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The Transseptal Introducer is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Transseptal Introducer is intended for single use only.

The Transseptal Introducer consists of a high-density polvethylene (HDPE) sheath, a dilator with a lubricious hydrophobic coating, and an uncoated introducer quidewire in a dispenser. The transseptal introducer comes in two French sizes, 8F and 8.5F, two lengths, 63cm and 81cm, and two curves, LO (50°) and L1 (40°, 51°). The components of the Transseptal Introducer include the transseptal sheath, transseptal dilator, introducer guidewire with dispenser, sterile packaging and labeling. There are eight model numbers: TSIL0863, TSIL1863, TSIL0881, TSIL1881, TSIL08563, TSIL18563, TSIL08581, and TSIL18581. The Transseptal Introducer is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Introducer is used in a healthcare facility/hospital.

The Transseptal Introducer is used in transseptal procedures to introduce cardiovascular catheters into the left side of the heart after transseptal access was achieved with a transseptal needle and dilator. The device is used by inserting the device through the femoral vein in conjunction with a transseptal needle. The introducer quidewire is inserted through the femoral vein and guides the needle up to the fossa ovalis in the right atrium. The needle punctures the fossa ovalis and the dilator is used to insert and dilate the fossa further where the needle has punctured. This allows the sheath to cross and creates access to the left side of the heart. The introducer's duration in the body is less than 24 hours.

Based on the provided text, the document describes a 510(k) premarket notification for a medical device (TSI Transseptal Introducer), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo clinical effectiveness. Therefore, the information typically associated with acceptance criteria and a study proving a novel device's performance (such as an AI algorithm's performance) is not present in this document.

For a 510(k) submission like this, "acceptance criteria" are generally related to engineering and performance verification tests to show the device functions as intended and is equivalent to the predicate, not clinical accuracy or diagnostic performance in the way an AI often requires. The "study" here is primarily a series of bench and biocompatibility tests, not a clinical study involving human patients or ground truth established by experts for diagnostic purposes.

Here's a breakdown of why many of your requested points cannot be answered from this document, and what is provided instead:

Information NOT Applicable/Present for this Type of Device Submission:

• Acceptance Criteria Table (Diagnostic Performance): This device is a catheter introducer, not a diagnostic tool or AI. Its "performance" is demonstrated through engineering and biocompatibility tests, not diagnostic metrics like sensitivity/specificity.
• Sample size for the test set (Diagnostic): No diagnostic test set is mentioned. The sample sizes would apply to the quantities of devices tested in bench studies.
• Data provenance (Diagnostic): Not applicable for bench tests.
• Number of experts and qualifications (Diagnostic Ground Truth): Not applicable as there's no diagnostic ground truth to establish.
• Adjudication method (Diagnostic): Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is typically for evaluating diagnostic tools where human readers interpret data, often with AI assistance. It's not relevant for a transseptal introducer.
• Effect size of human reader improvement with AI assistance: Not applicable as there is no AI component.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth (expert consensus, pathology, outcomes data): Not applicable, as the "ground truth" for a device like this is its physical properties meeting specifications and biocompatibility.
• Sample size for the training set: There is no AI model or training set.
• How the ground truth for the training set was established: Not applicable.

What the Document Does Provide (Related to "Acceptance Criteria" for a Device Submission of this Type):

The "acceptance criteria" for a 510(k) of a traditional medical device are met by demonstrating substantial equivalence to a predicate device through:

1. Direct Comparison of Characteristics: Showing the subject device has similar design, materials, and intended use as the predicate.
2. Performance Testing: Bench tests to confirm the device functions as expected and safely.
3. Biocompatibility Testing: Demonstrating the materials are safe for human contact.

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

As mentioned, a formal table of diagnostic acceptance criteria with specific performance metrics (like sensitivity, specificity, AUC) is not provided because this is a physical medical device, not a diagnostic algorithm.

Instead, the document lists "Performance Testing" and "Biocompatibility Data" as the studies performed to support substantial equivalence. The acceptance criterion for these tests is implicitly that the device performs equivalently or within acceptable limits to ensure safety and effectiveness, similar to the predicate.

Reported Device Performance (as stated in the document):
"The results of the testing demonstrated the subject device performed equivalently to the predicate device."
"The Transseptal Introducer met the requirements set forth in ISO-10993."

