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The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.

The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.

Unfortunately, the provided text does not contain information about an AI/ML-based medical device study. The document is an FDA 510(k) clearance letter for the "Freedom Wrist Arthroplasty System," which is a physical medical device (a wrist implant).

The text primarily focuses on:

• Device Description: The components and materials of the wrist implant.
• Intended Use/Indications for Use: What the implant is designed to treat.
• Predicate Device Comparison: How it compares to previously cleared devices.
• Non-Clinical Testing: Specifically, tests related to MRI safety and compatibility (Magnetically Induced Displacement Force, Torque, RF-Induced Heating, Image Artifacts).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or specific performance metrics for an AI/ML device, as this information is not present in the provided document.

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The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.

The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.

The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:

• "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
• The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"

Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.

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The Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:

• Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures . involving osteopenic bone
• Pseudoarthroses in the proximal humerus .
• Osteotomies in the proximal humerus .

The Integra Proximal Humeral Fracture Plate System is composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The GT plate is designed to cover the greater tuberosity and is available in four-hole , seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system features 3.5mm locking, non-locking and lag screws, in addition to, 2.7mm locking screws. The Integra Proximal Humeral Fracture Plate System is a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws are made from stainless steel (SS 316L).

This document is a 510(k) premarket notification for a medical device (Integra Proximal Humeral Fracture Plate System), not a study evaluating software or an AI device. Therefore, the requested information (acceptance criteria, study details, human reader performance, ground truth, etc.) is not applicable and cannot be extracted from the provided text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use for regulatory approval. It explicitly states, "Clinical performance data were not necessary to support substantial equivalence."

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The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:

• Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
• Pseudoarthroses in the proximal humerus
• Osteotomies in the proximal humerus

The Ascension® ATLAS® Humeral Plate System will be composed of left and right humeral reconstruction plate implants in four-hole (HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will also feature 3.5mm locking, non-locking and lag screws and 2.7mm locking and non-locking screws.
The ATLAS® Humeral Fracture Plate will be a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws will be made from stainless steel (SS 316L).

The provided text describes a 510(k) premarket notification for the "Ascension® ATLAS® Humeral Fracture Plate System," a bone fixation appliance. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or advanced AI performance.

Therefore, many of the requested sections related to acceptance criteria for AI/diagnostic devices and detailed clinical study parameters (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable or extractable from the provided submission.

However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence.

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

Note: ASTM F382-99 is a standard specification for metallic bone plates, covering mechanical performance requirements like static bending strength and stiffness. The document does not provide the specific numerical acceptance values within ASTM F382-99, nor the exact numerical performance results of the device, only a statement of compliance.

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

Not Applicable/Not provided. The provided document describes non-clinical mechanical testing, not a clinical study involving a test set of patient data.

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

Not Applicable/Not provided. This information is relevant for clinical studies, particularly those involving diagnostic devices or AI, which is not the subject of this 510(k) summary.

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

Not Applicable/Not provided. This is relevant for clinical studies or studies using human expert review as ground truth.

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/Not provided. This is relevant for AI-assisted diagnostic devices, which is not the nature of the "Ascension® ATLAS® Humeral Fracture Plate System."

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

Not Applicable/Not provided. This is relevant for AI-based algorithms, which is not applicable to a bone fixation plate.

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

For the non-clinical mechanical testing, the "ground truth" is defined by the specifications and methodology outlined in the ASTM F382-99 standard for metallic bone plates. Compliance with this standard indicates acceptable mechanical performance.

8. The sample size for the training set

Not Applicable/Not provided. This device is a medical implant, not an AI algorithm that requires a training set.

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

Not Applicable/Not provided. As above, this device does not utilize AI/machine learning requiring a training set with established ground truth.

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The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:

• Painful degenerative metatarso-phalangeal joint change .
• Hallux rigidus stage 3 and 4 ◆
• Hallux valgus and hallux rigidus .
• Hallux limitus with painful arthrofibrosis .
• Revisions after moderate proximal phalanx resection .

The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.

The provided text describes the Ascension® MOVEMENT™ Great Toe System, a total arthroplasty device. The submission focuses on establishing substantial equivalence to predicate devices based on testing and geometrical comparison, rather than clinical performance or AI/software system evaluation. Therefore, many of the requested categories are not applicable to this submission.

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

1. Table of acceptance criteria and the reported device performance

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

Not applicable. The submission is for a medical device (great toe implant) and relies on mechanical testing and geometrical comparison, not a test set of data typically used for AI or diagnostic devices.

