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Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Orbit Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. These sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base.

The Orbit Infusion Set is intended for the subcutaneous delivery of fluids and medication from an external infusion pump. The device aims to demonstrate substantial equivalence to the predicate device, Talon Infusion Set (K033290), by meeting performance and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study concluded that "The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product."

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

The document does not explicitly state the sample size used for each specific test. The data provenance is described as "relevant assessments specified in the following international and internal standards and protocols." This suggests that the tests were conducted in a controlled laboratory environment according to established engineering and medical device standards. There is no mention of country of origin of the data, or if it was retrospective or prospective human subject data, as these are technical performance tests on the device itself.

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

Not applicable. The ground truth for these performance tests is based on the specified engineering and medical device standards, which are objective measurements. Expert consensus or clinical interpretation of data is not required to establish ground truth for these types of device performance criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical outcomes where ambiguity might exist. For objective performance tests with clear pass/fail criteria based on standards, an adjudication method is not relevant.

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 submission is for a medical device (infusion set) and not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The ground truth for the performance tests is based on objective measurements defined by international and internal engineering/medical device standards. For example, "Material strength per ISO 9626," "No leak when subjected to pumping pressures up to 20psi," and "No separation...when subjected to a minimum force of 10N (ISO 10555-1, Annex B)."

8. The sample size for the training set

Not applicable. This is a physical medical device being evaluated against engineering and safety standards, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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• Device Functionality: Spirometry .
• Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
• Patient Population: Male/Female, Pediatric to Adult .
• Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)

The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.

The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.

The Orbit spirometer includes the following components:

• . Spirometer
• Spirometer Pressure Tube .
• Disposable pneumotachometer (mouthpiece)
• Office Medic Software .
• Host PC (User Provided) .

Here's an analysis of the provided text regarding the QRS Diagnostic Orbit Spirometer, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that the QRS Diagnostic Orbit Spirometer's performance is demonstrated by its compliance with established standards. The table below summarizes these standards and the reported compliance.

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

The document explicitly states: "The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards." However, it does not provide details on the sample size used for performance testing (if human subjects were involved), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The testing primarily focused on compliance with technical standards for spirometers rather than direct clinical performance data from a patient cohort.

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

Since the "study" primarily revolved around testing compliance with technical standards (ATS/ERS, IEC/EN), rather than a clinical trial with patient data and diagnosed outcomes, there's no mention of experts establishing ground truth for a test set in the traditional sense of clinical diagnosis. Compliance with standards would typically be assessed by engineers or technicians with expertise in medical device testing and regulatory standards.

4. Adjudication Method for the Test Set

As there's no mention of a clinical test set requiring diagnostic interpretation, there's no information provided on an adjudication method (like 2+1 or 3+1). The "adjudication" in this context would be the determination of whether the device's measurements meet the specifications outlined in the technical standards.

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

No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (SpiroCard) based on technical specifications and compliance with standards, not on comparing reader performance with and without AI assistance. The device itself is a spirometer, which measures physiological parameters, and not an AI-driven diagnostic imaging interpretation tool that would typically involve a MRMC study.

6. Standalone Performance Study

The "Summary of Performance Testing" refers to testing of the device itself to verify compliance with the listed standards. This implies a standalone performance evaluation (algorithm only performance, in the sense of the device's measurement and calculation capabilities) was conducted against the criteria set by these standards. The device's primary function is to acquire and analyze pulmonary function data, and its performance is judged on the accuracy and reliability of these measurements as per the standards.

7. Type of Ground Truth Used

The ground truth used for this device involves the specifications and requirements outlined in the American Thoracic Society (ATS/ERS) 2005 Standard for spirometry. This standard sets forth the acceptable ranges and accuracy for various spirometric parameters (e.g., volume, flow, timing). The device's measurements were compared against these established technical and physiological benchmarks, which serve as the "ground truth" for its accuracy and functionality.

8. Sample Size for the Training Set

This document describes a medical device (spirometer) that measures physiological parameters. It does not suggest the use of machine learning or AI models that require a "training set" of data in the typical sense. Therefore, there is no information provided about a training set size. The device's functionality is based on established physics and engineering principles, and its "training" would be its design, calibration, and manufacturing processes to meet the defined standards.

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

Given that there is no indication of a training set for machine learning, this question is not applicable to the information provided. The "ground truth" for the device's operation is inherently built into the design and calibration to comply with the ATS/ERS standards, which are developed by expert consensus in respiratory medicine.

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The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature.

The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.

The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.

The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.

