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MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patient s functional abilities, which allow for the patient's return to the previous level of activity. The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe. The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler. The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle. The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe. All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe are supplied sterile and are disposable.

The provided text, K182287, outlines the 510(k) summary for the MEDINAUT Plus Kyphoplasty System. However, it does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device performance evaluation (such as sensitivity, specificity, accuracy, or human reader improvement).

Instead, this document is a regulatory submission for a physical medical device (an inflatable bone tamp for kyphoplasty) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench tests, biocompatibility, sterilization, shelf life).

Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/algorithm performance studies typically found in submissions for AI-enabled software as a medical device (SaMD). The concepts of "acceptance criteria for algorithm performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth," and "training set" are not applicable to the non-clinical bench testing and physical device comparisons described in this 510(k) summary.

The document's "Non-Clinical Testing" section describes physical and material property tests:

• Sterilization validation: Ensuring the device can be sterilized.
• Shelf life validation: Ensuring the device maintains its properties over time.
• Biocompatibility testing: Ensuring the materials are safe for use in the body.
• Bench tests:
  • Visual Inspection
  • Size Measurement
  • Liquid leakage under pressure
  • Tensile force
  • Burst strength
  • Balloon fatigue
  • Inflated balloon size
  • Balloon deflation
  • EO Gas residue
  • Sterility Test
  • Balloon rated burst pressure (RBP) in constrained condition
  • Balloon rated burst pressure (RBP) in unconstrained condition
  • Freedom from leakage and damage on inflation
  • Balloon diameter to inflation pressure
  • Insertion force and withdrawal force

These tests are to confirm the physical and mechanical integrity and safety of the device, not the performance of an AI algorithm. The conclusion states that the test results supported "substantial equivalence to the predicate devices" based on these physical characteristics and performance.

In summary, none of the requested information regarding AI/algorithm performance studies can be provided from this document because it describes a physical medical device, not an AI/algorithm-driven one.

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For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

EPINAUT Spring Guide Epidural Catheter is constructed of a stainless steel continuous spring. EPINUAT Spring Guide Epidural Catheter offers two types of catheter. The catheter types, L330 & L600 have an uncoated distal tip which is flexible, smooth and rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap.

EPINUAT Spring Guided Epidural Catheter have enhanced tensile/ break strength and restrict longitudinal catheter stretch, while the spring coils make the catheter resistant to kinking and collapsing. Wire is also provided with the device which consists of a stainless steel and a molded plastic hub.

The introducer needle is inserted into the epidural space through the sacral hiatus under intermittent fluoroscopy. After appropriate determination of the epidurogram and target area, the catheter with the wire in it is advanced through the introducer needle to the concerned area as determined by MRI or symptomatology. When the catheter is approached to target site, the wire is removed from the catheter and then the medication can be injected by attaching the adapter to a syringe.

The medical device in question, EPINAUT, is an Anesthesia Conduction Catheter. The provided context does not include information about clinical studies involving human patients or AI-based performance metrics. The information focuses on non-clinical testing to establish substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various non-clinical tests performed to evaluate the performance of EPINAUT and to demonstrate substantial equivalence to the predicate device, the Racz Epidural Catheter. The acceptance criteria are implicitly met if the test results "met the pre-set criteria" or "supported that the subject device is substantially equivalent." Specific numerical acceptance criteria are not explicitly stated for all tests; rather, the successful completion of the test according to a standard often serves as the acceptance.

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The MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The MEDINAUT Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine, tibia, radius, and calcaneus. Bone cement insertion using cement dispensing plunger is applied for spinal use only.

The MEDINAUT Kyphoplasty System consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System).

The MEDINAUT-X is comprised of a Balloon Catheter and a Bone Expander Syringe. The Balloon Catheter's main components are the shaft, Y-hub and the inflatable balloon located at the distal tip. The inflatable balloon is covered with a maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Catheter and Bone Expander Syringe are supplied sterile and are disposable.

