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The FIREFLY® Cervical Navigation Guide system is intended to provide mechanical guidance for the preparation and drilling of pilot holes for the placement of posterior cervical spine (C1-C7) and the upper thoracic spine (T1-T3). Pilot holes are created using the FIREFLY® Cervical Navigation Guide in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) during open, posterior spinal fixation procedures, on skeletally mature patients, that are intended for fusion. The patient's pedicles, pars, or lateral masses must be dimensionally adequate to safely accommodate a posterior cervical screw, as determined on a preoperative CT/CTA scan.

The FIREFLY® Cervical Navigation Guide system is compatible with FDA cleared, legally marketed, posterior cervical screw systems (and their respective components) that are specified in the precautions. Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm each pedicle's integrity. Only qualified compatible OEM posterior cervical screw system taps may be used to visually guide the tapping of pilot holes. All other posterior cervical screw system components and accessories (including non-visually guided taps) are to be used, after removal of the FIREFLY @ Cervical Navigation Guide, as directed by the posterior cervical screw system's instructions for use.

The FIREFLY® Cervical Navigation Guide system is only compatible with consoles systems (attachments and burs) listed in the precautions.

This system (guide, bone model, drill bit, and depth stop) are intended for single use only.

The FIREFLY® Cervical Navigation Guide is intended to assist in the accurate placement of posterior cervical screws. It consists of single-use components designed for treatment of a specific patient.

The FIREFLY® Cervical Navigation Guide uses Patient-Specific Cervical Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT/CTA imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) for placing screws following the Approved Patient-Specific Surgical Plan.

Patient-Specific Bone Models are also provided.

The provided text describes a 510(k) premarket notification for the FIREFLY® Cervical Navigation Guide. It outlines the device's indications for use, technological characteristics, and a summary of performance data from cadaveric accuracy testing.

Here's the breakdown of the requested information based on the provided text:

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

The document states that "Cadaveric accuracy testing of the FIREFLY® Cervical Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Cervical Navigation Guide's performance is adequate to perform as intended." However, the specific quantitative acceptance criteria and the corresponding reported device performance values (e.g., accuracy in angle or translation) are not explicitly provided in the document.

Therefore, the table cannot be fully constructed.

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: Not explicitly stated in the document. The text only mentions "Cadaveric accuracy testing." It does not specify the number of cadavers or the number of pilot holes tested.
• Data Provenance: The study was "Cadaveric accuracy testing." The country of origin is not specified, and it is a type of prospective study on cadavers.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

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

• Adjudication Method: Not explicitly stated.

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

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described. The device is a "Cervical Navigation Guide" which provides mechanical guidance for instrument placement. It is not an AI-assisted diagnostic or interpretation tool for human readers but rather a surgical guidance tool.

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

• This question is less directly applicable to a mechanical surgical navigation guide. The "performance" described is the accuracy of the guide itself in directing instruments. Since it's a mechanical guide, its function is inherently "standalone" in guiding the physical instrument, although a human surgeon is always "in the loop" operating the instruments through the guide. The cadaveric testing assesses the mechanical accuracy of the guide as intended.

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

• For the cadaveric accuracy testing, the ground truth would typically be established by highly precise measurements of the actual pilot hole trajectory and depth in relation to the pre-surgically planned trajectory, often using imaging (e.g., post-procedure CT scans) and/or metrology. The document does not specify the exact method for ground truth establishment.

8. The sample size for the training set

• The document describes a cadaveric performance study, not a machine learning model that relies on a training set. Therefore, this question is not applicable.

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

• As this is not a machine learning device, this question is not applicable.

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The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The PuraCath Firefly Needleless Connector, Model 9001, is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.

Here's a summary of the acceptance criteria and the study details for the Firefly Needleless Connector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical bench testing as the study conducted to determine if the device is substantially equivalent to the predicate device. These tests covered biocompatibility testing and performance testing based on various international standards and FDA guidance documents.

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

The document does not specify the exact sample sizes (N-numbers) for each individual test conducted. It only states that "The following non-clinical data were provided in support of the substantial equivalence determination." and lists various test categories.

