The SOMAVAC™ Device is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The single-patient use SOMAVAC™ Device is capable of generating sustained vacuum at the end two surgical drains to effectively remove bodily fluids after plastic or general surgeries. The SOMAVAC™ Device has a battery-powered SOMAVAC™ Pump assembly to generate vacuum with accessories, including disposable collection units, two drain connectors, and one belt. All products are non-sterile. Surgical drains are not included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distal inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains can be attached to the SOMAVAC™ Device. Each disposable waste collection units collects up to 100 mL of fluid. Versions of the device will be marketed with factory-set single, vacuum pressure levels ranging from 60 to 350mmHg. The device maintains suction throughout its use in a manner analogous to a thermostat by selectively running the pump motors to maintain the preset pressure. The device stops when the collection units are full or if the collection units are detached from the device. SOMAVAC™ Pump assembly has light and sound indicators to help users identify when the collection unit is full and ready to be exchanged, the battery is ready to be changed, or if there is a malfunction.

The SOMAVAC™ Device, a portable battery-powered vacuum source/waste container for surgical and bodily fluid removal, underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in a side-by-side format. However, it lists several non-clinical tests conducted, implying that the device met the specifications and standards targeted by these tests. Based on the "Summary of non-clinical tests conducted for determination of substantial equivalence" section (page 6), the following can be inferred:

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

The study relies primarily on non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or samples from a typical clinical study is not applicable. The samples used would be:

• Physical units of the SOMAVAC™ Device and its components for performance, electrical safety, and endurance testing.
• Materials used in the device for biocompatibility testing.
• Software code for verification and validation.

Data Provenance: The tests are described as non-clinical tests. The country of origin for these tests is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards and potentially U.S. or internationally accredited testing laboratories. All tests are inherently retrospective in the sense that they evaluate manufactured device units against established specifications.

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

This information is not applicable as the determination of substantial equivalence was based on non-clinical engineering and bench testing, not on clinical assessment requiring expert interpretation of patient data or images to establish a "ground truth."

4. Adjudication Method for the Test Set:

This information is not applicable as there was no clinical study involving human judgment or interpretation of data that would require an adjudication method. Test results are compared against predetermined engineering specifications and industry standards.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s)." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is not relevant for this device.

6. Standalone Performance Study:

A standalone performance study in the context of typical AI device evaluation (algorithm only without human-in-the-loop performance using patient data) was not performed. The device is a physical medical device, not an AI diagnostic algorithm. The "standalone" performance described here relates to the device's technical specifications and functionality (e.g., vacuum, flow, battery life) as measured in a lab setting without human intervention beyond operating the test equipment.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests constitutes:

• Engineering Specifications: The design specifications the device was intended to meet (e.g., target vacuum pressure range, flow rate, battery operating times).
• Voluntary Standards: Established international and national standards for medical devices (e.g., ISO 14971, IEC 60601-1, ISO 10993).
• FDA Guidance Documents: Recommendations from FDA for software and other aspects.

8. Sample Size for the Training Set:

This information is not applicable. The SOMAVAC™ Device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

This information is not applicable because there is no training set for this device.

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The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks.

The device is introduced through the instrument channel of the bronchoscope. The device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap and stopcock. The B7-2C device is 1050 mm in working length, with a pre-inflation diameter of 2.55 mm and a post-inflation diameter of 13 mm, with a max volume of 1.7 cc.

The B7-2C Occlusion Balloon is intended for use in selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis, and airway occlusion to localize air leaks.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Airway Occlusion Test: N=30 tests.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies bench testing ("Performance testing has been completed on both the predicate device as well as the subject device...").

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

• This information is not provided in the document. The tests described are bench tests, not clinical studies involving human assessments.

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

• Not applicable as the performance tests described are objective bench tests, not human assessments requiring adjudication.

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 medical instrument (an occlusion balloon) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is not relevant.

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

• Not applicable as this is a medical device and not an algorithm.

