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The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization.

Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.

The Mi-CHORD™ System, shown in Figure 1, is a sterile, single use system, including the Mi-STITCH™ suturing device with its loaded LS-5™ expanded polytetrafluoro-ethylene (ePTFE) suture (Figure 2) and the Mi-KNOT™ device with its loaded Mi-KNOT™ titanium fastener (Figure 3).

The provided text describes a medical device (Mi-CHORD System) and its non-clinical and clinical performance data. However, it does not describe an AI/ML-based device, nor does it contain information about "acceptance criteria" in the context of an AI/ML study, or any "study that proves the device meets the acceptance criteria" in that context.

The document primarily focuses on:

• Device Description: The physical components and their functionality (Mi-STITCH and Mi-KNOT devices, ePTFE suture, titanium fastener).
• Nonclinical/Bench Studies: Biocompatibility, shelf life/sterility, and various engineering bench tests demonstrating mechanical performance, reliability, durability, and material properties. These are traditional engineering and material science tests for a physical medical device.
• Clinical Information: A single-center, single-cohort feasibility study conducted outside the United States (OUS) with 12 patients, focusing on operative times, echocardiographic outcomes, adverse events, and mortality in mitral valve repair.
• Regulatory Aspects: De Novo classification request, indications for use, risks to health, and special controls.

Since the prompt asks for information related to an AI/ML device's acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), the provided text does not contain the information requested in points 2-9 of your prompt. It describes the validation of a physical surgical device, not a classification algorithm or AI system.

Therefore, I cannot fulfill the request as presented, as the necessary information for an AI/ML device's acceptance criteria and proving study is absent from the provided text.

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The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.

The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MD™ MATTRESS Suture Placement Device.

Important Note: The provided document is a 510(k) Premarket Notification from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent effectiveness from scratch. Therefore, the "study" described here is primarily a comparison and verification against the predicate device and established standards, not a de novo clinical trial to establish efficacy in humans.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against specific numerical performance targets for the device's clinical operation (e.g., suture strength, success rate in tissue approximation). Instead, its acceptance criteria are primarily focused on:

• Meeting Design Input Requirements: All aspects of the device design and functionality must perform as intended.
• Equivalence to Predicate Device: The MD™ MATTRESS Device should perform comparably to the RD180® - THE RUNNING DEVICE®.
• Safety and Biocompatibility: The device should not introduce new risks and must be safe for patient contact.
• Sterility and Packaging Integrity: The device must maintain sterility and be appropriately packaged for its shelf life.

The reported device performance is largely qualitative and comparative, focusing on meeting these overarching criteria through various non-clinical tests.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices or tests performed) for the "Functional Design Verification and Validation Testing," "Biocompatibility" tests, or "Packaging/Shelf-life Testing." The nature of these tests (e.g., material testing, functional checks) typically involves specific batch sizes or replicates determined by testing protocols, but these numbers are not disclosed in the summary.
• Data Provenance: The tests are explicitly stated as "Bench top performance testing" and "non-clinical tests." This indicates the data is from laboratory (in-vitro) or simulated environments, not from human subjects. The country of origin for the data is not specified but implicitly would be from the manufacturer's testing facilities or contract labs. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission.

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

This section is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (biocompatibility, functional design, packaging) is established by adherence to recognized international standards (e.g., ISO 10993, ISO 11607), engineering specifications, and comparison to the predicate device. There is no mention of "experts" in the sense of clinical reviewers establishing a diagnostic ground truth for a test set. The evaluation of the test results against the acceptance criteria would be performed by qualified engineers, toxicologists, and regulatory experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers or readers interpreting data (e.g., imaging studies) where there might be inter-reader variability. For bench-top and non-clinical engineering tests, the results are typically objectively measured and evaluated against predetermined specifications, not subject to subjective adjudication among multiple human readers.

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

This is not applicable. The MD™ MATTRESS Suture Placement Device is a mechanical, hand-operated surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.

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

This is not applicable. As stated above, this device is a mechanical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this device, the "ground truth" for the non-clinical tests is established by:

• Engineering Specifications and Design Input Requirements: For functional performance, the device is tested against its own design specifications and expected performance characteristics.
• International Standards: For biocompatibility (ISO 10993) and packaging/shelf-life (ISO 11607), the "ground truth" is adherence to the scientifically validated methodologies and acceptance limits defined by these standards.
• Predicate Device Performance: For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the legally marketed predicate device (RD180® - THE RUNNING DEVICE®). The new device is evaluated to ensure it performs comparably and introduces no new risks.

There is no "pathology" or "outcomes data" directly from human patients contributing to the ground truth for this submission, as clinical testing was not performed or deemed necessary.

