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BD Enteric Bacterial Panel for BD COR™ System

BD Enteric Bacterial Panel for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR™ System detects nucleic acids from:

• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.

Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA.

This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, and Shiga toxin-producing E. coli (STEC). Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

BD Enteric Bacterial Panel plus for BD COR™ System

BD Enteric Bacterial Panel plus for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR™ System detects nucleic acids from:

• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
• Plesiomonas shigelloides
• Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae)
• Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT) / heat-stable enterotoxin (ST) genes
• Yersinia enterocolitica

Testing is performed utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA.

This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST, and Yersinia enterocolitica. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Enteric Bacterial Panel Diluent for BD COR™ System

The Enteric Bacterial Panel Diluent for BD COR™ System is intended to be used in clinical settings according to instructions provided for aliquoting into Molecular Aliquot Tubes by the BD COR™ System. The Enteric Bacterial Panel Diluent for BD COR™ System is only for use with BD Fecal Collection and Transport Kit specimens tested on BD COR™ Systems.

The BD Enteric Bacterial Panel for BD COR™ System (BD EBP for BD COR™ System) simultaneously detects pathogens responsible for gastroenteritis due to Salmonella spp., Campylobacter spp. (C. jejuni and C. coli), Shigella spp./EIEC, stx/stx1/stx2 found in Shiga toxin-producing E. coli and in Shigella dysenteriae, and an internal Sample Processing Control. The BD Enteric Bacterial Panel plus for BD COR™ Systems (BD EBP plus for BD COR™ System) additionally detects Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic E. coli (ETEC) LT/ST, Yersinia enterocolitica and an internal Sample Processing Control with a second master mix. The assays automate the testing process and minimize operator intervention from the time the sample is placed onto the BD COR™ System until results are available.

The BD COR™ System is comprised of a single BD COR™ PX System attached to a BD COR™ MX Analyzer as described in K210585 and K224653. Once the specimens are loaded, the BD COR™ PX System performs the necessary pre-analytical steps such as vortexing, aliquoting into a diluent filled molecular aliquot tube, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into the BD COR™ MX Analyzer, where extraction, amplification and detection take place.

Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates directly with the instrument.

Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system.

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The BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.

The subject BD Alaris™ Pump Infusion Set is a single-use infusion set incorporating a spiked drip chamber on the proximal end, which is inserted into a fluid container, and a male luer lock connector on the distal end which connects to a patient's access device. The spike cap and the male luer lock cap maintain sterility of the fluid path prior to use. The BD Alaris™ Pump Infusion Set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic. The subject BD Alaris™ Pump Infusion Set incorporates a pump segment designed to interface with the BD Alaris™ Pump Module for administration of fluids, medications, and parenteral nutrition through clinically acceptable routes of administration.

The BD Alaris™ Pump Infusion Set is available in six (6) configurations incorporating variations of the following components: roller clamp, pinch clamp, slide clamp, SmartSite™ Y-site(s), back check valve, and inline filter.

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The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.

The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.

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brAIn™ Shoulder Positioning is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

The brAIn™ Shoulder Positioning software is a cloud-based application intended for shoulder surgeons. The software does not perform surgical planning but provides tools to assist the surgeon with planning primary anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's shoulder CT-scan (DICOM series) accompanied with their information in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations serve as a foundation for the surgeon's manual planning, which is performed using an interactive 3D viewer that allows for soft tissue visualization. The surgeon positions the glenoid and humerus implants manually within this same 3D interface using a dedicated manipulation panel. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning multimodal summary that includes textual information (patient information, pre- and post-op measurements) and visual information (screen captures of the shoulder pre- and post-implantation).

Here's a breakdown of the acceptance criteria and the study details for the brAIn™ Shoulder Positioning device, based on the provided FDA 510(k) clearance letter:

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size for Test Set: 173 samples.
   • Data Provenance: Retrospective, with a split based on patient gender, shoulder side, and geographical region of origin.
     • Geographical Origin (Test Set):
       • Left shoulder: 58.2% Europe (46), 41.8% USA (33)
       • Right shoulder: 56.4% Europe (53), 43.6% USA (41)
     • The data corresponds to patients that underwent total shoulder arthroplasty with an FX Shoulder implant, with diversity in gender, imaging equipment, institutions, and study year. The image acquisition protocol was standard for this type of procedure.

