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The DELTAWAVE Nasal Pillows System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device.

This medical device is intended for adult patients weighing 66 lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home.

The DELTAWAVE™ Nasal Pillow System is the subject device for this submission. It is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea.

The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.

The DELTAWAVE Nasal Pillows System is a medical device intended to noninvasively deliver pressurized airflow from a CPAP or Bi-Level device to adult patients (weighing 66 lbs or 30kg) who have been prescribed such therapy. It is designed for single-patient reuse in the home.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents a comparison of the DELTAWAVE Nasal Pillow System (subject device) to a predicate device, the Fisher & Paykel EVORA™ Nasal Mask (Model A), across various characteristics and performance metrics. The underlying acceptance criterion for substantial equivalence is that the differences do not raise new or different questions of safety or effectiveness.

Below is a table summarizing the reported device performance, with the implicit acceptance being "similar" or "does not raise new/different questions of safety and effectiveness" compared to the predicate.

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

The document describes non-clinical performance testing. For specific performance metrics like Dead Space, Resistance, CO2 Rebreathing, and Sound Levels, it is likely that a sample size appropriate for engineering and laboratory testing (e.g., several units per size/type) was used, rather than a large clinical test set. The document does not specify the exact number of devices tested for each non-clinical performance test.

The data provenance is from non-clinical performance testing conducted by the manufacturer of the DELTAWAVE Nasal Pillows System (REMSLEEP Holdings Inc.). This type of data is typically collected prospectively in a laboratory setting. No country of origin for the non-clinical test data is specified, but it accompanies a US FDA submission, implying compliance with US regulatory standards.

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

This device is not an AI/CADe/CADx device that would typically rely on expert human interpretation to establish ground truth for a test set. The "ground truth" for the non-clinical performance tests (e.g., resistance, dead space, CO2 rebreathing) is established by using calibrated measurement equipment and adhering to recognized test standards (e.g., ISO, AAMI). Therefore, no human experts were used in this context to establish ground truth for a "test set" in the way it's understood for diagnostic imaging or AI devices. The product development and testing would involve engineers and quality control personnel with relevant expertise.

4. Adjudication method for the test set:

Not applicable, as this is primarily a non-clinical performance evaluation against predefined engineering specifications and international standards, not a diagnostic or AI performance study requiring human adjudication.

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

No. This is a physical medical device (nasal pillows system) and not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant or applicable.

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

Not applicable, as this is not an algorithm or AI device. It is a physical accessory for CPAP/Bi-Level therapy.

7. The type of ground truth used:

The ground truth for the performance characteristics (e.g., Dead Space, Pressure Drop, CO2 Rebreathing, Sound Levels) is established through objective, standardized measurements and adherence to international consensus standards (e.g., ISO 17510, ISO 5356-1, various ISO 10993 and ISO 18562 standards for biocompatibility). For biocompatibility, the "ground truth" is defined by the absence of toxicity, irritation, etc., as assessed by validated biological test methods.

8. The sample size for the training set:

Not applicable, as this is not a machine learning device 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 device.

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Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment dose calculation.

Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used radiation oncology personnel for quality assurance purposes.

Delta4 Insight is software specifically design for quality assurance of radiotherapy treatment plans generated by a treatment planning system. The device calculates a secondary dose calculation via an independent Monte-Carlo based dose calculation software and compares this to the treatment planning system dose. The device is used as a secondary check for the results of a TPS and not for comparison with a measurement.

Delta4 Insight is a software module within the General Delta4 software. The software module is independent of all other software modules within the Delta4 software. The device is NOT a treatment planning system or a radiation therapy delivery device. It is only used by trained radiation therapy oncology personnel for the purposes of quality assurance in a hospital setting.

Insight supports treatments with MV photons. No other radiation type is supported.

Here's a breakdown of the acceptance criteria and the study details for the Delta4 Insight device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Test plans were chosen to span the space of test parameters for the types of treatment types/modalities/energies/TPS/machines that are supported. The variety of plans tested are reflective of common clinical treatments and tumor sites and span many field sizes and tissue depths."
  • Interpretation/Clarification: The exact number of test plans used is not specified. However, the description implies a diverse set of clinically relevant plans.
• Data Provenance: "The dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared."
  • Interpretation/Clarification: The data consists of retrospective, anonymized DICOM patient treatment plans. The country of origin is not specified but is likely from European or North American oncology departments given the context of FDA submission and common practices.