8. The Sample Size for the Training Set

This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this type of device.

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The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.

The COR-KNOT MICRO™ Device is a sterile, single patient use device provided to the user preloaded with a single COR-KNOT MICRO™ fastener. Made from medical grade titanium, the COR-KNOT MICRO™ fastener is a hollow sleeve with a rounded base. A white plastic target holds the loop shape of a wire snare. The wire snare passes through the COR-KNOT MICRO™ fastener and is attached to a snare puller knob. A suture slot in the device shaft lies under the opening in the snare puller. The ends of a USP 6-0, 7-0, or 8-0 polypropylene suture are passed through the wire snare and subsequently threaded into the titanium fastener. The snare puller attached to its wire snare is pulled up along the device shaft until it snaps onto the puller retainer feature of the purple knob, which also has an integrated indicator fin. The suture slot and the indicator fin are located on the same side of the device shaft. The subsequently crimped fastener and remnant trimmed suture tails bend slightly in the direction away from or opposite from the suture slot and indicator fin. By rotating the purple knob and the device's white handle, the surgeon can ergonomically orient the direction of the suture tails, if desired. A yellow lever stop is located behind the purple lever to restrict inadvertent squeezing of the lever during device handling before crimping. The lever stop is removed by pinching its sides together and pulling it out of the handle. By squeezing the purple lever, the COR-KNOT MICRO™ Device crimps the COR-KNOT MICRO™ fastener to fasten together segments of suture and trims away excess suture.

One COR-KNOT MICRO™ Device is provided per package, and the COR-KNOT MICRO™ Device is not intended to be reloaded or reused.

The COR-KNOT MICRO™ device is intended for use in the approximation of soft tissue.

The acceptance criteria and device performance information for the COR-KNOT MICRO™ device are derived from the provided FDA 510(k) summary.

Acceptance Criteria and Reported Device Performance

Study Details:

1. A table of acceptance criteria and the reported device performance: (Provided above)

2. Sample sizes used for the test set and the data provenance:

   • Bench Testing (Functional Verification & Validation): The specific sample sizes for each of the functional verification and validation tests are not explicitly stated as numerical values in the provided text. The text states "all results met the performance and risk-based acceptance criteria," implying that adequate samples were tested for each criterion.
   • Malignant Hypertension Pressure Simulator (Durability):
     • Test Set: 60 COR-KNOT MICRO™ titanium fasteners (20 each for 6-0, 7-0, and 8-0 polypropylene suture).
     • Data Provenance: Retrospective, conducted in a laboratory setting (bench testing). No geographical data provenance is specified, but it's an in-vitro simulation.
   • Acute Animal Study (Safety & Effectiveness):
     • Test Set: Specific number of animal subjects is not given, but the study compared the COR-KNOT MICRO™ Device in worst-case size blood vessels to hand-tied knots under the same conditions.
     • Data Provenance: Prospective, conducted in an animal model (in vivo pig model). No geographical data provenance is specified beyond it being an "acute animal study."

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

   • The provided text does not indicate the use of experts to establish a "ground truth" in the traditional sense of human readers/interpreters adjudicating medical images or clinical outcomes.
   • The "ground truth" for this device appears to be established through objective performance metrics from standardized bench testing protocols, validated simulation models, and comparison to a known standard (e.g., USP KPA standards) or predicate device performance.
   • For the animal study, the "ground truth" for clinical endpoints (ease of use, wound approximation, hemostasis, burst strength, tensile strength) would have been established by the study investigators/veterinary surgeons performing the procedures and analyses, but their specific number or qualifications beyond being part of the "LSI" team are not detailed.

4. Adjudication method for the test set:

   • Not applicable in the context of human reader/AI adjudication. The testing involved objective measurements and comparisons against predetermined criteria and a predicate device's performance.

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 MRMC comparative effectiveness study was done. This is a medical device, not an AI software intended for image interpretation assistance to human readers.

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

   • This is a standalone medical device (a knot-tying device), not an algorithm. Therefore, "standalone performance" refers to the device's inherent mechanical and functional performance, which was extensively tested without human "interpretation" in the loop. The device's performance is tested directly (e.g., crimping strength, cutting ability, durability).

7. The type of ground truth used:

   • Objective Performance Metrics / Engineering Specifications: For functional verification, validation, and durability testing (e.g., KPA force, proper crimping, suture cutting, structural integrity under pressure). These are derived from established engineering standards and the device's design inputs.
   • Comparison to USP Standards: For Knot Pull Apart (KPA) force.
   • Comparison to Predicate Device Performance: The underlying performance of the predicate device serves as a benchmark for equivalence.
   • Animal Model Outcomes: For in-vivo safety and effectiveness, including measures like ease of use, wound approximation, hemostasis, burst strength, and tensile strength, compared to hand-tied knots. These are physiological outcomes observed and measured in the animal subjects.

