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The PROMO is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

The PROMO is based on predicate device TOPAZ and the x-ray detectors are the same as the predicate system. The PROMO is moved smoothly with manual by user. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator with excellent performance, lifetime and stability. Digital flat panel detector with CsI screen provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator which have worldwide reputation on excellent performance, lifetime and stability. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. The PROMO include imaging software that is the RADMAX. The RADMAX software can perform processing the radiological image acquired from solid state x-ray imaging device. The RADMAX software is based on predicate device TOPAZ. The CTR function is a manual quantitative imaging feature that allows users to measure the cardiothoracic ratio by manually selecting points using a mouse. The software function has been verified and validated as safe and effective.

The provided FDA 510(k) clearance letter and summary for the PROMO Mobile X-ray System do not contain information about specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a clinical study that proves the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TOPAZ) through non-clinical performance testing and compliance with various recognized standards and guidance documents. It confirms that the device's image performance was evaluated through bench testing.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's an breakdown of what can and cannot be answered based on the provided document:

Information that CANNOT be provided from the document:

• 1. A table of acceptance criteria and the reported device performance: The document mentions "bench testing was conducted to evaluate the image performance of the detector" and that "PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution." However, it does not provide specific numerical acceptance criteria for these metrics nor the quantitative reported performance of the device against them.
• 2. Sample size used for the test set and the data provenance: Since no clinical study or specific test set with patient data is described, this information is not available. The "test set" mentioned refers to non-clinical bench testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study involving expert interpretation is detailed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study involving expert interpretation is detailed.
• 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. The PROMO is a mobile X-ray system, not an AI diagnostic tool, and the document does not describe any MRMC studies. The "CTR function" mentioned is a manual measurement tool, not an AI feature for diagnostic assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device itself is the imaging hardware, not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing mentioned, the "ground truth" would be objective physical measurements of image quality parameters (e.g., standard phantoms for linearity, resolution, etc.). The document does not describe clinical ground truths.
• 8. The sample size for the training set: The document does not describe any machine learning or AI models with a "training set."
• 9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

Information that CAN be inferred or directly stated from the document (regarding non-clinical testing and general acceptance):

The document implicitly defines "acceptance criteria" by stating compliance with recognized national and international standards for medical electrical equipment, radiation protection, usability, software life cycle, risk management, and cybersecurity. The "study" that proves the device meets these (non-clinical) acceptance criteria is the bench testing and verification/validation processes conducted according to these standards.

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

Summary regarding the device performance study:

The PROMO Mobile X-ray System's substantial equivalence to its predicate (TOPAZ) and its safety and effectiveness are established through non-clinical performance testing (bench testing). This testing focused on comparing technical specifications and image quality metrics against the predicate and ensuring compliance with a comprehensive set of international and FDA-recognized standards and guidance documents. The document explicitly states: "Bench testing was conducted to evaluate the image performance of the detector. The results showed that PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution. Therefore, the substantial equivalence in image quality performance is supported by objective bench testing data."

Type of ground truth used (for bench testing):

For the non-clinical bench testing, the ground truth would be established by objective physical measurements using standardized phantoms and test objects to assess imaging characteristics (e.g., bar patterns for spatial resolution, step wedges for linearity, uniform fields for uniformity).

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Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular etiologies
• Full-thickness & partial thickness wounds
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds.

Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Partial-thickness burns
• Traumatic wounds healing by secondary intention
• Dehisced surgical wounds.

Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.TM Negative Pressure Wound Therapy.

3MTM Promogran Prisma™ is comprised of a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC), 55% collagen and 1 % silver ORC. Silver ORC contains 25% w/w ionically bound silver.

It is a primary dressing that can be cut with scissors to fit the wound and used in combination with either a semiocclusive or non-occlusive secondary dressing. The dressing is hexagonal in shape, provided in two sizes (28 cm² and 123 cm²) that are packaged in a hexagonal thermoformed tray and sterilized by gamma irradiation.

