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JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System may also be used in conjunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.

The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.

The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Implanet S.A.'s JAZZ System, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the JAZZ System as a bone fixation cerclage used in spinal surgery. The performance data focuses on mechanical and biocompatibility testing. The acceptance criteria generally state that the product met "necessary specifications" and "functioned as intended." Specific quantitative acceptance criteria are not detailed in the document, nor are specific quantitative performance results for each test.

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

The document does not specify the sample sizes used for the individual bench tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether the tests were retrospective or prospective, although bench testing would inherently be prospective in nature.

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

This information is not applicable to the provided document. The "ground truth" in this context refers to the results of engineering and biocompatibility tests, not clinical evaluations by human experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or assessment, not for direct engineering bench testing.

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

No MRMC comparative effectiveness study was mentioned. The document focuses on the mechanical and biocompatibility performance of the device itself, rather than its impact on human reader performance.

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

This concept is not applicable to an orthopedic implant like the JAZZ System. The device is a physical implant, not an algorithm. Therefore, "standalone performance" refers to its mechanical and biological characteristics, which were assessed through the described bench testing.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on engineering specifications and established test methodologies for mechanical performance (e.g., tensile strength, compression resistance, viscoelastic characteristics, dynamic loading) and recognized industry standards (ISO-10993) for biocompatibility.

8. Sample Size for the Training Set

This information is not applicable. The JAZZ System is a physical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set mentioned for this medical device.

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The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

The Calypso System is a posterior instrumentation system consisting of monoaxial and polyaxial pedicle screws, union rods, transverse connectors, and hooks. The implants in the system are composed of Ti6Al4V titanium alloy described by ISO 5832-3.

The Implanet S.A.'s Calypso System is a spinal fixation device. The provided text details the performance data for the device, focusing on its mechanical strength and biological compatibility to demonstrate substantial equivalence to predicate devices. It does not describe an AI medical device. Therefore, several of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as they pertain to AI/ML device studies.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size" in terms of number of devices tested for each mechanical test. It mentions "bench testing," implying a set of physical samples were tested.

• Data Provenance: The tests are bench tests performed by Implanet S.A. No country of origin for data or retrospective/prospective status is relevant for these types of mechanical and biological tests.

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

Not applicable. Ground truth for mechanical and biological testing is established by adherence to recognized international standards (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus interpreting complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies) to resolve disagreements. Here, objective measurements against pre-defined standards are used.

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

No. This is a spinal fixation device, not an AI medical device, so an MRMC study is not relevant to its regulatory submission.

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

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is defined by established industry standards and specifications (e.g., ASTM F1798, ASTM F1717, ISO 10993, ISO 11137, ISO 17665). The measurements taken during bench testing are compared directly against these quantitative and qualitative criteria.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set.

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The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion. Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire lesion is coagulated, waiting at least five seconds between exposures. The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.

The provided text describes a 510(k) premarket notification for the CooperSurgical Infrared Coagulator. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, a specific study design to prove acceptance criteria, or most of the requested information about sample sizes, ground truth establishment, or expert involvement for the current device.

However, the document does state that the safety and effectiveness are based on:

1. Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal.
2. The long history of use of lasers for the treatment of genital condylomas and general warts.
3. Two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.

Without the actual study reports for these "two recent clinical studies," it's impossible to extract the specific acceptance criteria and detailed study information as requested. The available document only provides a high-level summary of the basis for substantial equivalence.

Therefore, most of the requested information cannot be filled from the provided text.

Here's an attempt to answer what can be inferred from the document, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance

• The document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage of lesion clearance, a recurrence rate threshold, or a specific safety metric) for the CooperSurgical Infrared Coagulator or its performance in the context of acceptance criteria.
• It states that "two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts" were performed.
• Inference: The "acceptance criteria" for the CooperSurgical IRC was likely demonstrating equivalence (non-inferiority) to the established safety and efficacy profiles of the predicate devices for the new indicated uses (genital condylomas and general warts), rather than meeting predefined numerical thresholds reported in this summary. The performance would then be interpreted as "equivalent to predicate devices."

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

• The document mentions "two recent clinical studies," but does not provide any details on the sample size used for the test set (patients/cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.

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

• The document does not specify the number or qualifications of experts used to establish ground truth in the clinical studies. Given the context (treatment of condylomas and warts), it is highly probable that clinicians (e.g., dermatologists, gynecologists, urologists) would have been involved in diagnosing and assessing treatment outcomes, but no details are provided.

