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The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.

The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.

The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.

The provided text describes the 510(k) premarket notification for the "Bone Bolt System." It outlines the device's indications for use, description, predicate devices, materials, and performance data. However, the document does not contain information about a study proving the device meets acceptance criteria related to an AI/machine learning model.

The performance data section explicitly states: "No clinical or animal testing was conducted." The performance characterization was based on in vitro mechanical testing (Torsional Strength Testing, Driving Torque Testing, Axial Pull-out Strength Testing, Static and Dynamic Bending Testing) according to ASTM standards.

Therefore, I cannot fulfill the request to provide the detailed information about an AI/ML study, including:

1. A table of acceptance criteria and reported device performance (for an AI/ML model)
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and qualifications
4. Adjudication method for the test set
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
6. Standalone (algorithm-only) performance
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How ground truth for the training set was established

The document describes a traditional medical device (metallic bone fixation fastener) and its clearance based on substantial equivalence to predicate devices, supported by in vitro physical performance data. The questions posed are highly relevant to the evaluation of AI/ML-based medical devices, but this document does not pertain to such a device.

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Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.

The provided text describes the regulatory clearance of an orthodontic device called "Archworx." It details the device's intended use, manufacturing process, and comparison to a predicate device for substantial equivalence. However, the document does not contain information about the acceptance criteria and the results of a study (especially a clinical or AI-related study) that proves the device meets those criteria.

Specifically, the document mentions:

• Biocompatibility testing: "Biocompatibility testing was conducted...and that the device met the acceptance criteria for all tests." It does not specify what these criteria were or provide the results.
• Bench Performance Testing: "Physical properties testing was conducted, and testing information was obtained from the material manufacturer. All the physical properties testing met the pre-specified acceptance criteria." Again, the criteria and results are not detailed.
• Verification and Validation Testing: "Yes, Performed. For 3 different patient cases, aligners were evaluated at 3 different points through the sequence for each sequence point, 3 critical dimensions based on intended positions of these critical tooth structures. Testing indicated the aligner designed in the software meets the planned location, positions and all dimensions as expected; and as prescribed." This is the closest to study results, but it's very high-level and lacks specific quantitative data or acceptance criteria. It also doesn't fit the typical structure of an AI/human-in-the-loop study.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

The information provided is largely for a 510(k) submission for a physical medical device (orthodontic aligners), not an AI/ML-driven device that would necessitate the study details inquired about. The only software mentioned is "3Shape Ortho System Software (K180941)" which is used for scanning and designing models, implying it's a tool used in the manufacturing process rather than an AI-driven component of the "Archworx" device itself that requires clinical performance validation as per the prompt's implied context (e.g., diagnostic AI).

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The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.

The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

This document is a 510(k) premarket notification for the UTAH CVX-RIPE™ cervical ripening balloon catheter. It asserts substantial equivalence to a predicate device, the Cook® Cervical Ripening Balloon (K131206).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical or performance targets in a tabular format that is typically expected for, say, diagnostic accuracy or predictive power. Instead, it lists mechanical performance tests and states that the device successfully met the requirements of these tests.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance tests mentioned are mechanical/bench tests. For these mechanical tests, the sample sizes are not explicitly stated. The document does not refer to any human-patient data collection (retrospective or prospective) for this 510(k) submission, as it relies on substantial equivalence to a predicate device based on similar intended use and technological characteristics, supported by bench testing. Therefore, there is no information on data provenance (e.g., country of origin).

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

This information is not applicable and not provided. The "test set" here refers to mechanical performance tests, not clinical data requiring expert human assessment for ground truth.

4. Adjudication Method for the Test Set:

This is not applicable as the "test set" refers to mechanical performance tests, not a clinical study involving human readers or adjudicators.

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

This type of study was not done. The submission is for a mechanical medical device (a balloon catheter), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical medical device, not a software algorithm.

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

For the mechanical performance tests, the "ground truth" would be the engineering specifications and expected physical behavior validated through laboratory testing. For example, for "Balloon Deflation Reliability," the ground truth is simply whether the balloons did, in fact, deflate properly according to specified parameters. There is no biological or patient-related "ground truth" in this context.

8. The sample size for the training set:

This is not applicable. There is no machine learning or AI component to this device that would require a "training set." The training referenced in the document would be for healthcare professionals on how to use the device, not a dataset for an algorithm.