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

• The document does not explicitly state that human experts established a "ground truth" for the test set in the traditional sense of clinical assessment.
• Instead, the comparison is made against "reference algorithms" (Acuros, Monaco) which themselves are established dose calculation engines. The accuracy of these reference algorithms is implicit, and one (Acuros) is cited with a publication (Hoffman et al, MedPhys 2018).
• The study focuses on the agreement between software calculations, not expert visual assessment.

4. Adjudication Method for the Test Set

• The concept of "adjudication" (e.g., 2+1, 3+1 expert review) is not applicable to this type of study.
• The comparison method used is a gamma comparison between the Delta4 Insight dose results and the original reference TPS dose. Gamma analysis is a common method in radiation oncology for quantitatively comparing dose distributions.

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

• No, a MRMC comparative effectiveness study was not done.
• This device is a "secondary check QA software" designed for an algorithm-to-algorithm comparison (Delta4 Insight's calculation vs. Treatment Planning System's calculation), not for human reader performance evaluation. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant to this submission.

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

• Yes, a standalone performance evaluation was indeed done.
• The study explicitly describes comparing "the dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared." This is a direct measure of the algorithm's performance in matching established reference calculations.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the dose calculation results from established "reference algorithms" (Monaco, Acuros) within existing Treatment Planning Systems (TPS). It is not pathology, outcomes data, or human expert consensus in the diagnostic imaging sense. It is a comparison against other validated computational models for dose calculation.

8. The Sample Size for the Training Set

• The document does not specify a separate training set size.
• The description focuses on "validation testing involved testing of clinical treatment plans" and "test plans were chosen to span the space of test parameters." This suggests that the device's algorithms were likely developed and refined using internal data, but the 510(k) summary only describes the validation/test set and its performance.

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

• Since a training set is not explicitly mentioned with its own ground truth establishment in this document, this information is not provided.
• Typically, for a dose calculation algorithm, "ground truth" during development (training) would involve comparing the algorithm's output against physical measurements (e.g., phantom measurements, ionization chamber data) and/or highly accurate, gold-standard Monte Carlo simulations for a variety of beam configurations and patient geometries. However, this 510(k) summary focuses on the comparative performance against other clinical TPS algorithms for validation.

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The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.
The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table: .
• Control Desk/Image Storage (UIMS). .
  The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
  The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
  The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
  The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the document is a 510(k) submission for a Delta III Pro Lithotripter, which is a medical device for fragmenting urinary tract stones. The submission focuses on demonstrating substantial equivalence to a predicate device (Dornier Delta III Lithotripter, K201074) based on minor modifications.

The "Performance Data" section describes compliance with electrical safety, electromagnetic compatibility, radiation protection, safety of lithotripsy equipment, safety and performance of x-ray equipment, and usability engineering standards (IEC standards), as well as software verification and validation. These are engineering and regulatory compliance criteria, not performance metrics like sensitivity or specificity for a diagnostic AI.

Here's a breakdown of why the requested information for acceptance criteria and related study details cannot be found in the provided text:

• This is not an AI/ML device in the context of diagnostic performance: The device is a lithotripter, which physically breaks down stones. Its performance is measured by its safety, efficacy in stone fragmentation, and compliance with various engineering standards, not by diagnostic accuracy.
• The "Performance Data" section refers to regulatory compliance and non-clinical testing: "Non-clinical functional testing successfully passed and met all design requirements" and compliance with IEC standards are mentioned. This refers to engineering verification and validation, not a clinical study comparing its diagnostic performance against a ground truth with human experts.
• No mention of human readers, AI assistance, or diagnostic metrics: The text does not discuss human interpretation of images/data, AI algorithms for analysis, or metrics like accuracy, sensitivity, specificity, AUC, etc.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I cannot create the table or answer the questions the way they are designed for an AI/ML diagnostic device.

However, I can extract the information that is present regarding "performance" in the context of this device and its submission:

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

The document does not explicitly state "acceptance criteria" for diagnostic performance, but it lists standards with which the device complies. The "reported device performance" is primarily stated as successful compliance with these standards and established design requirements.