4. Adjudication method for the test set

• The document does not describe any adjudication method used in the clinical studies.

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 device is an infrared coagulator, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

• This device is a hardware medical device for tissue coagulation, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

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

• For the "two recent clinical studies," the ground truth for efficacy would likely be based on clinical assessment of lesion clearance/resolution and possibly recurrence rates as determined by treating physicians (outcomes data). For safety, it would involve monitoring adverse events. The document does not explicitly state the type of ground truth beyond "demonstrating that the IRC is equivalent."

8. The sample size for the training set

• As this is a hardware device cleared based on substantial equivalence and clinical studies, rather than an AI/ML algorithm requiring a training set, the concept of a "training set" in the AI sense is not applicable here. The design and parameters of the device were developed through engineering and pre-clinical testing, not a "training set" of data.

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

• Again, as this is not an AI/ML device, the concept of establishing ground truth for a training set is not applicable. Device design is typically based on engineering principles, material science, and pre-clinical/bench testing, as well as prior knowledge from predicate devices.

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The Bionx Bankart Tack is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.

The Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone.

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study designs, or detailed performance results that would allow for the complete filling of the requested table and study information. The document is a 510(k) summary for a medical device which focuses on demonstrating substantial equivalence to predicate devices, rather than providing an in-depth clinical trial report.

However, based on the available information, I can infer some aspects and highlight what is missing.

Analysis of the Provided Text:

The document states: "Additionally, performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use." and "Both the PLLA and polyglyconate materials are biocompatible and possess sufficient strength for this intended use, as demonstrated in clinical studies and performance testing." and "The minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness, as confirmed by performance testing and clinical studies."

These statements indicate that some form of performance testing and clinical studies were conducted and confirmed adequate fixation, biocompatibility, and sufficient strength. However, the document does not detail these studies' methodologies, sample sizes, specific acceptance criteria, or precise performance outcomes. It primarily asserts that these studies support the substantial equivalence claim.

Inferences and Missing Information Summary:

1. Acceptance Criteria and Reported Device Performance: The document generally states "adequate fixation," "sufficient strength," and "biocompatible" as performance goals, implying these were the de facto acceptance criteria. However, no specific numerical thresholds or metrics are provided.
2. Sample Size and Data Provenance (Test Set): Not mentioned.
3. Number and Qualifications of Experts (Ground Truth): Not mentioned.
4. Adjudication Method: Not mentioned.
5. MRMC Comparative Effectiveness Study: Not mentioned as a component for this 510(k) submission. 510(k)s typically focus on equivalence to existing devices rather than comparative effectiveness studies against unassisted human performance, especially for a physical implant.
6. Stand-alone Performance Study: The "performance testing and clinical studies" mentioned would likely involve standalone performance evaluation of the device's mechanical integrity, fixation strength, and biocompatibility, but details are not provided.
7. Type of Ground Truth: For a physical implant, "ground truth" would typically refer to objective measurements of mechanical properties (e.g., pull-out strength, degradation rate) from performance testing and clinical outcomes (e.g., successful reattachment, lack of adverse events) from clinical studies. The specific methods for establishing these are not detailed.
8. Training Set Sample Size: Not applicable since this is a physical device, not an AI/ML algorithm that requires a training set in the conventional sense.
9. Ground Truth for Training Set: Not applicable.

Based on the provided document, here is the most accurate response to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that performance testing and clinical studies demonstrated these, but does not provide specific quantitative acceptance thresholds or detailed performance metrics.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The document only generally refers to "performance testing and clinical studies."

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

• This information is not provided in the text. For a physical implant, "experts" in establishing ground truth would typically refer to surgeons or pathologists involved in clinical assessments, or engineers/scientists performing laboratory tests. Their specific roles or numbers are not mentioned.

4. Adjudication Method for the Test Set:

• Not applicable/mentioned. Adjudication methods like 2+1 or 3+1 are common in studies involving subjective interpretation (e.g., imaging reads by multiple radiologists) where expert consensus is needed. This document pertains to a physical implant where the "ground truth" would be more objective (e.g., mechanical test results, clinical outcomes).

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

• No, an MRMC comparative effectiveness study is not mentioned or implied by the document. This type of study is more relevant for diagnostic imaging AI devices where human readers' performance with and without AI assistance is compared. The Bionx Bankart Tack is a physical implant.

