which is a piece of physical medical equipment, not an AI or software algorithm requiring clinical accuracy validation as typically seen in AI/ML medical devices.

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

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" for this device are primarily met by demonstrating compliance with various national and international performance, safety, and quality standards, as well as showing substantial equivalence to existing predicate devices. The performance data presented are primarily in the context of electrical safety, EMC, usability, physical operation parameters, and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical dental unit and not an AI-powered diagnostic device, the "acceptance criteria" are compliance with established standards and comparable specifications to predicate devices. There aren't specific accuracy metrics like sensitivity or specificity for a diagnostic algorithm.

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

• Sample Size: Not applicable in the context of device performance testing. The "sample" here refers to the physical device units tested for compliance with standards. The document does not specify the number of units tested.
• Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory or manufacturing setting. The manufacturer is Mipont Medical Equipment Co., Ltd. from China. The data provenance is from non-clinical bench and laboratory testing of the physical dental unit, not clinical data from patients.

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

• Not Applicable: This document describes non-clinical performance and safety testing of a physical medical device (dental unit), not an AI algorithm requiring expert-established ground truth for clinical accuracy.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this pertains to clinical study design for AI algorithms, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No: The document states, "There was no clinical testing performed." This type of study is specifically for evaluating the impact of AI on human performance, which is not relevant to this device's clearance.

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

• No: This device is a physical dental unit, not a standalone algorithm. The document explicitly states "There was no clinical testing performed."

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and requirements outlined in the referenced international standards (e.g., IEC, ISO, ASTM). The device is tested against these predefined, objective engineering and safety criteria. There is no "expert consensus" or "pathology/outcomes data" in the clinical sense for these types of non-clinical hardware tests.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable: This device is not an AI/ML algorithm that requires a training set or associated ground truth.

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The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.

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The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

The Integral Titanium Cervical Interbody is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are additively manufactured using titanium alloy per ASTM F3001.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.

This document is a 510(k) Summary for the Integral Titanium Cervical Interbody and does not contain any information regarding clinical studies, acceptance criteria, or performance data related to AI/algorithm performance.

The document describes a medical device, an intervertebral body fusion device, and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. The listed tests are engineering and mechanical tests (e.g., static and dynamic compression, subsidence, expulsion) to assess the physical properties and safety of the implant itself, not its diagnostic or decision-making performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device's performance, as this information is not present in the provided text. The document focuses solely on the substantial equivalence of a physical medical implant based on its design, materials, and mechanical testing results.

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The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.

The INTEGRATE™-C Interbody Fusion System implant is made of a single, continuous piece of hydroxyapatite impregnated polyetheretherketone polymer (ASTM F2026 & F1185). The INTEGRATE™-C Interbody Fusion System implant body is monolithic with porous regions derived directly from the implant body, not a sintered or otherwise additive coating, and extended through the device. The device is available in a variety of footprints, lordosis and heights to accommodate variations in the individual pathology and anatomic of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Tantalum (ASTM F560) radiopaque markers are placed in the device to aid in determining the location of the implant intra- and post-operatively.

The provided document is an FDA 510(k) Premarket Notification for a medical device called "INTEGRATE™-C Interbody Fusion System." This type of document is filed for medical devices that are substantially equivalent to a legally marketed predicate device. The primary focus of a 510(k) submission is to demonstrate this substantial equivalence through various assessments including technological characteristics, performance data (often mechanical testing for implants), and indications for use.

Crucially, this document does NOT describe the acceptance criteria and the study that proves a digital health or AI/ML device meets those criteria. The device in question is a physical intervertebral body fusion system, an implant, not an AI/ML diagnostic or assistive device. The "Performance Data" section specifically lists mechanical tests (e.g., static and dynamic compression, shear, torsion, subsidence) that are relevant for a physical implant.

Therefore, I cannot extract the information requested about acceptance criteria and study design for an AI/ML device from this document. The questions posed (regarding human readers, MRMC studies, ground truth establishment, training set size, etc.) are pertinent to AI/ML device validation, but this document describes the validation of a physical surgical implant.

In summary, none of the requested information about AI/ML device acceptance criteria and study data can be found in the provided text. The document describes a traditional medical device (interbody fusion system) and its mechanical performance testing for FDA clearance, not a digital health or AI/ML product.

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INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.

INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.

The provided text is a 510(k) Pre-market Notification document for a medical device called INTEGRA® Wound Matrix (Macro-Channels). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device study might.

Since this document is not for an AI/ML device, the typical metrics and study designs (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size of a test set, etc.) are not applicable here. The device is a collagen wound dressing, meaning its evaluation relies on material properties, biocompatibility, and animal models, rather than diagnostic accuracy or human interpretation of outputs.

However, I can extract the information relevant to its acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria in the sense of predefined thresholds for clinical outcomes (e.g., wound closure rate) for the subject device. Instead, it focuses on demonstrating that the technological characteristics of the subject device are substantially equivalent to the predicate device, and that its performance meets general scientific and safety standards.

Here's a breakdown of the key characteristics and findings:

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

• Test Set Sample Size: Not specified for any of the individual tests. For the in vivo study, a "porcine wound healing model" was used, but the number of animals or wounds is not mentioned.
• Data Provenance: The biocompatibility data was leveraged from the predicate device (K022127). The in vivo study was conducted, likely by the manufacturer, but country of origin is not specified. The studies are retrospective in the sense that existing data from the predicate device was largely used, and any new tests (like the in vivo porcine study) would be considered prospective for the subject device.

