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The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

• 3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.

MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting.

The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system.

• Multi-Hole Acetabular Shells
  • Material: Ti alloy conforming to ASTM F620 O
  • Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®)
  • Outer diameters: 42mm to 68mm with 2 mm increments O
  • Variants: 10, 12, or 14 screw holes O
  • Sterilized using Gamma Radiation O

This FDA 510(k) summary (K201157) is for the Prime BIOFOAM® Multi-Hole Shells, an acetabular shell used in total hip arthroplasty. The document asserts substantial equivalence to existing predicate devices based on design features, materials, and nonclinical bench testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through design similarity and standard mechanical testing.

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

• Sample Size: Not specified. The document states "bench testing was performed" for mechanical tests, but doesn't quantify the number of units tested. For MR conditionality, predicate test results were leveraged, so no new test set was used for the subject device in this regard.
• Data Provenance: The document implies the mechanical bench testing was conducted by MicroPort Orthopedics Inc. The general provenance is regulatory submission data. The studies are non-clinical (bench) studies, not human subject studies, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way they would for clinical trials. The data is generated ex vivo.

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

This section is not applicable as the studies described are non-clinical bench tests. "Ground truth" in this context typically refers to clinical diagnosis or outcomes for human subjects. For mechanical and material testing, the "ground truth" is defined by the physical properties measured against established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data.

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 section is not applicable. The device described is a physical orthopedic implant (acetabular shell), not an AI/software device that assists human readers in interpreting medical images. Therefore, an MRMC study is outside the scope of this device's evaluation.

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

This section is not applicable. The device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

• Standardized Test Methods: Adherence to recognized international and national standards such as ISO 7206 series and ASTM F series (F620, F67, F3090, F1820, F2068, F2052, F2119, F2503, F2182). These standards define how performance characteristics (like fatigue, frictional torque, material properties) are measured and evaluated.
• Material Specifications: Compliance with ASTM standards for material composition (e.g., ASTM F620 for Ti alloy, ASTM F67 for Commercially Pure Ti Foam).

8. The Sample Size for the Training Set

This section is not applicable. As a physical orthopedic implant (not an AI/ML device), there is no "training set" in the context of machine learning. The design and manufacturing process are subject to engineering design principles and quality control, not algorithmic training.

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

This section is not applicable for the same reason as point 8.

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The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.

• Prime AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes: -
    • Solid (46mm-68mm outer diameter)
    • Quad (42mm- 68mm outer diameter) .
  • Sterilization: Gamma Sterilization -
• DYNASTY® AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes:
    • o Standard (46mm- 76mm outer diameter)
    • Primary (46mm-68mm outer diameter) o
    • Revision (46mm-76mm outer diameter) o
  • Sterilization: Gamma Sterilization -

The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, specifically Prime and DYNASTY® Additive Manufacturing Shells, which are hip implants.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria. The document details the substantial equivalence of the hip implants to legally marketed predicate devices based on non-clinical bench testing, material properties, and design similarity, not performance metrics for an AI algorithm.

Here's why the requested information cannot be provided from the given text:

• No AI/ML Component: The device described is a physical orthopedic implant. There is no mention of any AI or machine learning algorithm.
• No "Performance" in the AI/ML Sense: The "performance" discussed in the document relates to mechanical properties (tensile strength, fatigue, deformation, corrosion, shear strength, etc.) and biocompatibility of the implant, not the diagnostic or predictive performance of an algorithm.
• No Test Set/Training Set: These concepts are specific to AI/ML model development and evaluation. The document discusses "worst-case constructs" for physical testing and "predicate nonclinical test results," which are entirely different.
• No Experts for Ground Truth/Adjudication: Ground truth establishment and adjudication by experts are crucial for evaluating AI/ML models in medical imaging, but this is irrelevant for a physical implant.
• No MRMC Study: A Multi-Reader Multi-Case study is for evaluating human performance, often with or without AI assistance, in interpreting medical data. This device is not an interpretation tool.
• No Standalone Algorithm: This phrase applies to an AI algorithm operating without human intervention for diagnostic or predictive tasks.

