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The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.

The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.

The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.

This document describes a 510(k) premarket notification for the "Converge™" device, a bone plate and screw system. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "The results demonstrate substantial equivalence to predicate device" for a series of non-clinical tests. This implies that the acceptance criteria were met by demonstrating performance comparable or superior to the predicate devices.

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 the sample sizes used for each of the non-clinical tests. It only lists the types of tests performed. The data provenance (country of origin, retrospective/prospective) is not mentioned, but as this is a non-clinical study, it would typically be conducted at an engineering or testing lab and not involve human subjects or geographical 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)

This section is Not Applicable as the submission is for a medical device (bone plate and screws) and relies on non-clinical engineering and material testing, not human-read clinical data. Therefore, there's no "ground truth" to be established by medical experts in this context.

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

This section is Not Applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes.

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 document explicitly states "Clinical Evidence: Not Applicable." The submission is for a device, not an AI or imaging diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

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

This section is Not Applicable. The device is a physical bone plate and screw system, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by engineering standards and direct measurement according to scientifically validated test methods. For example, a "static bend" test would establish its ground truth based on measurable mechanical properties and material failure points as defined by engineering principles, rather than expert consensus or pathology reports.

8. The sample size for the training set

This section is Not Applicable. There is no "training set" as this is a non-clinical device submission, not a machine learning or AI algorithm.

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 CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via an existing mobile telecommunications and/or internet infrastructure.

The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational and motivational content from clinicians.

The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.

The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or step-down units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.

The CHM is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the patient and to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cell phones and computers) for the automated transmission of medical data to a remote secure server from where it can be viewed remotely by clinicians and patients for the purposes of storage and basic analysis. The CHM Device also provides educational and motivationalities allowing the clinician to send tasks, recommendations, surveys, and educational and motivational messages to patients.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Verizon Wireless Converged Health Management Device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "regression and usability testing was performed" and "additional verification and verification activities were performed." However, specific sample sizes for a 'test set' (e.g., number of data points, number of users, number of transfers) are not explicitly mentioned.

The data provenance (country of origin of the data, retrospective or prospective) is not mentioned in the provided text.

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

The document does not mention using experts to establish ground truth in the context of the performance data. The testing appears to be focused on software functionality and data transfer accuracy against design specifications rather than against expert interpretations of medical conditions.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1, none) is not applicable or mentioned given the nature of the testing described, which focuses on software functionality and data transfer accuracy rather than diagnostic performance requiring expert consensus.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "remote monitoring software solution" and not an interpretive or diagnostic AI. It collects and stores biometric data for clinicians to analyze. The document explicitly states: "It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals."

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

The performance evaluation described is a standalone algorithm-only performance assessment in the sense that the testing verified the software's ability to accurately transfer and handle data. There is no mention of human-in-the-loop performance measurement for the device's core functionality. The clinicians still analyze the data.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth used for the testing appears to be the expected behavior and functional requirements of the software, specifically related to accurate data transfer and functionality after changes. This is not a "medical ground truth" established by experts for diagnostic purposes but rather an engineering and software validation ground truth. For instance, for data transfer accuracy, the ground truth would be the original data from the glucometers.

8. The Sample Size for the Training Set:

The document does not mention a training set because the device is a data collection and management platform, not a machine learning or AI algorithm that requires training on a dataset to learn patterns or make predictions.

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

As there is no training set, this question is not applicable.

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The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• . Revision of previously failed hip arthroplasty.

The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.

The provided text describes a 510(k) summary for the "Converge RETi-Lock Multi-Hole Reinforcement Cup," a medical device for total hip arthroplasty. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or comparative effectiveness studies).

Instead, the document focuses on:

• Sponsor and Contact Information: Centerpulse Orthopedics, Inc.
• Trade and Common Name: Converge RETi-Lock Multi-Hole Reinforcement Cup, Non-porous, press-fit, acetabular shell system.
• Classification: Class II device (Product Codes LZO, KWA, JDI, LWJ).
• Predicate Devices: Ascendant Acetabular System (K022985) and Restoration GAP II Cup (K980774).
• Device Description: A hemispherical acetabular reinforcement shell made of titanium alloy, designed to expand treatment options for deficient acetabular bone stock, with a fixation plate and hook, and screw holes for fixation.
• Intended Use/Indications For Use: Treatment of noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed hip arthroplasty.
• Basis of Substantial Equivalence: Stated as "Performance testing, design comparisons, and functional analyses conducted on the Converge RETi-Lock Multi-Hole Reinforcement Cup demonstrate that this device is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the provided text. The document only states that performance testing was done to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, results, or methodology of that testing.

