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The Modular Medical MODD1 Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

The Modular Medical MODD1 Insulin Delivery System (i.e., MODD1 System) consists of the following:

• A reusable, software-controlled programmable Pump,
• A single-use, disposable 3.0mL (300 unit) Insulin Cartridge with an integrated battery to supply power to the Pump, infusion tubing, and Tubing Cap for attaching to the Infusion Set.
• . A single-use, disposable Adhesive Pad for affixing the MODD1 System to the user's body and allowing for temporary removal of the MODD1 System,
• A single-use, disposable Infusion Set inserted into the patient's subcutaneous tissue, and
• The MMI App, a smartphone application used to program the basal delivery schedule on the Pump.

Accessories to the MODD1 System are FDA-cleared and include the following:

• A single-use disposable syringe (K110771) and needle (K021475) used to fill the Insulin Cartridge reservoir, and
• A reusable Inserter (K163400), optionally used to insert the Infusion Set into the patient's subcutaneous tissue.

The MODD1 System has been demonstrated to be compatible with Humalog U-100 insulin.

The MODD1 System can deliver insulin at basal rates between 0.5 - 4 units per hour (programmable in 0.1-unit increments) and user-selected bolus doses of between 2 and 20 units (in 2-unit increments). Basal insulin delivery may also be suspended for a set period of 30 minutes when required by the user.

The delivery of insulin is achieved by gear motor rotation of a single fixed-position camshaft (components of the Pump controlled by software) that interfaces with the Insulin Cartridge pistons to control the movement of insulin from the insulin reservoir, into an interim chamber, and into the infusion tubing towards the Infusion Set inserted into the patient's subcutaneous tissue. Software monitors dispense output via feedback provided by multiple sensors, providing an alarm when issues with delivery (e.g., malfunctions, low reservoir volume, occlusions) are detected.

The Pump serves as the primary user interface of the MODD1 System. A Control Button is used to prime the fluid path, program bolus deliveries, check system status, and to temporarily suspend insulin delivery. The multi-color LED and piezo buzzer of the Pump provide audio-visual feedback to the user during the set-up process, programming of a bolus delivery, and changing of delivery modes (e.g., bolus, basal, suspend). Audio-visual feedback is also used to inform the user of system alarms (automatically generated) and system status (when requested by the user).

The MMI App is downloaded directly onto an Apple® iPhone 12 Pro Max running iOS version 16. The MMI App allows for the configuration of a basal delivery schedule on the Pump, consisting of up to two basal rates in a 24-hour period. The MMI App and Pump communicate using Bluetooth® Low Energy (BLE) and Near Field Communication (NFC). After the basal delivery schedule has been programmed on the Pump, all insulin delivery functions are controlled using the Pump user interface. Optional features of the MMI App include a dashboard display of current and historical Pump information and delivery history.

The provided text is a 510(k) Summary for the Modular Medical MODD1 Insulin Delivery System. It details the device, its indications for use, comparison to a predicate device, and a summary of non-clinical performance data.

However, the document does not provide information on an AI-driven medical device, nor does it conduct a study involving human readers or expert ground truth. It describes the regulatory submission for an insulin pump.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details from the provided text.

The text describes compliance with various medical device standards (e.g., ISO 14971, IEC 62366-1, ISO 10993-1, IEC 60601-1, IEC 62304) and includes bench testing for infusion delivery accuracy and occlusion detection, but these are part of standard medical device validation, not specific to AI performance as requested in the prompt.

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The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

• · There is destruction of the joint surfaces, with or without significant bone deformity
• · The cruciate and/or collateral ligaments do not stabilize the knee joint
• · The ligaments are inadequate and/or the musculature is weak and/or
  · Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

• · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed;
• · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
• · irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

• 2. Rheumatoid arthritis;

3. Correction of functional deformity:
4. Revision procedures where other treatments or devices have failed;
5. Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
6. Irreparable fracture of the knee
   When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
   The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
7. There is destruction of the joint surfaces, with or without significant bone deformity.
8. The cruciate and/or collateral ligaments do not stabilize the knee joint.
9. The ligaments are inadequate and/or the musculature is weak and/or,
10. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

• Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
• Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

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

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

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

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

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

Not applicable, as there is no training set for this type of device.