The MEDINAUT-I is a cement dispenser system consisting of a Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cannula Expander, Cement Pusher, Cement Filler, and Guide Wire. They are supplied sterile and are disposable.

This document is a 510(k) summary for the MEDINAUT Kyphoplasty System. It is an FDA submission seeking approval to market a medical device, asserting its substantial equivalence to previously cleared devices. It primarily details physical and functional attributes and does not contain detailed "acceptance criteria" or "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is not applicable or unavailable in this type of submission:

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

This information is not present in the document as it would be for a diagnostic AI device. For a device like the MEDINAUT Kyphoplasty System, "acceptance criteria" are related to mechanical performance, biocompatibility, and sterilization standards, and "reported device performance" refers to the results of non-clinical bench tests comparing these attributes to pre-set criteria or predicate devices.

The closest equivalent is the "Non-Clinical Testing" section and the comparison table.

Non-Clinical Testing Summary:

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

This information is not applicable/provided in this context. This document describes a medical device (kyphoplasty system), not an AI/software device that processes data. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset of patient information. No patient data or provenance are mentioned because it's a non-clinical submission.

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 applicable/provided. The "ground truth" for this type of device is established through engineering and laboratory standards (e.g., ISO standards for sterilization, biocompatibility, and mechanical properties). There are no "experts" in the sense of clinicians establishing a diagnostic ground truth for patient data. The "experts" involved would be engineers and laboratory technicians performing standardized tests.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations of diagnostic performance where human interpretation of medical data (e.g., images) is involved. For non-clinical bench testing of a physical medical device, test results are typically validated against established quantitative standards and protocols, not through expert adjudication of uncertain cases.

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/provided. MRMC studies are specific to evaluating diagnostic systems, especially AI in medical imaging, and its impact on human reader performance. This document concerns a physical surgical device for bone fracture reduction, not a diagnostic system. There is no AI component mentioned.

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

This information is not applicable/provided. As stated, this is a physical medical device (kyphoplasty system), not an algorithm or AI.

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

The "ground truth" for this device's safety and effectiveness is established through adherence to international standards (e.g., ISO 11137, ISO 11737, ISO 10993) and engineering specifications. For example:

• Sterilization: Demonstrated bacterial inactivation based on ISO standards.
• Biocompatibility: Demonstrated material safety based on ISO 10993.
• Mechanical Performance: Quantitative measurements (e.g., burst pressure, tensile strength) meeting design specifications and being comparable to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI model that requires a training set.

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

This information is not applicable/provided. As above, no training set for an AI model is involved.

Summary of Device and Equivalence Claim:

The document states that the MEDINAUT Kyphoplasty System (K153296) is substantially equivalent to its primary predicate device (MEDINAUT Kyphoplasty System, K133669) because it is identical in raw materials, design, and manufacturing processes. The purpose of the current 510(k) is to add more anatomical sites (tibia, radius, and calcaneus) to the indications for use. This expanded indication is supported by referencing an additional predicate device, the KyphX Inflatable Bone Tamp (K010246, K041454, K981251), which already has these broader claims and shares similar design, function, size, shape, materials, and physical specifications.

The "study that proves the device meets the acceptance criteria" (in this context, substantial equivalence to predicates for the expanded indications) is the non-clinical testing enumerated in section 8, which includes sterilization, shelf life, biocompatibility, and various bench tests. These tests confirmed that the device performs as intended and is safe when compared to established standards and the characteristics of the predicate devices.

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The SPINUAT-P is indicated for ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.

The provided text is a 510(k) summary for the SPINAUT-P device, an electrosurgical device for disc decompression. It details the device's technical specifications and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain any information about a clinical study involving human patients or the performance of a device against specific acceptance criteria in a clinical setting.

The document focuses on non-clinical (bench and lab) testing to support a premarket notification for a medical device. Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria in a clinical context, or information related to human reader studies.