In summary, the provided document does not describe an AI/ML device, and thus, the questions posed (which are relevant to AI/ML device evaluation) cannot be answered from this text.

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The Prime E-CLASS™ XLPE Liner is an acetabular liner intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
   Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The Prime E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' Prime Acetabular Cup System (K170444; K180798). The subject Liner is intended to be used with Acetabular Shells and optional Cancellous Bone Screws as part of a total acetabular system.
The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798).

The provided document is a 510(k) Summary for a medical device (Prime E-CLASS™ XLPE Liner), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the information required for a table of acceptance criteria and proven device performance as typically expected for a diagnostic AI/ML device is not available in this document. The document describes non-clinical testing performed to establish substantial equivalence for a physical implant, not a software algorithm.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

• Acceptance Criteria & Device Performance: The document does not define specific clinical or diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) that the device must meet. Instead, it details non-clinical tests (bacterial endotoxin, mechanical testing, material properties, wear analysis, fatigue, range of motion) to show the device performs similarly to predicate devices. The "reported device performance" are the results of these non-clinical tests, which aim to demonstrate equivalence rather than meeting independent performance criteria.

• Study Type: This is a premarket notification (510(k)) for a physical medical implant, not a study of an AI/ML diagnostic or prognostic device. The "study" here refers to non-clinical bench testing and analysis to show equivalence.

Given the nature of the document, most of the requested fields are not applicable or the information is not present.

However, I can extract what is available regarding the "studies" (non-clinical testing) performed:

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

As mentioned, specific acceptance criteria in terms of clinical performance metrics are not provided. The "acceptance criteria" for this 510(k) submission are implied by successful completion of tests demonstrating substantial equivalence to predicate devices. The "reported device performance" refers to the outcomes of these non-clinical tests.

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

• Sample Size: Not explicitly stated for each non-clinical test. For mechanical tests, standard testing protocols define sample sizes, but these are not enumerated here.
• Data Provenance: Not applicable. This refers to bench testing of physical components, not patient data.

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

• Not applicable. Ground truth for clinical data is not relevant to this type of non-clinical device testing.

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

• Not applicable. Adjudication is typically for human assessment of images or clinical outcomes, not for mechanical bench testing.

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/ML diagnostic device.

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

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

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

• For non-clinical testing, the "ground truth" is established by adherence to recognized national and international standards (ASTM, ISO, FDA Guidance) and laboratory measurements using calibrated equipment. For example, the ground truth for endotoxin levels is defined by the USP limit. For mechanical properties, it's the measured values compared to established benchmarks or predicate device performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML diagnostic device, and thus no "training set" of data in that context. The "training" for the device's design comes from engineering principles, material science, and prior designs.

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

• Not applicable. No "training set" in the context of AI/ML.

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The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusio acetabuli, and painful hip dysplasia:
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The Prime Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:

• · Acetabular Shells
  • Manufactured from titanium alloy о
  • BIOFOAM® coated o
  • Available in Solid or Quad configurations o
  • Outer Diameter sizes 42mm to 68mm in 2mm increments O
• Acetabular Liners ●
  • Manufactured from A-CLASS® (highly crosslinked ultra-high molecular o weight polyethylene)
  • Lipped Available in in Standard, or Face-changing Lateralized O configurations with 12 anti-rotational tabs
  • Inner Diameter sizes 22mm to 44mm O
• Bone Screws ●
  • Manufactured from titanium alloy o
  • 6.5mm diameter O
  • 0 Available in lengths 15mm to 80mm in 5mm increments

The subject Acetabular Liner has undergone design changes in regard to the locking detail; all other design aspects, intended use, fundamental scientific technology, and material remain identical to the predicate K170444 Acetabular Liner.