The provided text describes a Special 510(k) submission for the ORBIT GALAXY® G2 Microcoil System. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to existing predicate devices based on non-clinical testing. Therefore, the study described here is primarily a non-clinical bench testing study.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for a specific performance metric. Instead, it describes a comparative approach where the modified device (ORBIT GALAXY® G2 Microcoil System) is tested against the predicate devices (CASHMERE® SR Microcoil System and ORBIT GALAXY® Detachable Coil System) and is deemed to perform "equivalently" or "as designed." The acceptance criteria, therefore, are implied to be meeting the performance of the predicate devices for each test conducted.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of coils or tests) used for each bench test conducted. It states "bench testing data" and "results of verification and validation testing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Codman & Shurtleff, Inc. No information regarding country of origin of the data beyond the manufacturer's location in Raynham, MA (USA) is provided. It's an internal test, not a retrospective or prospective study in the typical human trials sense.

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

This section is not applicable as the study is a non-clinical bench testing study of a medical device, not a study involving human data, medical imaging, or expert interpretation for ground truth. Ground truth for device performance is typically established by engineering specifications, validated test methods, and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where opinions of multiple human reviewers or experts need to be reconciled.

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 done. This type of study involves human readers evaluating cases, often in radiology or pathology, with and without AI assistance to measure reader improvement. The described study is non-clinical bench testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No. This section is not applicable either in the sense of an "algorithm" or "AI." The device is a physical embolization microcoil system, not an AI or software algorithm that would have standalone performance. The testing performed is for the physical device's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical bench testing is engineering specifications, validated test methods, and the established performance characteristics of the predicate devices. The new device's performance in mechanical tests (delivery force, shape retention, tensile strength, durability, detachability) and material characteristics (biocompatibility, sterilization) is measured against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This section is not applicable for the same reason as above.

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The ORI II is intended for augmentation or restoration in the craniofacial region.

The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.

The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The Orbital Reconstructive Implant II (ORI II) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through
non-clinical performance testing and biocompatibility evaluation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified. The study involved bench testing of the Orbital Reconstructive Implant II (ORI II). This refers to a series of laboratory tests conducted on the device itself, rather than testing on biological samples or human patients.
• Data Provenance: The data is from non-clinical performance testing (bench testing) and biocompatibility evaluation. There is no information regarding the country of origin of the data as it's not clinically collected patient data. It is inherently prospective in the sense that the device was manufactured and then tested according to established protocols.

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

• This information is not applicable as the study is based on laboratory bench testing and biocompatibility assessment, not interpretation of clinical data or images by experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for mechanical properties is typically derived directly from the physical measurements themselves. Biocompatibility ground truth is established by standardized toxicity tests.

4. Adjudication Method for the Test Set:

• This information is not applicable as the study does not involve human readers interpreting data or making subjective judgments that would require adjudication. The testing methods are objective measurements of physical and chemical properties.

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 information is not applicable as the device is an implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed.

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

• This information is not applicable as the device is an implant, not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" in this context is based on objective measurements of physical properties (e.g., tensile strength, elongation, modulus) obtained through standardized engineering test methods (e.g., ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787).
• For biocompatibility, the ground truth is established by adherence to the ISO-10993 standard, specifically the long-term implant section, which involves standardized biological assessments to determine the device's compatibility with living tissues.

8. The sample size for the training set:

• This information is not applicable as the device is an implant and does not involve machine learning or an algorithm that requires a training set.

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

• This information is not applicable for the same reason as above; there is no training set for this type of device submission.

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The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The provided text describes a 510(k) submission for the Orbital Reconstructive Implant (ORI), which is a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document states:

• "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices."
• "The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."

This indicates that the submission relies on demonstrating similarity to already approved devices (predicates) in terms of materials, intended use, and general characteristics, along with biocompatibility and biomechanical performance data, rather than a clinical study establishing specific quantitative or qualitative performance metrics against predefined acceptance criteria for a new clinical application or diagnostic capability.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence, not on meeting specific quantitative or qualitative performance acceptance criteria from a clinical trial.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical "test set" study is described in this document. The evaluations mentioned are likely pre-clinical (biocompatibility, biomechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an implant, not an algorithm.
7. The type of ground truth used: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.

The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.

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

Acceptance Criteria and Device Performance Study

The provided document describes the Innovia Orbital Tissue Expander (OTE) and its premarket notification to the FDA. While it discusses performance data, it does not present specific, quantitative acceptance criteria for the device's performance that are then directly compared to reported device performance in a tabular format. The document focuses on demonstrating substantial equivalence to a predicate device and showing safety and effectiveness through various tests.

