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The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.

The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "PIVO™ Pro Needle-free Blood Collection Device." This document details the device's indications for use, technological characteristics, and comparison to a predicate device, along with a summary of performance tests. However, it does not describe an AI/ML powered device or a study involving human experts for ground truth establishment, MRMC studies, or training/test set sample sizes in the context of AI/ML.

The document primarily focuses on establishing substantial equivalence for the device itself (a needle-free blood collection device), specifically for the addition of blood culture collection and an extended shelf life. The performance tests mentioned (e.g., Insertion Test, Blood Leak Test, Package Integrity) are related to the physical and functional aspects of the hardware device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML powered device, the study proving its performance (in terms of AI metrics), sample sizes for AI test/training sets, expert involvement in ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
• "Summary of Performance tests completed on the subject devices were limited to those tests required Performance to support a determination of substantial equivalence to the predicate device."
• "Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device."

This indicates that internal performance tests were conducted against pre-determined acceptance criteria, but these are for the physical device's functionality and safety, not for an AI/ML algorithm's diagnostic or predictive performance.

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The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular catheter (IV) system. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing, and winged clip on the distal end. The winged clip attaches to the IV system. The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV.

The device is available in three sizes: 20GA, 22GA, and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPort™ IV Access.

The provided document is a 510(k) summary for the PIVOTM Pro Needle-free Blood Collection Device, which seeks to demonstrate substantial equivalence to a predicate device (PIVOTM Needle-free Blood Collection Device). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily through non-clinical performance testing and a comparison of technological characteristics.

Here’s a breakdown of the information requested, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the performance tests conducted and states that the device "met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

However, we can infer some "acceptance criteria" based on the tests performed:

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

The document does not specify the exact sample sizes (N values) for each individual performance test (e.g., how many devices were tested for catheter perforation, how many for flow rate). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab tests for device clearance, they are inherently prospective.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for this device is based on objective measurements and compliance with recognized standards and internal design requirements, not expert consensus on interpretations like with diagnostic imaging. Usability testing would involve users, but the number and qualifications of those users are not detailed.

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

This concept is not applicable here as these are performance and engineering tests, not studies requiring human interpretation and adjudication (e.g., clinical trials for diagnostic algorithms).

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

An MRMC study was not conducted. This type of study applies to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic performance. The PIVOTM Pro is a physical blood collection device, not an AI software. The submission explicitly states: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."

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

This concept is not applicable as the device is a physical medical device, not an algorithm or AI system. Its performance is evaluated through physical and functional testing.

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

For this device, the "ground truth" relates to meeting engineering specifications, material properties, sterility, and functional performance benchmarks derived from industry standards (e.g., ISO, ASTM), internal design requirements, and prior knowledge from the predicate device. It is primarily based on:

• Physical measurements and criteria: e.g., acceptable flow rates, specified dimensions, absence of leaks, specified pull force.
• Compliance with recognized standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-1 for sterilization, ASTM D4169 and ISO 11607-1 for packaging.
• Functional tests: verifying proper insertion, alignment, and absence of catheter perforation.

8. The sample size for the training set

This is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

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

This is not applicable for the same reason as above.

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The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use by cigarette smokers as an educational and motivational tool to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other combustible, inhaled products.

The Pivot Breath Sensor is a personal, portable, lithium ion battery powered breath carbon monoxide ("CO") monitoring device that measures the level of CO in an individual's exhaled breath. It is intended for single-user over-the-counter ("OTC") use by cigarette smokers (users) to measure CO levels in their exhaled breath. This parameter correlates closely with carboxyhemoglobin levels and with cigarette smoking behavior. Hence, the more a person smokes, the higher are their exhaled breath CO levels. The user submits a breath sample by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor which is directed over electrochemical sensors to quantify the CO level in the breath. The sensor has two buttons - a front, center button and a side button - to help with user inputs and navigation. It also has a rechargeable battery that can be charged using a micro-USB cable by plugging into USB compatible charging sources such as a computer, USB adapter for power outlet, or car USB port. The calculated CO concentration/ level of the exhaled breath is displayed to the user in whole number parts-per-million ("ppm") on the LCD screen of the sensor. The Pivot breath sensor measures and displays CO concentrations from 0 to 100 ppm. Each of the breath sample results is shown to the user with a corresponding color and a number. The color is intended to aid in giving context to the quantitative CO value, aligning with the predicate device's color coding and scientific literature. The sensor can display multiple samples as the CO log and helps to graphically show the user their relative levels of exhaled breath CO throughout the day and between days. Hence, periodic measurements of CO levels may provide users with feedback regarding their smoking exposure, thus helping them to become educated and motivated to quit smoking, as supported by reference literature.

