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The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.

The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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HyperSuture™ White/Green Extension Line sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

HyperSuture™ White/Green Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture™ White/Green Extension Line cables are available in USP #2-0. USP #2. and USP #5 and tapes are available in 0.8mm (USP 2-0 equivalent), 1.5mm (USP 2 equivalent) and 2.0mm (USP 5 equivalent). Both HyperSuture™ White/Green Extension Line cables and tapes are available in white/green, 36 inches or 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture™ White/Green Extension Line." This document is a clearance letter from the FDA, indicating that the device is substantially equivalent to a previously cleared predicate device.

The information given is typical for a 510(k) submission for a physical medical device (suture) and does not contain the details typically found in a study proving an AI/software as a medical device (SaMD) meets acceptance criteria. Therefore, I am unable to construct the requested table and provide information on many of the points (sample size, expert ground truth, MRMC study, etc.) because the provided document is not about an AI/SaMD.

This document focuses on the physical and material properties of the suture (e.g., tensile strength, diameter, needle attachment, material composition, biocompatibility) and its substantial equivalence to a predicate suture. It does not mention any AI or algorithm component.

Therefore, I cannot fulfill the request as it pertains to an AI/SaMD and the provided text describes a traditional medical device.

If you have a document describing the study and acceptance criteria for an AI/Software as a Medical Device (SaMD), please provide that text for analysis.

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HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.

HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).

Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the HyperSuture All Blue Extension Line. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to a predicate device. It does not contain information related to software performance, clinical studies, or AI algorithm validation. The device in question is a surgical suture, not a software or AI-powered diagnostic tool.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because these are concepts applicable to software or AI device validation, which is not what this document addresses.

The document focuses on establishing substantial equivalence to a predicate device based on material, manufacturing, and physical performance characteristics, primarily adhering to USP (United States Pharmacopeia) standards for surgical sutures.

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HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture Extension Line". This process is for claiming substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study of its performance in a clinical setting (such as for an AI/ML device where performance metrics like sensitivity/specificity are evaluated).

The documentation does cover acceptance criteria for physical and material characteristics of the suture, and outlines how the device meets these in comparison to a predicate device. So, while it doesn't involve an AI/ML style study, I can extract information related to acceptance criteria for the suture itself and the testing performed.

Here's a breakdown of the requested information based on the provided text, focusing on the available information regarding the device's characteristics and acceptance, rather than an AI/ML performance study:

Acceptance Criteria and Study for the HyperSuture Extension Line (K234079)

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove clinical efficacy through a multi-reader, multi-case study, or standalone algorithm performance. The "acceptance criteria" here refer to the physical and material performance specifications of the suture itself, as well as biocompatibility, to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each physical test (e.g., how many sutures were measured for diameter or tensile strength). However, it states that "The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength." This implies adherence to the sample size and testing methodology defined by the USP standards for those specific tests.

• Data Provenance: The document does not explicitly state the country of origin of the data. The testing appears to be non-clinical (mechanical and biocompatibility testing) and not based on prospective or retrospective patient data.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies validating AI/ML algorithms, especially in diagnostic imaging, where human expert consensus is used to establish "true" disease presence. For this device, the "ground truth" for the physical characteristics and biocompatibility is established by adherence to recognized international and national standards (USP, ISO, ASTM).

The biocompatibility evaluation of the blue dye was conducted "by trained, board certified veterinary pathologists." The number of such pathologists is not specified.

4. Adjudication Method for the Test Set

Not applicable in the context of physical property testing or substantial equivalence claims for a medical device like a suture. Adjudication methods (e.g., 2+1, 3+1) are primarily used in clinical studies where human readers provide interpretations (e.g., radiology reads) and their disagreements need to be resolved to establish ground truth.

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

No. An MRMC study is relevant for evaluating the performance of AI-assisted systems in diagnostic scenarios (e.g., whether AI improves a radiologist's accuracy). This submission is for a surgical suture, which is a physical medical device, not an AI/ML algorithm.

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

No. This concept is applicable to AI/ML algorithms. The HyperSuture Extension Line is a physical surgical suture. The "performance" assessment refers to its physical and material properties, not an algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the device's characteristics (diameter, tensile strength, biocompatibility, etc.) is established by:

• Established Standards: Compliance with United States Pharmacopeia (USP) standards (USP 43 <861> for Diameter, <881> for Tensile Strength, <871> for Needle Attachment).
• International Standards: Compliance with ISO 10993-1:2009 for Biological Evaluation of Medical Devices.
• Material Specifications: Adherence to material specifications (e.g., AISI 302 Medical Grade Stainless Steel per ASTM F899 for needles).
• Expert Evaluation: Biocompatibility evaluation of the blue dye was assessed by trained, board-certified veterinary pathologists.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this type of medical device submission.

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HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surqical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical device called "HS Fiber Sutures." This document is not about an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and studies for AI/ML device performance.