6. If a Standalone Performance Study was done:

• Yes, implicitly. The document states "performance testing and clinical studies have demonstrated..." This suggests standalone evaluations were conducted to assess the device's mechanical, material, and functional properties independent of direct human-AI interaction comparisons. However, the details of these standalone studies (methodology, results) are not provided.

7. The Type of Ground Truth Used:

• For the performance testing, the ground truth would likely be based on:
  • Objective Measurements: Mechanical properties (e.g., pull-out strength from bone, degradation rate) assessed in laboratory settings.
  • Biocompatibility Assessments: Standardized tests for material interaction with biological systems.
• For clinical studies, the ground truth would likely be based on:
  • Clinical Outcomes Data: Successful tissue reattachment, stability of the joint, absence of complications, healing assessed through follow-up examinations (e.g., imaging, physical exams).

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

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

• Not applicable, as there is no "training set" for this physical device.

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The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.

The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.

The DRTS™ Drape is a sterile plastic bag to cover the DRTS™ Dual Radiation Targeting System. The drape contains an optically flat clear window that will allow undistorted transmission of the laser beam from the DRTS™ to the patient.

I am unable to provide a comprehensive answer to your request because the provided text describes a 510(k) Pre-Market Notification for a medical device called the "MINRAD DRTS™ Drape." This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined for an AI/algorithm-based device.

Here's why and what I can extract:

• No Acceptance Criteria or Performance Data: The 510(k) summary explicitly states: "Any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This indicates that a detailed performance study with quantifiable acceptance criteria and reported device performance, as you'd expect for an AI algorithm, was not conducted or required for this type of submission. The focus is on demonstrating that the new device is essentially the same as a legally marketed predicate.
• Device Type: The DRTS™ Drape is a sterile plastic bag (equipment drape) designed to prevent contamination of another device (DRTS™ Dual Radiation Targeting System). It's a physical, disposable accessory, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "test set," "ground truth," "MRMC study," "standalone performance," "training set," and "adjudication method" as applied to AI/algorithms do not apply to this product.

What I can provide based on the given information:

Since the request asks for specific sections, I will structure the answer by addressing each point, even if the information is not present or applicable.

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

Explanation: The 510(k) submission for the DRTS™ Drape focuses on demonstrating substantial equivalence to existing predicate devices (Microtek Medical, Inc. Large C-Arm Drape Product Number 4982 and Contour Fabricators Number CFI-600, equipment drape). The document explicitly states that "any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This implies that extensive performance testing with specific acceptance criteria, as one would see for a novel diagnostic or therapeutic device, was not deemed necessary for this classification. The primary "performance" is that it functions as an equipment cover without introducing new risks.

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: Not applicable / Not reported.
• Data Provenance: Not applicable.

Explanation: As this is a sterile equipment drape, not a data-driven diagnostic or AI device, there was no "test set" in the context of data analysis. The submission focuses on physical characteristics and intended use.

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)

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

Explanation: Ground truth establishment is relevant for tasks involving interpretation (e.g., image analysis, diagnoses). An equipment drape does not require "ground truth" to be established by experts.

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

• Adjudication Method: Not applicable.

Explanation: Adjudication is used to resolve disagreements in expert interpretations for establishing ground truth. This is not relevant for an equipment drape.

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

• MRMC Study: No.
• Effect Size: Not applicable.

Explanation: MRMC studies are for evaluating interpretative performance, often of AI-assisted systems versus unassisted human readers. This concept does not apply to a sterile equipment drape.

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

• Standalone Performance Study: No.

Explanation: The device is a physical drape, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept.

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

• Type of Ground Truth: Not applicable.

Explanation: Ground truth refers to the true state or outcome being predicted or interpreted. For an equipment drape, the "truth" is its ability to cover and provide a sterile barrier, which is evaluated through physical properties and sterilization validation, not expert consensus on an interpretation task.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not reported.

Explanation: This device is not an AI/machine learning model, so there is no "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Explanation: As there is no training set, there is no ground truth establishment for one.

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The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). FOR IN VITRO DIAGNOSTIC USE.

The Ribosomal P ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Ribosomal P in human sera. The Ribosomal P ELISA test is an enzyme linked immunosorbent assay to detect IgG, M, A, antibodies to Ribosomal P. Purified Ribosomal P antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman IgG, M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Ribosomal P ELISA Test Kit:

Acceptance Criteria and Reported Device Performance

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