To answer your request, I would need a different type of document that includes the actual study results, acceptance criteria, and methodological details of the performance testing.

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Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed hip arthroplasty.

The Converge Acetabular System consists of four modular shell options which mate with currently marketed insert components for replacement of the acetabulum during total hip arthroplasty. They are designed to provide congruency with the ability to effectively seal the acetabulum, and may be implanted with or without bone cement.

Common Features:

• Substrate Material: All of the Converge shells are manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136).
• Porous Coating: Cancellous Structured Titanium (CSTi) porous coating (commercially pure titanium, ASTM F1580) covers the entire outer surface of the Converge shells, with the exception of regions adjacent to the dome hole and screw holes, and a small band around the opening of the shell. The porous coating allows for biological fixation to occur.
• Shell/Insert Locking Mechanism: Because all four shells of the Converge System share the same internal locking mechanism, they can be used with the currently marketed Sulzer Orthopedics Inter-Op Acetabular inserts (standard polyethylene, Durasul and Metasul).
• Threaded Dome Hole Dome Hole Plug: A threaded dome hole is common to all four shells. During implantation, an impactor/alignment instrument is inserted into the dome hole. Once the shell is inserted and the tool removed, the dome hole provides visual access to the acetabulum. A threaded titanium dome hole plug (ASTM F67) can be screwed into place to prevent unwanted material migration.

Shell Options:
A. Converge Cluster-Hole Porous Shell with Sealed Screw Holes: Hemispherically shaped with screw holes sealed with plugs that can be removed for supplemental fixation. Features superior holes for increased fixation options. Sizes range from 39mm to 71mm in 2mm increments.
B. Converge Rim Flare Porous Shell with Spikes and Sealed Screw Holes: Designed to facilitate load transfer, limit tilting/rotation, and give flexibility in press-fitting. Features an offset radius in the rim region and three dome spikes. Includes two sintered screw hole covers that can be removed for supplemental fixation. Outer diameters range from 39-71mm in 2mm increments.
C. Converge Multi-Hole Porous Shell with Sealable Screw Holes: Hemispherical shell designed for scenarios with deficient acetabular bone stock (e.g., revision cases). Features five to nine screw holes (depending on size) for placement into the ilium, ischium, and pubis. Unused screw holes can be plugged with plugs manufactured from either Ti-6Al-4V (ASTM F136) or unalloyed titanium (ASTM F67). Available in outer diameters ranging from 43mm to 81mm, in 2mm increments.
D. Converge Protrusio Porous Shell with Sealable Screw Holes: Designed to accommodate a deeper acetabular socket caused by protrusio defects. Features a gradual buildup of material from the rim to the dome. Like the Multi-Hole shell, it features five to nine screw holes (depending on size) and uses the same screw hole plugs. Available in external shell diameters ranging from 53mm to 81mm, in 2mm increments.

This document (K012739) is a 510(k) summary for a medical device and therefore does not contain acceptance criteria or detailed study results. 510(k) summaries are intended to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical effectiveness or meet specific performance criteria through detailed studies.

Therefore, most of the information requested cannot be extracted from this document.

Here's what can be stated based on the provided text:

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

   • Not Available: This document does not specify acceptance criteria for performance or report device performance data from a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device.

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

   • Not Applicable/Not Available: This document does not describe a clinical performance study with a test set. This is a premarket notification for a new device based on substantial equivalence.

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/Not Available: No test set or ground truth establishment by experts is described in this document, as it's not a performance study.

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

   • Not Applicable/Not Available: No test set or adjudication method is described.

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

   • Not Applicable: This device is a mechanical implant (acetabular system for hip replacement), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or described.

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

   • Not Applicable: This is a mechanical device, not an algorithm.

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

   • Not Applicable/Not Available: As no performance study with a test set is described, no ground truth is detailed.

8. The sample size for the training set

   • Not Applicable/Not Available: This isn't a machine learning algorithm or a study that would involve a "training set" in that context.

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

   • Not Applicable/Not Available: As above, the concept of a training set and its ground truth is not relevant to this type of device submission.