The provided text details the 510(k) summary for the Carrot Inc. Pivot Breath Sensor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory document outlines several studies and their success criteria, which act as acceptance criteria.

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

• 18-RP-1061A (Human Factors):
  • Sample Size: 15 subjects.
  • Data Provenance: Prospective, single-center study. The document does not specify the country of origin but implies it was conducted under the direct supervision of Carrot Inc. or a contracted research institution.
• 18-RP-1062A (Comparative Performance):
  • Sample Size: 70 subjects.
  • Data Provenance: Prospective, single-center study. No country of origin is specified.
• 20-RP-1083A (Expanded Indications):
  • Sample Size: 234 subjects, split into two cohorts (40-60% smoking 10-19 CPD, 40-60% smoking 20+ CPD).
  • Data Provenance: Prospective, single-center study. No country of origin is specified.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets in the same way one might describe for an imaging AI device. Instead, the "ground truth" for each study is inherent to its design:

• 18-RP-1061A (Human Factors): The ground truth was the observable ability of untrained lay users to operate the device and interpret results against explicit instructions, likely assessed by study personnel. No specific "experts" are mentioned for establishing ground truth in this context.
• 18-RP-1062A (Comparative Performance): The ground truth was established by a prescription-use CO breath sensor used with guidance by a trained health care professional. This serves as the reference standard against which the Pivot Breath Sensor's performance was compared. The number and qualifications of these healthcare professionals are not specified, but they are implied to be "trained."
• 20-RP-1083A (Expanded Indications): The ground truth was self-reported data from participants regarding their "Stage of Change" for quitting smoking, quit attempts, and reduction in cigarettes per day (CPD) compared to baseline. No external "experts" were used to establish this ground truth; it was based on participant responses.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1, 3+1 consensus by multiple readers) typically found in AI imaging studies. The studies described are either:

• Observational (Human Factors): Study personnel observed participants' interactions.
• Comparative Measurement (Comparative Performance): Direct comparison of measurements from two devices.
• Self-Reported Outcomes (Expanded Indications): Based on participant responses and observed changes.

Therefore, "none" in the traditional sense of expert adjudication for diagnostic discrepancies.

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 comparative effectiveness study of human readers with vs. without AI assistance was not done. The Pivot Breath Sensor is a direct-to-consumer device that provides readings to a single user, not an AI system assisting human experts in making a diagnosis.

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

Yes, in the context of this device, the "standalone" performance is effectively the performance of the Pivot Breath Sensor itself.

• The "Sensor Performance" bench tests (accuracy, precision, linearity, cross-sensitivity) are a direct assessment of the device's standalone algorithmic and hardware performance against controlled environments and known gas concentrations.
• The 18-RP-1062A (Comparative Performance) study also assesses the standalone performance of the Pivot Breath Sensor by comparing its readings (taken by self-trained users) to a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." The correlation coefficient of 0.9710 indicates a strong standalone performance in agreement with a reference standard.

7. The Type of Ground Truth Used

• Bench Tests: Controlled laboratory measurements and standards for physical and electrical properties, and established ISO standards for biocompatibility.
• 18-RP-1061A (Human Factors): Observational data of user interaction against predefined criteria for correct operation and interpretation.
• 18-RP-1062A (Comparative Performance): Measurements from a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." This acts as the clinical gold standard for CO breath measurement.
• 20-RP-1083A (Expanded Indications): Self-reported outcomes data from participants regarding their smoking behavior, motivation to quit, and quit attempts.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm development as one would typically see for complex learning models. Given that the device relies on electrochemical sensors, the "training" analogous to machine learning would typically involve:

• Sensor calibration: Manufacturers perform extensive calibration on sensor batches using known gas concentrations. This is implied by the "Sensor Performance" bench tests covering multiple lots.
• Algorithm development: The internal algorithm that converts sensor signals to ppm readings is developed and refined based on engineering principles and empirical data, not necessarily a separate "training set" in the common AI sense.

Therefore, a specific "training set sample size" as might be used for supervised machine learning is not provided or applicable in the traditional sense for this type of device.

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

As explained above, a distinct "training set" with ground truth in the AI/ML sense is not described. For sensor calibration and algorithm development, the "ground truth" would be established through:

• Known gas concentrations: When calibrating electrochemical sensors, the device is exposed to precise, certified concentrations of carbon monoxide (and potentially interfering gases). These known concentrations serve as the ground truth for fine-tuning the sensor's response curve and the device's internal conversion algorithm.
• Engineering and chemical principles: The fundamental operation of an electrochemical sensor is based on established scientific principles, which guide the development of the algorithms that translate raw sensor signals into ppm values.