As described in the product labeling, when used with the ActiV.A.C.TM Negative Pressure Wound Therapy System, seven slits are cut into the 3M™ Promogran Prisma™ by the health care provider before applying the dressing and the components of the ActiV.A.C.™ Negative Pressure Wound Therapy System.

After reviewing the provided document, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested.

The document is an FDA 510(k) clearance letter and its associated summary for the PROMOGRAN PRISMA Matrix wound dressing. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and performance data for an AI/ML-driven medical device.

Here's why the requested information cannot be extracted:

• Device Type: PROMOGRAN PRISMA Matrix is a wound dressing, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system.
• Study Focus: The "Performance Data" section (page 11) explicitly states:
  • "Summary of non-clinical tests conducted for determination of substantial equivalence": This refers to biocompatibility and bench studies for the physical dressing and its compatibility with Negative Pressure Wound Therapy, not an algorithm's performance.
  • "Summary of clinical tests conducted for determination of substantial equivalence": This states "No clinical tests were necessary to demonstrate acceptable use of the Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy." It mentions a "human factors engineering assessment" with 30 subject nurses and doctors to ensure changes to labeling for combined use are safe and effective. This is not a study proving an AI/ML device's diagnostic performance.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, image analysis, diagnostic performance metrics (e.g., sensitivity, specificity, AUC), ground truth establishment by experts, test sets, training sets, or MRMC studies, all of which are pertinent to AI/ML device evaluations.

Therefore, the requested tables and details pertaining to AI/ML device acceptance criteria and performance studies are not present in this document. The document describes a traditional medical device's clearance process based on substantial equivalence.

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The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:

• Relining a denture surface that contacts tissue ●
• Repairing a fractured denture, or
• Forming a new denture base

Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
• Promolux: A heat processed PMMA denture base resin
• Promolux Hi: A heat-processed PMMA denture base resin formulated for greater strength
· Weropress: A two part cold curing PMMA denture base resin
: PremEco PCS: A two part cold curing PMMA denture base resin with individual tints for aesthetic coloration of gingival portion of a denture base
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.

This document is a 510(k) Summary for Merz Dental GmbH Denture Base Resins with Prosthetic Color System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a medical imaging AI would. Therefore, many of the requested categories (e.g., sample size for test/training, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this type of submission.

Here's a breakdown of the available information:

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

The acceptance criteria are that the device materials meet the requirements of two international ISO standards for denture base polymers. The reported device performance is that the materials met these standards.

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

This information is not provided in the document. Performance testing for material properties typically involves laboratory-controlled testing of material samples, not patient data. The provenance for such tests would usually be the testing laboratory, which is not specified beyond being performed by the manufacturer.

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/provided. Ground truth, in the context of this 510(k), refers to material property measurements against established international standards (ISO). This typically involves laboratory technicians and machinery, not clinical experts establishing a ground truth from patient data.

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

This information is not applicable/provided. Adjudication methods are relevant for clinical assessments, especially in cases where human readers are establishing ground truth from medical images. For material property testing, the measurements are objective.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation, which is not the subject of this 510(k) submission.

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

This information is not applicable. This submission details physical material properties of denture resins, not the performance of an algorithm.

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

The "ground truth" for the material performance testing was based on references to international standards (ISO 1567:2000, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). The materials were tested to ensure they met the specified requirements in these standards for physical and biological properties.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of material property testing for denture resins. The submission focuses on demonstrating that the final product meets specified standards.

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

This information is not applicable/provided. As there is no training set, there is no ground truth established for one.

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Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.

The provided text describes the device "Callos ProModel Bone Void Filler" and its regulatory clearance process, including summaries of non-clinical tests. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in human patients, as would be expected for a device with a focus on AI performance or clinical efficacy against measured outcomes.

Instead, the document states:

• "Callos ProModel does not meet the criteria to require clinical testing."
• "In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices."

This indicates that clearance was based on substantial equivalence to existing devices and non-clinical data, not on a clinical effectiveness study with defined acceptance criteria for patient outcomes.

Therefore, I cannot provide the requested table and information as the document does not contain the specific details about acceptance criteria, device performance against those criteria, or a qualifying clinical study.

