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The Treasure Bipolar Head is intended for use as follows:

• A. Fractures of the proximal femur;
• B. Nonunions of proximal femoral neck fractures;
• C. Aseptic necrosis of the femoral head;
• D. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum;
• E. Salvage of failed total hip arthroplasty.
  The Treasure Bipolar Head is intended for cementless use. The Treasure Bipolar Head is intended for use with the Helicon Hip System.

The TGM Medical, Inc. Treasure Bipolar Head consists of a bipolar femoral head component, locking ring, and a bipolar insert component. The Treasure Bipolar Head is available either fully preassembled, or with the bipolar femoral head and locking ring preassembled and the insert separate. The bipolar femoral head component is manufactured from cobalt chrome alloy (CoCrMo, ASTM F75, ASTM F799, or ASTM F1537). The bipolar head has a highly polished spherical outer surface with a cylindrical bored internal diameter which accepts the polyethylene bipolar insert. The bipolar insert component and locking ring are manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The bipolar insert and locking ring are designed for use with the appropriate size bipolar head component.

The provided text describes a 510(k) premarket notification for the "Treasure Bipolar Head." This is a medical device submission, and the focus of such submissions is typically demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria in the way a clinical trial might.

Based on the provided text, here is the information regarding acceptance criteria and the "study" (which in this context is the substantial equivalence claim):

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

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

The document explicitly states, "No new performance data was required for the Treasure Bipolar head." Therefore, there was no "test set" in the sense of a new study involving human subjects or laboratory testing specifically for this 510(k) application. The substantial equivalence claim relies on the existing clearances and data for the predicate devices.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission. The ground truth for the safety and effectiveness of the predicate devices would have been established during their original clearance processes.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was conducted for this 510(k) submission.

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 hip prosthesis, 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 hip prosthesis, not an algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate devices (Consensus Bipolar System K922560, Consensus TaperSet Hip System K102399, and Helicon Hip System K111472), implying that these devices were deemed safe and effective based on their original data and regulatory review. The current submission's argument is that the Treasure Bipolar Head is sufficiently similar to these predicate devices not to raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of this 510(k) submission, as no new performance data or clinical study was conducted.

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

Not applicable, as no training set was used.

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The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Treasure Floppy Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a stainless steel and platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature. A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.

The provided text describes a medical device, the ASAHI Treasure Floppy Peripheral Guide Wire, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of device performance metrics with numerical values, statistical analysis, or clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various bench testing and biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Tensile Strength
• Turns to Failure (Torque Strength)
• Torqueability (Torque Response)
• Tip Flexibility
• Coating Adhesion
• Slipping Ability of Guide Wire in PTA Balloon Catheter
• Particulate testing
  The document states: "Enclosed within this submission is performance data that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire meets all predetermined performance criteria. ... This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire performs as intended." |
  | Biocompatibility Testing: | Not explicitly defined in numerical terms in the provided document. The implied acceptance criterion is that the device materials are "proven to be biocompatible" and are consistent with predicate devices. | Biocompatibility testing included:
• Systemic Toxicity Study
• In Vitro Hemolysis Study
• Intracutaneous Study
• Cytotoxicity Study
• Sensitization Study
• Pyrogen Study
• Plasma Recalcification Time Coagulation Study
• In Vivo Thromboresistance Study
• C3a Complement Activation Study
• SC5b-9 Complement Activation Study
  The document states: "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to predicate ASAHI devices that use the same materials as used in the subject device." Biocompatibility testing was "leveraged from predicate devices with identical materials and manufacturing process." |

Key takeaway for this section: The document states that the device meets predetermined performance criteria, but the actual, quantifiable acceptance criteria and the detailed numerical results showing how it meets them are not provided in this summary. The evaluation relies on demonstrating substantial equivalence to predicate devices.