Regarding data provenance, the tests are non-clinical (bench testing), so there is no patient data involved from specific countries or retrospective/prospective collection. The provenance here refers to the standards and guidance followed (e.g., ISO, ASTM, USP, FDA Guidance).

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

This information is not applicable (N/A) as the tests are non-clinical bench tests (e.g., material compatibility, mechanical performance) and do not involve human interpretation or clinical ground truth established by experts in the typical sense of a diagnostic device. The "ground truth" for these tests are the defined pass/fail criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth for diagnostic decisions. In this case, the test results are objective measurements against predefined standards.

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

There is no indication that an MRMC comparative effectiveness study was done. This device is a passive medical device (a needleless connector), not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

This information is not applicable (N/A). The device is a physical medical device, not an algorithm, so standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by objective measurements and observations performed according to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. The acceptance criteria for each test are defined by these standards, and the device's performance is compared against these predetermined thresholds. For biocompatibility, this involves evaluating biological responses to materials. For performance, it involves mechanical, fluid dynamic, and durability assessments.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context. The "design" and "testing" of the device are based on engineering principles and regulatory standards.

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

This information is not applicable (N/A), as it's not an AI/machine learning device requiring a training set.

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The firefly T-2 is intended for stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-2 is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind.

The firefly™ T-2 Neuromuscular Stimulator (firefly™ T-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating that provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The firefly™ T-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

This document, K201131, is a 510(k) summary for the firefly™ T-2, a powered muscle stimulator. It is not a study proving the device meets acceptance criteria for a new AI/ML-driven medical device, but rather a submission demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML accuracy metrics (e.g., sensitivity, specificity, AUC) or the other points typically associated with the rigorous validation of an AI/ML model (sample sizes for test/training, expert adjudication, MRMC studies, etc.).

The document focuses on comparing the firefly™ T-2 to its predicate device, the firefly™ T-1, based on technical specifications and functional performance, rather than clinical performance metrics, especially those that would require AI-specific validation.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML validation criteria:

Device Type and Purpose:

• The firefly™ T-2 is a powered muscle stimulator. Its "intended for stimulation of healthy muscles in order to improve or facilitate muscle performance."
• It is explicitly stated as not intended to be used in conjunction with therapy or treatment of medical conditions of any kind.
• It operates by stimulating the common peroneal nerve to cause calf muscle contraction, increasing blood flow. This is a biophysical mechanism, not an AI/ML-driven diagnostic or prognostic one.

Reason for Submission (Differences from Predicate):

• The firefly™ T-2 is a redesigned version of the firefly™ T-1. The redesign aimed for more efficient current delivery, shorter pulse widths, and improved prevention of current leakage between electrodes by using discrete hydrogel pieces.
• The user interface was also improved for ease of use.
• Crucially, the document states: "The changes resulting in the firefly™ T-2 device do not alter the device intended use, indications for use or fundamental scientific technology, and none of the changes significantly affect the safety or effectiveness of the device." This implies an engineering change, not a change incorporating AI/ML.

"Acceptance Criteria" implicitly addressed by the submission (not AI-specific):
The "acceptance criteria" here are implicitly related to demonstrating that the redesigned firefly™ T-2 is still substantially equivalent to the predicate firefly™ T-1 and continues to meet relevant safety and performance standards for a powered muscle stimulator.

• Safety Standards Compliance:
  • IEC 60601-1:2005 + A1:2012 (Medical Electrical Equipment - General Requirements for Safety)
  • IEC 60601-2-10:2016 (Particular requirements for the safety of nerve and muscle stimulators)
  • IEC 60601-1-2: 2014 (Electromagnetic compatibility)
  • ISO 10993-1:2009 (Biocompatibility of materials)
• Performance Verification (Comparison to Predicate):
  • Output waveform characteristics (verified via oscilloscope).
  • Output current measurements under various loads (compared to T-1).
  • Validation of hardware and firmware functionality.
  • Demonstration that the T-2 performs as designed and intended and is substantially equivalent to the T-1.