Therefore, for the acceptance criteria table, I will infer the types of performance criteria based on the described tests and present the qualitative findings. It's important to note that the document does not provide numerical thresholds for "acceptance."

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

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

• Animal Study: The document refers to "the animal study" and "all animals" but does not specify the exact number of animals (sample size).
• Data Provenance: The animal study was conducted, which implies prospective data collection, but the country of origin is not specified.

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

• The document does not specify the number of experts or their qualifications for evaluating the animal study results (e.g., interpreting CT scans or histology). It states that the qualitative difference "can be observed on CT scans as well as in gross photos" and histology was performed, suggesting expert review, but details are absent.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the animal study results.

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

• No, an MRMC comparative effectiveness study was not done. The document describes bench, in vitro, and animal testing. There is no mention of human readers evaluating cases with or without AI assistance. The device itself is a physical implant, not an AI-driven diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The OTE is a medical device, not an algorithm or software. The performance studies evaluate the physical properties and biological effects of the expander.

7. Type of Ground Truth Used

• For the animal study:
  • Qualitative Observation: Orbital expansion and bone growth compared to the contralateral non-enucleated side (visual assessment on CT scans and gross photos).
  • Pathology/Histology: Histological analysis of tissues for foreign body reaction and normalcy.

8. Sample Size for the Training Set

• The document describes manufacturing of the OTE and subsequent testing. There is no mention of a "training set" in the context of machine learning or algorithm development, as this is a physical medical device. The "training" for the device would be its design and manufacturing processes, which are not quantified in terms of a "sample size" in this context.

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

• Since there is no "training set" in the machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing relies on engineering principles, materials science, and pre-clinical animal models to demonstrate safety and efficacy for human use.

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The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

The Orbital Atherectomy System (OAS) is intended for use in treatment of artificial arteriovenous dialysis fistula stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is placed sub-dermal to support kidney dialysis. A consequence of the body's reaction to the foreign material of the A-V shunt is to form clots and neointimal stenosis of the A-V shunt. The most common location for A-V shut stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System is applied to remove neointimal tissue causing a stenosis in the A-V shunt.

The Orbital Atherectomy System (OAS) provides a method of removing occlusive neointimal tissue. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate neointimal tissue. The resulting particles of removed neointimal tissue are very small and can be absorbed by the body.

This document is a 510(k) premarket notification for the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS). It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating performance against such criteria. The "Summary of Safety and Effectiveness" primarily discusses the device's technical aspects, intended use, and comparison to predicate devices, rather than data from a performance study with defined acceptance criteria.

Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the available information, noting the missing details:

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

This information is not present in the provided document. The document primarily focuses on establishing substantial equivalence based on intended use and technology, rather than presenting a performance study with specific acceptance criteria and results.

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

This information is not present in the provided document. The document mentions "Laboratory and animal data" but does not provide details on sample sizes, provenance, or study design (retrospective/prospective).

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 information is not present in the provided document.

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

This information is not present in the provided document.

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 information is not present in the provided document. The device is a physical medical device (atherectomy system), not an AI-based diagnostic tool, so an MRMC study related to human reader performance with AI assistance would not be applicable.

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

This information is not present and not applicable as the device is a physical atherectomy system, not an algorithm.

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

The document refers to "Laboratory and animal data" as support for safety. It's highly probable that pathology/histology and direct observation of animal tissue would have been used as ground truth for assessing the efficacy of tissue removal and safety aspects in the animal studies. However, explicit details are not provided.

8. The sample size for the training set

This information is not present in the provided document. The concept of a "training set" is typically associated with AI/machine learning models and is not relevant for this type of physical medical device submission.

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

This information is not present and not applicable for a physical medical device.

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Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Orbiter PV Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter PV catheter will be offered in 7.5F diameter (7F shaft with a 5F tip) with 1-24 electrodes with a variety of inter-electrode spacings. The distal curve is capable of forming a 360-degree loop.

The provided text describes a 510(k) premarket notification for the Orbiter PV Diagnostic Electrode Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics typically seen for novel medical devices or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not explicitly present in the provided document, as it pertains to a regulatory clearance based on substantial equivalence to predicate devices, not a standalone performance study as would be required for a novel device or an AI/ML algorithm.

However, I can infer some aspects based on the nature of the submission:

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

• Acceptance Criteria: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. There are no specific quantitative performance metrics listed for the Orbiter PV itself in this summary that would typically be seen for AI/ML performance.
• Reported Device Performance: The document states that the Orbiter PV Diagnostic Electrode Catheter is "typical of electrode recording catheters currently sold" and will be offered with similar specifications (7.5F diameter, 1-24 electrodes, variety of inter-electrode spacings, 360-degree loop capability). This implies that its performance is expected to be comparable to these existing devices.