Here's a breakdown of what can be extracted from the document regarding non-clinical performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document primarily focuses on demonstrating that the SPINAUT-P device meets electrical safety, biocompatibility, sterilization, and some performance characteristics comparable to predicate devices. It lists test descriptions and referenced standards, implying that the acceptance criteria are met by adhering to these standards and the established "pre-set criteria" mentioned.

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

• Test Set Sample Size: The document mentions tests on "porcine spines" for performance comparison, but does not specify the number of porcine spines or individual tests conducted. For other tests (sterilization, shelf life, biocompatibility, electrical safety), it refers to established standards (e.g., ISO, ASTM, ANSI/AAMI, USP) which dictate sample sizes, but these specific numbers are not presented in the summary.
• Data Provenance: The data is from non-clinical (bench and lab) testing, not human studies. The tests were performed by or for IMEDICOM Co., Ltd. (Republic of Korea). The specific location of testing labs is not detailed beyond the company's origin.

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

• This information is not applicable to the non-clinical testing described. Ground truth or expert consensus is typically associated with clinical studies involving human data, where human experts (e.g., radiologists, pathologists) provide annotations or diagnoses.

4. Adjudication Method for the Test Set

• This information is not applicable as the document describes non-clinical laboratory testing, not a clinical study where adjudication of human expert opinions would be necessary.

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

• No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through non-clinical testing, not a clinical trial comparing human readers with and without AI assistance. The device itself is an electrosurgical tool, not an AI diagnostic or assistance system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone algorithm performance study was not conducted. This device is an electrosurgical accessory, not an AI algorithm.

7. Type of Ground Truth Used

• For the non-clinical performance comparison using porcine spines, the "ground truth" would be the objective measurements and observations of tissue removal, durability, and navigability, compared against the predicate device under controlled experimental conditions.
• For other tests (electrical, sterility, biocompatibility), the "ground truth" is adherence to the published specifications and pass/fail criteria defined by the referenced international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP).

8. Sample Size for the Training Set

• This information is not applicable. The device is an electrosurgical tool, not an AI/ML 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 point 8.

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When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

The SPINAUT-S is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endoscope.

SPINAUT-V consists of a flexible catheter, steering handle and associated ports for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain. SPINAUT-V is a sterile, single use device. When placing SPINAUT-V into the patient, SPINAUT-I can be used instead of SPINUT-V as an introducer device.

SPINAUT-S is a surgically invasive flexible fiberoptic system that can be used either with a video guided catheter (SPINAUT-V or other video guided catheters with proper catheter size) or with an introducer device such as SPINAUT-I. The SPINIUT-S is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The SPINAUT-S can be used with the light source and camera system.

SPINAUT-I is intended to be used to prepare or preserve a path for a video guided catheter or an endoscope. It is supplied sterile and for single use.

The provided document describes the substantial equivalence of the SPINAUT-V, SPINAUT-S, and SPINAUT-I devices to a predicate device, Myelotec Video Guided Catheter (K980734). It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of a typical AI/ML medical device submission.

The document is a 510(k) summary for a traditional medical device (arthroscope/catheter/introducer) and focuses on bench testing, biocompatibility, and sterilization validation to demonstrate substantial equivalence to a predicate device, rather than clinical performance based on defined acceptance criteria like sensitivity/specificity/accuracy or multi-reader studies.

Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to the type of device and submission described here.

Here's a breakdown of what can and cannot be provided based on the input:

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

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 describes bench tests and validation tests rather than clinical studies with "test sets" in the context of diagnostic accuracy. Therefore, information on sample size for image/patient data and data provenance like country of origin or retrospective/prospective is not applicable/provided. The tests cited are standard methods for device manufacturing and safety.

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. The tests performed are engineering and material science tests, not clinical performance evaluations requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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/ML device, and no MRMC study information is provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench tests, the ground truth is the performance standards and specifications defined by the referenced ISO, ASTM, MFDS, and USP standards (e.g., a catheter must not leak under a certain pressure, a material must be biocompatible, a sterilization process must achieve a certain Sterility Assurance Level).
For the biocompatibility tests, the ground truth is adherence to specific biological response criteria as per ISO 10993 and USP standards.
For sterilization and shelf-life validation, the ground truth is the scientific principles and validated methodologies outlined in the relevant ISO and ASTM standards.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device using training data.

