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XTRA4 is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).

XTRA4 (ref. EXT4 001-01) is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8°C for up to 14 days. It is designed as a single use 20 mL solution in glass vials. XTRA4 is intended to be used only by physicians or highly skilled personnel such as eye bank operators. The preservation of donor cornea is traditionally performed by storing them at temperatures between 2°C and 8°C in a storage medium containing deswelling agent(s).

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For XTRA Collection sets:
"The XTRA Autotransufion System (including the XTRA Collection sets) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

• Cardiovascular
• Orthopedics
• Thoracic
• Transplant surgery
• Emergency (Trauma)
• Neurosurgery
• Obstetrics and Gynecology
• Urology"

For XTRA Sequestration set X:
"The XTRA Autotransufion System (including the XTRA Sequestration set X) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

• Cardiovascular
• Orthopedics
• Thoracic
• Transplant surgery
• Emergency (Trauma)
• Neurosurgery
• Obstetrics and Gynecology
• Urology"

XTRA Sequestration set X: The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion. The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586).

XTRA Collection sets: The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

This document describes a 510(k) premarket notification for the XTRA Collection sets and XTRA Sequestration set X, which are autotransfusion apparatus. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel AI/software-driven medical device. Therefore, a significant portion of the requested information regarding AI acceptance criteria and performance studies (e.g., MRMC studies, standalone AI performance, training/test set details, expert involvement in ground truth establishment) is not applicable to this filing as it does not describe an AI medical device.

The provided text indicates that the changes to the device are primarily related to material changes (removal of DEHP from PVC components) and a minor design change in an Aspiration and Anticoagulation line, along with a change in supplier for a drip chamber component. No clinical testing was conducted because the device's indications for use and technical characteristics are considered equivalent to the predicate devices with proven safety and efficacy.

However, I can extract information related to the non-clinical performance data and the basis for the substantial equivalence claim.

Here's the breakdown of the information that can be gleaned from the document, along with explanations for the parts that are not applicable:

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

Since this is not an AI/software device, there isn't a table of AI-specific acceptance criteria like accuracy, sensitivity, specificity, etc. The acceptance criteria are implicitly met by demonstrating substantial equivalence through non-clinical performance testing validated against applicable voluntary standards.

The document states:

• "The XTRA Sequestration set X and XTRA Collection sets comply with all the applicable voluntary standards related to Autotransfusion systems. The devices passed all the testing in accordance with national and international standards."

This implies that the acceptance criteria are adherence to these standards, which encompass various performance aspects such as material compatibility, sterility, pyrogenicity, and mechanical integrity of the components required for safe and effective autotransfusion.

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

This information is not applicable as this is not an AI/software device submission requiring a test set for performance evaluation in the context of machine learning. The "testing" referred to is non-clinical verification and validation (e.g., bench testing, material testing, mechanical testing). No patient data is involved in this type of submission for demonstrating substantial equivalence based on material and minor design changes.

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 not applicable. Ground truth establishment by experts is relevant for AI/software submissions that rely on human-labeled data for training and evaluation. For this device, "ground truth" would relate to the functional specifications and safety/performance standards for autotransfusion apparatus, which are established through engineering design, material science, and regulatory compliance, not expert image/data labeling.

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

This is not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling for AI ground truth or in reader studies. This type of review is not relevant for non-clinical device testing in a 510(k) for material changes.

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

This is not applicable. MRMC studies are used to evaluate the impact of AI assistance on human performance in diagnostic tasks. This device is an autotransfusion apparatus, not a diagnostic AI system, and therefore, no MRMC study was conducted.

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

This is not applicable. Standalone performance is evaluated for AI algorithms. This device does not contain an AI algorithm.

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

As explained previously, "ground truth" in the AI context is not applicable here. The "truth" or "basis" for device performance is demonstrated through:

• Compliance with applicable voluntary standards: This includes national and international standards for autotransfusion systems.
• Non-clinical verification and validation testing: This covers aspects like material properties, functional performance (e.g., blood collection, washing, concentrating), sterility, and pyrogenicity.
• Substantial equivalence to predicate devices: The predicate devices have a proven track record of safety and efficacy.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This is not applicable. As no training set exists, no ground truth needed to be established for it.

