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The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.

I am sorry, but the provided text is a 510(k) summary for a medical device called the "Orbit Subretinal Delivery System." This document focuses on demonstrating substantial equivalence to a predicate device and outlines various performance tests conducted.

However, it does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set for an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

The document describes performance data related to biocompatibility, sterilization, packaging, shelf life, and simulated use for a physical medical delivery system, not an AI/ML algorithm.

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The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit. All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components: Subretinal Injection Cannula, Ophthalmic Marker, Syringes, and Tubing Set. The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use. Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Simulated use evaluation: Eight (8) procedures were conducted in a porcine model.
  • Specific sample sizes for other tests (e.g., biocompatibility, sterilization, packaging) are not detailed in the provided document. The document states "Testing demonstrated product performance met all prior established acceptance criteria," implying that adequate samples were used for these regulatory tests, but the numbers themselves are not specified.
• Data Provenance: The simulated use test was performed in a porcine model, indicating animal testing. The document does not specify the country of origin for the data, nor does it explicitly state whether it was retrospective or prospective. Given the nature of medical device validation testing, it would generally be prospective.

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

• The document describes laboratory and animal model testing, not human clinical studies involving expert observers to establish ground truth in the way one might for diagnostic AI.
• For the simulated use evaluation, the procedures were performed in a porcine model. It is implied that qualified personnel (e.g., surgeons, researchers) carried out these procedures and observed the results (formation of subretinal blebs), but the number and specific qualifications of these individuals are not stated.

4. Adjudication Method for the Test Set

• The document describes engineering and simulated use testing, not a scenario where human observers would require an adjudication method for ground truth. Observations from the simulated use evaluation (formation of subretinal blebs) are presumably directly observable outcomes rather than requiring expert consensus. Therefore, an adjudication method in the context of expert consensus is not applicable/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 comparative effectiveness study was not done. The Orbit Subretinal Delivery System is a physical medical device (a microinjection system), not an AI algorithm or a diagnostic tool that assists human readers.

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

• Not applicable. This device is a manual ophthalmic surgical instrument designed for human operators; it is not an algorithm, and therefore, standalone algorithmic performance is not relevant.

7. The Type of Ground Truth Used

• For the simulated use evaluation, the "ground truth" was the direct observation of the physical outcome: the successful formation of a subretinal bleb after injection into a porcine model.
• For other tests like biocompatibility, sterilization, and performance testing, the ground truth refers to established scientific and regulatory standards (e.g., ISO standards, FDA guidance, pre-established test criteria) that define acceptable performance.

8. The Sample Size for the Training Set

• Not applicable. The Orbit Subretinal Delivery System is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As stated above, this is not an AI model requiring a training set.

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The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Orbitum Bone Staple Implants, X and VI, have either radial or hourglass shaped superior profiles in three distinct sizes to coincide with the surgical approach. The legs of the device are configured to create compression upon implantation.

Orbitum Bone Staple Implants , are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Orbitum Bone Staple Implant, X and VI." This document describes the device, its intended use, and how it demonstrates substantial equivalence to predicate devices, primarily through non-clinical testing. It does not describe or reference a study involving acceptance criteria related to device performance in a clinical or diagnostic setting, nor does it involve AI or human readers.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance (in a clinical/diagnostic context).
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The information provided in the document focuses on non-clinical engineering and mechanical testing to establish substantial equivalence for regulatory approval.

Here's what the document does state concerning testing:

Non-clinical Testing:

• Study described: Testing according to ASTM F564 was performed on the ORBITUM Bone Staple.
• Tests performed: These included static compression bending, dynamic compression bending, and axial pull-out testing.
• Purpose: To establish equivalency to the predicate device in mechanical function and properties.
• Conclusion drawn: The Orbitum Bone Staple Implants are equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.

This kind of testing is typically done in a lab setting to ensure the device meets engineering specifications and performs mechanically as intended, rather than assessing diagnostic accuracy or clinical outcomes with human subjects.

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The Orbit Inserter is indicated to aid the user with the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.