Based on the provided text, the following points can be addressed, but the core request for acceptance criteria and a study proving their fulfillment cannot be fully met:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical effectiveness study in the provided text. The criteria are implied to be "substantial equivalence" to predicate devices based on non-clinical data (biocompatibility, bench testing, animal study).
   • Reported Device Performance:
     • "Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices."
     • "radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006."
     • "Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use." (Specific numerical performance metrics are not provided).
     • "The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use." (Specific outcome data or statistical comparisons are not provided).

2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" (human patient data) is described in the context of proving efficacy against acceptance criteria. The non-clinical studies involved bench testing (materials, mechanical properties) and an animal model. The sample size for the animal study is not specified, nor is the provenance of the animals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of clinical cases is described for establishing ground truth, as no clinical effectiveness study requiring such review was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical "test set" requiring adjudication by multiple experts is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a bone void filler, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this device.

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

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

   • For biocompatibility: Adherence to ISO standards.
   • For sterilization: Compliance with ANSI/AAMI/ISO standards.
   • For bench testing: Comparison to predicate device performance (implied physical/mechanical properties). The "ground truth" would be objective measurements of these properties.
   • For animal study: Biologic response compared to predicate devices in a large animal model. "Ground truth" would likely involve histological assessment, imaging, or gross observation of bone healing and integration in the animals, as interpreted by veterinary or pathological experts.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set. The "development" would involve material science and engineering, not machine learning.

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

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The Promos Modular Shoulder System is indicated for:

• Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or . inflammatory arthritis '
• Avascular necrosis of the humeral head o
• Complex fractures of the proximal humerus
• Complex freetarse of the precially in the case of post-traumatic loss of the joint configuration .

The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only

The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.

The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.

The provided document describes a 510(k) premarket notification for the Promos Modular Shoulder System. This notification focuses on modifications to the inclination set components of an already cleared device, intended to increase overall strength and stability. The submission highlights mechanical testing as the basis for demonstrating safety and effectiveness, and no clinical data or studies comparing AI to human performance were conducted as this is a device modification submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." Specific quantitative acceptance criteria or threshold values for the mechanical tests are not detailed in this summary.

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

• Sample Size: The document does not specify the exact sample size (number of units tested) for each mechanical test. It generally refers to "mechanical data" and "mechanical testing."
• Data Provenance: The data is generated from retrospective mechanical testing performed on the modified Promos Modular Shoulder System components. The country of origin for the testing data is not explicitly stated but is implicitly within the scope of Smith & Nephew's internal development and testing processes, likely in the US or where their manufacturing/R&D facilities are located.

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

• Not Applicable. This submission is for a medical device modification based on mechanical performance, not a diagnostic or AI-driven system requiring expert assessment of a test set for ground truth. The "ground truth" here is the physical performance of the device against engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there is no expert-adjudicated test set in the context of this 510(k) submission. Mechanical test results are interpreted against established engineering principles and standards.

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

• No. A MRMC comparative effectiveness study was not conducted. This is a submission for a mechanical device modification, not a diagnostic or AI-assisted system. No human readers or AI assistance are involved in the performance evaluation described.

6. Standalone (Algorithm Only) Performance Study

• No. A standalone performance study of an algorithm was not conducted. This submission pertains to a physical medical device.

7. Type of Ground Truth Used

• Engineering Standards and Mechanical Properties. The ground truth for evaluating the device's performance is based on established engineering principles, material properties, and mechanical test standards (e.g., ISO 5832-3 for Ti-6Al-4V material). The "review of mechanical data" against expected in vivo loading conditions serves as the basis for determining safety and effectiveness.

8. Sample Size for the Training Set

• Not Applicable. This is a mechanical device submission. There is no "training set" in the context of algorithm development. The design and manufacturing processes are iterative but do not involve machine learning training sets.

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

• Not Applicable. As per point 8, there is no training set for which ground truth would need to be established.