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The XTRA Autotransfusion System (including the XTRA bowl set) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

• Cardiovascular
• Orthopedics
• Thoracic
• Transplant Surgery
• Emergency (Trauma)
• Neurosurgery
• Obstetrics and gynecology
• Urology

The XTRA Autotransfusion System (with XTRA Bowl Sets) are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, intraoperative cell salvage, and/or postoperative cell salvage, aimed at autotransfusion.

The XTRA Autotransfusion System (with XTRA Bowl Sets) consist of a disposable bowl pre-connected with a system of tubing lines and bags, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment), then the blood is pumped with a roller pump (provided into the equipment) into the bowl separation chamber and centrifuged. Because of centrifugal force the blood components are separated and the RBC, PPP and PRP are collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product.

The XTRA Autotransfusion System (with XTRA Bowl Sets) are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586).

This document describes the XTRA Autotransfusion System, a medical device for blood processing in surgical settings. However, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria, particularly for an AI-enabled device.

The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive de novo clinical trials with specific acceptance criteria as might be seen for novel AI/ML devices.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Metrics: The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) for the device's performance. It primarily focuses on the technical characteristics and intended use being equivalent to a predicate device.
• No "Study" in the traditional sense for AI/ML: The document states, "No clinical testing was conducted in support of the XTRA Autotransfusion System (with XTRA Bowl Sets), as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use." This explicitly states that no clinical study was performed to demonstrate performance against acceptance criteria.
• Device Type: The device is an "Autotransfusion apparatus," which is a physical medical device (bowl sets, tubing, bags) for processing blood. It is not an AI/ML-enabled device. Therefore, questions about training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this type of device.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving an AI-enabled device meets those criteria. The document is a regulatory submission for a non-AI medical device demonstrating substantial equivalence.

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The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Xtrallux devices are non-invasive, low level laser therapy (LLT) devices containing red, visible light diode lasers operating at 650 nm wavelength. The maximum power output of each diode is 5 mW. The diodes are configured within a cap, enclosed between the outer shell and inner liner. They deliver non-thermal energy to hair follicles via photostimulation of the scalp and are intended to stimulate hair growth. Xtrallux has developed four models: Xtrallux Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro, Xtrallux Extreme RX.

This FDA 510(k) summary (K222364) for the Xtrallux devices does not include a clinical study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device.

The document indicates that the Xtrallux devices are Low-Level Laser Therapy (LLLT) devices intended to treat Androgenetic Alopecia (AGA) and promote hair growth. The FDA clearance is based on the devices being substantially equivalent to predicate devices (CapillusX & CapillusX+ and HairMax Laser).

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those specific acceptance criteria, as this type of study was not conducted or presented in this 510(k) summary.

Instead, the summary focuses on non-clinical testing to demonstrate safety and substantial equivalence to existing devices.

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

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

   • Not applicable / Not provided. The 510(k) relies on substantial equivalence to predicate devices, not on a standalone performance study against specific acceptance criteria for efficacy. The non-clinical tests performed were for safety (biocompatibility, electromagnetic compatibility, electrical safety, usability, and laser safety) to ensure the device is as safe as legally marketed predicate devices.

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. There was no clinical "test set" in the context of an AI/ML medical device performance study described. The non-clinical tests are on the device itself, not on data from patients.

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. There was no clinical "test set" requiring expert ground truth in this submission.

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

   • Not applicable. No clinical test set requiring adjudication was described.

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

   • No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in interpreting medical images or data. The Xtrallux devices are therapeutic LLLT devices, not diagnostic AI.

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

   • Not applicable. The Xtrallux devices are hardware-based therapeutic devices, not AI algorithms.

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

   • Not applicable. There was no clinical performance study requiring ground truth in this submission. The "ground truth" for the non-clinical tests would be the established safety standards and regulatory requirements.

8. The sample size for the training set

   • Not applicable. No AI model was trained for this device.

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

   • Not applicable. No AI model was trained for this device.

In summary, the provided document describes a 510(k) submission for Low-Level Laser Therapy devices based on substantial equivalence to predicate devices, primarily demonstrating safety through non-clinical testing rather than clinical efficacy studies with specific performance metrics and acceptance criteria.

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The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead. The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle. The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements). The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip. The Xtractor™ device is visible under fluoroscopy during the procedure.