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Smith&Nephew Modular Rail System:

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction
5. Correction of bony or soft tissue deformities
6. Infected fractures
7. Nonunions

Smith & Nephew Taylor Spatial Frame Fixator:

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction
5. Correction of bony or soft tissue deformities
6. Joint arthrodesis
7. Infected fractures
8. Nonunions

Smith & Nephew JET-X Fixator:

1. Open and closed fractures fixation
2. Bony or soft tissue deformities
3. Infected fractures
4. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

Smith & Nephew Ilizarov System:

1. Fractures and disease which generally may result in ioint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
5. Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge)
6. Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
7. Infected fractures
8. Nonunions

The Smith & Nephew External Fixation Systems consist of the TAYLOR SPATIAL FRAME Fixator, ILIZAROV External Fixator, JET-X Fixator and the Smith & Nephew Rail System. In general, each system consists of a unique combination of pins, bars, clamps, rings, struts, rods and/or rails to achieve fixation of a bone or joint. The JET-X system can be used with various clamps, pins, and carbon fiber bars to provide versatility in achieving fixation. The JET-X MINI system utilizes a smaller subset of components from the JET-X system. The MRS consists of a combination of pins, modular rail segments (linear or arcs), clamps, and distraction/compression device(s) to provide fixation. The TSF assemblies generally utilize 2-3 rings (half ring, 2/3 ring, full ring, and/or foot ring) or plates (U-plate), as well as struts to provide the framework for fixation. A series of rods, pins, and wires are then used to provide stability and fixation to the bone. The ILIZAROV system generally implements thin wire fixation alone or as an adjunct to internal fixation. Like the TSF, the ILIZAROV system contains a frame that consists of a combination of rings and rods, while pins and wires provide fixation of the frame to the bone.

This document is a 510(k) premarket notification for Smith & Nephew's Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, and Other External Fixation systems. The primary purpose of this submission is to add MR safety information to the labeling and update indications for use and package inserts due to European MDR related changes.

Here's an analysis of the provided information regarding acceptance criteria and the study:

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 "MRI compatibility testing/assessment was conducted." However, it does not specify the sample size for the test set (number of devices tested for MRI compatibility). The data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to FDA guidance, suggesting a U.S. regulatory context. It is a prospective assessment of the device's MR safety characteristics.

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

This information is not provided in the document. For MRI compatibility testing, ground truth is typically established by comparing test results against established safety limits and standards (e.g., maximum temperature increase, allowable displacement). This typically involves engineering and physics experts rather than medical experts for ground truth establishment.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data, which is not directly applicable to a performance study for MRI compatibility of an external fixator. The assessment relies on meeting predefined technical standards.

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:

This is not applicable to this submission. This submission is for physical devices (external fixators) and their MRI compatibility, not for 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 to this submission as it concerns physical medical devices, not algorithms or AI.

7. The type of ground truth used:

The ground truth used for this study is based on established scientific and regulatory standards for MRI compatibility. Specifically, the document references:

• FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014.
• International standards: ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119.

These standards define the acceptable limits for various magnetic resonance interactions (displacement, torque, heating, artifact) for medical implants.

8. The sample size for the training set:

This is not applicable. This submission is for the physical performance testing of medical devices, not for a machine learning or AI model that requires a training set. The devices being cleared are substantially equivalent to existing predicate devices, with the primary new information being MR safety data.

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

This is not applicable as there is no training set for an AI model mentioned in this submission.

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Operating Room Innovation's Modular Toga are components of a personal protection system and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Modular Toga

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Modular Toga". This document does not describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the other information you requested about a study (sample size, experts, adjudication, etc.).

The letter is a regulatory document stating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory requirements and refers to the "Indications for Use" statement, but it does not contain scientific study details about the device's performance.