Summary of available information related to "proof" of meeting criteria:

The document states that the Sulzer Orthopedics Converge Acetabular System is found to be substantially equivalent to legally marketed predicate devices. This is the "proof" required for a 510(k) clearance, indicating that the device is as safe and effective as a device already on the market.

The basis for this substantial equivalence is described as similarities in:

• Materials: All shells manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136) with Porous Coating Cancellous Structured Titanium (CSTi) via commercially pure titanium (ASTM F1580). Dome hole plug material is titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).
• General design features: Modular shell options, internal locking mechanism, threaded dome hole, screw holes with optional plugs, and variations for different anatomical needs (Cluster-Hole, Rim Flare, Multi-Hole, Protrusio).
• Intended uses/Indications for Use: Total hip arthroplasty for noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed arthroplasty.

Predicate Devices cited for substantial equivalence:

• Sulzer Orthopedics Inter-Op Acetabular System
• Zimmer Trilogy Acetabular System
• Stryker/Osteonics/Howmedica System 12 Acetabular System
• Smith & Nephew Orthopaedics Reflection Acetabular System
• DePuy Duraloc Acetabular System

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Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• revision of a previously failed arthroplasty where there is sufficient bone stock to support the implant.

The Converge Acetabular System consists of the following shell components:

• I. Hemispherical: The Converge Hemispherical Shell is a porous coated, Ti-6A1-4V (ASTM F136) shell. The outer surface of the shell has CSTi porous coating (commercially pure titanium) to provide for biological fixation. The shell is available in various sizes ranging from 39mm to 65mm (in 2mm increments). The shell features 2 screwhole plugs that are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws. When left in place (no supplemental screws used), the screwhole plugs limit material ingress and egress (e.g., tissue, debris particles, cement, etc.).
• II. Rim-Flare: The Converge Rim Flare Shell is a Ti-6AI-4V metallic acetabular shell coated with CSTi porous coating. It is designed with an offset outer radius in the rim region which permits the loads to be transmitted to the periphery of the outer surface. An initial press-fit of the component is achieved by the offset radius in this region. Additionally, the outer design of the shell incorporates three pegs which are press-fit into the cancellous bone of the reamed acetabulum to minimize the potential for tilting or rotation of the device. The shell is available in various sizes ranging from 39mm to 71mm (in 2mm increments).
• III. Revision: The Converge Revision Shell is a Ti-6Al-4V metallic acetabular shell coated with CSTi porous coating. The Revision shell has up to nine screwholes which allow for screw placement into the illum, ischium and pubis. Those screwholes that are not utilized may be plugged after implantation to limit passage of tissue, debris particles, cement, etc. The shell is available in various sizes ranging from 43mm (in 2mm increments).
  All three Converge shells feature a central dome hole which allows for interface with the impactor/alignment instrument as well as for visualization of the acetabulum to ensure complete seating of the device. The dome hole may be plugged using a threaded cover to restrict unwanted material migration through the hole.
  All three of the Converge shell components will use existing Inter-Op instrumentation and will mate with currently marketed Inter-Op Acetabular Inserts (oxygenless packaged polyethylene, Durasul, or Metasul).

The provided text is a 510(k) summary for the Sulzer Orthopedics Converge Acetabular System. It details the product, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document focuses on regulatory compliance through substantial equivalence, not on a performance study with defined acceptance criteria.

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Intended uses of Convergence™ CDR®M for Hitachi SPECTRADigital™V250DSP Gameras is identical to the principle of coincidence imaging used by EPIC-MCD Cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include:

• Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo.
• Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
• Reformation of coincidence data to images frames with subsequent reconstruction of transmission and Wholebody ECT data via FBP and/or ML-EM/OSEM reconstruction methods.
• Analysis and generation of attenuation maps and coefficients to apply to emission ECT slice/volume sets.

Convergence sm for for Hitachi with Imaging capabilities SPECTRADigital™ V250DSP Gamma Cameras option include:

• All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
• Use in conjunction with FDA approved 511 keV emitting radiopharmaceuticals
• High and normal count-rate dynamic and non-temporal ECT
• In conjunction with Coincidence based imaging, the detector performance and NUA® acquisition and processing characteristics are available for non-uniform attenuation ECT, attenuation correction in CID and CID based ECT imaging.
• Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

CONVERGENCE®M CDR §™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras, cleared under K954129 is an Coincidence Imaging Device (CID) option that provides capability to acquire 511 keV coincidence events and form images in 1D, 2D and 3D modes of operation. With the addition of ATTCOR, non-linear scaled low energy transmission correction utilizing NUA88 submitted under K991318) mapping of anatomical information using external radioactive line source transmission with analysis of densities and assignment of patient specific attenuation coefficients to minimize distortion due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide detection, decoding, image formation with corrections and Whole body and tomographic reconstruction. When the system is equipped with thicker 5/8" crystals submitted under K991129, the V250DSP efficiency for 511 keV events is improved.