This looks like a 510(k) summary for a medical device (Prime Acetabular Cup System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily provides:

• Device Description and Intended Use: Details the components of the Prime Acetabular Cup System (Acetabular Shells, Liners, Bone Screws) and their intended applications in total hip arthroplasty.
• Substantial Equivalence Justification: States that the device is substantially equivalent to predicate devices (PROCOTYL® PRIME Acetabular Cup System, K170444) based on identical indications for use, similar materials (for the liner, drawing on K052026), and unchanged design features for shells and screws since K170444.
• Nonclinical Testing: Lists bench tests performed on the subject device (liner push-out, lever-out, torque-out per ASTM F1820, ASTM STP1301) and references tests performed on the predicate device and deemed applicable (deformation, frictional torque, wear, fatigue, range of motion, screw properties).
• Clinical Testing: Explicitly states that clinical data was not provided for the subject devices.
• Biocompatibility: Justifies not performing specific biocompatibility tests on the subject implants as their materials and patient contact are identical to predicate devices.
• Compatibility Tables: Details compatibility with other MicroPort Orthopedics products.
• Sterilization Residuals: Discusses previous evaluations and current applicability.

Therefore, I cannot populate the requested table and answer your questions directly from the provided text. The document does not describe a study with acceptance criteria in the context of clinical performance or diagnostic accuracy, which is implied by your prompt's questions. It focuses on engineering and material equivalence testing for an orthopedic implant.

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The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.

The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for the Prime™ Adaptive Ultrasonic Scalpel System, focusing on its substantial equivalence to predicate devices and adherence to various performance and safety standards.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily details:

• Device Name: Prime™ Adaptive Ultrasonic Scalpel System
• Indications for Use: Cutting and coagulation in open, laparoscopic, and endoscopic surgery where control of hemostasis and thermal spread is desired. Used for dissection, sealing, transection, and vessel coagulation. Can be an adjunct or substitute for electrosurgery, lasers, or steel scalpels.
• Key Components: Generator (Prime™ 6000), Transducer Handpiece, and Instruments/Blades.
• Technological Characteristics: Automatically adapts ultrasonic power output to tissue load, consistent vibration, non-sterile reusable blades validated for cleaning/sterilization, and a cable disconnect feature at the transducer handpiece for convenience.
• Predicate Devices: Ultracision® Harmonic Scalpel® series from Ethicon Endo-Surgery, Inc.
• Reference Device: Sonopet® Surgical Aspirator for its blue anodized blade tip surface.
• Standards Met: A comprehensive list of IEC, ISO, AAMI, CAN/CSA, and EN standards related to electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software life cycle processes. These are general safety and performance standards for medical devices, not specific clinical performance criteria or results.

The document asserts "no new questions of safety or effectiveness" and concludes substantial equivalence, which is the basis for 510(k) clearance, rather than presenting a detailed clinical study demonstrating meeting specific performance criteria.

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The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.

The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The provided text describes the Stryker Prime Series® Stretcher with Zoom® Motorized Drive, and its acceptance criteria are primarily demonstrated through substantial equivalence to a predicate device and verification and validation (V&V) testing to ensure safety and effectiveness.

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

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

The document does not explicitly present a table of "acceptance criteria" in the format of defined thresholds with corresponding "device performance" results. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and passing functional, performance, safety, and efficacy specifications through V&V testing. The reported device performance is largely a direct comparison to the predicate device, indicating that the new device performs at least as well as the predicate and meets relevant standards.

Here's an attempt to extract and present the closest information to your request, focusing on comparative aspects and testing outcomes:

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 mentions "Physical and mechanical testing has been performed on individual components and on the system" and "bench and software testing." However, it does not specify the sample size for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a physical medical device like a stretcher, the testing would be considered prospective as it's conducted specifically for demonstrating compliance before market approval.

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

This section is not applicable as the document describes a physical medical device (a stretcher), not an AI/diagnostic software. "Ground truth" in the context of expert consensus is typically relevant for evaluating diagnostic accuracy, which is not the primary concern for a patient transport stretcher. The "truth" in this context is defined by engineering specifications and recognized performance standards.

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

This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies.