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The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc.

The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position.

The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.

The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°.

The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.

The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.

Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.

The Modula Power Standing System (MPSS) aims to add standing (and other features) to a power wheelchair. The relevant information from the provided text has been extracted for your request. It should be noted that this is a 510(k) summary, and as such, detailed study information like sample sizes for test sets, the number and qualifications of experts, adjudication methods, and explicit effect sizes for human improvement with AI assistance are typically not part of such submissions, particularly for mechanical devices without AI components.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria (Performance Data) and Reported Device Performance

The acceptance criteria for the Modular Power Standing System (MPSS) are demonstrated by adherence to various ISO standards and by exhibiting similar technological characteristics to the predicate device (Levo C3) and a reference device (Motion Concepts Modular Power Positioning System). The 'Reported Device Performance' columns below reflect the characteristics of the Subject Device (MPSS) as provided in the comparison table.

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

• Sample Size: The document does not specify a "sample size" in terms of subject count for clinical testing. Instead, the performance data refers to various engineering and materials testing (biocompatibility, software, electrical, mechanical). For mechanical and electrical tests, it's typically performed on a limited number of device units rather than a "sample size" of users.
• Data Provenance: The testing appears to be internal verification and validation testing performed by Motion Concepts. There is no mention of country of origin for data or whether it was retrospective or prospective in the context of user studies.

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 testing described is primarily engineering-based, not clinical trials requiring human expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as the testing is not based on expert review or adjudication of clinical cases.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." The device is a mechanical system, not an AI or imaging device that would typically undergo such a study.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a mechanical device and does not involve AI assistance for human readers.

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

• Not applicable, as this is a mechanical device; there is no "algorithm only" performance study in the context of AI or diagnostic interpretation. The device's performance is its direct mechanical functionality.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized international technical standards (ISO). For example, static stability (ISO 7176-1) is a directly measurable property against a standard, not subject to expert consensus or pathology. Biocompatibility is verified against ISO 10993 standards using laboratory tests.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical product; there is no "training set" in the context of machine learning or AI algorithms.

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

• Not applicable, as there is no training set for this type of device.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.

The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pediatric pediatic pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.

The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cross connectors and offset connectors. The head and taper lock are assembled together during manufacturing to create the modular tulip assembly. The cross connectors are also assembled during manufacturing. The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer.

The provided text (FDA 510(k) K183430 submission for the Modular Spinal Fixation System) describes the acceptance criteria and supporting studies for a spinal implant system, not an AI-powered medical device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, ground truth establishment) is not applicable or cannot be extracted from this document.

The document focuses on demonstrating the substantial equivalence of the new spinal fixation system to existing predicate devices based on design, materials, indications for use, and mechanical performance through bench testing.

Here's the information that can be extracted or deduced from the provided document, focused on the acceptance criteria and the study that proves the device meets them, insofar as they relate to a medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

For a spinal implant system like this, "acceptance criteria" primarily revolve around meeting established mechanical performance standards for spinal implants and demonstrating material biocompatibility, as well as being substantially equivalent to legally marketed predicate devices.

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

• Sample Size for Test Set: This document does not specify exact sample sizes for the mechanical bench tests (e.g., number of implants tested). For mechanical tests per ASTM standards, a sufficient number of samples are typically tested to ensure statistical validity and representativeness of the product. The focus is on demonstrating "substantial equivalence" of the new device's mechanical properties to the predicate, rather than clinical performance on a "test set" of patient data.
• Data Provenance: The data is derived from bench testing (laboratory studies) of the physical implant components, not from patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

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

• This is not applicable as the "ground truth" for a mechanical implant is adherence to specified material and mechanical performance standards, not expert consensus on medical images or diagnoses. The "experts" involved would be engineers/technicians conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

• Not applicable for mechanical bench testing. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involve human interpretation of data where consensus is needed to establish a "ground truth" (e.g., reading medical images).