The Orbit Inserter is intended to be used to assist patients and their caregivers by providing a mechanism to automate the insertion of compatible Ypsomed Infusion Sets primarily in a home setting.

The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Orbit infusion sets. It assists the user with insertion of the infusion set cannula into the subcutaneous tissue. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The Orbit Inserter is made of plastic and is powered by a stainless-steel spring.

This document is a 510(k) Summary for the Orbit Inserter, a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, nor does it present data from diagnostic imaging studies or multi-reader multi-case studies typically associated with AI performance evaluations.

Therefore, many of the requested points in your prompt are not applicable to the content of this document. I will answer the applicable questions and explain why others do not apply based only on the provided text.

Here's a breakdown of the acceptance criteria and study information for the Orbit Inserter 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

The document mentions "after 550 activations" for Life-cycle Testing, which implies a sample size of at least one device tested for 550 activations. It doesn't explicitly state the number of devices or the data provenance (country of origin, retrospective/prospective). However, the company, Ypsomed AG, is based in Switzerland.

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

This is not applicable. The device is a mechanical inserter, not an AI or diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the device's physical performance according to engineering and usability specifications.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device performance test, there's no need for adjudication by multiple experts in the sense of agreeing on a diagnosis or marking a lesion. The results are objective measurements and observations against pre-defined specifications.

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. This document describes a mechanical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance is relevant to its performance evaluation.

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

This is not applicable. The device is a mechanical inserter; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and ISO standards for mechanical, visual, functional, and biological properties, as well as summative user validation for usability. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical device. This concept applies to machine learning models.

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

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

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Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

All Orbit micro Infusion Sets are used for the subcutaneous delivery of fluids and medication from an external infusion pump. All Orbit micro Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. All Orbit micro Infusion sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base. The subject devices use a stainless steel indwelling cannula instead of the Teflon cannula in the predicate devices.

This document describes the 510(k) submission for the Orbit®micro Infusion Set. This is a medical device and not an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices, such as those related to accuracy, sensitivity, specificity, MRMC studies, or ground truth establishment based on expert consensus/pathology, are not applicable here.

The provided text details the performance testing conducted to demonstrate the substantial equivalence of the Orbit®micro Infusion Set to a predicate device (K130468). The acceptance criteria are essentially the specifications that the device must meet, and the "results" column indicates whether these criteria were passed.

Here's the information as requested, adapted to the context of a medical device rather than an AI system:

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

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

The document does not specify the exact sample sizes used for each performance test. The tests are physical/mechanical property tests of the device components and entire system, not tests on biological or imaging data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for an AI/ML context. The tests were conducted by Ypsomed AG, a Swiss company.

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

Not applicable. Ground truth for these types of device performance tests is established by adherence to international standards (e.g., ISO) and engineering specifications, often measured by calibrated equipment, rather than requiring expert human interpretation.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation.

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, not an AI system. 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, not an algorithm. The performance tests ("standalone") refer to the device's inherent mechanical and material properties.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established engineering principles, international standards (like ISO 9626, ISO 10555-1, ISO 8536-8, ISO 10993-1), and the predefined specifications set by the manufacturer to ensure the device performs as intended and is safe. This isn't "expert consensus," "pathology," or "outcomes data" in the context of diagnostic accuracy, but rather compliance with physical and biological requirements through standardized testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that requires a training set.

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

Not applicable. No training set for an algorithm was used.

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Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Orbit Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. These sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base.

The Orbit Infusion Set is intended for the subcutaneous delivery of fluids and medication from an external infusion pump. The device aims to demonstrate substantial equivalence to the predicate device, Talon Infusion Set (K033290), by meeting performance and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study concluded that "The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product."

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

The document does not explicitly state the sample size used for each specific test. The data provenance is described as "relevant assessments specified in the following international and internal standards and protocols." This suggests that the tests were conducted in a controlled laboratory environment according to established engineering and medical device standards. There is no mention of country of origin of the data, or if it was retrospective or prospective human subject data, as these are technical performance tests on the device itself.