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

   • The document does not explicitly state the number of experts used.
   • Qualifications: "Medical professionals" are mentioned for creating manual segmentation labels. For landmark performance, "experts" adjusted final positions, but their specific qualifications are not detailed beyond "medical professionals." For shoulder side detection, a "Clinical Solutions Specialist" performed a manual assessment.

3. Adjudication Method for the Test Set:

   • The document does not specify an explicit adjudication method such as 2+1 or 3+1 for establishing ground truth from multiple experts. It mentions labels created "manually by medical professionals" and "final positions adjusted by experts," implying a consensus or single-expert approach, but no detailed adjudication process is described.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI vs. without AI assistance was not explicitly mentioned or described in the provided information. The studies primarily focus on the standalone performance of the AI for various tasks.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, a standalone performance study was conducted. The "Segmentation Performance Testing," "Shoulder Side Detection performance testing," "Measurement Accuracy performance testing," "Landmark Performance Testing," "Streaming Stability Testing," and "Ruler Performance Testing" sections all describe the evaluation of the brAIn™ Shoulder Positioning software's algorithmic performance against established ground truths or benchmarks, without explicit human-in-the-loop interaction as part of the primary evaluation metrics.

6. Type of Ground Truth Used:

   • Segmentation: Manual segmentation performed by medical professionals.
   • Shoulder Side Detection: Manual assessment performed by a Clinical Solutions Specialist.
   • Measurement Accuracy: Reported accuracy of the predicate device (for comparison when editing positions) and theoretical distances calculated from spatial coordinates (for ruler tool).
   • Landmark Performance: Final positions adjusted by experts.

7. Sample Size for the Training Set:

   • Sample Size for Training Set: 335 samples (corresponding to 65.9% of the total dataset).

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

   • The labels (ground truth) for both the training and testing sets were created "manually by medical professionals."

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The single-use Biopsy Port Adapter (BPA) converts the biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. This adapter supports luer-lock-connector fine needle biopsy (FNB) and fine needle aspiration (FNA) devices used during an EndoSound EUS endoscopic procedure, while maintaining scope suction.

The Biopsy Port Adapter (BPA) converts the non-luer-lock biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port to support Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) luer endoscopic procedures using luer-lock-type needles. The adapter also seals the port during use and maintains the ability of the scope to provide suction throughout the procedure. The BPA works in tandem with the EndoSound Vision System™ when performing ultrasound-guided FNA and FNB procedures.

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The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures.

The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The BioBrace® Reinforced BioInductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The BioBrace® Extra-Articular Ligament Augmentation Kit is a single-use augmentation procedure kit for use in general surgical procedures for BioBrace® Reinforced BioInductive Implant ("BioBrace® implant") reinforcement of soft tissue where weakness exists, specifically in the extra-articular knee ligaments.

The kit is comprised of bioabsorbable implants and instrumentation. The kit includes one (1) tapered BioBrace Implant 5x250mm, which is threaded through the anchor eyelet.

Kit components are assembled in a single PETG tray and retainer then sealed in a Tyvek pouch. The BioBrace® Extra-Articular Ligament Augmentation Kit is supplied sterile (ETO).

Identical to K240090
Argo Knotless® GENESYS™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Identical to K244025
Argo Knotless® GENESYS™ Anchor: The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Identical to K242187
BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

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Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.

Bonafix Abutment Solutions are a dental implant abutments system that includes three abutment design types (Temporary, Straight Ti-Base and Multi-Unit), that can be used to support single-unit or multi-unit prosthetic restorations. These abutments incorporating interface features compatible with sixteen (16) endosseous dental implant system platforms (Eight (8) designs from five (5) manufactures). The subject device abutments platform diameters range from 3.5mm to 6.3mm, and the corresponding compatible implant body diameters also range from 3.5 mm to 6.3mm. The system also includes corresponding abutment screws.