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

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SPINAUT-E is used for delivery of drugs that have been indicated for the epidural space.

SPINAUT-I is intended for the percutaneous introduction and placement of an epidural catheter.

SPINAUT-E consists of a flexible catheter, steering handle and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.

There are 9 models in SPINAUT-E: E1000, E2000, E1100, E2100, E3100, S1000, S2000, and S3000. The catheter tip of the model E1000, and E3000 can be bent 50° to the left or to the right (the user can rotate the tip to adjust the direction), but the tip of the model E1100, E2100, and E 3100 can be bent either direction up to 100°. The S1000, S2000, and S3000 have an extra infusion port for drug so that the other main port can be used for other devices. Each model is characterized by the additional port, the lever, and the dimensions.

The SPINAUT-I is intended to be used to prepare or preserve a path for an epidural catheter. When placing SPINAUT-E into the patient, SPINAUT-I can be used as a replacement of the SPINUT-E Catheter Introducer Set. It is supplied sterile and it is for single use.

There are 3 models in SPINAUT-I: ID1000, ID2000, and ID3000 and each model is characterized by the length.

This is a 510(k) premarket notification for a medical device (SPINAUT-E and SPINAUT-I anesthesia conduction catheters), not a study demonstrating AI performance. Therefore, most of the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance is not applicable to this document.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, which serves a similar purpose of validating device performance against pre-set criteria.

Here's a summary based on the provided text, focusing on the available non-clinical testing details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "the test results met the pre-set criteria" for all tests. It does not provide specific numerical acceptance criteria or detailed numerical device performance outcomes for each test. Instead, it lists the types of tests conducted and concludes that the predefined criteria were met.

Specific Tests listed under "Performance Bench Tests" (SPINAUT-E and SPINAUT-I):

• Visual Inspection (Appearance)
• Size Measurement (SPINAUT-E only for shelf life, SPINAUT-I for shelf life and performance)
• Leakage Test (Catheter)
• Tensile strength (Catheter)
• Curved strength (Catheter)
• Fatigue test (Catheter)
• X-ray impermeable test
• Corrosion resistance test
• Flexural Rigidity (Catheter introducer and the needle)
• Pulling (Drawing) Test (Catheter introducer and the needle)
• Package Tensile Test
• Package Peeling Test
• Package Burst Test
• Package Dye Penetration Test
• Package Bubble Test
• Sterility Test
• Connecting Part (Conical) Fitting (SPINAUT-I only)

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

• The document does not specify the exact sample sizes used for each individual non-clinical test. It only states that tests were performed.
• Data Provenance: The tests are "non-clinical testing" and "bench tests" performed by the manufacturer, IMEDICOM Co., Ltd., which is based in the Republic of Korea. The data provenance is industrial laboratory testing, not patient-derived data.

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

• Not applicable. This is not a study involving expert assessment or ground truth establishment in the traditional sense of medical image analysis or clinical trials. The "ground truth" for these non-clinical tests is based on objective measurements against established engineering and medical device standards (e.g., ISO, ASTM, USP).

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

• Not applicable. This is not a study requiring adjudication of expert opinions.

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 document describes a traditional medical device (catheter) and its non-clinical testing for 510(k) clearance, not an AI-powered device or an MRMC study.

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.

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

• The "ground truth" for the non-clinical tests is based on objective measurements against established international and national standards (e.g., ISO 11137, ISO 11737, ASTM F1980-07, ISO 10993, USP 37, USP 38) and the manufacturer's pre-set internal criteria for performance specifications (e.g., tensile strength, leakage rates, sterility).

8. The sample size for the training set:

• Not applicable. There is no AI training set involved.

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

• Not applicable. There is no AI training set involved.

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