Since the submission is for substantial equivalence to predicate devices, a table like the one requested, with specific quantitative performance metrics and acceptance criteria, is not included in the provided text. The "performance data summary" section refers to technological characteristics and references predicate devices.

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

• Not applicable/Not provided: This information is typically for de novo studies evaluating a device's performance against specific endpoints. For a 510(k) based on substantial equivalence, a formal "test set" with a specified sample size for clinical validation is generally not required unless new clinical questions arise. The regulatory review focuses on whether the new device is as safe and effective as the predicate.

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

• Not applicable/Not provided: As no specific "test set" for performance evaluation is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication method for the test set:

• Not applicable/Not provided: Without a test set and experts, there is no adjudication method 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:

• No: This device is an electrode catheter used for intracardiac sensing, recording, stimulation, and pacing. It is not an AI-assisted diagnostic imaging device, so an MRMC study comparing human readers with and without 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: The device is a physical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The type of ground truth used:

• Not applicable/Not provided: As discussed, no formal performance study requiring ground truth establishment is detailed in this 510(k) summary. The ground truth for regulatory clearance in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable/Not provided: This device is not an AI/ML algorithm, so there is no "training set."

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

• Not applicable/Not provided: As above, this is not an AI/ML device.

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Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Orbiter ST extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.

The Orbiter ST Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter ST catheter will be offered in 7F diameter with 2-20 electrodes with a variety of inter-electrode spacings and curve styles.

An accessory to the Orbiter ST Diagnostic Electrode Catheter, the Orbiter ST Extension Cable will be sold separately.

The provided K992373 document is a 510(k) summary for the Orbiter ST Diagnostic Electrode Catheter and Orbiter ST Extension Cable. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the document primarily discusses performance testing against specified requirements rather than a clinical study comparing device performance against a gold standard or human readers.

Here's an analysis of the provided information, framed by your request, and identifying where the document does not contain the requested details:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document states that the Orbiter ST catheter underwent "performance testing" to demonstrate its safety and effectiveness, and that it met all testing acceptance criteria. However, the specific quantitative acceptance criteria for each test are not detailed in this summary document. The document refers to "Appendix 2" for detailed protocols and results, which is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria and detailed performance results are not present in the provided 510(k) summary. These would typically be found in the appendices (Appendix 2, for performance testing). The document only states that the device "meets the requirements of the specified performance testing" and "was found to meet all testing acceptance criteria and was therefore acceptable."

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

• Sample Size for Test Set: Not specified in the provided summary. The summary refers to "in vitro bench testing" and "performance testing" but does not give the number of devices or units tested.
• Data Provenance: The testing was "in vitro bench testing," meaning it was conducted in a laboratory setting. The country of origin for the testing itself is not explicitly stated, but the submitter (C.R. Bard, Inc.) is based in Massachusetts, USA. The data is prospective, meaning the tests were performed specifically for this submission.

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

This information is not applicable to this type of submission or the reported testing. The "ground truth" for in vitro bench testing is typically based on established engineering principles, regulatory standards, and material science, rather than expert clinical consensus. For example, a test for tensile strength would compare the device's performance against a pre-defined strength requirement, not against an expert's opinion.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth establishment, which is not the nature of the reported in-vitro performance testing.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a medical device (electrode catheter) and its accessory, not for an AI or diagnostic imaging algorithm that requires human interpretation. Therefore, a study to assess the improvement of human readers with AI assistance is irrelevant and was not performed.

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

No, a standalone algorithm performance study was not done. This device is a physical electrode catheter and an extension cable, not a software algorithm.

7. The Type of Ground Truth Used

For the reported performance and biocompatibility testing, the "ground truth" was based on:

• Established Scientific Methods and Standards: The document states that "Tests were chosen and developed based on the 1995 Draft Guidance and through previous experience with the Viking catheter 510(k)." This implies that the 'ground truth' for whether the device performed adequately was defined by these regulatory guidelines and historical performance benchmarks for similar devices.
• Biocompatibility Standards: The biocompatibility testing results demonstrated that the materials are "nontoxic and biocompatible," which refers to compliance with recognized biological safety standards.
• Engineering Specifications: Implicitly, the performance tests would have measured various physical and electrical properties against pre-defined engineering specifications and safety margins.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware medical device, not a machine learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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