2. Sample size used for the test set and the data provenance
This information is not provided because it's a non-clinical, engineering verification for a physical device, not an AI/ML diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" in the diagnostic sense is established for this type of device.

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 not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the diagnostic sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks for stone fragmentation, which are not detailed in this summary.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context.

9. How the ground truth for the training set was established
Not applicable.

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The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy.

DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation or diagnosis of acute encephalopathy.

The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed healthcare physician.

The use environment is in hospitals:

· non-sterile environments;

· ICUs, wards, and other patient evaluation locations;

The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary connector design.

The DeltaScan Monitor provides EEG signal acquisition and analysis technology intended for use as an adjunct to clinical judgment. The DeltaScan Monitor provides support in clinical decision-making by providing an assessment for a patient having acute encephalopathy or not, based on a measure of the detected polymorphic delta (PMD) waves in the EEG.

The DeltaScan Monitor consists of a Monitor and a Patch connector. The Patch connector contains the EEG amplifier hardware. The Monitor contains electronics for galvanic isolation to the EEG cable with Patch connector, storage of EEG recording and log files (eMMC memory chip), processing capacity to run software (DeltaScan Monitor Application, or DMA), user interface elements (e.g., screen, keys, recording button), battery (FEY PA-IEC-LNB162Q.R001), and the charging circuitry. EEG data is collected by the DeltaScan Monitor using a DeltaScan Patch. Collected EEG signals are amplified, digitized, and then processed by the software algorithms to provide the user with the DeltaScan Output. The DeltaScan Monitor Application is stand-alone software running on an Embedded Linux OS.

This document describes the acceptance criteria and the study that proves the device (DeltaScan Monitor R2) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 434 patients (195 on ICUs and 239 on wards) fulfilled inclusion, but not exclusion, criteria.
• Data Provenance:
  • Country of Origin: The Netherlands (geographically distinct clinics: 6 ICUs and 15 wards).
  • Retrospective or Prospective: Prospective. The study "DeltaStudy" was designed to evaluate diagnostic performance and repeatability, involving the collection of EEGs with DeltaScan and clinical data on ICUs and wards.

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

• Acute Encephalopathy (EEG reference standard): 3 separate EEG experts. Qualifications are not explicitly detailed beyond being "EEG experts." They visually assessed 4-minutes of EEG data for the presence of polymorphic delta activity.
• Delirium (clinical reference standard): 3 clinical delirium experts. Qualifications are not explicitly detailed beyond being "clinical delirium experts." They assessed clinical data including researcher's interview based on DSM-5 criteria A-C, Electronic Health Record data, and description of patient behavior.

4. Adjudication Method for the Test Set

The ground truth for both acute encephalopathy and delirium was established using consensus (majority vote) among the experts.

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

No MRMC study comparing human readers with and without AI assistance was reported. The study focused on the standalone diagnostic performance of the DeltaScan Monitor in comparison to expert consensus (ground truth).

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The "DeltaScan Output" (binary positive/negative for acute encephalopathy) was determined by the DeltaScan Monitor from EEG recordings, and these outputs were compared against the expert committee's estimated diagnoses for acute encephalopathy and delirium.

7. Type of Ground Truth Used

• Acute Encephalopathy: Expert consensus from 3 EEG experts visually assessing EEG data for polymorphic delta activity.
• Delirium: Expert consensus from 3 clinical delirium experts assessing clinical data and DSM-5 criteria.

8. Sample Size for the Training Set

The document mentions that the DeltaScan was calibrated based on a "previous clinical calibration dataset" from Numan et al., 2019, BJA. This dataset contained 321 EEG recordings. This is the sample size for the calibration dataset, which effectively serves as a training or development set for the algorithm's scoring and thresholding.

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

For the calibration dataset (Numan et al., 2019, BJA), the ground truth for acute encephalopathy and delirium was established through expert labels. The document states that the calibration dataset contained "321 EEG recordings with expert labels for acute encephalopathy and delirium." This suggests a similar expert review process to the test set, where experts provided their diagnoses to create the ground truth.

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The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.

The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.

The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.

The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).

Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").

Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.

Acceptance Criteria and Reported Device Performance

As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.

Study Details (Based on the provided text)

Since the document states "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch itself, the following sections will reflect the lack of such clinical performance study data in this submission. The "studies" mentioned are largely engineering verification and validation for safety and functional aspects.