The provided document does not contain information about the acceptance criteria and study that proves the device meets them as typically presented for AI/ML-driven medical devices.

The document is a 510(k) premarket notification for the Xtractor™ device, which is a mechanical device for lead extraction, not an AI/ML diagnostic or prognostic tool. Therefore, it does not include details such as:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used for diagnostic accuracy, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods for ground truth.
• Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (pathology, outcomes data, etc.) for diagnostic accuracy.
• Training set sample size or ground truth establishment for a machine learning model.

Instead, the performance data section focuses on standard medical device testing for a physical device, including:

• Biocompatibility: Tests like cytotoxicity, irritation, sensitization, systemic toxicity, complement activation, hemolysis, and pyrogenicity per ISO 10993-1.
• Sterilization, Packaging, and Shelf Life Testing: Validation per ISO 11135-1, transportation simulation, and environmental tests.
• Performance Testing (Mechanical/Physical):
  • Bending Test
  • Corrosion Resistance (ASTM A967/A967M)
  • Device Radiopacity
  • Dimensional Verification
  • Tensile Strength
  • Extended Use
  • Torque Test
  • Simulated Use (in an anatomical model simulator at T0 and Tx shelf life)
  • Hydrophilic Coating Testing (particles, visual, pinch test)
  • Xtractor™ vs. Predicate comparison test
• Software Validation: Conducted as per FDA guidance for contained software, with a moderate level of concern.
• Electrical Safety and EMC: Per IEC 60601-1 and IEC 60601-1-2.

The document states that "All tests passed and met the predefined acceptance criteria," but it does not explicitly list these criteria in a table alongside reported performance for each test. The predefined acceptance criteria would be specific thresholds or results required for each of the performance tests listed above (e.g., "no signs of defects, wear or deformations" for extended use, or specific values for tensile strength, etc.). An "Xtractor™ vs. Predicate comparison test" is mentioned, indicating a direct comparison was likely part of the performance evaluation.

In summary, the provided text details the type of non-clinical performance studies conducted for a mechanical medical device to demonstrate safety and effectiveness for 510(k) clearance, rather than the kind of AI/ML evaluation typically requested in the prompt.

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UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.

A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.

Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.

The provided text does not describe acceptance criteria or a study proving that a device meets such criteria.

Instead, the document is an FDA 510(k) clearance letter for the XTRAC Momentum Excimer Laser System, Model AL10000. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (XTRAC Velocity Excimer Laser System, Model AL10000), rather than proving performance against specific acceptance criteria through a clinical study.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• "No mechanical, animal or clinical testing was performed."
• "The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent."

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) from this document, as the clearance was not based on a clinical study designed to prove the device met specific performance acceptance criteria. The clearance was based on demonstrating the new device is as safe and effective as an already cleared device through comparison of technological characteristics and non-clinical performance testing (biocompatibility, electrical safety, EMC, software verification/validation).

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The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:
-Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
-Arthrodesis and osteotomies with associated soft tissue problems;
-Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
-Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. Specifically, the system is intended for:

• Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Arthrodesis and osteotomies with associated soft tissue problems;
• Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
• Stabilization of non-unions; and
• Intraoperative temporary stabilization tool to assist with indirect reduction.

The purpose of this traditional 510(k) is to seek clearance to market the line additions to the XtraFix Large and Small Systems. This traditional 510(k) also covers the proposed change to add a MRI conditional symbol on the existing carbon fiber bars in the XtraFix Large System so that the XtraFix Large System constructs with carbon fiber bars can be used in the MR environment (entirely outside the bore of the MRI scanner).

A Bar to Pin, 2D, independent locking clamp and a half pin are being added to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D, independent locking clamp and carbon fiber bars are being added to the XtraFix Small System. The XtraFix Large and Small Systems include the following elements: clamps, bars and half pins. The XtraFix Large and Small Systems are designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.

This document is a 510(k) summary for the Zimmer XtraFix External Fixation System and XtraFix Small External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices and establishing MRI conditional status for specific components, rather than providing a study on the effectiveness of a diagnostic or AI-based device. Therefore, a direct answer to the acceptance criteria and study proving device meets acceptance criteria in the requested format for AI/diagnostic devices is not applicable.

However, I can extract information related to the performance testing and acceptance criteria as provided for this external fixation system in the context of its regulatory clearance.