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

• Sample Size (Test Set): Not specified. The document mentions "bench testing" and "shelf-life testing" but does not give the number of units tested for each parameter.
• Data Provenance: The studies were in vitro bench testing and shelf-life testing. The country of origin for the data is not specified, but the applicant is from Japan, and the US correspondent is in Santa Ana, CA. Given it's a 510(k) submission to the FDA, results would be expected to be presented to US regulatory standards. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, not a prospective clinical trial.

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

This information is not applicable as the studies described are bench tests and biocompatibility assessments, not studies involving human interpretation where medical experts establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

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

• Was it done? No. This type of study (comparing human readers with and without AI assistance) is not mentioned or relevant for this type of device (guide wire).
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was it done? No. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

• For mechanical/functional bench testing: The "ground truth" would be established by validated test methods and specifications (e.g., a certain force in Newtons for tensile strength, a certain number of turns for torque strength, etc.).
• For biocompatibility testing: The "ground truth" is established by standard ISO and FDA-recognized biological evaluation tests to determine the device's interaction with the biological system. In many cases, these are in vitro or in vivo (animal) studies, not human data.
• The document explicitly states that biocompatibility data was "leveraged from predicate devices with identical materials and manufacturing process," implying that the ground truth for biocompatibility was previously established for those materials.

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device 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 above.

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The ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The Asahi Treasure peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal nod of the guide wire has a radiopaque tip that is straight and is soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

This is a medical device 510(k) summary for a guide wire, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific performance metrics is not available in the provided text. The submission focuses on substantial equivalence to predicate devices based on materials, dimensional specifications, and bench testing.

Here's an analysis of what is provided, in relation to your questions, and why AI/ML specific information is absent:

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

• Acceptance Criteria: Not explicitly stated as a table with numerical targets. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices and performing "as intended" through bench testing.

• Reported Device Performance: The document states:

  • "The ASAHI Treasure guide wire is made of the same materials that have been used in other predicate devices that are labeled for the similar indications."
  • "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices."
  • "mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended."
  • "Bench testing demonstrates that the device functions as intended."

  Table (Reconstructed from text, but not explicit in the document):

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 provided. The study is described as "mechanical and functional bench testing" which typically involves laboratory testing of physical samples of the device itself, rather than data from human patients. Therefore, concepts like data provenance or retrospective/prospective don't apply in the same way.

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. "Ground truth" in the context of this device's evaluation would refer to the established performance standards or safety profiles against which the bench test results are compared. There is no mention of experts establishing a "ground truth" for the test set, as this is a physical device evaluation, not an image analysis or diagnostic AI tool.

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

• Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). This document describes bench testing, which is objective and mechanistic.

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 device.

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

• Not applicable. This is not an AI device.

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

• For this type of device, the "ground truth" is implicitly defined by the regulatory standards and the performance of the legally marketed predicate devices. The device is being evaluated against established engineering specifications and historical performance of similar devices. There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for its performance.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. This is not an AI device, so there is no "training set."

Summary of why AI/ML specific information is absent:

The document describes a conventional medical device (a guide wire) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. This regulatory pathway primarily focuses on comparing material composition, dimensional specifications, and fundamental functional performance through bench testing. It does not involve AI/ML technology, imaging analysis, or diagnostic capabilities that would necessitate the study design and evaluation metrics typically associated with AI/ML device submissions.

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The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Fluid Filled Teether

This document is a 510(k) submission for a fluid-filled teether, which is a medical device. However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The provided text is a summary of the 510(k) submission, primarily focusing on the administrative details, intended use, and substantial equivalence determination by the FDA. It states that the Global Fluid Filled Teether is substantially equivalent to a previously cleared device (K031094). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require extensive clinical trials or performance studies if the technological characteristics are similar and the intended use is the same.

Therefore, I cannot provide the requested information based on the input text. The information typically requested (such as sample sizes, ground truth, expert qualifications, efficacy studies, etc.) is more relevant for novel or high-risk devices that require more rigorous performance testing and clinical data. For a device like a teether seeking substantial equivalence, such detailed performance studies as those outlined in your request are generally not required for the 510(k) pathway.

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