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

• Not Applicable. This is not a diagnostic device that requires expert interpretation for ground truth. The evaluation is based on material science, chemical analysis, and animal model outcomes.

4. Adjudication method for the test set:

• Not Applicable. No human adjudication of results in the context of interpretation of diagnostic outputs. Results are from laboratory tests and an animal study.

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

• Not Applicable. This is not an AI/ML device, nor does it involve human readers or comparative effectiveness in that sense.

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

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• Laboratory Measurements & Animal Study Outcomes:
  • Compositional analysis: Used to confirm material identity.
  • Physical property measurements: (e.g., pore size, thickness, resistance to collagenase, endotoxin levels).
  • Biocompatibility test results: Against ISO 10993 standards.
  • Histopathological & clinical observations from porcine wound healing model: To assess safety and effectiveness in wound healing.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As there is no training set.

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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The Integra TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The TITAN Reverse Shoulder System is indicated for primary fractures, including proximal humeral or revision total shoulder replacement, for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The implant scope of the RSS is being expanded to include additional options for humeral liners manufactured from highly crosslinked Ultra High Molecular Weight Polyethylene (XLPE) per ASTM F2565. The existing humeral liners are manufactured from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners.

I am sorry, but the provided text describes a medical device called the "Integra TITAN Reverse Shoulder System" which is a shoulder joint prosthesis. The document is a 510(k) premarket notification from the FDA. This type of document pertains to the mechanical and material characteristics of an implantable device, rather than the performance of a software algorithm or AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria and studies related to AI/software performance is not present in the provided text. The document focuses on bench testing (nonclinical performance data) for the physical properties of the implant, such as fatigue, disassembly, rotational resistance, and wear.

Here's a breakdown of why I cannot fulfill your request based on this document:

• No AI/Algorithm: The Integra TITAN Reverse Shoulder System is a physical medical implant, not a software or AI-driven device.
• No Diagnostic Claims: It does not make diagnostic claims that would require evaluation of metrics like sensitivity, specificity, or reader performance.
• No Test Set/Training Set: Concepts like test sets, training sets, ground truth, expert adjudication, or MRMC studies are irrelevant to this type of device and its regulatory review.

The document states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device." This indicates that the evaluation for this device relies on non-clinical (bench) testing, rather than clinical trials or studies involving human readers or algorithm performance.

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Salto Talaris Total Ankle Prosthesis : The Salto Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

Integra XT Revision Ankle Replacement System: The Integra XT Revision Ankle Replacement System is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. Components are intended for cemented use only.

The Integra Salto Total Ankle System (Salto Talaris Total Ankle Prosthesis and the Integra XT Revision Ankle Replacement System) is a semi-constrained anatomical design. Both subsystems consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.

This document is a 510(k) premarket notification from the FDA for a medical device called the "Integra Salto Total Ankle System." It's a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the context of an AI-powered diagnostic device, as the prompt requests.

The document discusses the substantial equivalence of the Integra Salto Total Ankle System to a predicate device, based on material, intended use, fundamental scientific technology, and functional/technological characteristics.

Specifically, it states:

• "Nonclinical Performance Data": The Salto Talaris Total Ankle Prosthesis and Integra XT Revision Ankle Replacement System were subjected to verification per standard ASTM F2665 to establish equivalent performance in comparison to the predicate device, covering tests like Tibial Tray Fatigue, Tibial Tray/Insert Locking, Tibial Tray Bone Fixation, Talar Dome Bone Fixation, and Talar Dome Fatigue.
• "Clinical Performance Data": "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device."

Since this is a mechanical orthopedic device clearance and not an AI/diagnostic device, the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), sample sizes for test sets (in the context of images), expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Therefore, I cannot provide the requested information based on the provided text.

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The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The stems are intended for cemented and cementless use. The scope of the RSS is being expanded via a line extension to include additional options for baseplates, glenospheres, and screws. The baseplate option features a smaller post in comparison to the currently commercialized baseplate options, along with glenospheres that work in conjunction with the baseplate. The baseplate under this line extension is referred to as the Small Post Baseplate (SPB). Additional Star screw options have also been incorporated as part of the line extension.

The provided text is related to a 510(k) premarket notification for a medical device: the Integra TITAN Reverse Shoulder System. It describes the device, its intended use, and the nonclinical performance data used to demonstrate substantial equivalence to a predicate device.

However, the text does not contain any information about:

• Acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/algorithm-based device.
• A study comparing algorithm performance against a ground truth or human readers.
• Sample sizes for test or training sets for an AI device.
• Ground truth establishment methods (expert consensus, pathology, etc.).
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

The document is a regulatory submission for a physical medical implant (shoulder prosthesis) and focuses on engineering testing (e.g., fatigue, taper disassembly, torsional properties) to demonstrate mechanical equivalence, not the performance of a diagnostic or AI-driven device. The "Clinical Performance Data" section explicitly states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device."

Therefore, I cannot provide the requested information based on the provided text, as it describes a different type of medical device and regulatory submission where AI performance metrics are not applicable.

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