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

   • Biocompatibility: Not specified for the number of samples, but "all parts of the DeltaScan Patch R2" were tested.
   • Mechanical Testing (Labels & Packaging): Not specified.
   • Shelf Life: Not specified for the number of patches or test duration, but based on accelerated aging.
   • Electrical Signal Transfer ("Verification Report"): Not specified.
   • Data Provenance: The studies appear to be internal verification and validation studies conducted by the manufacturer (Prolira B.V.). No information on country of origin of data or retrospective/prospective nature is given beyond the type of studies (e.g., accelerated aging).

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

   • Not applicable as no clinical performance study with expert ground truth data is described for the DeltaScan Patch itself. The "ground truth" for the verification activities would be established by industry standards (e.g., ISO 10993-1) and internal engineering specifications.

3. Adjudication method for the test set:

   • Not applicable as no clinical performance study requiring expert adjudication is described.

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 MRMC study was done. The DeltaScan Patch is an EEG electrode, not an AI-powered diagnostic device, and thus this type of study is not relevant to its primary submission. The document explicitly states "No dedicated clinical study is needed to validate the device performance" and that the patch does not contain software.

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

   • Not applicable. The DeltaScan Patch is a hardware component (an electrode); it is not an algorithm. Its function is to acquire signals for a separate device (DeltaScan Monitor, K222680).

6. The type of ground truth used:

   • For Biocompatibility: Established by adherence to ISO 10993-1:2018 standards and their defined acceptance criteria.
   • For Mechanical Testing (Labels & Packaging): Established by internal specifications for legibility, durability, compliance, and shipping integrity.
   • For Shelf Life: Established by accelerated aging protocols and internal specifications for electrode degradation.
   • For Electrical Signal Transfer: Established by internal verification that the patch "transfers the electrical signals as intended." Specific metrics or objective "ground truth" (e.g., comparison to a gold-standard EEG recording) for signal fidelity are not detailed in this summary.

7. The sample size for the training set:

   • Not applicable. The DeltaScan Patch is a hardware device; it does not involve machine learning algorithms requiring a training set.

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

   • Not applicable (no training set as it's a hardware device).

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DeltaFil (in capsule) is used for geriative filling procedures. The procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.

DeltaFil Conditioner:

• Treatment of the smear layer
• Conditioning of the cavity

DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form (DeltaFil in capsule), and a compatible tooth conditioner (DeltaFil Conditioner). DeltaFil Conditioner and DeltaFil (in capsule) are used together for the creation of permanent or temporary dental restorations as described in the device labelling. DeltaFil is available in Vita shades A1, A2, A3, A3.5, and A4.

DeltaFil (in capsule) is a two-part powder/liguid glass polyalkenoate restorative cement as defined in ISO 9917-1:2006 Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements. The powder and liquid components are supplied in the correct mixing ratio in disposable "Applicap" capsules for use with the DMG Applicap Dispenser. DeltaFil Conditioner is a 10% aqueous polyacrylic acid solution, which is applied to the prepared tooth surface prior to placement of the mixed DeltaFil (in capsule) material. DeltaFil Conditioner improves the adhesive bond between the tooth tissue and the restorative cement material by treating the smear layer and conditioning the prepared cavity.

This is a 510(k) premarket notification for a dental device, not an AI/ML device, so the usual criteria for AI/ML acceptance and studies are not applicable. The document discusses performance criteria for a dental cement and conditioner.

Here's an analysis based on the provided text, focusing on the nearest equivalents to your requested categories for a non-AI/ML medical device:

The device under review is DeltaFil (in capsule), a radiopaque glass ionomer restorative material, and DeltaFil Conditioner, a 10% aqueous polyacrylic acid solution. Both are used in dental filling procedures.

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

The document provides a comparison table against two predicate devices (GC Fuji IX GP for DeltaFil and 3M Espe Ketac Conditioner for DeltaFil Conditioner), which implicitly sets the acceptance criteria by demonstrating "substantial equivalence." The acceptance criteria are essentially defined by meeting or being similar to the performance characteristics of the legally marketed predicate devices, and in some cases, meeting ISO standards.