The questions are specifically about:

• Table of acceptance criteria and reported device performance (for an AI/ML model)
• Sample size and data provenance for a test set (for an AI/ML model)
• Number and qualifications of experts for ground truth (for an AI/ML model)
• Adjudication method for a test set (for an AI/ML model)
• MRMC comparative effectiveness study (for an AI/ML model)
• Standalone performance (for an AI/ML model)
• Type of ground truth (for an AI/ML model)
• Sample size for training set (for an AI/ML model)
• Ground truth establishment for training set (for an AI/ML model)

Instead, this document describes a traditional medical device (surgical sutures) and demonstrates its substantial equivalence to a predicate device. The performance data mentioned for the HS Fiber Sutures relates to:

• USP performance requirements for needle attachment and tensile strength.
• Biocompatibility (per ISO 10993-1:2018).
• Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments.

The conclusion is that the HS Fiber Suture (K231163) is substantially equivalent to the predicate device (K190817), primarily due to identical intended use, materials, manufacturing processes (sterilization), and meeting established physical performance standards for sutures. There are no mentions of AI, machine learning, algorithms, or any studies involving human readers or expert consensus for image interpretation.

Therefore, I cannot extract the requested information from this document.

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HyperSutures (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.

HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).

Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the device "HyperSuture." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of statistical comparisons or clinical outcomes for an AI/software device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, manufacturing, and general performance requirements for surgical sutures.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it is for a physical medical device (surgical sutures), not a diagnostic AI/software device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document states "HyperSuture cables... meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures." and "HyperSuture tapes... meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures." The specific numerical or qualitative targets for these USP requirements are not detailed in this summary document, but the device states it meets them.)

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

• Not Applicable. This document is for a physical medical device (suture) and the "test set" would refer to physical or mechanical bench testing, not a data-driven clinical study. The performance data section refers to "HyperSuture cables are tested per USP performance requirements..." but does not specify sample sizes or data provenance in the context of an AI/software device.

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 expert consensus is not relevant for the performance testing of a surgical suture.

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

• Not Applicable. This pertains to expert review of data, not physical 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

• Not Applicable. This device is a surgical suture, 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 is not an algorithm or AI device.

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

• Standards-based performance: The ground "truth" or reference standard for this device's performance is established by the United States Pharmacopeia (USP) requirements for surgical sutures, as well as Threadstone's internal specifications for tape width. Biological evaluations followed ISO 10993-1:2018 and endotoxin assessments followed FDA guidance for "Pyrogens and Endotoxins Testing."

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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Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.

This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.

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 in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.

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. This document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).

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

Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require an adjudication method.

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. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.

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

Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.

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The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.

The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only.

The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior).

This is not an AI/ML device, therefore the requested information regarding AI/ML device performance and study design is not applicable.

Device Name: SuperBall™ "18º-Up", "24º-Up" and "12º-Reverse" Meniscal Repair System

Device Description:
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene.

Indications for Use:
The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.

Acceptance Criteria and Reported Device Performance:

Study Information (Not Applicable for this type of device submission as it is not an AI/ML device):

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was conducted on physical devices and simulating materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance is based on established engineering and material science standards and physical measurements, not expert human interpretation.
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-assisted device.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for this device's performance is based on engineering specifications, material properties, and standardized mechanical test results.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.

The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:

• The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
• MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.
  Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use

The provided text is a 510(k) summary for the Menix®/Menix® Duo Meniscal Suture Systems. It describes a medical device and its equivalence to a predicate device, based on non-clinical performance data. This document does NOT describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it establish ground truth with human experts.

Therefore, I cannot provide information for most of the requested points, as they are not relevant to the content of this 510(k) summary. I can only provide details on the acceptance criteria and performance as they relate to the mechanical and biological testing for this specific type of medical device (surgical suture system).

Here's what can be extracted and what cannot:

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

The document states:

• "The mechanical performance data demonstrates that MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)."
• "All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe."

However, specific numerical acceptance criteria or the reported performance values (e.g., actual traction strength in Newtons or displacement in mm) are not provided in this summary. The table below reflects the general statements made.

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 specified in the document for any of the tests (biocompatibility or mechanical performance).
• Data Provenance: The device manufacturer (S.B.M. SAS) is located in Lourdes, France. The studies are non-clinical, likely laboratory-based. No mention of retrospective or prospective 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. This relates to human expert review for AI/ML ground truth, which is not described in this document. The "ground truth" for this device's performance is established via standardized laboratory mechanical and biological testing.

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

• Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document.

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, an MRMC study was not done. This document describes a medical device, not an AI/ML diagnostic or assistive tool. The comparison is between the new device's mechanical properties and those of a predicate device, using non-clinical testing.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's safety and effectiveness relies on results from standardized mechanical performance tests (traction strength, fatigue displacement traction strength) and biocompatibility tests (per ISO 10993-1), compared against established specifications and a predicate device. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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