Why the requested AI/ML criteria are not applicable/found:

1. AI/ML Specific Acceptance Criteria and Performance Table: Not applicable. The device is a muscle stimulator, not an AI/ML diagnostic.
2. Sample Size for Test Set and Data Provenance: Not applicable for AI/ML validation. The "testing" refers to electrical and functional verification of the physical device, not an AI model trained on data.
3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth for an AI model (e.g., disease presence in an image) isn't relevant here. The "ground truth" for this device is simply its physical and electrical properties conforming to specifications.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses how AI assistive tools affect human reader performance in tasks like image interpretation. This device has no imaging component or human reader interaction for AI-driven interpretation.
6. Standalone (Algorithm Only) Performance: Not applicable. There is no standalone algorithm in the sense of a medical AI.
7. Type of Ground Truth Used: The "ground truth" for this device would be its engineering specifications and the physical laws governing electrical stimulation, verified through laboratory testing (e.g., oscilloscope measurements, impedance tests). It's not clinical "outcomes data" or "expert consensus" in the context of an AI model's output.
8. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device is not developed using AI/ML training data. Its "design" is based on electrical engineering principles and the performance of its predicate device, not on patterns learned from a large dataset.

In summary, the provided document is a regulatory submission for a powered muscle stimulator, focusing on demonstrating substantial equivalence to a predicate device through engineering changes and traditional electrical/mechanical testing, rather than the validation of an AI/ML medical device.

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The FIREFLY® Midline Navigation Guide can be used with any 510(k) clearly marketed, pedicle screw spinal system (for its cleared indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures (T10-S2) intended for fusion, with the additions listed below:

• o Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• . Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Midline Screw Navigation Guide
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used with the FIREFLY® Midline Navigation O Guide to confirm pedicle integrity
  • All other pedicle screw spinal system components and accessories [including non-guided taps] are to be O used, after removal of the FIREFLY® Midline Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

The FIREFLY® Midline Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient.

The FIREFLY® Midline Navigation Guide uses Patient-Specific Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation Guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Surgical Plan.

Patient-Specific Bone Models are also provided.

Here's a breakdown of the acceptance criteria and study information for the FIREFLY® Midline Navigation Guide, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size Used for Test Set: Not specified. The document only mentions "Cadaveric accuracy testing."
• Data Provenance: Cadaveric. The document does not specify the country of origin or if the cadavers were retrospectively or prospectively selected.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not specified. The document does not mention the involvement of experts in establishing ground truth for the cadaveric accuracy testing. It's likely that the ground truth for pedicle screw placement in cadaveric studies is often established by comparing the guided placement to anatomical landmarks or established safe zones, which may involve expert anatomical assessment, but the details are not provided.

4. Adjudication Method (Test Set)

Not specified. No information is provided regarding any adjudication method used for the cadaveric accuracy testing.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device is a "Navigation Guide," implying it assists in physical placement rather than image interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

Yes. The "Cadaveric accuracy testing" appears to be a standalone performance study of the device's ability to guide instruments accurately, without human-in-the-loop performance being assessed in a comparative manner with human readers. The device guides the surgeon to create pilot holes, meaning its performance is inherently linked to its interaction with a surgeon, but the "accuracy testing" usually refers to the precision of the guide itself.

7. Type of Ground Truth Used

The type of ground truth used for the cadaveric accuracy testing is implicitly anatomical/physical measurement. The device guides instrument placement, and "accuracy testing" in this context would likely involve measuring the deviation of the guided trajectories from the presurgically planned trajectories or known correct anatomical paths within the cadaveric pedicles.

8. Sample Size for Training Set

The document does not mention a training set. The FIREFLY® Midline Navigation Guide uses "Patient-Specific Guides" based on "the patient's CT imaging data" and "trajectories chosen presurgically, by the surgeon." This suggests a patient-specific design approach rather than a machine learning model that requires a large training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set for an AI/machine learning model is described. The device's operation is based on pre-surgical planning by a surgeon using patient CT data, not on a trained algorithm.

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The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below:

• . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion ●
• Pedicle screw is intended to be inserted into a pilot hole ●
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
  • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes
  • All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.

The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.

Patient-Specific Bone Models may also be provided.

The provided text describes the 510(k) summary for the FIREFLY® Pedicle Screw Navigation Guide (K181399). Based on the text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document simply states "Additional cadaveric accuracy testing" was performed. It does not specify the number of cadavers or pedicles used in this test set.
• Data Provenance: The study was "cadaveric accuracy testing," implying it was conducted on human cadavers. The country of origin and whether it was retrospective or prospective are not mentioned.