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To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

The UroVal BRS System is used to record and display electromyogram (EMG) signals. In addition, the BRS System will determine latency time intervals of the bulbocavernous reflex (BCR). The UroVal BRS System also has report generation capabilities. The UroVal BRS System uses a probe, with a single use disposable tip to evoke a BCR response, and activate recording and timing of EMG signals. The UroVal BRS System uses pregelled surface electrodes to monitor the muscle activity.

The UroVal BRS System is used to record and display electromyogram (EMG) signals and determine latency time intervals of the bulbocavernous reflex (BCR).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for the UroVal BRS System's performance in terms of specific EMG signal parameters or BCR latency measurements. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through conformity with recognized standards and a comparative clinical trial.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a clinical trial" but does not provide the number of participants or cases included in this trial.
• Data Provenance: The study was a "clinical trial," which implies prospective data collection. The country of origin for the data is not specified.

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

This information is not provided in the document. The study focuses on comparing the device's performance to a predicate device, not on establishing a new ground truth based on expert consensus. The "ground truth" implicitly would be the measurements obtained from the predicate device (CTS 2000).

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of comparing device measurements, a formal adjudication process involving multiple experts to resolve discrepancies in the test set ground truth would likely not be relevant, as the predicate device's output serves as the reference.

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

• Was an MRMC study done? No, the document describes a clinical trial comparing the UroVal BRS System to the CTS 2000 ("The UroVal BRS System performance was compared to the CTS 2000 in a clinical trial"). This is a device-to-device comparison, not an MRMC study evaluating human reader performance with and without AI assistance.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an MRMC study with AI assistance.

6. Standalone (Algorithm Only) Performance:

• Was standalone performance done? Yes, the clinical trial compared the UroVal BRS System (algorithm/device only) directly against the predicate device (CTS 2000), which can be considered a standalone assessment of its measurement capabilities. The comparison concluded that the UroVal BRS System "performs safely and effectively, and is substantially equivalent to the predicate devices."

7. Type of Ground Truth Used:

The ground truth used for the comparison was the performance of a legally marketed predicate device, specifically the CTS 2000. This implies that the measurements (EMG signals, BCR latency) obtained from the CTS 2000 were considered the reference "truth" against which the UroVal BRS System's measurements were compared.

8. Sample Size for the Training Set:

This information is not provided. The document describes a medical device, not a machine learning or AI algorithm that would typically have a separate training set. The UroVal BRS System itself performs the measurements.

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

Not applicable, as there is no mention of a separate training set for an AI algorithm. The device's underlying principles are based on established physiological measurements and comparisons to existing, validated devices.

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The PROMOS 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The humeral stem and body components are intended for cementless use.

The implants of the PROMOS Reverse Shoulder System are single use device

Subject of this Traditional 510(k) premarket notification is the PROMOS Reverse Shoulder System. The glenohumeral articulation of the Promos Reverse Shoulder is inverted - when compared to traditional total shoulder prostheses. Unlike traditional fotal shoulder prostheses, the Promos Reverse Shoulder is designed so that the "ball" component of the shoulder is assembled to the glenoid baseplate and the "cup" component is assembled onto the humeral stem.

I am sorry, but I cannot provide the requested information because the document describes a medical device (PROMOS Reverse Shoulder System), not an AI/ML-driven device.

The document discusses the regulatory approval (510(k)) of a prosthetic shoulder system. It details the device's description, intended use, and substantial equivalence to existing predicate devices. However, there is no mention of any AI or machine learning component, nor any study involving performance metrics like sensitivity, specificity, or AUC, which would be relevant for establishing acceptance criteria for an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they pertain to an AI device's performance, is not available in the provided text.

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The PROMOS Modular Shoulder System is indicated for:

• Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis
• Avascular necrosis of the humeral head
• Complex fractures of the proximal humerus
• Functional impairment especially in the case of post-traumatic loss of the joint configuration
  The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.

The modified PROMOS® Modular Shoulder System is intended to aid in the restoration of shoulder motion and elimination of pain. This device consists of two primary components, the glenoid component and the modular humeral component. The changes to the PROMOS® Shoulder that resulted in the modified PROMOS® Shoulder and are subject of this 510(k) include:

• Addition of size 3.5 humeral stem, cementless .
• Addition of six humeral ball heads R21 R26, with 4 mm eccentricity .
• Redesign of body and inclination set to add face gear to area between . inclination set and body
• Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm .
• Various labeling changes .
  The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
  The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper.
  The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
  The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw.
  The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities.
  Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.