The additional Hardware which consists of Aperture Grids with graded absorbers, high speed pre-amps with coincident signal timing, high speed decoding and correction circuitry and acquisition control software. 1-D framing at the camera system is provided and 2-D, 3-D frame formation via workstation based FORE (Fourier Rebinning) and OS-EM processes. When equipped with ATTCORSM, a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and non-linear scaling processing is provided. The software consists of FORE rebinning. OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, transmission acquisition control and coefficient determination in the correction to ECT slice data per NUASM submitted under K991318.

The provided document describes a 510(k) premarket notification for the "Convergence SM CDR SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras," a Coincidence Imaging Device (CID) option. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a detailed clinical study with statistical endpoints.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a detailed performance table in the typical sense of a clinical trial. Instead, it asserts that the device has been "thoroughly tested and verified to operate properly and as intended" and that the "results of transmission reconstruction and attenuation coefficient determination has proven effective." It also mentions "Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution."

The primary performance claim is substantial equivalence to predicate devices. The testing that was conducted was to "establish the basis for proper operation" and included phantom studies.

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

• Sample Size: The document does not specify a "sample size" in terms of patient cases for clinical testing. For phantom testing, it states the device was tested with the Data Spectrum Delum 5000 Phantom, Data Spectrum PET Phantom, and NEMA Scatter Phantom.
• Data Provenance: The document mentions "Clinical tests have documented effective application," but provides no details on the origin, retrospective/prospective nature, or location of these clinical tests. The phantom studies are likely internal testing.

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

• This information is not provided in the document. The "clinical tests" are mentioned vaguely, but no details on expert involvement or ground truth establishment are given. The phantom studies use physical phantoms as their "ground truth".

4. Adjudication Method for the Test Set:

• This information is not provided. Given the nature of a 510(k) supporting substantial equivalence, a formal adjudication process with multiple experts for a clinical dataset is typically not the primary method of evaluation described in these types of submissions, unless it's a more complex diagnostic algorithm.

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

• No, an MRMC comparative effectiveness study is not mentioned. The document states that "Clinical tests have documented effective application and expected results consistent with predicate devices," but this does not describe an MRMC study comparing human readers with and without AI assistance. The focus is on the device's inherent functionality and equivalence, not reader performance.

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

• Yes, a form of standalone testing was done. The phantom studies ("code implementation, simulation and phantom processed studies") assess the algorithm's performance in generating images and performing corrections without direct human interpretation in a comparative effectiveness setting. The device itself (the hardware and software) is the "standalone" entity here, performing image acquisition, processing, and reconstruction.

7. The Type of Ground Truth Used:

• For the phantom studies, the ground truth is the known physical properties and characteristics of the phantoms (e.g., known activity distributions, anatomical structures, scatter properties).
• For the "clinical tests," the type of ground truth and how it was established is not specified.

8. The Sample Size for the Training Set:

• This document describes a device (hardware and software) for image acquisition and reconstruction, not a machine learning algorithm that requires a "training set" in the modern sense of supervised learning. Thus, the concept of a training set sample size is not applicable here. The software components like OSEM and FBP are well-established reconstruction algorithms, not models trained on large datasets.

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

• As the concept of a training set is not applicable (see point 8), this information is not provided and not relevant to this specific device submission.

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Intended uses of Convergences™ NUA® for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the ADAC Vantage ExSPECT 2.1 cleared under K971878 in system function and operational software. These include:

• Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
• Reconstruction of transmission and emission SPECT data via FBP and/or ML-EM/OSEM reconstruction methods
• Analysis and generation of attenuation maps and coefficients to apply to emission SPECT slice/volume sets.

The acquisition of SPECT is as cleared under SPECTRADigital™Series V250DSP system K954129, with addition of transmission acquisition protocols to produce images which depict anatomical density of a patient. The device is intended to provide an enhancement to the emission images acquired SPECTRADigital™ Series V250DSP by correcting for attenuation and scatter effects in the patient. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination.