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

This information is not provided in the document. The text does not describe how ground truth was established for the cadaveric accuracy testing, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance.
• Effect size: Not applicable, as no such study is described.

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

The FIREFLY® Pedicle Screw Navigation Guide is a physical device intended to guide surgical instruments. It is not an AI algorithm in the traditional sense that would have "standalone" performance without human-in-the-loop. The "performance data" section refers to cadaveric accuracy testing of the physical guide's ability to direct instrument placement, which inherently involves human surgeons using the device.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the cadaveric accuracy testing. For such a device, ground truth would typically be established by precise measurements of actual screw placement in relation to planned trajectories, possibly using highly accurate imaging techniques (e.g., post-operative CT scans with fiducial markers, or direct anatomical measurements). However, the specific method is not detailed.

8. Sample Size for the Training Set

The document states, "The FIREFLY® uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data." This indicates that each guide is patient-specific and generated from individual patient CT data. There isn't a "training set" in the conventional machine learning sense for the device itself, as it's a patient-specific physical guide based on pre-operative imaging rather than a learned algorithm trained on a large dataset.

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

As explained above, there isn't a traditional "training set" for an AI algorithm here. The "training" for the patient-specific guide comes from the individual patient's CT imaging data and the surgeon's presurgical planning. The "ground truth" for this process would be the surgeon's intended screw trajectory based on their anatomical assessment from the CT.

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The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/ilium) intended for fusion, with the additional conditions listed below:

• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion ●
• Pedicle screw is intended to be inserted into a pilot hole ●
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
• Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide .
  • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
  • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be 0 guided to tap pilot holes
  • All other pedicle screw spinal system components and accessories lincluding non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.

The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.

Patient-Specific Bone Models may also be provided.

The purpose of this traditional 510(k) is to expand the FIREFLY® indications for use to allow compatibility with all pedicle screw systems (for their cleared indications for use) meeting certain criteria and use at an additional spinal level. The FIREFLY® design is the same as was originally cleared in K143222.

The provided document, K162419, describes the substantial equivalence determination for the "FIREFLY® Pedicle Screw Navigation Guide". While it mentions that "Additional cadaveric accuracy testing of the FIREFLY® Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended," it does not fully detail the acceptance criteria or the specifics of the study in a manner that allows for a comprehensive answer to all parts of your request.

Here's an attempt to answer based on the available information, noting where details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document states that acceptance criteria were met but does not explicitly list the specific quantitative acceptance criteria. It only generally refers to "accuracy."

Reported Device Performance: The document states that "Additional cadaveric accuracy testing... demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended." Specific performance metrics (e.g., mean angular deviation, mean translational error) are not provided in this document.

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

• Sample Size for Test Set: The document simply mentions "Additional cadaveric accuracy testing" without specifying the number of cadavers, pedicles, or screws tested.
• Data Provenance: "Cadaveric accuracy testing" implies the data was derived from cadaveric studies. The country of origin is not specified but given the FDA submission, it's likely a study conducted in the USA or adhering to US standards. It's inherently a retrospective analysis of the device's accuracy on cadaveric specimens.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the cadaveric study. For cadaveric studies involving pedicle screws, ground truth often involves post-operative CT scans or direct measurement by skilled researchers/surgeons.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. This type of study is more common for diagnostic imaging AI systems to assess human performance with and without AI assistance. This device is a surgical navigation guide.

6. Standalone (Algorithm Only) Performance Study

The document describes "accuracy testing," which is inherently a standalone performance evaluation of the device as it guides surgical instruments. However, the exact methodology and quantitative results for this standalone performance are not provided beyond the statement that acceptance criteria were met.

7. Type of Ground Truth Used

For "cadaveric accuracy testing," the ground truth typically involves:

• Post-operative imaging: High-resolution CT scans of the cadaveric spine with inserted pedicle screws, where the actual position of the screws relative to the pedicle canal is measured.
• Direct measurement: Physical dissection and measurement, though less common for pedicle screw accuracy compared to imaging.