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

• No. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interpret medical images. This document pertains to a physical surgical implant, not an AI device.

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

• Not Applicable. This is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to standardized engineering specifications and mechanical performance criteria (e.g., ASTM F543, ASTM F1717) and the established material properties of the chosen medical-grade alloys (ASTM F136, ASTM F1537). This is a physical and engineering ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient data. The ultimate 'ground truth' for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set" in the machine learning sense.

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

• Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.

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The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• All positioning benefits associated with the tilt/recline product:
  Comfort: As with any individual, able-bodied or disabled, changes in position are necessary to maintain a state of comfort.
  Positioning: Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction: Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining, By changing the individual's orientation in space, pressures caused by gravity will shift.
• Positioning/Versatility: Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
  Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

The Modular Power Positioning System is a seating system which is added to a power wheelchair base to provide three basic functions, power recline including shear reduction, and power elevate (or lift). Note the Modular power positioning system in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.
The Tilt unit utilizes a center of gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances the stability since the center of gravity is kept substantially in place while the user is tilting. The Tilt unit may be one of two similarly designed systems, one designed for 50° tilt, and one for 45° tilt which is integrated with the 12 inch linkage style lift.
The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The latter is accomplished by using a linkage that slides the backrest down on the back posts as the back reclines. The range of Recline is 90° to 168°.
The Elevating seat (or Lift) module allows the user to elevate the entire seat by up to 12 inches. It consists of a standard linkage style mechanism.
The maximum occupant weight for the system is up to 300 lb depending on the features of the wheelchair base and system modules selected. The Modular Power Positioning System is assembled using primarily laser-cut steel tube, machined aluminum, and mounting hardware.
The various power positioning modules may be activated via two options: using switches or through the wheelchair manufacturer's controller. Switches consist of either push button or toggle style.
Safety features include a drive lock-out which prevents the user from driving the power chair while tilted, reclined, or elevated beyond a certain pre-set limit. Electrical components are maximum 24 volts, and include a current limiter in the relay box. Stability of the Modular Power Positioning System was tested on various wheelchairs commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the power positioning system.

The provided document is a 510(k) premarket notification for a medical device called the "Modular Power Positioning System," which is a component added to power wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data from various types of testing, but it does not describe an AI/ML powered device or a study involving human readers or ground truth established by experts in the context of diagnostic performance. Therefore, many of the requested categories in your prompt are not applicable to the information contained in this document.

However, I can extract the information that is available regarding the device's acceptance criteria and the studies performed.

Here's a breakdown based on the information provided:

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

The document does not explicitly state "acceptance criteria" in a quantitative format as would be typical for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, it lists various tests performed and implies that compliance with relevant standards and successful completion of these tests constitute meeting the acceptance criteria for safety and effectiveness.

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

The document does not specify sample sizes for any of the performance tests. The testing appears to be primarily bench testing (mechanical, electrical, software) and material biocompatibility, rather than human clinical data. The device manufacturer, Motion Concepts, is based in Concord, Ontario, Canada, suggesting the testing was likely conducted in Canada or by labs associated with the manufacturer. These would be considered prospective tests performed on the physical device components.

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. This device is a mechanical/electrical system, not a diagnostic AI/ML system requiring expert interpretation of medical data to establish ground truth.

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

Not Applicable. No human adjudication of results is mentioned or relevant for the types of tests performed.

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

Not Applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted.

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

Not Applicable. This device does not have an AI algorithm with standalone performance to evaluate in this context. While it has software, its V&V is focused on functional safety rather than diagnostic accuracy.

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

The "ground truth" for this device's performance would be the physical and electrical properties of the device components and system as measured against engineering specifications and industry standards (e.g., ANSI/RESNA, ISO). For example:

• Biocompatibility: In vitro cytotoxicity results as per ISO 10993.
• Electrical Safety/EMC: Compliance with RESNA Section 21.
• Mechanical Performance: Functionality according to relevant ANSI/RESNA standards (e.g., static stability, dynamic stability, impact, fatigue strengths).
• Software Safety: Verification against documented requirements and risk analysis.