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

This is not applicable for the reasons stated in point 8.

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The FINESSE+ and FINESSE II+ are intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the FINESSE+ and FINESSE II+ systems is Loop Excision of the Transformation Zone (LETZ®).

The Finesse 3rd Generation combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single compact unit. This integrated system is designed to perform low-power excision and coagulation procedures of short duration. The Finesse 3rd Generation is comprised of two models: FINESSE+ and FINESSE II+. The FINESSE II+ is identical to the FINESSE+, but does not have as many user adjustable features.

The provided text is a 510(k) summary for the Utah Medical Products, Inc. Finesse 3rd Generation electrosurgical and suction unit. This document focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, the supplied text does not contain information typically found in a clinical study report for AI/ML-enabled devices. Specifically, it does not include details on:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• A test set sample size, provenance, or how ground truth was established for AI/ML performance evaluation.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm-only performance.
• Training set sample size or ground truth establishment for a training set.

The performance data mentioned in the document states:

"Laboratory testing was conducted to certify the Finesse 3rd Generation's compliance with the requirements of ANSI / AAMI ES 60601-1:2005, AAMI / ANSI / IEC 60601-1-2:2007, and ANSI / AAMI / IEC 60601-2-2:2009. The operating principle of the Finesse 3rd Generation is identical to the predicate device."

This indicates that the acceptance criteria and study proving device performance are based on compliance with electrical safety and electromagnetic compatibility standards for electrosurgical devices, rather than performance metrics for an AI/ML algorithm.

Given the information provided, it is not possible to fill out the requested table or answer the specific questions about AI/ML device performance or clinical study details. The device described is an electrosurgical unit, not an AI/ML-enabled medical device requiring a study of AI performance.

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The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.

The UTA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA are placed on top of implants to protect the inner components of the implants throughout the healing phase. UHA creates support for gingival architecture and can be used with cement-retained temporary prostheses. It should be placed in non occlusal loading. It can be used for up to 180 days.

The UHA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.

1. Table of Acceptance Criteria and Reported Device Performance

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BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BT-Cath device:

1. Table of Acceptance Criteria and Reported Device Performance

• Relationship of volume of saline infused into the balloon and resulting balloon diameter.
• Burst volume of the balloon.
• Ability of the balloon to hold its shape and not leak during repeated and prolonged inflations. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the balloon, matching the predicate.) |
  | Mechanical Integrity - Catheter | Structural integrity of the catheter using leak tests. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the catheter, matching the predicate.) |
  | Tensile Strength | Tensile strength in each joint in the devices. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the tensile strength requirements for joints, matching the predicate.) |
  | Clinical Performance/Safety | Device consistently achieving its intended purpose without reported likelihood of patient injury. | "Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury." (This is presented as evidence of field performance meeting the safety and efficacy expectations.) |

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

• Sample Size: "about 840 uses"
• Data Provenance: "U.S. clinicians" (prospective, real-world clinical feedback after deployment, rather than a controlled test set from a formal clinical trial for pre-market submission directly).

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

• The document mentions "U.S. clinicians" providing feedback. It does not specify a number of experts or their qualifications for establishing a ground truth in the context of a controlled test set with expert consensus. The feedback provided is general clinical observation rather than a structured expert review of specific cases.

4. Adjudication Method for the Test Set

• No formal adjudication method is described. The "clinical feedback" appears to be an aggregation of observations from multiple clinicians.

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 MRMC comparative effectiveness study was done, nor is AI involved with this device. This is a medical device, specifically a balloon tamponade catheter, not an AI/software-as-a-medical-device (SaMD).

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

• Not applicable as this is a physical medical device and does not involve an algorithm.

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

• The "ground truth" for the clinical performance assessment seems to be real-world clinical outcomes and observations as reported by clinicians using the device. This is more akin to post-market surveillance data contributing to a pre-market submission, rather than a pre-defined ground truth for a structured clinical trial.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

• Not applicable as this is a physical medical device.

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The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

UHC APL is the compression sleeve component of a non-invasive external compression system consisting of a pump/controller, connecting tube and limb sleeve/garment device.

