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The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.

The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.

Acceptance Criteria and Device Performance Study for Pristine™ Long-Term Hemodialysis Catheter (K203767)

The information provided describes the substantial equivalence determination for the Pristine™ Long-Term Hemodialysis Catheter (K203767) by comparing it to a predicate device, the Pristine™ Hemodialysis Catheter (K182443). The regulatory submission focuses on demonstrating that the new device meets the same performance criteria as the previously cleared predicate device, with additional testing for specific design changes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device met "all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)."

For the specific design changes in the subject device, the verification testing was performed to the "exact same acceptance criteria as K182443."

The following table summarizes the acceptance criteria categories mentioned and the general reported performance. Specific numerical acceptance values are not provided in this document but are implied to be identical to those established for the predicate device.

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

The document states: "All samples used for final testing of each product attribute were representative of finished products." However, specific numerical sample sizes for each test are not provided.

The data provenance is implied to be from internal laboratory testing conducted by the manufacturer, C. R. Bard, Inc. The document does not specify country of origin for the data nor explicitly state if it was retrospective or prospective, but given the context of design verification and validation, it would be considered prospective testing of newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a device performance verification and validation study against established engineering and performance criteria, not a study involving human interpretation of medical images or expert consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. As this is a physical device performance study, there's no "adjudication" in the sense of reconciling multiple expert opinions. Test results are compared against pre-defined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes a design verification and validation study for a medical device against pre-defined engineering acceptance criteria, not a study evaluating human reader performance with or without AI assistance.

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

No. This document pertains to a physical medical device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the pre-established engineering and performance specifications and acceptance criteria for the device's physical and functional attributes. These criteria are derived from applicable standards, guidance documents, test protocols, and customer inputs, which would have been established internally by the manufacturer and validated during the predicate device's clearance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is a device performance study, not a machine learning model development or validation study; therefore, there is no "training set."

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

This information is not applicable and not provided. As there is no training set, the establishment of ground truth for it is irrelevant to this document.

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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Surgical Mask

I am sorry, but the provided text content does not contain any information about medical device acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a "Surgical Mask" (K201871), outlining its regulatory classification, indications for use, and general regulatory requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.

The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.

The provided text describes the regulatory clearance of a medical device, the GlidePath 10F Long-Term Hemodialysis Catheter, and its substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML device.

This document is a 510(k) summary for a physical medical catheter, not an AI/ML device. Therefore, questions relating to AI/ML device performance (e.g., test sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to the information provided.

The document discusses performance data for the physical catheter, but these tests are related to mechanical and physical properties of the device, not diagnostic accuracy or AI performance.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

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

The document lists various in vitro tests performed to demonstrate substantial equivalence, and states that the "subject device... meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a table detailing the specific acceptance criteria (e.g., numerical thresholds for flow rates, tensile strength) or the reported numerical performance data for the GlidePath 10F Long-Term Hemodialysis Catheter against those criteria. It only lists the types of tests performed.

Note: The phrase "Met predetermined acceptance criteria" is inferred from the statement "The subject device... meets all predetermined acceptance criteria of design verification and validation." Specific numerical values for the criteria or the device's performance are not provided.

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 does not specify sample sizes for the "test set" in the context of diagnostic performance, nor does it describe data provenance for patient data. The "performance data" refers to in vitro mechanical/physical tests on the device itself, not a clinical study on 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, as this is not an AI/ML device or a diagnostic device relying on expert interpretation for 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, as this is not an AI/ML device.

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 device.

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

For the physical device performance tests, the "ground truth" or reference is established by the specifications in applicable standards, guidance documents, and internal test protocols. For example, a "burst" test would have a specified pressure it must withstand, and the device either passes or fails that engineering specification.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The iSight, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The iSight, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The iSight, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The iSight, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The iSight, irregular cornea (efrofilcon A) Silicone Hvdrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

The iSight Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The provided document describes a contact lens (iSight, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)) seeking 510(k) clearance, asserting substantial equivalence to existing predicate devices. The information focuses on non-clinical testing and leveraging prior clinical data from an equivalent device rather than conducting a new clinical study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a traditional "test set" in the context of an AI/ML clinical study. Instead, it relies on a combination of non-clinical (in vitro and in vivo toxicology/biocompatibility) testing and a claim of substantial equivalence to a previously cleared device.

• Non-clinical testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." No specific sample sizes for these tests are mentioned.
• Clinical data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that new clinical data specific to this device was not generated or tested. Data provenance for prior clinical studies is not detailed.

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

Not applicable. The document does not describe a test set requiring expert ground truthing in the context of an AI/ML device. The "ground truth" for the non-clinical tests would be established by laboratory standards and validated methods for physical properties and toxicity.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set with human assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a contact lens, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable. This device is a contact lens, not an algorithm, so standalone performance is not relevant in the AI/ML sense. The "standalone" performance here relates to the physical and chemical properties of the lens itself, which were evaluated through non-clinical testing.

7. The Type of Ground Truth Used

• Non-clinical testing: The ground truth for physical properties (e.g., refractive index, water content, oxygen permeability) would be established through standardized laboratory measurement protocols. For biocompatibility and toxicology, the ground truth would be established against accepted safety standards and protocols (e.g., GLP regulations, ISO standards for medical devices).
• Clinical data: For the previously established clinical performance of the material, the ground truth would have been patient outcomes data from those prior studies, observed by clinical investigators.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (contact lens) and its non-clinical evaluation, not an AI/ML model that requires a training set.

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

Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth establishment.

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The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the IntraTemp™ Solution Warmer. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach: a
• as a single device via a transforaminal (TLIF) approach: or -
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

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 non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device testing.

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

There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

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