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The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needlefree blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.

This looks like a 510(k) summary for a medical device called PIVO™. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than a study proving performance against acceptance criteria in the context of AI/ML.

Here's why it's not applicable to the requested information and what information it does contain:

• No AI/ML Component: The PIVO™ device is a "blood specimen collection device" (a needle-free blood collection device that attaches to a peripheral IV catheter). There is no mention of any AI or machine learning component in its functionality or development. Therefore, questions related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance, are not relevant.

• Substantial Equivalence, Not De Novo Performance: The document's primary purpose is to justify that the modified PIVO™ device is "substantially equivalent" to an already legally marketed predicate device (K190604). This means the focus is on showing that the changes (alternate colorant material, second contract manufacturer, alternate packaging material) do not raise new questions of safety or effectiveness. It's not about proving inherent performance against new, specific acceptance criteria for a novel device.

• Performance Testing for Equivalence: The "Performance Testing" section lists tests conducted to demonstrate that the modifications do not negatively impact the device's performance compared to the predicate. These are:

  • Leak testing
  • Dimensional testing
  • Joint strength testing
  • Flow rate testing
  • Packaging testing (per ASTM D4169-16, ASTM F1980-16, ISO 11607-1:2019)
  • Biocompatibility testing (per ISO 10993-1)

  The document states: "All testing was performed on sterilized product." And, "The changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."

Since it's not an AI/ML device and the submission is for substantial equivalence rather than original performance evaluation, I cannot fill in the requested table and study details related to an AI/ML device. The document does not provide information on:

1. Acceptance Criteria and Reported Device Performance (as typically defined for AI): It states "same acceptance criteria as the predicate device" for the performance tests listed, but doesn't quantify them.
2. Sample sizes for test set and data provenance.
3. Number of experts used to establish ground truth and qualifications.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles:

Enclosure Pivot System Sterilization Tray Cycle Pre-Vacuum 132°C (270°F) Temperature Sterilization Time 4 minutes Pressure 2-15 PSIA Minimum Dry Time 30 minutes in chamber

The maximum validated product loads for the trays in containers are as follows: 2-Level Rack, Level 2, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 3 each 39.1960.02, RP OST Tool Rod, 3 each 39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each 39.1960.51.02 RP OST Tool 1D RH 22mm, 1 each 39.1960.20.01 RP OST Angle 162mm, 1 each 39.1960.20.02 RP OST Angle 19mm, 1 each 39.1960.20.03 RP OST Angle 21.5mm , 1 each 39.1960.40.01 RP TM Spike Blade, 1 each 39.1960.60.01 OST Reverse Blade 11mm, 1 each 39.1960.60.02 OST Reverse Blade 16mm, 1 each 39.1960.30.01 RP OST Tool Curve 16mm, 1 each 39.1960.30.02 RP OST Tool Curve 19mm, 1 each 39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each 39.1960.10.01 RP OST Straight 20mm, 1 each 39.1960.10.02 RP OST Straight 40mm, 1 each 39.1960.10.03 RP OST Straight 43mm, 1 each 39.1960.10.04 RP OST Straight 47.5mm, 1 each 39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each 39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each

2-Level Rack - Level 1, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 1 each 39.1960.02, RP OST Tool Rod, 1 each 39.1960.05, Retractor, 1 each 39.1960.07, RP OST System, 1 each 39.1960.70.01 RP Curved Hip Long, 1 each 39.1960.70.02 RP Curved Hip Short, 1 each 39.1960.70.03 RP Curved Hip, 1 each

The RP Medical Pivot System Sterilization Tray System platform is designed to be compatible with the RP Medical Pivot Implant Extraction Osteotome surgical instruments. The Pivot System Sterilization Tray is constructed from thermoplastic plastics, aluminum and stainless steel. Each tray has evenly distributed steam holes.

Individuals instruments were designed to slide into 2 level storage racks. The racks have handles on the side to facilitate carrying. The Pivot System Sterilization Tray has a sliding latch mechanism to facilitate containment.

Each storage rack is set to a specific configuration and have stainless steel and silicone brackets and silkscreened artwork to assist the end user in correct placement of the instruments. The rack is designed to fit in a standard autoclave. The Pivot System Sterilization Tray System is reusable and provided in a non-sterile condition.

This document is a 510(k) Pre-market Notification for the RP Medical Pivot System Sterilization Tray System. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device and includes non-clinical testing results.