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. The device is a motorized stretcher, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effect size in improving human reader performance with AI is irrelevant to this device.

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

This is not applicable. There is no algorithm in the sense of an AI or diagnostic software being evaluated. The "Zoom Motorized Drive" is an electromechanical system that assists a human caregiver. Its performance is always "human-in-the-loop" as it requires a caregiver to operate it.

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

For this device, the "ground truth" is established by engineering specifications, performance standards (e.g., IEC, ISO, AAMI), and predefined functional requirements. These are generally objective, measurable parameters rather than subjective expert consensus, pathology, or outcomes data. For example, the "ground truth" for patient capacity (700 lbs max) would be determined by structural integrity tests and engineering calculations.

8. The sample size for the training set

This is not applicable. This is a physical electromechanical device, not a machine learning model that requires a "training set" of data.

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

This is not applicable for the same reason as point 8.

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The PRIME ECG® with enhanced Diagnostic Algorithm is intended to be used for the recording of electrocardiographic signals.

The PRIME ECG® with enhanced Diagnostic Algorithm is indicated for the recording of electrocardiographic signals on the body surface

The device consists of the following components and accessories: PRIME ECG Cart, PRIME ECG Algorithm, PRIME ECG Single-Use Patient Vest.

Data recording and analysis is contained within a durable medical device that is used to record, analyze and display electrocardiographic signals from the body surface. The system features a power supply with battery back-up, signal acquisitioning and processing hardware and firmware, a computer and a software, including automated analysis software, a flat panel color display and a color printer.

The PRIME ECG System incorporates computer processing that can present conventional ECG waveforms as color images displayed on a simulated torso. Each PRIME ECG recording captures body surface potentials for analysis. The PRIME ECG System translates the segments of the ECG waveform into ranges of color based on measured values. The range from vellow to red is assigned to positive values, with deep red assigned to the highest value. Green is assigned to neutral values and shades of blue are assigned to negative values with deep blue assigned to the highest negative value. This information allows physicians to identify areas of abnormality for interrogation.

The PRIME Diagnostic Algorithm is an adjunct to the color displays of the underlying ECG waveforms to assist the physician in coming to a conclusion on the patient's cardiac status. The Diagnostic Algorithm uses multiple parameters of ECG potentials and ECG morphology to make a recommendation on whether the patient has a Normal, Abnormal or Acute MI condition. An explanation window describes to the physician the basis of the Diagnostic Algorithm conclusion. Thus, the physician is at liberty to interrogate the recommendation and agree to or override it.

The PRIME ECG data recording and analysis system is attached to a single-patient electrode array (vest) that is placed on the patient in two parts consisting of a 64 lead anterior and a 16 lead posterior segment. Electrodes and signal conduction pathways are screen-printed onto a clear plastic substrate. The vest is secured to the patient with a pre-applied conductive adhesive gel. The vest is a single use device and cannot be re-used.

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as a target for the enhanced algorithm. Instead, it demonstrates improved comparative performance against a predecessor and the 12-lead ECG. The implication is that "improvement" is the de facto acceptance criterion.

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

• Test Set Description: The "FDA Troponin" set.
• Sample Size (Positive Cases): 78 (True Positive cases for MI)
• Sample Size (Negative Cases): 147 (False Positive cases for MI, implying these were non-MI patients from the overall cohort)
• Total Test Set Size: 225 (78 + 147)
• Data Provenance: This sub-set was generated from the Company's IDE study (G990171), which gathered data from "a number of institutions." The text implies this data was historic, and the specific "FDA Troponin" set was created retrospectively from this larger dataset, as it was used to confirm previous algorithm versions. The context suggests the IDE study was prospective data collection.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated, though the MI diagnosis was "confirmed by Troponin as a Gold Standard," indicating a clinical diagnostic process. The involvement of "institutions" suggests clinical experts were involved in the initial diagnosis.

