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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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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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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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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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Promotor Final Rinse Sperm Wash is to be used as a sperm processing medium in washing procedures and for transport of sperm during reproductive technology procedures.

Not Found

I am sorry, but the provided text is a set of FDA letters regarding a product called "Promotor Final Rinse Sperm Wash Medium" and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval letter, not a clinical study report. Therefore, I cannot fulfill your request based on the given input.

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Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

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This document is a 510(k) clearance letter from the FDA for a device called "Promotor Regulation Number: 21 CFR 884.6180". It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document primarily focuses on the regulatory clearance and the administrative details of the approval process.

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PROMOGRAN Matrix Wound Dressing is intended for the management of exuding wounds including:

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

PROMOGRAN Matrix Wound Dressing is a sterile primary dressing comprised of a freeze-dried composite of 55% collagen and 45% oxidised regenerated cellulose. (Ratios are presented as weight-to-weight).

This document is a 510(k) summary for the PROMOGRAN Matrix Wound Dressing. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any of the specific details requested in the prompt (e.g., sample sizes, expert qualifications, ground truth methods, or MRMC studies).

The document is a regulatory submission for premarket notification, focusing on establishing equivalence for marketing purposes. It highlights biocompatibility studies showing the device to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic, but these are general safety assessments, not performance criteria with associated studies as requested.

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