7. The type of ground truth used:

• The ground truth for the performance tests (e.g., airway occlusion, burst testing) was based on objective, quantifiable measurements from bench tests. For biocompatibility and sterilization, the ground truth was regulatory standards and established testing protocols.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML model, so there is no concept of a "training set."

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

• Not applicable.

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ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.

The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.

The provided FDA 510(k) summary for the ReLeaf™ Catheter focuses on demonstrating substantial equivalence to a predicate device (Axiom Multipurpose Wound Drain, K993592) through bench-top and animal testing. It does not contain information about a study involving human readers, AI assistance, or the specifics of ground truth for a test set in the context of diagnostic accuracy. This is a medical device approval for a physical catheter, not a diagnostic imaging or AI-driven decision support system.

Therefore, many of the requested categories in your prompt are not applicable to the provided document.

However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally qualitative (meets standards, no new safety/effectiveness issues) and demonstrate performance comparable to the predicate. The "reported device performance" are the results of various bench and animal tests.

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

• Test Set Sample Size: Not applicable. The "test set" here refers to the actual devices subjected to bench and animal testing. The document does not specify the number of catheters tested for each bench test or the number of animals used.
• Data Provenance: Bench-top testing and simulated use animal testing. No country of origin is specified for the animal testing, but the submission is to the U.S. FDA. The data is prospective as it was generated specifically for this 510(k) submission.

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

• This concept is not applicable as this is a physical medical device. "Ground truth" for device performance is established through objective measurements in laboratory and animal testing, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of diagnostic cases, not for assessing the physical performance of a catheter.

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 device for anesthesia and drainage, not an AI-assisted diagnostic tool. No human reader studies comparing AI vs. no AI assistance were conducted or are relevant for this type of device.

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

• Not applicable. There is no algorithm or AI component in the ReLeaf™ Catheter.

7. The Type of Ground Truth Used

• For Bench Testing: Objective physical measurements, engineering standards, and performance specifications (e.g., tensile strength in Newtons, leak rate, patency flow rates, force measurements for insertion/removal).
• For Animal Testing: Physiological responses, tissue reactions, and the functional success of the catheter in a living system, often assessed by veterinary pathologists or researchers.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm for this device. The development of the catheter would involve iterative design, prototyping, and testing, but not in the machine learning sense of a training set.

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

• Not applicable. As there's no training set for an AI, establishing ground truth for it is irrelevant in this context.

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Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

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: Not explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
• Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.

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

• Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.

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

• MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Performance Testing (as per document):

The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."

This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.

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The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.

REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.

The provided text describes a 510(k) submission for the REDYROB® Closed Wound Drainage System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing new performance metrics or acceptance criteria as one might find for a novel, high-risk device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a Class I device of this nature. The "acceptance criteria" here primarily refer to the product meeting its design specifications and demonstrating suitability through material testing and physical testing, rather than clinical performance metrics.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for material or physical testing. The context implies routine quality control testing of manufactured units, which would involve a representative sample size based on manufacturing volumes and statistical sampling plans, but the specific numbers are not provided in this regulatory summary.
• Data Provenance: Not explicitly stated regarding country of origin for testing data. The testing is described as occurring internally by B. Braun Medical, Inc. (USA-based company). The testing is retrospective, as it's part of post-manufacturing quality control and validation.

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

• Not applicable in the context of this 510(k) summary. The "ground truth" for the device's technical performance is based on internal quality control standards and specifications, not expert clinical diagnosis or interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for a diagnostic device. Here, the "truth" is whether a manufactured unit meets its engineering specifications.

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, nor is it a device that involves human readers or interpretation of results in that sense. It is a physical medical device (a wound drainage system).

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

• Not applicable. The REDYROB® is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

• For material safety, the ground truth is established by ISO Standard 10993 requirements for biocompatibility.
• For product performance, the ground truth is established by product design specifications, quality control test procedure documents, and established testing parameters. This is based on engineering and manufacturing standards.
• For substantial equivalence, the ground truth is the performance and safety profile of the legally marketed predicate device (Varidyne Model 250 Suction Drainage System).

