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Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. The PTFE material has been impregnated with an absorbable mammalian gelatin that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.

This document is a 510(k) Summary for a medical device (Sulzer Vascutek SEALPTFE™ Vascular Prosthesis) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance against those criteria, or a detailed study design that would fit the requested format for AI/ML device studies. Instead, it describes in vitro and animal testing to show equivalence to existing devices.

Therefore, most of the requested information cannot be directly extracted or inferred from the provided text. I will address the points that can be, and explicitly state when the information is not available.

Description of the acceptance criteria and the study that proves the device meets the acceptance criteria:

The provided document describes the Sulzer Vascutek SEALPTFE™ Vascular Prosthesis and asserts its substantial equivalence to commercially distributed Impra grafts. The "acceptance criteria" in this context are not quantitative performance metrics as expected for AI/ML device studies, but rather demonstration of similar properties and safety to legally marketed predicate devices.

The study proving the device meets these "acceptance criteria" (i.e., substantial equivalence) involved:

• In vitro testing: Comparing the Sulzer Vascutek SEALPTFE™ graft line to Impra commercial grafts.
• Animal studies: Demonstrating the equivalence of Sulzer Vascutek standard wall grafts to Impra standard wall grafts.
• Biomaterial testing: Confirming that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.

The document concludes that "all testing demonstrates that the Sulzer Vascutek SEALPTFE™ graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access."

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

As mentioned, quantitative acceptance criteria and performance metrics for an AI/ML device are not present in this document. The "performance" is substantial equivalence based on the types of tests listed above.

The following information is not available in the provided document:

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 in vitro or animal studies.
• Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

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 and not present, as the "ground truth" here refers to physical and biological properties of the graft materials, evaluated through laboratory and animal testing, not expert interpretation of diagnostic data.

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

• Not applicable; this method is typically used for expert consensus in diagnostic imaging or clinical trials, not for material property 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

• Not applicable. This is a medical device (vascular prosthesis), not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" in this context would be objective measurements of material properties (e.g., tensile strength, porosity, suture retention), results from standardized biocompatibility tests, and observations from animal implantation studies. Specific details are not provided beyond the general categories of "in vitro testing", "animal studies", and "biomaterial testing."

8. The sample size for the training set

• Not applicable. 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.

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The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
• revision of a previously failed arthroplasty. .

The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.

The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.

The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.

This document does not contain information about acceptance criteria and a study proving a device meets these criteria. It is a 510(k) summary for a medical device (APR Metasul Acetabular Inserts) which describes the product, its intended use, and claims substantial equivalence to previously marketed devices.

There is no mention of specific performance measures, thresholds, or studies designed to assess the device against predefined acceptance criteria. Instead, the submission relies on demonstrating similarity in design, materials, sterilization, manufacturing methods, and intended use to existing cleared devices, as per the 510(k) pathway for medical device clearance in the US.

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Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels.

The device is composed of polytetrafluoroethylene, which has been fabricated in tubular form and expanded to impart porosity to the structure.

The provided text is a 510(k) summary for the Sulzer Vascutek ePTFE Vascular Prosthesis, asserting its substantial equivalence to an existing device rather than presenting a study to prove its inherent performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted directly from this document.

However, I can extract the information that is present and indicate what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not explicitly stated. The document refers to "in vitro testing," "animal studies," and "biomaterial testing" without specifying the number of grafts or animals used in each.
• Data provenance: Not explicitly stated. The testing was conducted by Sulzer Vascutek Inc. or on their behalf, but the location or whether the data was retrospective or prospective is not mentioned.

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

• Not applicable. The document describes engineering and biological testing against a predicate device, not a diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. The methods described are laboratory and animal testing, not human expert 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 is not an AI/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

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

• The "ground truth" here is the performance of the predicate device (Impra commercial grafts and Impra standard wall grafts) as established through:
  • In vitro measurements: For evaluating mechanical properties and overall equivalence.
  • Animal study results: For assessing in-vivo equivalence.
  • Biomaterial test standards: For biocompatibility and non-toxicity.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

Summary of what the document indicates instead:

This 510(k) submission primarily relies on demonstrating substantial equivalence to an already legally marketed predicate device (Impra's ePTFE vascular grafts) rather than proving performance against independent acceptance criteria. The "study" mentioned involves various forms of testing (in vitro, animal, biomaterial) to compare the Sulzer Vascutek ePTFE grafts to the predicate device. The goal is to show that the new device performs similarly and is as safe and effective as the predicate.

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