The provided text describes the 510(k) premarket notification for the University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device. The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices, specifically the Healthcare Service and Supply ALP® Alternating Leg Pressure Garment (K000303), after being reprocessed multiple times.

Here's an analysis of the acceptance criteria and the study as per the request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It mentions "reprocessed sleeve device six (6) times" for bladder function and safety/efficacy testing. This implies at least one device was reprocessed six times and tested after each reprocessing cycle, or multiple devices were tested after six reprocesses. However, the exact number of individual sleeve devices tested is not specified.

The data provenance is retrospective in the sense that it's comparing a reprocessed device to an already marketed new device. The testing itself would have been prospective to generate the new data for the reprocessed device. However, the origin of the data (e.g., country) is not specified beyond being submitted by the University of Utah Hospitals and Clinics in Salt Lake City, UT, USA.

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

This information is not provided in the document. The study focuses on technical performance testing (e.g., bladder function, biocompatibility, cleaning efficacy) rather than diagnostic accuracy involving expert interpretation. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., for image interpretation) does not apply here.

4. Adjudication Method for the Test Set

This information is not applicable for this type of technical performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers provide interpretations (e.g., diagnostic image reading), and disagreements need to be resolved. This study involves objective laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable. This submission is for a medical device (compression sleeve) and its reprocessing, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this context.

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

This information is not applicable as this is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The ground truth used for comparison is the performance and characteristics of the new, original ALP® sleeve device (K000303), which is the predicate device. This is a form of "predicate performance" or "established equivalent performance." For instance:

• For bladder function: The performance of new ALP® sleeves.
• For biocompatibility: The known biocompatibility profile of the predicate device.
• For cleaning efficacy: The cleanliness/TOC levels of new sleeves or an established acceptable limit.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the development and validation of the reprocessing protocol itself, but a "training set" in the computational sense is not relevant.

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

This information is not applicable for the reasons stated in point 8.

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TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.

TVUS (SIS) with saline infusion:

• persistent abnormal or dysfunctional uterine bleeding .
• suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps)
• . thickened or irregular endometrium
• recurrent pregnancy loss t
• pre- and post-operative assessment of uterine pathology . HSG with contrast media:
  • unexplained infertility .
  • recurrent pregnancy loss

Not Found

The provided document is a 510(k) summary for the TVUS/HSG-Cath™ Saline/Contrast Media Infusion Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the 510(k) summary (specifically Section 9 from the first page) indicates that the device's substantial equivalence is based on its similarity in intended use, indications for use, and technological characteristics to a predicate device, the "H/S Elliptosphere Catheter, (K013972) ACKRAD Laboratories, Inc."

The document details the intended use and indications for use of the TVUS/HSG-Cath™, which are consistent with the predicate device. For devices seeking 510(k) clearance, the primary "proof" that the device is safe and effective is its substantial equivalence to a legally marketed predicate device, not typically a de novo clinical study against specific performance acceptance criteria like those outlined in the request.

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The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: *valgus, varus or flexion extension deformities of the knee (femur and/or tibia) *valgus, varus or plantar flexion deformities of the ankle *valgus or varus deformities of the elbow (humerus) *radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

The two hole plate features a contoured waist and low profile for pediatric usage. There is a center hole for accurate application of the plate over a temporary guide pin. This is to facilitate precise and reproducible placement of the implant relative to the adjacent growth plate that is localized radiographically.. The plate is available in two sizes (small / large) to accommodate the variations of bone size and geometry. It is transfixed to the bone using two parallel cannulated titanium screws. The Guided Growth Plate is made out of titanium which is (by design) flexible and compatible with both radiographic imaging and MRI.

The provided text is a 510(k) summary statement for a medical device called the "Guided Growth Plate Device." This type of document is for regulatory clearance, specifically demonstrating "substantial equivalence" to a predicate device, not typically for performance studies with acceptance criteria in the way you've outlined for AI/software.

Therefore, an exhaustive answer to your request, particularly concerning acceptance criteria, ground truth, training sets, and MRMC studies, cannot be fully provided from the given input. The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving a specific performance metric against a defined acceptance criterion through a clinical study for novel functions.

Here's an attempt to extract and interpret information based on your categories, given the nature of the document:

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

The concept of "acceptance criteria" and "reported device performance" are not presented in the context of a clinical trial demonstrating efficacy against a pre-defined metric for this device. Instead, the document focuses on regulatory acceptance based on substantial equivalence to a predicate device.