This document describes the 510(k) Premarket Notification for the PROMOS® Modular Shoulder System. The submission focuses on modifications to an existing device, K032126. It is a traditional 510(k) and primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards and design controls rather than extensive clinical studies or acceptance criteria defined in terms of device performance metrics like sensitivity/specificity.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI/software device, because it is a submission for a physical medical device (shoulder prosthesis). Instead, the acceptance criteria are related to compliance with established standards for materials, sterility, and design controls for mechanical devices.

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

This is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/software performance study. The data provenance refers to materials (e.g., titanium alloy, UHMWPe) and the design files, not a clinical dataset. The testing performed is bench testing (e.g., mechanical, material characterization), not a study on patient data.

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

This is not applicable. Ground truth, in the context of an AI/software device, refers to a definitive answer derived from expert review or a gold standard. For this physical device, "ground truth" relates to the specification of material properties and design requirements, which are established by engineering standards and internal design teams, not by medical experts reviewing a test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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

No. This is a physical orthopedic implant, not an imaging analysis or diagnostic AI device. An MRMC study is designed to assess the performance of human readers, with and without AI assistance, on a set of clinical cases. This type of study is not relevant to the evaluation of a shoulder prosthesis.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating performance is based on:

• Engineering Standards: Compliance of materials (UHMWPe, Ti6Al4V, CoCrMo) with recognized ISO standards (e.g., ISO 5834-2, ISO 5832-3, ISO 5832-12).
• Sterilization Standards: Compliance with AAMI/ANSI/ISO 11137 for radiation sterilization.
• Design Controls: Verification and validation activities performed as per FDA's Design Control Requirements (21 CFR Part 820.30), which would involve testing against predefined engineering specifications and functional requirements.
• Predicate Device Comparison: Establishing substantial equivalence by comparing technical characteristics and indications for use to the legally marketed predicate device (K032126).

8. The Sample Size for the Training Set

This is not applicable. There is no AI/machine learning algorithm involved that would require a "training set."

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

This is not applicable for the reasons stated above.

In summary:

This 510(k) submission is for modifications to a physical orthopedic implant. The "acceptance criteria" and "studies" are focused on demonstrating manufacturing quality, material compatibility, and engineering performance through adherence to recognized standards and bench testing, rather than clinical performance metrics typically associated with AI or diagnostic devices. The core of the submission relies on establishing substantial equivalence to a previously cleared predicate device based on these engineering and material considerations.

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For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only, Not to be used with heat.

The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.

This document describes the regulatory submission for the "i-Promotions Contact Lens Case" and does not contain information about the acceptance criteria or a study that proves a device meets such criteria in the context of advanced medical technologies or AI/ML.

The provided text focuses on the device's classification, intended use, and summary of safety testing carried out for regulatory clearance. It benchmarks the device against predicate devices based on design and materials, rather than performance metrics.

Therefore, I cannot provide the information requested in your bullet points (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details) because the document does not discuss these aspects in the context of device performance or clinical studies. The "Summary of Safety Testing" section only mentions cytotoxicity testing to demonstrate the product is safe for its intended use, but doesn't provide specific performance acceptance criteria or detailed study results beyond a general statement of safety.

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The PROMOS® Shoulder is indicated for:

• Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis
• Fracture or avascular necrosis of the humeral head
• Post-traumatic loss of joint configuration, especially in the case of functional impairment
• Humerus fracture
  The humeral component is intended for cemented or cementless use.
  The glenoid component is for use with bone cement only.

The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.

This document is a 510(k) summary for the PROMOS® Shoulder device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The "Summary Non-clinical Tests" section briefly states: "The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading." This is a very high-level statement and does not provide quantifiable acceptance criteria or detailed results of the study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you're looking for (performance metrics, study details, sample sizes, etc.) is typically found in the full 510(k) submission, not in the summary document.

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