8. The sample size for the training set

Not Applicable. This device uses conventional engineering design, not a machine learning model that requires a training set.

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

Not Applicable. No training set for an AI model is involved.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Subject of this Abbreviated 510(k) premarket notification is the Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MDF Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is a straight, tapered, distally fixed stem with a modular female 12/14 neck taper. The subject device is manufactured from titanium alloy (Ti-6Al-4V) and has a grit-blast finish. The stems will be available in lengths of 240mm and 300mm in sizes 12-27. The subject devices will mate with the cobalt chrome modular necks cleared with the MDF Revision Hip Stems in premarket notification K081124, but are not designed to utilize the modular sleeves included as part of the MDF Revision Hip System.

The provided text describes the Smith & Nephew Modular Proximally Fluted Hip Stem, an orthopedic implant. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The document discusses performance data related to the mechanical integrity of the hip stem, not an AI or software-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, AI multi-reader multi-case studies, ground truth for training) are not applicable to the content provided.

Here's a breakdown of the information that can be extracted, and where the requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Performance testing has been conducted," but does not mention the number of units tested.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. For the mechanical tests, the data was generated internally by Smith & Nephew.

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

• Not applicable. This is a mechanical device, and "ground truth" in the AI/ML sense (e.g., expert consensus on images) is not relevant. The "review of the testing and analysis" would have been performed by engineers or scientists familiar with the test methods and device specifications.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. This refers to consensus building among experts for labeling data, which is not relevant for mechanical testing of a hip stem.

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

• No, an MRMC study was not done. The document explicitly states "Clinical data was not needed to support the safety and effectiveness of the subject devices." MRMC studies are relevant for evaluating diagnostic software where human readers are involved.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Not applicable. This device is not an algorithm.

7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the mechanical performance of the device would be the physical properties and behavior of the tested samples as measured against predetermined engineering specifications and industry standards (e.g., ISO standards for implants, though not explicitly cited, the guidance documents imply this). This is not "expert consensus" or "pathology" in the medical sense.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of what the document does provide regarding performance and equivalence:

• Guidance Documents: Performance testing was conducted in accordance with:
  • Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
  • Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
• Tests Performed: Environmental corrosion fatigue, post-fatigue pull-off, fatigue strength testing, and range of motion evaluation.
• Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to the predicate device (MDF Revision Hip Stem, K081124) by showing similarities in materials (Ti-6AL-4V), intended/indications for use, sterilization, overall design philosophy, and performance, despite minor modifications (e.g., size offerings, absence of modular sleeves). The "Conclusion" explicitly states this.
• Clinical Data: No clinical data was required or used to support the safety and effectiveness of this device.

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The MDMIM liner and X30 Acetabular Inserts are a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.

The indications for use for total hip arthroplasty include:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed;
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

The MDM™ liners are intended for cementless use only.

The Modular Dual Mobility (MDM™) liner is a highly polished cobalt chrome liner that features a Trident® locking mechanism. This feature will allow for compatibility with other acetabular cups containing the same locking mechanism. A Duration® or X3® polyethylene insert will articulate within the MDM™ liner. The additional X3® Acetabular Inserts are intended to accommodate the size range of the MDM™ liner device.

This 510(k) summary describes the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert, which are components for artificial hip replacement. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that testing was performed to "demonstrate equivalence" to predicate devices. However, it does not provide specific acceptance values (e.g., minimum push-out strength in Newtons) or the exact quantitative results achieved by the MDM™ Liner and X3® Acetabular Insert for the mechanical or biomechanical tests. The K103233 does not contain a formal "Clinical Study" section with detailed performance results against pre-defined acceptance criteria for the new device.

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

• Sample Size for Test Set: Not mentioned. The document primarily refers to "testing" and "engineering analysis" to demonstrate equivalence rather than a specific clinical or performance test set with a defined sample size. These tests are typically benchtop mechanical tests on a limited number of device samples.
• Data Provenance: Not explicitly stated. For benchtop mechanical testing, the "provenance" would typically refer to the manufacturing batch or lot of the devices tested. It is not clinical data, so country of origin of patient data or retrospective/prospective status is not applicable here.