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

This document does not describe a clinical study with a test set of data in the manner an AI/software device would. The 510(k) submission primarily relies on demonstrating equivalence through design, materials, and intended use to an existing, legally marketed device (the predicate). There is no mention of patient data, clinical trials, or any "test set" in this context.

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. As there is no "test set" or clinical study described for performance evaluation, there's no mention of experts establishing ground truth for data for this device.

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

Not applicable. No test set or clinical study 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. This device is a physical orthopedic implant, not an AI/software device. Hence, no MRMC studies or human reader improvement with AI assistance are relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable in the context of an AI/software performance study. The "ground truth" for this device's efficacy is the clinical observation of growth plate modulation and angular deformity correction, which is implicitly assumed to be similar to the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. No training set is involved.

Summary based on 510(k) Submission:

The provided document is a 510(k) Premarket Notification. For such submissions, the primary objective is to demonstrate substantial equivalence to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are different technological characteristics, that these differences do not raise new questions of safety and efficacy.

The "study" that proves the device meets the acceptance criteria in this context is the comparison to the predicate device and the rationale provided by the manufacturer (Morphpgraphics LC) and reviewed by the FDA. The "acceptance criteria" are the regulatory requirements for substantial equivalence, which are implicitly met if the FDA clears the device. The "device performance" relies on the established performance and safety profile of the predicate device (Blount Zimmalloy staple) and the new device's design and material specifications. No clinical trials or performance studies with defined endpoints and statistical significance are detailed in this 510(k) summary.

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UUHC's reprocessing methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.

The description of UUHC's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that UUHC's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a nonsterile product that has not been reprocessed. The studies summarized in section 9,0 Safety and Efficacy and the comparison tables in section 5 demonstrate that UUHC's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.

Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

The provided 510(k) summary for UUHC's Reprocessed Compression Sleeve Devices describes a submission for substantial equivalence to legally marketed predicate devices (Kendall K94664 and K890938 Compression Sleeve Predicate Devices). This type of submission focuses on demonstrating that the reprocessed device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease state or clinical outcome.

Therefore, the "acceptance criteria" here are essentially showing that the reprocessed device does not perform worse than the predicate device across several key attributes. The "study" refers to the testing performed to demonstrate this equivalence.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the devices can be reprocessed "as many as eleven (11) times" and that "the CSDs can be reprocessed several times". It also mentions "the seal strength of the samples reprocessed." However, specific sample sizes for each test (functional, disinfection, seal strength, biocompatibility, cleaning efficacy) are not provided in this summary. The provenance of the data is from UUHC's internal testing as part of their 510(k) submission. This is a prospective set of tests conducted specifically for this submission.

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

This submission is not clinical in nature in the sense of diagnosing a disease, but rather demonstrating the safety and effectiveness of a reprocessed medical device through bench testing. Therefore, there is no concept of "ground truth" derived from expert consensus like in an imaging study. The "ground truth" for each test is the objective measurement against established standards or the performance of the predicate device. The experts involved would be the engineers, microbiologists, and other technical specialists who conducted the tests and interpreted the results according to validated protocols. Their qualifications are not specified in the summary but would be relevant to the specific testing performed (e.g., a microbiologist for disinfection testing, material scientist for seal strength).

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings or diagnoses.

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

Not applicable. This is a 510(k) submission for a reprocessed physical medical device (compression sleeve), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the various tests was based on:

• Objective measurements and engineering specifications: For functional performance, seal strength, and cleaning efficacy, tests would have compared physical properties and cleanliness against predefined acceptable ranges or against the performance of new predicate devices.
• Microbiological standards: For intermediate disinfection, the "ground truth" would be the demonstrated reduction in microbial load to meet specific disinfection levels.
• Biocompatibility standards: For biocompatibility, the "ground truth" would be passing assays and tests against established ISO standards (e.g., ISO 10993).
• Intended Use of Predicate Devices: For intended use, the "ground truth" is the established indications for use of the original, legally marketed predicate devices.

Essentially, the ground truth is the performance of the predicate device and relevant industry/regulatory standards for medical device safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no "training set."

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

Not applicable. There is no training set.

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