Temporary Abutments are manufactured from Titanium Grade 5 and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a prosthetic screw which is also manufactured from Titanium Grade 5. The prosthetic screw is delivered with the abutment. Angular correction of temporary abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Modifications can be made by the end-user only in the minimum post height. Minimum post height – 4.0 mm. Temporary Abutments have a maximum duration of usage of 180 days.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The superstructure are fabricated using a CAD/CAM process in Zirconia. The apical end is prefabricated to fit the compatible implant platform, as shown above, and is available with implant connections for crowns (with socket) or bridges (without socket). Angular correction of abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Each abutment is provided with a screw designed to fit the compatible implant. The design parameters for the fabrication of the zirconia superstructure, which are already locked in the CAD/CAM software, are as follows: Minimum wall thickness – 0.45 mm, Minimum abutment post height – 4.0 mm, Maximum abutment post height – 6.5mm, Maximum gingival height – 5.0 mm, Minimum gingival height – 0.7 mm, Angulation – 0°. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. The required cement for bonding the zirconia superstructure to the Bonafix TiBase abutments to create the final two-piece abutment is G-CEM LinkAce™ cleared in K120243. Bonafix Ti-Base Abutments are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) with the superstructure made of zirconia conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The Multi-unit abutments are screw-attached to the implant to restore fully or partially edentulous arches. Their use is not intended for single-unit crowns. They are designed with various gingival heights (1.5, 2.5 and 3.5mm) and can be screwed directly to a compatible implant. They use a titanium Multi-unit sleeve, which is cemented to the prosthesis. Together with a titanium prosthetic screw, the prosthesis is ready to be screwed onto the Multi-unit abutment, which in turn is screwed onto the implant, thus completing the restoration. This multi-unit abutments are not intended to provide angle or divergence correction. For all system, are manufactured from Titanium Grade 5. Multi-unit sleeve can only be modified in the post height and that the minimum post height is 4mm from gingival collar.

The Prosthetic screw is used to seat all abutments for the system, included the temporary abutments and ti-bases, to the dental implant. They are provided along the prosthetic components, but they are also provided as standalone screws. The Abutment screws are manufactured from titanium alloy conforming to ASTM F136.

All system abutments are provided non-sterile with instructions for end user steam sterilization. The subject devices are provided non-sterile and required to be sterilized. All Bonafix TiBase abutments are packaged into PET bag.

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BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient's subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient's peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

BD Saf-T-Intima™ Subcutaneous Catheter System is an over-the-needle subcutaneous and intravenous (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle attached to a wire stylet, wings for insertion assistance and catheter securement, integrated extension tubing, a clamp, a single or dual port, a BD ® PRN Adapter, vent plug (dual port only), and a needle shield. The needle and catheter are protected by a needle cover.

BD Saf-T-Intima™ Subcutaneous Catheter System is designed to keep blood contained within the device throughout the insertion process. The needle is passively protected when it is removed, reducing the risk of accidental needlestick injury. Both the wings and single port or dual port are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue).

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The device is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients aged 18 years or older with suspected disease.

Blineslide is a cloud service application that helps qualified users with image-based assessment of lung ultrasound (LUS) cines acquired from the anterior or anterolateral chest regions during a physician-led LUS examination of patients aged 18 years or older. It does not directly interface with ultrasound systems.

Blineslide takes as input user-uploaded B-Mode LUS video clips (cines) in MP4 format and allows users to detect the relevant medical parameters of structures and function (LUS artifacts). Key features of the software are:

• B Line Artifact Module: an AI-assisted tool for detecting the presence or absence of B line artifacts in LUS cines

Blineslide is incompatible with:

• Cines that are acquired from Linear array ultrasound transducers;
• Cines acquired at less than 18 frames per second;
• Cines that require more than 2048 megabytes of memory;
• Cines that are less than 2600 milliseconds in duration; and
• Cines that are greater than 7800 milliseconds in duration

Each of these exclusion criteria are automatically assessed by the software. If detected, an output of Cannot Evaluate is returned to the user to minimize the risk of false LUS artifact detections.