Summary of "Performance Tests" (acting as the "study" for this type of device):

• Particulate testing (USP , Light Obscuration Method)
• Liquid leakage from sheath introducers under pressure
• Air pressure leak test
• Sideport-stopcock-hub tug test
• Sheath joint pull tests
• Guidewire restriction
• Curve template inspection
• Dilator flexibility testing
• Corrosion resistance
• Guidewire tensile strength
• Fracture and flex testing
• Curve integrity testing
• Packaging testing
• In vitro simulated use
• Surface morphology assessment | The results of the testing demonstrated the subject device performed equivalently to the predicate device. |
  | Sterilization Validation | - Validated in accordance with ANSI/AAMI/ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices). | Sterilized to a SAL of 10^-6^. |
  | Biocompatibility | - ISO 10993-5 Cytotoxicity
• ISO 10993-10 Sensitization
• ISO 10993-10 Irritation/Intracutaneous Reactivity
• ISO 10993-11 Acute Systemic Toxicity
• ISO 10993-11 Pyrogenicity
• ISO 10993-3 Genotoxicity
• ISO 10993-4 Hemocompatibility ASTM Hemolysis Complete
• ISO 10993-4 Hemocompatibility - Complement Activation Complete with C3a & SC5b-9
• ASTM F2382-17 Partial Thromboplastin Time (PTT) testing
• Platelet/Leukocyte Count (Guideline: ASTM F2888-13) | The Transseptal Introducer met the requirements set forth in ISO-10993. (Considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours)). |

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

• Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for engineering validation. (e.g., "The results of the testing demonstrated...") This is typical for bench testing where the focus is on meeting specifications rather than generalizability to a patient population.
• Data Provenance: Not applicable. These are laboratory-based engineering and biological tests, not patient data from specific countries.

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. There is no ground truth established by medical experts in the context of diagnostic accuracy for this device. The "ground truth" is that the device physically meets its engineering specifications and is biocompatible.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies. Bench tests follow objective pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, this type of study was not done. It is not relevant for a catheter introducer.

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

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

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

• The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and biocompatibility requirements (e.g., ISO 10993 standards) which are objectively measured.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not an AI model.

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

• Not applicable.

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TSIII BA Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

TSIII BA Fixture has features of single threads, internal hex connection, taper body, and BA surface treatment. TSIII BA Fixture System is permanent dental implant made with Pure Titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations). Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is supplied sterile.

This document is a 510(k) premarket notification for a medical device called the "TSIII BA Fixture," which is an endosseous dental implant. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the requested information regarding detailed acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions is largely not present in this document because it is not typically required for a 510(k) submission that relies on substantial equivalence.

Based on the provided text, here's what can be extracted and inferred:

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

The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for success/failure rates, stress values, etc.) that the device must meet, nor does it present "reported device performance" in terms of clinical outcomes or performance metrics from a dedicated study. Instead, the device's characteristics are compared to those of predicate devices to establish substantial equivalence.

The table below summarizes the comparison points for substantial equivalence:

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

• Sample Size for Test Set: Not applicable/not explicitly stated in the context of clinical or performance testing on the subject device. The document states "No clinical studies are submitted." Nonclinical tests were primarily based on equivalence to predicate devices, not on new testing of a "test set" of the subject device in the way a clinical trial would. For sterilization, bioburden was 1.000 cfu/unit; for packaging validation, the predicate device was tested.
• Data Provenance: The document does not specify data provenance in terms of country of origin for any "test set" data for the subject device, as most testing was waived or referenced predicate devices.

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. No clinical or performance studies requiring ground truth from experts for a "test set" of the subject device were submitted.

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

Not applicable. No studies requiring adjudication by experts were submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental implant, not an AI algorithm.

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

Not applicable. No new clinical or performance studies requiring ground truth for the subject device were submitted. The basis for approval is substantial equivalence to legally marketed devices, verified through nonclinical tests where applicable (e.g., sterilization dose verification, biocompatibility, LAL testing, material and design comparisons).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

The provided text (K090174) is a 510(k) summary for a dental implant called TSI & ERI. It outlines the device description, indications for use, and claims substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-based devices or complex diagnostic tools.

Dental implants like TSI & ERI are cleared through the 510(k) pathway by demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. Clinical studies or performance data with acceptance criteria are generally not required if substantial equivalence can be demonstrated through non-clinical means (e.g., comparison of materials, design, manufacturing processes, and published literature on the predicate devices).

Therefore, I cannot provide the requested information because it is not present in the provided text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of 510(k) clearance. Performance is inferred through substantial equivalence to predicates.
2. Sample size used for the test set and the data provenance: No test set or associated data for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: 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 a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary for TSI & ERI focuses on demonstrating that its materials, design, intended use, packaging, and sterilization processes are similar enough to existing cleared devices (Immediate Stabilizing Implant (ISI) K033392, OCO 5.0mm Taper Implant K023336, and MegaGen ExFeel K052369) such that it does not require new efficacy or safety studies.

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