The document does not explicitly state how the ground truth was established, but the context of pedicle screw accuracy testing points to methods that objectively verify screw placement against anatomical goals.

8. Sample Size for the Training Set

The document describes a "Pedicle Screw Navigation Guide," which is a mechanical guidance device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense. The device's design is based on patient-specific CT imaging for pre-surgical planning, but this is a process of individual case design, not an algorithm being "trained" on a large dataset. Therefore, the concept of a training set sample size is not applicable here.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of mechanical surgical navigation guide.

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The PuraCath™ Firefly IM Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange dialysis patiens as a nethod of connector Disinfecting System is comprised of Firefly™ UV Purification Device, FireflyTM Transfer Catheter, FireflyTM Luer Cover, and FireflyTM 99% IPA bottle.

The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in viro against The enectivelless of the Funceoccus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococus Staphylococcus autous, Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in microorganisms.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System provides a way for patients to ensure the cleanliness of the fluid connections associated with ambulatory peritoneal dialysis. The system accomplishes cleaning with a combination of alcohol, flushing with sterile dialysate, and ultraviolet (UV) light. The System consists of the components shown below.

The Firefly UV Purification Device is a multi-year reusable device which helps to clean the connection between the Firefly Transfer Catheter and the dialysate Y-set (Y-set). The UV Purification Device is powered by off-the-shelf, replaceable AA batteries. The UV Purification Device directs ultraviolet (UV) light through the Transfer Catheter connector. UV Purification Device uses lights and an audible alert to indicate device status.

The Firefly Transfer Catheter is a sterile, 6 month use, disposable device providing communication between the indwelling patient catheter and the Y-set. A proprietary, UV transparent control valve on the end of the Transfer Catheter allows for draining and filling the peritoneum. The control valve is actuated manually, adjustable between fully open and fully closed. The Transfer Catheter also has a flush feature. The flush feature allows for flushing of air and potential contaminants from the Y-set prior to fluid exchange.

The Firefly Luer Cover is a 6 month use, disposable, UV transparent component designed to protect the Transfer Catheter connector between uses and to aid in keeping the control valve closed.

The Firefly IPA Dropper Bottle provides a convenient way to apply 99% IPA solution to the inside of the Y-set and Transfer Catheter connectors.

Acceptance Criteria and Study for the Firefly™ Peritoneal Dialysis Connector Disinfecting System

This document describes the acceptance criteria and the study conducted to prove that the Firefly™ Peritoneal Dialysis Connector Disinfecting System meets those criteria, as detailed in the provided FDA 510(k) summary (K151620).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document primarily details in vitro studies for microbiological efficacy and various bench tests for physical and electrical performance.

• Microbiological Testing: The sample size for the microbiological efficacy testing is not explicitly stated. It is described as "in vitro antimicrobial efficacy studies," suggesting laboratory-based experiments using cultured microorganisms.
• Other Performance Tests (Biocompatibility, Sterilization, Electrical Safety, Life Cycle, Light Leak, Transit, Water Ingress, Human Factors): The sample sizes for these tests are not explicitly stated in the summary. These would typically involve testing a representative number of devices or components.
• Data Provenance: All described studies are pre-market, laboratory-based in vitro and bench testing. No clinical data from human subjects is mentioned for performance evaluation. The data provenance is implied to be from the manufacturer's testing facilities or accredited laboratories. There is no indication of country of origin of the data beyond the manufacturer being US-based, and the submission being to the US FDA.

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

This information is not provided in the given 510(k) summary. For in vitro and bench testing, "ground truth" is typically established by the reference standards and protocols of the tests themselves, conducted by qualified scientists and engineers in a laboratory setting, rather than through expert consensus on observational data.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of studies presented (in vitro microbiological tests and various bench performance tests). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review settings where human interpretation introduces variability requiring a consensus process.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant for this device as it is a physical disinfecting system, not an AI-assisted diagnostic tool.

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

Yes, a form of standalone performance was assessed. The "Microbiological testing" section describes the device's ability to achieve a "≥ 4 log reduction in micro-organisms" in vitro. This demonstrates the device's inherent capability to disinfect independently of human factors (beyond proper operation of the system). Similarly, other bench tests (e.g., electrical safety, life cycle) evaluate the device's inherent performance characteristics as a standalone product. The device itself is not an "algorithm" in the sense of software for interpretation, but rather a physical system.