Blineslide does not perform any function that could not be accomplished by a trained user manually. Patient management decisions should not be made solely on the results of Blineslide's analysis.

Here's a breakdown of the acceptance criteria and study details for the BlineSlide device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

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

Note: The FDA 510(k) summary does not explicitly state pre-defined acceptance criteria for statistical metrics like sensitivity and specificity. Instead, the reported performance is presented to demonstrate substantial equivalence to the predicate device. The "implied" acceptance criteria are derived from the need for the device to be "as safe and as effective as the predicate device."

Study Details

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

• Sample Size for Test Set: Initially 1005 cines. After exclusions for poor image quality, the final dataset comprised 326 positive class examples (B Line Artifacts Present) and 679 negative class examples (B Line Artifacts Absent), totaling 1005 cines.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but mentioned as "various clinical sites in cities with diverse race and ethnicity populations," and "geographically distinct from the data sources used in the development set." This implies a diverse, likely multi-site, geographical origin.
  • Retrospective or Prospective: Not explicitly stated, but typical for these types of studies, the data is likely retrospective, collected from existing archives, then curated into a test set.

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

• Number of Experts: "Two or more experts."
• Qualifications of Experts: Not explicitly stated beyond "experts." However, given the context of identifying B line artifacts in lung ultrasound, it can be inferred that these experts would be physicians credentialed to use lung ultrasound clinically, such as intensivists, emergency physicians, pulmonologists, or other clinicians interpreting LUS cines, as described in the "Intended User" section.

4. Adjudication method for the test set:

• Adjudication Method: Consensus agreement of two or more experts. In rare cases where consensus could not be reached due to poor image quality, clips were excluded.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly reported in this 510(k) summary. The evaluation focused on the standalone performance of the AI algorithm against expert ground truth.

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

• Yes, a standalone performance assessment was done. The summary explicitly states: "The performance of the B Line Artifact Detection Module was successfully evaluated on a test dataset..." and "Performance was assessed by measuring agreement using sensitivity and specificity as co-primary endpoints with Cannot Evaluate outputs scored as false predictions." This directly describes standalone performance.

7. The type of ground truth used:

• Type of Ground Truth: Expert consensus (two or more experts).

8. The sample size for the training set:

• The sample size for the training set is not explicitly stated in the provided 510(k) summary. It only mentions that the "test data was entirely separated from that used for development" and the "data sources used in the test set were entirely different and geographically distinct from the data sources used in the development set."

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

• How the ground truth for the training set was established is not explicitly stated in the provided 510(k) summary. It is implied that ground truth was established during the development phase to train the "non-adaptive machine learning algorithms." This would typically involve expert annotations or labels, similar to the test set, but the specific methodology is not detailed.

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Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
• Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
• Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

Here's a detailed breakdown of the acceptance criteria and the study proving the Bunkerhill MAC device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of cases, but referred to as "the pivotal dataset."
   • Data Provenance: "curated from multiple sites across three geographical regions in the United States." (Retrospective study).

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

   • The document states "agreement of the device output compared to the established reference standard." It does not explicitly state the number of experts used or their qualifications for establishing this "established reference standard." It only refers to "clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" as informing the acceptance criteria.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It refers to an "established reference standard."

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not conducted or reported in this document. The study was a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

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

   • Yes, a standalone study was performed. The document explicitly states: "The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

6. The type of ground truth used:

   • The ground truth was an "established reference standard" which was used for comparison against the device's output. The document implies this reference standard is based on non-gated CT reference measurements and potentially "manual segmentation" informed by clinical literature. It does not explicitly state pathology confirmation or direct outcomes data as the primary ground truth.

7. The sample size for the training set:

   • The sample size for the training set is not provided in the document.

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

   • The document does not provide information on how the ground truth for the training set was established. It only refers to the performance validation on a "pivotal dataset" (test set).

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