Acceptance Criteria and Reported Device Performance (Derived from Comparison Tables):

For DeltaFil (in capsule) vs. Predicate GC Fuji IX GP (K961448):

For DeltaFil Conditioner vs. Predicate 3M Espe Ketac Conditioner (K872984):

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

The document states "Performance data demonstrated that DeltaFil (in capsule) and DeltaFil Conditioner meet all predetermined acceptance criteria contained in the product specification and are suitable for their intended use." It also mentions "Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation."

However, specific sample sizes for each physical test (e.g., compressive strength, radiopacity, shear bond strength, acid erosion) are not detailed in this summary. The provenance of the data is not explicitly stated beyond being studies conducted to support the substantial equivalence claim for the subject device. It is generally understood that such testing is conducted by the manufacturer (DMG Chemisch-Pharmazeutische Fabrik GmbH, Germany). The studies are likely prospective tests performed specifically for this submission.

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

This question is not applicable as this is not an AI/ML device, and therefore no "experts" are adjudicating image interpretations or similar for ground truth. The "ground truth" for the performance tests comes from objective physical and chemical measurements (e.g., MPa for strength, mm for erosion, %Al for radiopacity) against established ISO standards and comparisons to predicate device data.

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

Not applicable, as there is no human adjudication of results in the way it would be for an AI/ML diagnostic device interpreting images. Physical and chemical tests typically involve standardized protocols and measurements.

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 dental material, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm. The performance evaluation is inherently for the materials themselves.

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

For the DeltaFil and DeltaFil Conditioner, the "ground truth" is established through:

• International Standards: Primarily ISO 9917-1:2007 (Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements) for physical and chemical properties like compressive strength, radiopacity, acid erosion, and acid soluble lead content.
• Predicate Device Data: Performance characteristics of legally marketed devices (GC Fuji IX GP and 3M Espe Ketac Conditioner) serve as a benchmark for comparison.
• Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. There is no training set. The regulatory path is based on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards through physical and biocompatibility testing.

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The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

DELTA XTEND™ Hemi-Shoulder Replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.

The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.

The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cementless use.

All other metallic components are intended for cemented use only.

The DELTA XTEND Reverse Shoulder System consists of humeral stems, modular epiphysis, humeral spacers, humeral cups, glenospheres, metaglenes and metaglene screws used for reverse shoulder arthroplasty. Humeral heads can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The metaglenes are available in various design configurations including standard and augmented designs. The metaglenes allow for the placement of a central screw down the center of the post. A separate collet component is inserted into the metaglene post to receive the locking screw of the glenospheres.

The provided text describes a 510(k) premarket notification for a medical device, the DELTA XTEND Reverse Shoulder System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or AI-driven performance metrics.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for AI/algorithm performance are not applicable to this 510(k) submission.

This submission is for a mechanical medical device (shoulder prosthesis), not a diagnostic or AI-based device that would typically undergo studies with the kind of performance metrics and ground truth establishment outlined in the request. The "Performance Data" section lists various mechanical tests (e.g., Pullout Evaluation, Fatigue Evaluation, Micromotion Evaluation), which are standard for orthopedic implants to demonstrate their physical properties and durability, ensuring they are comparable to existing, legally marketed devices.

Here's why the queried information is not present in the provided text:

• Acceptance Criteria & Reported Performance Table: The document doesn't provide numerical acceptance criteria for clinical performance (like sensitivity/specificity for a diagnostic device) or reported performance against such criteria. Instead, it demonstrates equivalence through design, materials, and mechanical testing.
• Sample Size & Data Provenance (for test/training sets): These are relevant for clinical trials or AI model validation datasets. For a 510(k) for a mechanical implant, the "sample size" would refer to the number of devices or test specimens used in engineering bench testing, not patient data for algorithm training/testing. Such detailed numbers are typically found in the full technical reports submitted to FDA, not in the summary document.
• Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These concepts are specific to diagnostic devices, especially those involving image interpretation or AI algorithms where human readers' performance is augmented or replaced. They are not applicable to the evaluation of a shoulder prosthesis itself.
• Type of Ground Truth: For this device, the "ground truth" would be established through engineering specifications, material science, biomechanical principles, and the established performance of predicate devices. There wouldn't be "expert consensus" or "pathology" in the sense of diagnosing a condition; rather, it refers to engineering and clinical consensus on mechanical properties and surgical outcomes.
• Training Set Sample Size & Ground Truth Establishment: Again, these are AI/machine learning terms and do not apply to this type of device submission.