Hitachi capabilities with with with with and Convergence SM NUA SM for for lmaging SPECTRADigital™ V250DSP Gamma Cameras option include:

• I All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
• 트 High and normal count-rate dynamic and non-temporal SPECT
• 트 In conjunction with additional options for Coincidence based imaging, the detector performance and NUA®ª acquisition and processing characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs)
• I Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

Convergence 3M NUA 3M for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is an optional Attenuation Correction Device (ACD) that provides capability to map anatomical information using external radioactive line source transmission, analyze densities and assign patient specific attenuation coefficients to minimize distortion caused by false information in the emission computer tomographic images due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide transmission, collimation, acquisition and analysis/correction of ECT data.

The Hardware which consists of a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and fan beam collimation. The standard source is Gadolinium 153 (240.4d T1/2, 97.4~103.2 keV, while the system has been confirmed with Technetium 99m ( 6hr T1/2, 140.5 keV) and Cerium-139 (137.6d T1/2, 165.8 keV).

The software consists of camera based transmission acquisition control and workstation based OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, coefficient determination and correction to ECT slice data. The system uses the same camera mechanical platform, table, collimators, electrical system and acquisition/system operating software cleared under K954129, with the addition of acquisition/processing sequences to correct for scatter and effects of attenuation. The acquisition of transmission and emission data is performed via fast sequential orbit acquisition to minimize effects of cross-spill and cross falk.

The provided document is a 510(k) submission for the Hitachi Medical Corporation's Convergence SM NUA SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras. This device is an optional Attenuation Correction Device (ACD). The document focuses on establishing substantial equivalence to a predicate device rather than providing detailed performance studies against specific acceptance criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert qualifications, and ground truth establishment is not explicitly present in the provided text. The document refers to "clinical tests" and "phantom processed studies" but does not provide the details requested.

However, based on the available information, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit quantitative acceptance criteria or detailed performance metrics are provided in the document. The evaluation relies on establishing substantial equivalence to a predicate device (ADAC Vantage ExSpect 2.1 system cleared under K971878) and verifying proper operation through specific tests.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "phantom processed studies" (using Data Spectrum Anthromophic Phantom, Data Spectrum Delux 5000 SPECT Phantom, Data Spectrum Cardiac Phantom, and NEMA Scatter Phantom) and "clinical tests," but does not provide the number of cases or subjects for these tests.
• Data Provenance: Not explicitly stated. Clinical data is implied to be from patient studies, but the country of origin or whether it was retrospective or prospective is not mentioned. Phantom studies are laboratory-based.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states that when resulting images are interpreted by a "trained physician," the information can be useful in diagnosis. However, it does not detail the use of experts to establish ground truth for the device validation itself.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: Not explicitly mentioned or detailed. The document states the device provides an "enhancement" to emission images and that the information can be useful in diagnosis when interpreted by a trained physician. However, it does not provide an effect size comparing human readers with AI assistance versus without AI assistance (as this is an attenuation correction device, not an AI interpretation tool in the modern sense).

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Implied. The phantom studies and simulations ("code implementation, simulation and phantom processed studies") assess the device's ability to operate properly and as intended in determining attenuation coefficients and correcting images. While human interpretation is mentioned for diagnosis, the core function of the Attenuation Correction Device itself (mapping anatomical information, analyzing densities, assigning attenuation coefficients, and correcting ECT slice data) is described as being tested and proven effective.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • For phantom studies: The "ground truth" would be the known physical properties and activity distributions within the phantoms.
  • For clinical tests: The document does not explicitly state how ground truth was established for clinical effectiveness. It refers to "effective application and expected results consistent with predicate devices." This implies a comparison to established clinical outcomes or expert judgment, but no specific method (e.g., pathology, outcomes data, expert consensus on uncorrected vs. corrected images) is outlined.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable/Not mentioned. This device utilizes established scientific concepts and algorithms (OSEM iterative reconstruction, FBP, fan beam acquisition, scatter window sampling) for attenuation correction rather than a machine learning model that would typically require a distinct training set. The "code implementation, simulation" refers to verification of the implemented algorithms, not training a model from data.

9. How Ground Truth for Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a distinct training set in the context of machine learning. The algorithms are based on scientific principles of physics and image reconstruction.

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