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

Not applicable. The ground truth for these performance tests is based on the specified engineering and medical device standards, which are objective measurements. Expert consensus or clinical interpretation of data is not required to establish ground truth for these types of device performance criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical outcomes where ambiguity might exist. For objective performance tests with clear pass/fail criteria based on standards, an adjudication method is not relevant.

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 submission is for a medical device (infusion set) and not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The ground truth for the performance tests is based on objective measurements defined by international and internal engineering/medical device standards. For example, "Material strength per ISO 9626," "No leak when subjected to pumping pressures up to 20psi," and "No separation...when subjected to a minimum force of 10N (ISO 10555-1, Annex B)."

8. The sample size for the training set

Not applicable. This is a physical medical device being evaluated against engineering and safety standards, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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• Device Functionality: Spirometry .
• Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
• Patient Population: Male/Female, Pediatric to Adult .
• Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)

The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.

The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.

The Orbit spirometer includes the following components:

• . Spirometer
• Spirometer Pressure Tube .
• Disposable pneumotachometer (mouthpiece)
• Office Medic Software .
• Host PC (User Provided) .

Here's an analysis of the provided text regarding the QRS Diagnostic Orbit Spirometer, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that the QRS Diagnostic Orbit Spirometer's performance is demonstrated by its compliance with established standards. The table below summarizes these standards and the reported compliance.

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

The document explicitly states: "The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards." However, it does not provide details on the sample size used for performance testing (if human subjects were involved), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The testing primarily focused on compliance with technical standards for spirometers rather than direct clinical performance data from a patient cohort.

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

Since the "study" primarily revolved around testing compliance with technical standards (ATS/ERS, IEC/EN), rather than a clinical trial with patient data and diagnosed outcomes, there's no mention of experts establishing ground truth for a test set in the traditional sense of clinical diagnosis. Compliance with standards would typically be assessed by engineers or technicians with expertise in medical device testing and regulatory standards.

4. Adjudication Method for the Test Set

As there's no mention of a clinical test set requiring diagnostic interpretation, there's no information provided on an adjudication method (like 2+1 or 3+1). The "adjudication" in this context would be the determination of whether the device's measurements meet the specifications outlined in the technical standards.

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

No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (SpiroCard) based on technical specifications and compliance with standards, not on comparing reader performance with and without AI assistance. The device itself is a spirometer, which measures physiological parameters, and not an AI-driven diagnostic imaging interpretation tool that would typically involve a MRMC study.

6. Standalone Performance Study

The "Summary of Performance Testing" refers to testing of the device itself to verify compliance with the listed standards. This implies a standalone performance evaluation (algorithm only performance, in the sense of the device's measurement and calculation capabilities) was conducted against the criteria set by these standards. The device's primary function is to acquire and analyze pulmonary function data, and its performance is judged on the accuracy and reliability of these measurements as per the standards.

7. Type of Ground Truth Used

The ground truth used for this device involves the specifications and requirements outlined in the American Thoracic Society (ATS/ERS) 2005 Standard for spirometry. This standard sets forth the acceptable ranges and accuracy for various spirometric parameters (e.g., volume, flow, timing). The device's measurements were compared against these established technical and physiological benchmarks, which serve as the "ground truth" for its accuracy and functionality.

8. Sample Size for the Training Set

This document describes a medical device (spirometer) that measures physiological parameters. It does not suggest the use of machine learning or AI models that require a "training set" of data in the typical sense. Therefore, there is no information provided about a training set size. The device's functionality is based on established physics and engineering principles, and its "training" would be its design, calibration, and manufacturing processes to meet the defined standards.

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

Given that there is no indication of a training set for machine learning, this question is not applicable to the information provided. The "ground truth" for the device's operation is inherently built into the design and calibration to comply with the ATS/ERS standards, which are developed by expert consensus in respiratory medicine.

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The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature.

The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.

The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.

The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.