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

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

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

The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of sterilization cases tested for cytotoxicity or reliability). The data provenance is not specified, but the applicant is RP Medical, Inc. from Maple Ridge, BC, Canada, suggesting the testing likely occurred in North America or at a lab collaborating with the applicant. The testing is for a new device seeking clearance, making it prospective in nature for regulatory purposes.

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)

This is a non-clinical device submission for a sterilization tray and does not involve human expert interpretation or ground truth establishment in the way that an AI/imaging device would. The "ground truth" for these tests are objective measurements and observations against pre-defined engineering and biological safety standards (e.g., cytotoxicity score, absence of visible damage, structural integrity).

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

Not applicable, as this is a non-clinical device test where results are based on objective measurement against defined criteria, not human adjudication of subjective data.

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 a non-clinical device that is not an AI-powered diagnostic or interpretive tool, so no MRMC study was conducted.

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

Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI.

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

The "ground truth" for the non-clinical tests is based on objective laboratory measurements and observations against established industry standards and internal specifications regarding:

• Biocompatibility: Absence of cytotoxicity as per ISO 10993-5.
• Mechanical Integrity: Absence of visible deformation or damage under specified weight (AAMI ST77:2013).
• Durability and Wear: Absence of "significant wear" (extreme discoloration, peeling, cracking) after a specified number of sterilization cycles.

8. The sample size for the training set

Not applicable. This is a non-clinical device; there is no "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 device.

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The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.

The provided text describes a 510(k) premarket notification for the PIVO™ device, a blood specimen collection device. The submission is for a line extension to include a 24G compatible size device, along with some dimensional and material changes to existing 20G and 22G devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of acceptance criteria with corresponding performance metrics. However, it lists several performance tests conducted and states that "All testing was performed on sterilized product." The overarching acceptance criterion for the subject device (PIVO™ 24G and modified 20G/22G) is that it "demonstrated that there are no new risks and the device is substantially equivalent" to the predicate devices. It also states that testing used "the same acceptance criteria as the predicate device."

Here's an inferred table based on the provided information:

The subsequent information is either not applicable (N/A), not explicitly stated (NSE), or can be inferred as follows:

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

• Sample Size for Test Set: NSE. The document states that testing was performed, but does not specify the number of devices or samples used for each test.
• Data Provenance: NSE regarding country of origin or whether it was retrospective/prospective. The testing was conducted by the manufacturer, Velano Vascular (based in San Francisco, California, though this doesn't specify test location).

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)

• N/A. This device is a blood collection device, not an AI/diagnostic imaging device requiring expert interpretation of results for ground truth. Performance testing would rely on objective physical and chemical measurements rather than expert consensus on a 'ground truth' image or diagnosis.

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

• N/A. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for the performance testing described for this physical device.

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

• N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

• N/A. This device is not an algorithm or AI.

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

• Physiological standards and engineering specifications. For a blood collection device, "ground truth" would be established by predefined engineering specifications (e.g., specific dimensions, flow rates), established biochemical limits (e.g., for hemolysis), and relevant international standards (e.g., ISO 10993-1 for biocompatibility). The claim of "no new risks" and "substantially equivalent" implies meeting these objective standards relevant to the device's function.

8. The sample size for the training set

• N/A. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

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

• N/A. As there is no training set for a physical device, this question is not applicable.

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The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gage PIV's, respectively.

The provided document is a 510(k) premarket notification for a medical device called PIVO™, a blood specimen collection device. It details the device's characteristics, indications for use, and a comparison to its predicate device, TIVA™.

However, the document does not contain information related to a study proving the device meets acceptance criteria for an AI-powered medical device, or any acceptance criteria related to AI/algorithm performance. The acceptance criteria mentioned are for a physical medical device, PIVO™, comparing its performance characteristics to a predicate device (TIVA™) after material and component changes.

Therefore, I cannot extract the information required by your prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm.

The document discusses:

• Device Performance Testing:
  • Clamp functional testing
  • Leak testing
  • Dimensional testing
  • Joint strength testing
  • Performance testing
  • Flow rate testing
  • Biocompatibility testing (per ISO 10993-1, -4, -5, -10, -11)
• Summary of Substantial Equivalence: It states that the changes made to PIVO™ (formerly TIVA™) do not raise new questions regarding safety and efficacy, and that PIVO™ is equivalent to the predicate device based on identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. It explicitly states: "The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent."

Based on the provided text, the device is a physical blood collection device, not an AI or algorithm-driven device. Thus, your request for an AI acceptance criteria table or details about an AI study (sample size, experts, adjudication, MRMC, standalone, ground truth, training set) cannot be fulfilled from this document.

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The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.

The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.

The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.