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

Not applicable. Ground truth for a test set is not relevant for this type of device submission.

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

Not applicable. Adjudication methods are not relevant for this type of device submission.

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-assisted diagnostic device.

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

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

7. The type of ground truth used

Not applicable in the context of clinical "ground truth" as typically defined for diagnostic or AI devices. The "ground truth" for this device's acceptance would be established by validated engineering and biomechanical testing standards for orthopedic implants.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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 Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
   Shoulder Hemiarthroplasty is also indicated for:
4. Ununited humeral head fractures.
5. Avascular necrosis of the humeral head.
6. Rotator cuff arthropathy.
7. Deformity and/or limited motion.
   The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.

The provided document is a 510(k) summary for a medical device (Ascension® Modular Total Shoulder System) and primarily focuses on establishing substantial equivalence to predicate devices through design, function, and laboratory testing. It does not describe a study involving a comparison of device performance against pre-defined acceptance criteria related to a specific diagnostic or clinical efficacy outcome that would typically apply to AI/ML or imaging devices.

Instead, the "acceptance criteria" and "study" in this context refer to the engineering and biocompatibility tests conducted to demonstrate that the new device is as safe and effective as the predicate devices. The "performance" being reported is the outcome of these engineering tests, not a clinical diagnostic performance.

Therefore, many of the requested categories in your prompt related to diagnostic studies (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable to this type of device submission.

Here's an adaptation of your requested table and information based on the content available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted to demonstrate the device meets the acceptance criteria was primarily a series of benchtop engineering tests and a geometrical comparison to establish substantial equivalence with legally marketed predicate devices.

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

• Test Set Sample Size: Not applicable in the context of human subjects or imaging data. The "sample size" refers to the number of device components or assemblies tested for each engineering test. Specific numbers were not provided in the summary, but standard engineering practices would dictate sufficient samples for valid statistical analysis for each test type.
• Data Provenance: The data originates from laboratory testing performed by or for Ascension Orthopedics, Inc. The location of the testing facility is not specified, but it's internal to the device development and regulatory submission process. It is prospective in the sense that these tests were specifically designed and executed for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is determined by engineering specifications, material properties, and established test standards (e.g., ASTM or ISO standards for orthopedic implants), not by clinical experts interpreting data.

4. Adjudication method for the test set: Not applicable. The "adjudication" is based on objective measurements and comparison against predefined engineering performance limits or performance of predicate devices, not on expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for an orthopedic implant's substantial equivalence submission based on mechanical testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not done. This concept is specific to AI/ML algorithms, not to mechanical orthopedic implants.

7. The type of ground truth used:

• Engineering Specifications: Performance standards derived from industry norms (e.g., ISO, ASTM for orthopedic implants) and the known performance characteristics of the predicate devices.
• Predicate Device Performance: The primary "ground truth" for showing substantial equivalence is the established safety and effectiveness profile of the predicate devices (Smith & Nephew/PLUS PROMOS Modular Shoulder System and Osteonics' All Polyethylene Glenoid Shoulder Keeled Components). The new device's performance in mechanical tests is compared against that of these predicates.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission. The design and manufacturing process are analogous to "training" in the sense of refinement and optimization, but not in the data-driven AI sense.

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

In summary, this 510(k) submission is for an orthopedic implant, where substantial equivalence is demonstrated through engineering characterization and comparison to predicate devices, rather than through clinical diagnostic performance studies typically associated with AI/ML or imaging devices. Therefore, many of your specific questions are not relevant to the type of data presented in this document.

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The Ascension® Ankle Fusion Nail System is intended for the following:

• . Charcot Foot
• Avascular necrosis of the talus .
• Failed total ankle arthroplasty .
• . Trauma (malunited tibial pilon fracture)
• Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
• . Revision ankle arthrodesis
• . Neuroarthropathy
• . Rheumatoid arthritis
• Osteoarthritis .
• Pseudoarthrosis .
• Post-Traumatic arthrosis .
• Previously infected arthrosis .
• Severe end stage degenerative arthritis t
• Severe defects after tumor resection .
• Pantalar arthrodesis .

The Ascension® Ankle Fusion Nail System is to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared for correction of deformity, or arthodesis.

The Ankle Fusion Nail System consists of nails, screws and an end cap. The standard nails are offered in three diameters and 3 lengths (150mm, 180mm and 210mm). Longer lengths up to 460mm will be made upon request. Fixation screws consist of one diameter and 27 lengths, and an end cap offered in one size. All three implant components will be manufactured from titanium 6AL-4V.