8. The sample size for the training set:

   • Not applicable. This is a physical, mechanical medical device, not an AI/ML algorithm that requires a training set.

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

   • Not applicable, as no training set was used.

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The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.

LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.

This document does not describe a study involving an AI/Medical Device that requires the establishment of ground truth, expert consensus, or multi-reader multi-case studies. Instead, it is a 510(k) premarket notification for a surgical suture, the RD QUICK LOAD SUTURE, asserting its substantial equivalence to a previously cleared predicate device.

The acceptance criteria and proof of substantial equivalence for this suture device are based on non-clinical performance testing and biocompatibility assessment, not on clinical performance studies involving a test set, expert consensus, or multi-reader studies as one would expect for an AI/Medical Device.

Here's why and what information is provided:

1. Acceptance Criteria and Device Performance (for a Suture)

The acceptance criteria for the RD QUICK LOAD SUTURE are based on established standards for surgical sutures. The performance of the device is evaluated against these standards.

2. Sample Size and Data Provenance for Testing:

• Data provenance: The document states "Biocompatibility results from Teleflex® Medical OEM were leveraged." This implies testing was conducted by the raw material supplier.
• The specific sample sizes for the USP and biocompatibility testing are not explicitly stated in this document. These would typically be defined by the relevant standards and internal test protocols. The nature of this 510(k) summary means highly detailed test parameters are usually omitted, with the FDA reviewing the full test reports.
• The tests are non-clinical (benchtop and lab-based biocompatibility), not clinical.

3. Number of Experts/Qualifications (Not Applicable for Suture Evaluation):

This information is not relevant to the evaluation of a surgical suture's substantial equivalence based on physical and biocompatibility properties. There are no "experts" establishing ground truth in the context of image interpretation or diagnosis.

4. Adjudication Method (Not Applicable):

Not applicable for a medical device cleared through substantial equivalence based on physical and biological testing.

5. MRMC Comparative Effectiveness Study (Not Applicable):

• No MRMC study was done. This is a surgical suture, not a diagnostic AI device. There are no "human readers" to improve with AI assistance. Clinical studies were deemed unnecessary.

6. Standalone Performance (Not Applicable as AI):

This is not an AI/algorithm. Its performance is its tensile strength, knot security, and biocompatibility, which are tested through benchtop methods defined by USP standards.

7. Type of Ground Truth (for Suture Properties, not a Diagnostic):

• The "ground truth" for the suture's performance is established by validated physical test methods (USP standards) and biocompatibility testing against ISO standards.
• For the claim of substantial equivalence, the "ground truth" is also the performance of the predicate device, against which the new device is compared.

8. Sample Size for Training Set (Not Applicable - No AI/Machine Learning):

This device does not involve a "training set" in the context of AI or machine learning. It is a manufactured physical good.

9. How Ground Truth for Training Set was Established (Not Applicable):

Not applicable, as there's no training set for an AI model.

In summary, this FDA clearance document is for a traditional medical device (surgical suture) demonstrating chemical and physical equivalence to a predicate device, not an AI-powered diagnostic tool. Therefore, many of the requested criteria, which are standard for AI/ML device evaluations, are not applicable here.

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The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.

The LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories, a medical device intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures, demonstrated its effectiveness and safety through various performance tests and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LSI SOLUTIONS® ForniSee™ System are implicitly derived from the successful outcomes observed during its clinical performance testing and the comparison to the predicate device. The primary criteria revolve around safe and effective uterine manipulation and delineation of vaginal fornices during laparoscopic hysterectomy procedures, without causing device-related adverse events, maintaining pneumoperitoneum, and facilitating successful surgical outcomes.

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

• Sample Size: 50 elective hysterectomy patients.
• Data Provenance: Prospective. The clinical performance testing was achieved through Institutional Review Board (IRB) approved studies. The studies were conducted at two separate medical centers within the USA, each with its own gynecological surgeon Principal Investigator (PI).

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

• Number of Experts: At least two gynecological surgeon Principal Investigators (PIs) (one at each medical center) were involved in conducting the studies and evaluating the device's performance.
• Qualifications: The experts were described as "gynecological surgeon Principal Investigator (PI)s." While specific experience levels (e.g., "10 years of experience") are not provided, their role as PIs in IRB-approved surgical studies implies significant clinical expertise in gynecological surgery and hysterectomy procedures.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple independent expert assessments of an outcome.