7. Type of Ground Truth Used

The ground truth for the performance evaluations described in this document is primarily based on:

• In Vitro Microbiological Reference Standards: For the microbiological testing, the ground truth is the known concentration of specified microorganisms and the quantitative measurement of their reduction after exposure to the device. This is a highly controlled, objective, and quantifiable measure.
• Engineering Specifications and Standardized Testing Protocols: For other performance tests (e.g., electrical safety, life cycle, light leak), the ground truth is established by meeting predefined engineering specifications and adhering to recognized industry standards (e.g., ISO, IEC, AAMI/ANSI). These are objective, measurable criteria.
• Physical Measurements and Observations: For tests like transit or water ingress, the ground truth is the observable outcome or measured performance against defined pass/fail criteria.

8. Sample Size for the Training Set

This is not applicable. The Firefly™ Peritoneal Dialysis Connector Disinfecting System is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

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

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The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.

Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use.

This device is intended for single use only.

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY ™ Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models may also be provided.

The provided text describes the FIREFLY™ Pedicle Screw Navigation Guide and its performance data. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information on ground truth establishment, expert consensus, or MRMC studies. The document is a 510(k) summary for FDA clearance, which typically presents a high-level overview rather than detailed scientific study breakdowns.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical or qualitative acceptance criteria for accuracy and sterilization stability are not detailed in this document.

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

The document mentions "Cadaveric accuracy and sterilization stability testing."

• Sample Size for Test Set: Not specified.
• Data Provenance: Cadaveric testing. (Country of origin is not specified, and it's a prospective study as it was performed for this specific device).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes accuracy testing, but not a comparison of human readers with and without AI assistance to measure improvement effect size.

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

The device is a "Pedicle Screw Navigation Guide," which implies it is a physical guide used by a surgeon during surgery. It is not an AI algorithm in the traditional sense that would have "standalone" performance independent of human interaction in the operating room. Therefore, the concept of "standalone algorithm performance" as typically applied to AI image analysis is not relevant here. The accuracy refers to the guide's precision in directing the surgical instruments.

7. The Type of Ground Truth Used

• Ground Truth: For accuracy, the "ground truth" would likely be the actual placement of the pilot holes or screws in the cadavers, as measured post-procedure (e.g., via CT scanning and comparison to pre-operative plans). This is implied by the term "accuracy testing," but the specific method of establishing this ground truth (e.g., using a gold-standard imaging technique and detailed measurements) is not specified.

8. The Sample Size for the Training Set

The device is a physical navigation guide, not a machine learning algorithm that requires a "training set" in the computational sense. The planning software uses patient CT images, but these are for individual patient planning, not for training a generalized model. Therefore, this question is not applicable.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The document states: "Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY Pedicle Screw Navigation Guide performance is adequate to perform as intended."

This indicates that an experimental study was conducted using cadaveric specimens to evaluate the precision of the guide in directing surgical instruments and to confirm its sterility after processing. However, the details of these studies, including specific methodologies, data collected, statistical analyses, and the actual numerical results against defined acceptance criteria, are not provided in this 510(k) summary.

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The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical conditions of any kind.

The firefly™ T-1 device is a disposable, fully integrated neuromuscular stimulator for muscle conditioning composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The firefly™ T-1 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

Here's an analysis of the acceptance criteria and supporting studies for the firefly™ T-1 device, based on the provided 510(k) summary:

This device is a Powered Muscle Stimulator, which typically focuses on performance characteristics rather than diagnostic accuracy like AI-powered imaging devices. Therefore, the traditional metrics of sensitivity, specificity, AUC, and multi-reader multi-case studies are not applicable in this context. Instead, the acceptance criteria relate to its functionality, safety, and effectiveness in stimulating muscles as intended.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a powered muscle stimulator, acceptance criteria are generally based on meeting industry standards for electrical safety, biocompatibility, and demonstrating the intended physiological effect. The document focuses on demonstrating substantial equivalence to a predicate device and proving its safety and effectiveness through non-clinical and limited clinical studies.

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