4. Adjudication Method for the Test Set:

• The document states that the original IDE study "allowed the institutions to follow their normal protocol in the treatment of suspect MI. As a result there were a number of methods of confirmation of the diagnosis, no one methodology had been mandated."
• For the "FDA Troponin" sub-set, the MI diagnosis was specifically "confirmed by Troponin as a Gold Standard." This implies a biomarker-driven adjudication, rather than a human expert consensus adjudication for the ground truth of MI.

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

• Was an MRMC study done? No. The study compares algorithmic performance to human interpretation and other algorithmic versions, but it does not describe an MRMC study where human readers interpret cases with and without AI assistance to measure improvement. The row "PRIME ECG, physician interpretation (K012414)" refers to a past evaluation of physician interpretation, not a concurrent AI-assisted reading study.

6. Standalone Performance Study:

• Was a standalone study done? Yes. The "Enhanced PRIME Algorithm (this application)" row in Table 1 represents the standalone performance of the algorithm itself without human intervention (as it reports algorithm sensitivity and specificity). The purpose of the algorithm is to make a "recommendation," which a physician can then agree to or override, implying standalone assessment followed by physician review in practice.

7. Type of Ground Truth Used:

• For the test set ("FDA Troponin" set): Biomarker (Troponin) confirmed MI was used as the "Gold Standard" for diagnosis.

8. Sample Size for the Training Set:

• The Company "created 3 training sets of cases (called Alpha, Beta and Charlie)."
• Specific sample sizes for Alpha, Beta, and Charlie are not provided.

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

• The training cases "have been drawn from Acute Coronary Syndrome patients attending a UK hospital."
• The exact method for establishing ground truth for these training sets is not explicitly stated, beyond being from diagnosed ACS patients. However, given the context of the "FDA Troponin" set, it is highly probable that clinical diagnoses, potentially involving biomarkers and other standard clinical assessments, were used to establish the ground truth for training.

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A powdered vinyl examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Not Found

This document is a 510(k) summary for powdered vinyl examination gloves. It does not contain information about the acceptance criteria or a study proving device performance as typically understood for AI/ML devices. The document is an FDA letter granting substantial equivalence for a medical device which is a physical product (gloves), not an AI/ML software.

Therefore, I cannot provide the requested information.

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The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.

The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.

Acceptance Criteria and Study Details for PRIME ECG System with Diagnostic Algorithm

The provided 510(k) summary for the PRIME ECG System with Diagnostic Algorithm (K030104) offers limited details on specific acceptance criteria and the comprehensive study that proves the device meets them. However, it does state that a clinical study was performed to demonstrate the algorithm's utility in diagnosing AMI. Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative metrics for the "assistance in diagnosis of AMI" nor does it provide a specific performance target or range for this criterion. It merely states that the study "demonstrated" this capability.

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

The 510(k) summary does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study validating the diagnostic algorithm.

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

The 510(k) summary does not provide details on the number of experts used to establish ground truth or their qualifications for the clinical study.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide details on the adjudication method used for the test set in the clinical study.

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

The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study described appears to focus solely on the algorithm's ability to "provide information that may assist in the diagnosis of AMI," rather than a comparative study with human readers.

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

Yes, a standalone study appears to have been conducted. The description "a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction" suggests that the algorithm's performance in providing diagnostic information was evaluated. There is no mention of human-in-the-loop performance in the context of this specific clinical study for the diagnostic algorithm.

7. Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used for the clinical study demonstrating the diagnostic algorithm's utility for AMI. Given the nature of AMI diagnosis, it is highly probable that a combination of clinical assessment (symptoms, physical exam), biomarkers (cardiac enzymes), follow-up outcomes, and potentially expert consensus on other diagnostic tests (e.g., echocardiography, coronary angiography) would have been used to establish the ground truth for AMI. However, this is an inference and not explicitly stated in the document.

8. Sample Size for the Training Set

The 510(k) summary does not provide details on the sample size for the training set used for the diagnostic algorithm.

9. How Ground Truth for the Training Set Was Established

The 510(k) summary does not provide details on how the ground truth for the training set was established for the diagnostic algorithm.

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