In summary, the provided document is a regulatory submission for a physical implant, not an AI/diagnostic device. The "study" referenced in the document (under "Performance Data") refers to benchtop mechanical and material testing, performed to demonstrate that the device is as safe and effective as its predicate devices, rather than a clinical study evaluating diagnostic accuracy or human performance improvement.

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The DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.

The DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: severe arthropathy and/or; a previous failed joint replacement and/or: fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

The DELTA XTEND™ Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated: Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes

The provided text is a 510(k) Summary for the DELTA XTEND™ Reverse Shoulder System. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the primary purpose of this submission (as stated in section 510(K) SUMMARY) is "to extend the current approved shelf life of 5 years to 10 years" of the DELTA XTEND™ Reverse Shoulder System.

Therefore, the performance data provided focuses solely on testing related to shelf-life extension, specifically regarding the HA coating on shelf-aged products. There is no information within this document about acceptance criteria or studies related to AI-powered medical devices, human reader improvements with AI assistance, or algorithm-only performance.

The document explicitly states:
"NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE."

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance), expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device, as this documentation pertains to a traditional medical device (shoulder replacement system) and not an AI/ML device.

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The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."

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

The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.

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

This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.

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

This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.

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 MRMC comparative effectiveness study was done or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.

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

This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.

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

For the described tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
• Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
• Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.

8. The sample size for the training set

Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.

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

Not applicable, as there is no mention of a training set.

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Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.

Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.

Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector.

Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version).

The provided text describes a 510(k) summary for the Delta Med S.p.A Deltaven Fast Flash Closed I.V. Catheter Systems. This document pertains to a medical device (intravascular catheter) and not an AI/ML-driven device or an imaging device. Therefore, a study proving an AI device meets acceptance criteria, including elements like expert consensus, MRMC studies, or training/test set details, is not applicable to this document.

The document discusses acceptance criteria and the study that proves the device meets them in the context of a physical medical device (intravenous catheter), not an AI/ML system. The "acceptance criteria" here refer to the performance standards, regulatory requirements, and safety benchmarks for this type of medical device.

Here's a breakdown of the acceptance criteria and the study as described in the document, tailored to a medical device:

Acceptance Criteria for Deltaven Fast Flash Closed I.V. Catheter Systems

The acceptance criteria for the Deltaven Fast Flash Closed I.V. Catheter Systems are primarily based on established international and FDA-recognized standards for intravascular catheters, and proving substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-AI Device)

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

   • The document does not explicitly state the specific number of units used for each test (e.g., functional, biocompatibility, sterility) as a "sample size" in the way one would for a clinical trial or AI test set.
   • Instead, for medical devices, testing is performed on representative samples of the device, often according to guidelines within the referenced ISO standards (e.g., ISO 10993 specifies sample preparation, ISO 11135 specifies sample sizes for sterility validation).
   • Data provenance: The testing was performed by Delta Med S.p.A (Italy) through their various testing procedures and subcontractors. The tests are "non-clinical" (bench and lab-based), not from patient data.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as this is a physical medical device, not an AI/ML system requiring expert labeling or ground truth establishment from medical images/data. The "ground truth" is defined by the physical and chemical properties of the device and its performance against engineering and biological standards.

3. Adjudication Method:

   • Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

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

   • Not applicable. This type of study is used for diagnostic AI systems where human readers interpret medical images. This document describes a physical medical device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is not an algorithm. The performance evaluation is of the physical catheter and its components.

6. Type of Ground Truth Used:

   • The "ground truth" for this device is based on:
     • Standard Compliance: Adherence to internationally recognized standards (ISO, ASTM, USP) for materials, design, manufacturing, sterility, and performance.
     • Bench Test Results: Direct measurements and observations from laboratory testing (e.g., flow rate, force at break, particulate counts, endotoxin levels).
     • Biocompatibility Assay Results: Laboratory tests on biological interactions.
     • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K171530).

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is manufactured. The manufacturing process ensures consistency, and the testing evaluates that consistency and adherence to design specifications.

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

   • Not applicable for the reasons mentioned above. The design and manufacturing specifications are based on engineering principles, regulatory requirements, and historical data from similar devices.

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