Acceptance Criteria for the XtraFix External Fixation System (Non-Clinical Performance)

The relevant "acceptance criteria" and "device performance" in this context are derived from non-clinical performance data, primarily demonstrating mechanical and MRI-compatibility characteristics.

Information Relevant to Study Details (within the context of this 510(k) submission):

This document describes a 510(k) submission for line additions and MRI conditional claims for an existing medical device, not a diagnostic or AI study. Therefore, many of the requested details for AI/diagnostic studies are not applicable.

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

   • Mechanical Testing: Not specified as a "sample size" in terms of patient data. It refers to "line additions" (new device components) that underwent testing. The context implies mechanical testing was performed on representative units of these new components.
   • MRI Testing: The tests were conducted on "worst-case constructs" of the XtraFix Large System and XtraFix Small System with carbon fiber bars. The sample size for these physical tests would likely be a small number of physical prototypes or manufactured units rather than patient data.
   • Data Provenance: The tests are non-clinical, performed in a laboratory setting (implied). No country of origin for patient data is relevant.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and MRI conditional testing is established by engineering standards and physical measurements, not expert consensus on medical images or pathology.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human interpretation or adjudication.

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 medical device for fracture fixation, not an AI or diagnostic imaging device.

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

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

   • Mechanical Testing: Ground truth is based on engineering specifications, physical properties, and comparative performance against predicate devices as defined by standards like ASTM F1541-02 (2011) e1.
   • MRI Testing: Ground truth is based on physical measurements of magnetic force, torque, temperature change, and image artifact size as per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."

7. The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.

8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device submission.

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The XTRA Autotransfusion System is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, and Urology.

XTRA is an Autotransfusion System designed to recover shed blood during intraoperative and postoperative procedures and for collection of platelet poor plasma (PPP) and platelet rich plasma (PRP) in preoperative procedures.

It is a software-controlled device provided with disposable and hardware elements that include the following major components: master, driving actuators (pump, centrifuge, clamps, pump loop ejector, cover lock), control and monitoring sensors, and an user interface (display panel and keyboard).

The modified device is a software upgraded version (SW 1.05.0) of the unmodified device (SW 1.02.0).

The current SW release 1.05.0 has been implemented to improve device's performances and to respond to feedback/indications coming from the users in the field. Other minor changes have been also implemented for user convenience and some bugs have been fixed. The main performances improvement implemented with the new SW upgrade consists of the introduction of a new factory protocol (Pfat) that has been optimized to eliminate non emulsified fat from the processed blood. The labeling and the instructions for use have been generally updated to include Pfat features as well as to reflect the modifications, where applicable.

Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the in vitro test set. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."

The data provenance is internal to the manufacturer (Sorin Group Deutschland GmbH) as the tests were performed "in vitro" and according to their "internal methods." The country of origin of the data is implicitly Germany, where the submitter is located. The tests were prospective in vitro experiments.

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

Not applicable. This device is an autotransfusion system, and the reported tests are in vitro performance evaluations of its processing capabilities (fat removal and washing performance), not diagnostic interpretations requiring expert human review. The "ground truth" for these tests would be objective measurements of the device's output (e.g., amount of fat removed, effectiveness of washing).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are in vitro performance evaluations, not diagnostic image interpretations that would require adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study performed was an in vitro performance test of the device itself, comparing its performance to an unmodified version of the device, rather than assessing human reader performance with or without AI assistance.

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

Yes, the studies described are standalone in vitro performance tests of the device (which includes software) without human intervention in the performance evaluation itself. The device is a software-controlled system, and its "algorithm" (the software upgrade to version 1.05.0) was tested for its impact on fat removal and washing performance.

7. The Type of Ground Truth Used

The ground truth used for these in vitro performance tests would be objective measurements and laboratory results related to the device's functional outputs, specifically:

• For "fat removal performance": objective measurements of the presence or absence of non-emulsified fat in processed blood.
• For "washing performance": objective measurements of the effectiveness of the washing process (e.g., removal of plasma, waste products).

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance testing. The device is a "software upgraded version" of an existing system, and the reported tests are in vitro performance validations of this upgrade. There's no indication that machine learning or AI models requiring a training set were developed or validated in this submission. The software upgrade focused on "improving device's performances and to respond to feedback/indications coming from the users in the field."