8. The Sample Size for the Training Set:

• Not applicable. This document does not describe the development of a predictive model or algorithm that would require a training set. The device is a physically manufactured product.

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

• Not applicable for the same reason as above. There is no training set for this type of device.

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To drainage excessive body fluid away from the wound site in the Surgery or after Surgery

This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following: Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered. Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered. Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.

The provided text is a 510(k) summary for a medical device (Axiom Closed Wound Drain With Trocar) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The document focuses on product description, intended use, and substantial equivalence to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and a study that proves the device meets those criteria based solely on the provided text.

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The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections.

The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.

This document is a Summary of Safety and Effectiveness for a medical device submitted to the FDA, specifically the Cordis Suction Reservoir Kit. It is a pre-market notification (510(k)) and does not contain the type of detailed performance criteria, study design, and results typically found in publications for AI/ML device approval.

Therefore, I cannot provide the information requested in your numbered list. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through rigorous clinical studies with AI components.

Here's why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe quantitative performance metrics or acceptance criteria beyond functional statements like "provides consistent negative pressure." There are no reported device performance numbers.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set," "sample size," or data origin for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of ground truth establishment by experts for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
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 device is a physical suction reservoir, not an AI/ML-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no mention of ground truth as it pertains to performance evaluation in the context of AI/ML or complex diagnostic devices.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

In summary, the provided text describes a traditional medical device (a suction reservoir) and seeks 510(k) clearance based on substantial equivalence, not on the performance metrics and study types associated with AI/ML device evaluations.

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Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.

Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.

The provided text describes a 510(k) summary for the Sil-Med Corporation's Penrose Drain, comparing it to a predicate device, the Davol Gravity Drain. The information focuses on a comparison of device characteristics and biocompatibility testing, not on clinical performance or diagnostic accuracy. Therefore, the questions related to AI/algorithm performance, ground truth, expert opinions, and reader studies are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Reported Performance for Sil-Med Penrose Drain

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

The document refers to various standard biocompatibility tests (e.g., Rabbit Pyrogen Test, Hemolysis-Rabbit Blood, Salmonella typhimurium REVERSE Mutation ASSAY, Kligman Maximization Study, USP CLASS VI, Elution Test, USP MUSCLE IMPLANTATION STUDY IN RABBITS WITH HISTOPATHOLOGY). The sample sizes are inherent to the standard protocols for these specific biological tests (e.g., number of rabbits for pyrogenicity or implantation, number of wells/bacteria for mutagenesis). The document does not explicitly state the specific number of samples or animals used beyond what is implied by the test names.

Data provenance (country of origin, retrospective/prospective) is not mentioned, as these are lab-based biological tests, not clinical studies involving patient data.

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

Not applicable. This submission concerns biocompatibility and dimensional equivalence, not diagnostic performance or expert review of medical images/data. The "ground truth" here is established by the validated methods of the specified biological and physical tests and their established pass/fail criteria.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving disagreements in expert readings of medical data. The tests described are objective biological and physical assessments.

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 a submission for an AI/CAD device.

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

Not applicable. This is not a submission for an AI/CAD device.

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

The "ground truth" for the tests performed is based on:

• Established Biomedical Standards: For tests like USP CLASS VI, the ground truth is defined by the requirements outlined in the United States Pharmacopeia.
• Standardized Laboratory Protocols: For tests like pyrogenicity, hemolysis, mutagenesis, and sensitization, the ground truth is determined by the specific, validated methods and endpoints of these universally accepted in vitro and in vivo biological assays.
• Physical Measurement Comparisons: For dimensional equivalence, the ground truth is direct measurement and comparison to the predicate device's specifications.

8. The sample size for the training set

Not applicable. There is no AI/machine learning model being developed, so no training set is relevant.

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

Not applicable. As there is no AI/machine learning model, there is no training set and therefore no ground truth establishment for it.

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