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

• Not Applicable. This information is relevant for studies involving human data and expert review (e.g., image interpretation, clinical outcome assessment). The provided document describes engineering and mechanical tests aimed at demonstrating equivalence to predicate devices, not clinical performance assessed by experts.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth in studies involving human assessment. This is not relevant to the engineering and mechanical tests described.

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

• Not Applicable. This device is a hip implant component. The provided documentation does not involve Artificial Intelligence (AI) or human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

• Not Applicable. This question pertains to AI algorithm performance. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical and engineering tests described would be the established scientific and engineering principles, material properties, and the performance characteristics of the predicate devices as defined by their own testing and regulatory clearance. For example, for push-out strength, the "ground truth" is a measurable force value, and the new device's performance is compared against that of the predicate to demonstrate equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This information is relevant for AI models, which require training data. This device is a physical implant.

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

• Not Applicable. This information is relevant for AI models.

In summary: The provided 510(k) summary for the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert focuses on demonstrating substantial equivalence through benchtop engineering and mechanical testing against a set of predicate devices. It does not provide detailed quantitative acceptance criteria or specific performance data in the context of a clinical study or a study directly addressing human performance or AI. Therefore, much of the requested information, which is typically found in clinical trial reports or AI/CADe system submissions, is not contained within this document.

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The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.

The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.

The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.

The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.

An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.

The provided text describes the Sialo Technologies Ltd. Modular Endoscope and its 510(k) submission (K093785). The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists various performance standards the device complies with. However, it does not contain explicit acceptance criteria or a detailed study description of how the device meets specific performance metrics beyond compliance with general standards.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will, however, extract all relevant information to the best of my ability and indicate where information is missing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for "Resolution and Distortion testing" are not provided.
• The actual results of the "Resolution and Distortion testing" are not detailed beyond the statement that it was performed.

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

The document states: "The Modular Endoscope has been tested for performance as follows: - Resolution and Distortion testing" and "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20."

• Sample Size for Test Set: Not specified for non-clinical testing. Clinical data was deemed not required, and no specific test set sample size for "Resolution and Distortion" is provided.
• Data Provenance: Not specified. It's non-clinical performance data, so country of origin isn't directly applicable in the same way as clinical data. The testing would have been conducted by the manufacturer, Sialo Technologies Ltd. (Israel).
• Retrospective/Prospective: Not applicable, as no clinical data is primarily presented for substantial equivalence.

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

• Number of Experts: Not applicable, as detailed clinical data requiring expert ground truth is not the primary basis for the 510(k) clearance in this document. The "Resolution and Distortion" testing likely involved objective measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no mention of a human-reviewed test set or a need for adjudication for the performance testing described.

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

• MRMC Study: No, the document explicitly states: "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope..." Therefore, an MRMC comparative effectiveness study was not conducted or presented for the 510(k) submission.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is an endoscope, a hardware device for visualization, not an algorithm. Its performance is inherent in its optical and mechanical characteristics, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "Resolution and Distortion testing," the ground truth would typically be established based on standardized test patterns and objective measurements, not pathology, outcomes data, or expert consensus in the clinical sense. For compliance with standards, the ground truth is the adherence to the requirements outlined in those specific standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a hardware endoscope, not an AI model that requires a training set.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for an AI model.

Summary of what's missing and why:

The provided document is a 510(k) summary for a physical medical device (an endoscope). While it details compliance with various engineering and safety standards, it does not involve artificial intelligence, machine learning, or extensive clinical trials with human readers. Therefore, many of the questions related to AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies, and adjudication methods are not applicable to this specific device as described in this regulatory submission. The primary "proof" that this device meets acceptance criteria is its stated compliance with established voluntary standards and the performance testing of resolution and distortion.

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