The PIVOX™ Oblique Lateral System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft or allograft and must be used with supplemental fixation. The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral System plate and bone screws are made from titanium alloy and are provided sterile.

The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

The provided text describes a 510(k) premarket notification for the PIVOX™ Oblique Lateral Spinal System, which is a medical device for spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and biocompatibility assessments. It does not contain information about studies involving human readers, AI, or clinical ground truth derived from expert consensus, pathology, or outcomes data in the context of device performance evaluation as one might find in an AI/ML device submission.

Therefore, many of the requested elements are not applicable to the information contained in this 510(k) summary. I can, however, extract the relevant acceptance criteria, reported performance, and details about the studies reported.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." However, the specific numerical acceptance criteria values for each test are not explicitly detailed in the provided text; only that they were met.

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

This submission pertains to mechanical and biocompatibility testing of a physical implant device, not a data-driven AI/ML model for diagnostic or prognostic purposes. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI studies are not applicable here.

The tests were conducted according to ASTM standards for spinal implants (ASTM F1717, F2077, F2267, and F-04.25.02.02). The sample sizes (number of constructs or samples tested) for these specific mechanical tests are not explicitly mentioned in the provided text.

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

Not applicable. The "ground truth" for this device's performance is established through standardized laboratory mechanical testing based on engineering principles and material science, not through expert human interpretation of medical images or other data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to expert discrepancies in establishing ground truth for diagnostic AI, which is not relevant to this device's 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 is a physical spinal implant, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This question relates to AI algorithm performance for diagnostic/prognostic tasks, which is not relevant to this device.

7. The Type of Ground Truth Used

The "ground truth" for the PIVOX™ Oblique Lateral Spinal System is established through pre-defined engineering specifications and performance standards for medical implants, primarily determined by:

• Mechanical Testing Standards: Adherence to ASTM standards (F1717, F2077, F2267, F-04.25.02.02) which define how mechanical properties (e.g., strength, durability, resistance to subsidence/expulsion) are measured and what qualifies as acceptable performance for a device of this type.
• Biocompatibility Standards: Compliance with ISO-10993 for biological evaluation, confirming the safety of materials (PEEK, titanium alloy, tantalum, stainless steel, silicone) for long-term implantation, relying on material specifications and a history of safe use.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning models. This submission describes an implantable medical device undergoing mechanical and biocompatibility testing. The "design verification testing" is analogous to a validation step rather than a training process.

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

Not applicable, as there is no "training set" in the context of this device's submission. The ground truth for evaluating the device's substantial equivalence is established by universally recognized engineering and material science standards and guidance documents for spinal implants.

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The Pivotec LIFD implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Pivotec LIFD is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made of PEEK-Optima with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant within the intra-vertebral disc space.

The provided text describes a 510(k) summary for the Pivotec Lumbar Interbody Fusion Device (LIFD). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing, rather than a clinical study evaluating diagnostic or prognostic performance in the way an AI/ML medical device might undergo.

Therefore, many of the requested sections related to AI/ML device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission. The study described is a mechanical performance study.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on its mechanical performance, demonstrating functionality and safety comparable to legally marketed predicate devices. The "reported device performance" refers to the results of these mechanical tests.

Key Finding on Performance: "The device performed as designed and met, or exceeded, all product specifications."

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for mechanical testing, but typically involves a number of device samples (e.g., n=5 or n=10 per test condition) to perform the specified ASTM tests. The focus here is on device physical properties, not patient data.
   • Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering laboratory testing of the manufactured devices.

2. 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. Mechanical testing does not involve human experts establishing ground truth in the context of diagnostic or prognostic accuracy. The "ground truth" is defined by the objective physical properties and performance benchmarks established by the ASTM standards.

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

   • Not Applicable. Adjudication methods are used to resolve disagreements among human reviewers on clinical data. Mechanical testing involves objective measurements of physical properties.

4. 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 a mechanical device, not an AI/ML diagnostic or prognostic tool.

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

   • Not Applicable. This is a mechanical device.

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

   • Mechanical Standards: The "ground truth" (or benchmark for performance) is established by the relevant ASTM (American Society for Testing and Materials) standards:
     • ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices)
     • ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression)
   • The device's performance is compared against the requirements and typical performance characteristics of predicate devices that have successfully met these standards.

7. The sample size for the training set:

   • Not Applicable. This device uses mechanical testing, not a machine learning algorithm that requires a training set.

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

   • Not Applicable. (See point 7).

Conclusion of the Study:
"The documentation provided demonstrates that the Pivotec LIFD is substantially equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, function and mechanical function."

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