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

Not applicable, as no training set for a machine learning model is mentioned in the provided text.

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The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. Specifically, the system is intended for:

• Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Arthrodesis and osteotomies with associated soft tissue problems;
• Stabilization of limbs after removal of total joint arthroplasty for infection or other failure:
• Stabilization of non-unions; and
• Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix Small External Fixation System subject of this 510(k) submission includes the following elements: Clamps (Bar/Pin to Bar/Pin, Integrated Multi-Pin); Bars; and Half Pins. The XtraFix Small External Fixation System is designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.

The provided document describes a 510(k) premarket notification for the Zimmer XtraFix® Small External Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and ground truth establishment are not applicable.

The document discusses the substantial equivalence of the XtraFix® Small External Fixation System to previously cleared predicate devices based on technological characteristics and performance data.

Here's the relevant information based on the provided text, adapted for a medical device rather than an AI system:

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

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

The document does not specify a "test set" in the context of an AI/ML system. Instead, it refers to non-clinical performance data obtained through characterization and evaluation.

• Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for MRI compatibility or mechanical strength). The evaluation was conducted on the "XtraFix Small External Fixation System," implying various components and configurations were subject to testing.
• Data Provenance: The tests were conducted according to established standards (ASTM F1541-02(2007)) and FDA guidance documents. This indicates laboratory testing and analysis, not data collected from human subjects (prospective or retrospective).

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

Not applicable. This is not an AI/ML device, and ground truth, in this context, is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device. Performance is determined by meeting physical and material standards measured by equipment, not by human adjudication of results.

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

Not applicable. This is not an AI/ML device. The study focused on the physical performance and safety characteristics of the device itself, not on human reader interpretation.

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

This refers to the performance of the device itself in a standalone capacity, as its function is mechanical/structural, not diagnostic or AI-driven. The "performance data (nonclinical)" presented (interconnection strength, system rigidity, MRI compatibility) reflects the intrinsic properties and behavior of the device without human interaction once installed or during the MR environment.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Engineering Standards and Specifications: Adherence to requirements outlined in ASTM F1541-02(2007) for external fixation devices.
• FDA Guidance Documents: Specific guidelines for orthopedic external fixation devices and establishing safety/compatibility of passive implants in MRI environments.
• Measured Physical Properties: Quantified measurements for force, torque, heating, and image artifact extension in MRI, compared against predefined safety thresholds.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that sense.

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

Not applicable. As there is no training set for an AI/ML system, this question is not relevant.

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The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Arthrodesis and osteotomies with associated soft tissue problems; o
• Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
• Stabilization of non-unions; and 0
• Intraoperative temporary stabilization tool to assist with indirect reduction. 0

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.

The provided document describes the 510(k) summary for the XtraFix External Fixation System Line Additions, focusing on its substantial equivalence to predicate devices rather than a de novo study with acceptance criteria and performance data. Therefore, many of the requested sections regarding user studies, ground truth, and sample sizes for AI/algorithm performance cannot be extracted directly from this document.

However, based on the information provided, here's what can be stated:

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

Since this is a 510(k) submission for line additions to an existing device, the acceptance criteria are primarily defined by "substantial equivalence" to predicate devices and adherence to relevant industry standards. The performance is demonstrated through mechanical testing.

Regarding the remaining questions, the provided 510(k) summary does not contain information about:

• 2. Sample size used for the test set and the data provenance: This document describes mechanical and MR compatibility testing, not clinical or AI/algorithm performance studies with test sets of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical images/data requiring human interpretation for ground truth were part of this 510(k) submission's evidence.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical or MR compatibility 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 medical device (external fixation system), not an AI algorithm for diagnostic assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical and MR testing, "ground truth" would be established by the physical properties measured against the standard specifications. This is not comparable to clinical ground truth.
• 8. The sample size for the training set: Not applicable. No AI/algorithm training set was used.
• 9. How the ground truth for the training set was established: Not applicable. No AI/algorithm training set was used.

Summary of what the document implies for the study:

The study referenced is not a clinical efficacy study involving patient data, but rather benchtop mechanical testing and MR compatibility testing. The primary method for demonstrating "device meets acceptance criteria" is via adherence to established ASTM standards and FDA guidance documents for external fixation devices and MR safety, coupled with successfully proving substantial equivalence to existing predicate devices.

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