The provided text describes a 510(k) submission for the "Ascension® Ankle Fusion Nail System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a novel device might.

Therefore, the study described does not involve a traditional "acceptance criteria" and "device performance" in the sense of a diagnostic or AI device study. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence, and the "study" is an engineering analysis comparing the new device to predicates.

Here's a breakdown of the requested information based on the provided text, acknowledging the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the context of this 510(k) submission. There was no "test set" of patient data in the clinical study sense. The "study" was an engineering analysis comparing the physical characteristics of the device to its predicates. Data provenance, therefore, refers to the design specifications and material properties of the devices, not patient data.

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

Not applicable. No ground truth based on expert clinical assessment was established for a test set. The assessment relied on engineering principles and comparison to existing, cleared devices.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication by experts.

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

No. An MRMC study was not conducted as this is a device clearance based on substantial equivalence, not a comparative clinical effectiveness study of different clinical interventions or diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not a software algorithm device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profile of the legally marketed predicate devices. The new device's material properties, design, and mechanical performance (specifically bending strength) were compared against these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There was no patient-based "training set" for an algorithm or clinical model.

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

Not applicable. As there was no training set, this information is irrelevant to this submission. The "ground truth" for the equivalence assessment was based on the physical and mechanical properties of the predicate devices themselves, which were presumably cleared based on their own safety and performance data.

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The Ascension Ankle Fusion Plate System is intended for the following:

• Arthrodesis of the ankle joint and distal tibia
• Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

The Ascension® Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a maior thread diameter of 4.5 or 6.5mm. All plates and screws will be manufactured from stainless steel or titanium.

This document describes a 510(k) premarket notification for a medical device, the Ascension® Ankle Fusion Plate System. It is focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing primary performance through a new clinical or non-clinical study against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically seen in performance studies for novel devices or AI algorithms, is not applicable in this context.

Here's why and what the document does provide:

1. Acceptance Criteria and Reported Device Performance: Not applicable. The submission is based on substantial equivalence, meaning the new device is deemed safe and effective because it is essentially the same as a device already legally marketed. There are no performance metrics or acceptance criteria presented as there would be for a de novo device or a device requiring new clinical evidence.

2. Sample Size used for the test set and data provenance: Not applicable. No new test set data was generated or analyzed for this 510(k) submission. The equivalence is based on comparison of design, materials, and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment was used.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 surgical implant (plate system), not an AI algorithm.

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

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

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

What the document does state regarding verification:

The document explicitly states: "Due to the similarity of materials and design to both pre-enactment and postenactment devices, it is believed that the Ankle Fusion Plate System does not raise any new safety or effectiveness issues and does not require any nonclinical testing. A comparison of dimensions/sizing addressing worst-case plates between the Ascension Ankle Fusion Plate System and the predicate devices was presented to support substantial equivalence."

This indicates that the "study" demonstrating the device meets the "acceptance criteria" (which in this case is substantial equivalence) involved a comparison of dimensions/sizing of the new device to existing predicate devices. However, the specific data from this comparison is not provided in this summary. The "acceptance criteria" for substantial equivalence are qualitative: "similar in design, materials and indications" and "does not raise any new safety or effectiveness issues." The "study" was a non-clinical engineering comparison of physical attributes to demonstrate these similarities, not a performance study against specified quantitative criteria.

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The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemi-arthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:

• Hallux valgus or Hallux limitus
• Hallux rigidus
• Unstable or painful metatarsal/phalangeal (MTP) joint

The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The components are anatomically designed, monolithic devices designed for resurfacing of the head of the 1st metatarsal or the phalangeal (MTP) joint. The devices are made from cobalt chromium alloy with a commercially pure titanium plasma spray. These devices are intended as hemi-arthroplasties at either surface and are press-fit.
Each device is boxed individually and delivered sterile for single use.

This 510(k) summary for the "Ascension® Metal Great Toe System" does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a submission to the FDA for premarket notification, seeking substantial equivalence to already legally marketed predicate devices. The basis of substantial equivalence is stated as: "There are no significant differences between the Ascension Metal Great Toe System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

This type of submission typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than providing a detailed study with acceptance criteria for device performance. Performance data, if any, for demonstrating equivalence would usually be comparative to the predicate devices and might not be presented in the format of "acceptance criteria" and "reported device performance" against those criteria in the summary.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory approval through substantial equivalence, not on specific performance studies with acceptance criteria.

Information not available in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

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