Search Results

The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

The provided document, an FDA 510(k) Clearance Letter for the Testa TP Pivoting Spacer System, does not contain information regarding an AI/ML-based device. Instead, it describes a traditional medical device: an intervertebral body fusion device.

Therefore, many of the requests in your prompt, which are specific to the regulatory approval process for AI/ML medical devices (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and AI ground truth establishment), cannot be answered from this document.

The document states: "Nonclinical testing was performed on the Testa™ TP Pivoting Spacer System to support substantial equivalence to the predicate device. The following testing was performed: Static and dynamic axial compression testing per ASTM F2077, Static and dynamic compression shear testing per ASTM F2077, Subsidence testing per ASTM F2267, Particulate and wear analysis per ASTM F1877. Clinical testing is not applicable." This indicates that the device was evaluated through bench testing and mechanical performance standards, not through AI/ML performance metrics or studies involving human readers or expert consensus on AI outputs.

Summary based on the provided document:

Since the device is a physical medical implant (intervertebral body fusion device) and not an AI/ML software, the requested information on AI-specific acceptance criteria and study methods is not applicable and is not present in the provided FDA 510(k) clearance letter. The document focuses on demonstrating physical and mechanical substantial equivalence to predicate devices through non-clinical bench testing.

Ask a specific question about this device

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.

Ask a specific question about this device

The ProLift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Pivot Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) and Cobalt Chrome (CO- 26Cr-6MO) as described by ASTM F136and ASTM F1537. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The ProLift® Pivot Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient.

• The ProLift implants are fabricated and manufactured from titanium alloy (Ti-6Al-. 4V ELI) as described by ASTM F136.
  . The ProLift Pivot-U implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537.
  The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
  All ProLift Pivot implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Pivot Expandable Spacer System components with components from any other system or manufacturer.

This document pertains to the clearance of a medical device, the ProLift Pivot Expandable Spacer System, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for AI models is not applicable to this submission.

The document discusses the substantial equivalence of the ProLift Pivot Expandable Spacer System to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal table of acceptance criteria with reported performance values in the context of an AI/ML study. Instead, it states that "Performance Data: Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 was presented to demonstrate the substantial equivalency of the Life Spine ProLift Expandable Spacer System (K190488)." This implies that the acceptance criteria are adherence to the mechanical testing standards outlined in ASTM F2077, and the device performance met these standards to demonstrate substantial equivalence to the predicate device (K190488).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a medical device clearance based on mechanical testing, not an AI/ML study involving a test dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of this device refers to the mechanical properties and performance standards defined by ASTM F2077 and assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the mechanical testing standards outlined in ASTM F2077. This standard defines the methodologies and expected performance for intervertebral body fusion devices under various loading conditions (static compression shear, static axial compression, dynamic compression shear, dynamic axial compression).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the document describes the clearance of a physical medical implant (ProLift Pivot Expandable Spacer System) based on its substantial equivalence to previously cleared devices, supported by mechanical performance data against recognized ASTM standards.

Ask a specific question about this device

Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.

• . Prostate - Biopsy and minimally invasive puncture
• . Surgical (Prostate) - Biopsy and minimally invasive puncture

The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.

The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.

The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)

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

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
• Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.

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

• Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.

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

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.

8. Sample Size for the Training Set

• Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

• Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Coated with Titanium Niobium Nitride
• Sizes 1-8, left and right

This document is a 510(k) Premarket Notification for the EVOLUTION® NitrX™ Medial-Pivot Knee. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing an independent study to prove the device meets acceptance criteria as would be done for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable in this context.

Here's why and what information is available:

• Device Type: The EVOLUTION® NitrX™ Medial-Pivot Knee is a physical orthopedic implant (knee prosthesis), not an AI/software medical device. The "acceptance criteria" for such a device are typically met through demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness information.
• Study Focus: The submission is a "Traditional 510(k)" which aims to show the new device is as safe and effective as an already cleared device. This is done through nonclinical testing (e.g., biocompatibility, mechanical testing) and comparison to predicate devices, rather than clinical efficacy studies against specific performance metrics for diagnostic or prognostic tasks.
• Clinical Testing: The document explicitly states: "Clinical data was not provided for the subject devices." This further confirms that a prospective clinical study with human readers and ground truth, as implicitly requested by your prompt's structure, was not conducted or submitted for this specific device clearance.

Available Information from the document, rephrased to fit the prompt's categories where possible but noting the lack of direct applicability:

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

   • Acceptance Criteria (Implicit for 510(k) clearance): Substantial equivalence to predicate device(s) regarding indications for use, technological characteristics, and safety and effectiveness.
   • Reported Device Performance:
     • Nonclinical Testing Performed on Subject Device: Biocompatibility evaluation/testing, Tibial baseplate component fatigue testing, Wear analysis (Mode 1 and aggressive Mode 3), Morphological analysis, Metal ion analysis.
     • Nonclinical Predicate Test Results Used to Support Subject Device: Range of motion analysis, Stability/Constraint, Contact area/stress, MR Assessments (Field Interactions, Torque, Displacement, RF Heating), Gravimetric Analysis, Bioburden Testing.
     • (Specific quantitative performance values for these tests are not provided in this summary document.)

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

   • Not applicable in the context of mechanical and material testing for an implant. The "samples" would be the manufactured device components subjected to various engineering tests. No test set of patient data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. Ground truth for an AI/software device involving human interpretation is not relevant for this orthopedic implant. The "ground truth" for mechanical testing would be established by industry standards, engineering principles, and validated test methods.

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

   • Not applicable. This is a concept used for human reader studies, not for mechanical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done (not applicable for this device type).

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the nonclinical testing, the "ground truth" implicitly relies on established engineering principles, material science standards, and accepted testing methodologies (e.g., ISO standards for wear testing, biocompatibility standards).

8. The sample size for the training set:

   • Not applicable. There is no AI model or training set for this physical implant.

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

   • Not applicable. There is no AI model or training set for this physical implant.

In summary, this document is a regulatory submission for a physical medical device (a knee implant) cleared via the 510(k) pathway, which fundamentally differs from the type of device (e.g., AI/ML-based software) that would involve the specific "acceptance criteria" and "study" details requested in your prompt regarding human reader performance or algorithm-specific metrics.

Ask a specific question about this device

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.

Ask a specific question about this device