The provided text describes a Special 510(k) submission for the ORBIT GALAXY® G2 Microcoil System. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to existing predicate devices based on non-clinical testing. Therefore, the study described here is primarily a non-clinical bench testing study.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for a specific performance metric. Instead, it describes a comparative approach where the modified device (ORBIT GALAXY® G2 Microcoil System) is tested against the predicate devices (CASHMERE® SR Microcoil System and ORBIT GALAXY® Detachable Coil System) and is deemed to perform "equivalently" or "as designed." The acceptance criteria, therefore, are implied to be meeting the performance of the predicate devices for each test conducted.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of coils or tests) used for each bench test conducted. It states "bench testing data" and "results of verification and validation testing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Codman & Shurtleff, Inc. No information regarding country of origin of the data beyond the manufacturer's location in Raynham, MA (USA) is provided. It's an internal test, not a retrospective or prospective study in the typical human trials sense.

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

This section is not applicable as the study is a non-clinical bench testing study of a medical device, not a study involving human data, medical imaging, or expert interpretation for ground truth. Ground truth for device performance is typically established by engineering specifications, validated test methods, and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where opinions of multiple human reviewers or experts need to be reconciled.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often in radiology or pathology, with and without AI assistance to measure reader improvement. The described study is non-clinical bench testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No. This section is not applicable either in the sense of an "algorithm" or "AI." The device is a physical embolization microcoil system, not an AI or software algorithm that would have standalone performance. The testing performed is for the physical device's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical bench testing is engineering specifications, validated test methods, and the established performance characteristics of the predicate devices. The new device's performance in mechanical tests (delivery force, shape retention, tensile strength, durability, detachability) and material characteristics (biocompatibility, sterilization) is measured against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This section is not applicable for the same reason as above.

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The ORI II is intended for augmentation or restoration in the craniofacial region.

The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.

The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The Orbital Reconstructive Implant II (ORI II) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through
non-clinical performance testing and biocompatibility evaluation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified. The study involved bench testing of the Orbital Reconstructive Implant II (ORI II). This refers to a series of laboratory tests conducted on the device itself, rather than testing on biological samples or human patients.
• Data Provenance: The data is from non-clinical performance testing (bench testing) and biocompatibility evaluation. There is no information regarding the country of origin of the data as it's not clinically collected patient data. It is inherently prospective in the sense that the device was manufactured and then tested according to established protocols.

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

• This information is not applicable as the study is based on laboratory bench testing and biocompatibility assessment, not interpretation of clinical data or images by experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for mechanical properties is typically derived directly from the physical measurements themselves. Biocompatibility ground truth is established by standardized toxicity tests.

4. Adjudication Method for the Test Set:

• This information is not applicable as the study does not involve human readers interpreting data or making subjective judgments that would require adjudication. The testing methods are objective measurements of physical and chemical properties.

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 information is not applicable as the device is an implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed.

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

• This information is not applicable as the device is an implant, not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" in this context is based on objective measurements of physical properties (e.g., tensile strength, elongation, modulus) obtained through standardized engineering test methods (e.g., ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787).
• For biocompatibility, the ground truth is established by adherence to the ISO-10993 standard, specifically the long-term implant section, which involves standardized biological assessments to determine the device's compatibility with living tissues.

8. The sample size for the training set:

• This information is not applicable as the device is an implant and does not involve machine learning or an algorithm that requires a training set.

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

• This information is not applicable for the same reason as above; there is no training set for this type of device submission.

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The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The provided text describes a 510(k) submission for the Orbital Reconstructive Implant (ORI), which is a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document states:

• "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices."
• "The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."

This indicates that the submission relies on demonstrating similarity to already approved devices (predicates) in terms of materials, intended use, and general characteristics, along with biocompatibility and biomechanical performance data, rather than a clinical study establishing specific quantitative or qualitative performance metrics against predefined acceptance criteria for a new clinical application or diagnostic capability.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence, not on meeting specific quantitative or qualitative performance acceptance criteria from a clinical trial.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical "test set" study is described in this document. The evaluations mentioned are likely pre-clinical (biocompatibility, biomechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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. This is a medical implant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an implant, not an algorithm.
7. The type of ground truth used: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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