Instead, the clinical performance results were directly reported by the "gynecological surgeon Principal Investigator (PI)s" at each of the two medical centers. Observations and outcomes, including adverse events, estimated blood loss, pneumoperitoneum maintenance, and overall effectiveness, were reported by these PIs. For example, "Several minor intra-operative observations were noted but deemed by the PIs as expected in their patients or of no significant consequence." This suggests that the PIs' individual clinical judgment served as the primary basis for evaluating events and outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the standalone performance of the ForniSee™ system in a clinical setting, without directly comparing its AI-assisted performance (as no AI component is mentioned) against human readers or human readers without AI assistance. The comparison was primarily against a predicate device's technological characteristics and overall intended use, not its clinical outcomes in a head-to-head MRMC trial.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, from the perspective of the device itself (not an algorithm in the AI sense), a standalone performance assessment was conducted through the clinical study. The ForniSee™ System was used by surgeons in a real-world surgical setting, and its direct performance (e.g., ability to manipulate the uterus, identify fornices, maintain pneumoperitoneum) was evaluated by the operating surgeons (PIs). The study assessed the device's efficacy and safety when used as intended, independent of a comparison to a human performing the task without the device.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing was established by expert clinical assessment and surgical outcomes data. The PIs (gynecological surgeons) directly observed and assessed the device's performance during surgery, recorded clinical outcomes (e.g., successful hysterectomy, blood loss, pneumoperitoneum maintenance, adverse events), and conducted post-operative follow-ups. This involved:

• Clinical observation: Direct assessment by operating surgeons of the device's functionality and impact during the procedure.
• Surgical outcomes: Documentation of successful completion of the hysterectomy, conversion rates, and intra-operative issues.
• Patient follow-up: Post-operative examinations and patient reports to assess recovery and any long-term complications.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI development. The device is a mechanical uterine manipulator, not an algorithm that requires a training set. The "development" of the product line involved "Cadaver research" and extensive "non-clinical tests" (biocompatibility, sterilization, aging, shipping, bench testing), which serve as pre-clinical development and validation phases, rather than a "training set" for an algorithm.

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

Since the device is a mechanical instrument and not an AI algorithm, there is no "training set" in the conventional sense of machine learning, nor a "ground truth" to be established for such a training set. The development process, including "Cadaver research" and extensive "non-clinical tests," provided data and insights that informed the device's design and confirmed its physical and material properties, but this is distinct from establishing ground truth for algorithmic training.

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These LSI SOLUTIONS® suture placement products are intended for use in the approximation of soft tissue and prosthetic materials.

LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick Load® products, specifically the RD-180 suturing device and its 2-0 non- absorbable polyester and polypropylene suture load units along with the TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will effectively approximate tissue and prosthetic material.

The provided document describes the LSI SOLUTIONS® Suture Placement Devices and Accessories, detailing their intended use and the testing conducted for their 510(k) premarket notification (K100593).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All data fell within internal specification requirements, as well as external standard requirements and device performance expectations" and that the product was compared to Coalescent U-Clip® predicate device and USP standards. However, specific quantitative values for these standards or the device's performance against them are not provided in this summary. The summary indicates successful compliance.

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

• Test Set Sample Size: "Multiple tests were performed covering a variety of different prosthetic material types." A precise numerical sample size for the test set is not explicitly stated.
• Data Provenance: The study employed an ex-vivo porcine tissue model. This indicates the data was collected from animal tissue, not human subjects. The country of origin for this specific ex-vivo model is not specified. The study is characterized as a "Prosthetic Fixation Study," suggesting it was conducted specifically for this submission, likely making it prospective for the purpose of the 510(k).

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

• The document does not mention the use of experts to establish ground truth for the "Prosthetic Fixation Study." This type of study, involving mechanical testing on ex-vivo tissue, typically relies on quantitative measurements and comparisons against established standards rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

• An adjudication method is not applicable and therefore not mentioned, as the study involves objective mechanical testing on tissue models rather than subjective clinical assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The study described is a "Prosthetic Fixation Study" using an ex-vivo porcine tissue model, which is a bench-top/pre-clinical study, not a clinical study involving human readers or cases.

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

• This question is not applicable to this device. The LSI SOLUTIONS® device is a physical surgical instrument (suture placement device and accessories), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

• The "ground truth" for the "Prosthetic Fixation Study" appears to be based on objective measurements and comparisons against established industry standards (e.g., USP standards) and internal/external specifications for prosthetic fixation performance (e.g., tensile strength, knot security). It is not pathology, outcomes data, or expert consensus in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models.

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

• This question is not applicable for the same reason as point 8.

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