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It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.

The ROC Lumbar Plating System is a spinal fixation system that consisting of a variety of nonsterile, single use implants that facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

This document is a 510(k) summary for the Alphatec Spine ROC Lumbar Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy). Therefore, the requested information regarding acceptance criteria, study details for device performance, expert involvement, and ground truth establishment is not entirely applicable in the context of this specific regulatory submission.

However, I can extract and interpret the available information to address your request in the most relevant way possible for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical and dynamic performance characteristics are equivalent to, or better than, predicate devices and satisfy recognized consensus standards for posterior lumbar fixation.

Study Details for Device Performance

1. Sample Size used for the test set and the data provenance:
   This submission relies on nonclinical performance data, specifically mechanical and dynamic testing. The document does not specify a "sample size" in terms of human subjects or patient data. Instead, it would refer to the number of device components or assemblies tested. This information is not provided in the summary document. The "data provenance" would be laboratory testing conducted by or for Alphatec Spine, not patient data from a specific country or retrospective/prospective study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and specifications (e.g., ASTM standards for spinal implants) and the performance of predicate devices. There wouldn't be "experts" establishing a ground truth in the same way as for diagnostic accuracy studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods typically relate to clinical trial outcomes or image interpretation where human judgment is involved. Mechanical testing results are objective measurements against defined standards.

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 device is a spinal implant, not a diagnostic or AI-powered device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

5. 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.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical and dynamic testing, the "ground truth" is established by:

   • Recognized consensus standards: These are industry-accepted standards (e.g., ISO, ASTM) that define test methods, performance requirements, and acceptable ranges for spinal implant characteristics.
   • Guidance documents: Specific FDA guidance documents, such as "Spinal System 510(k)s - Guidance for Industry and FDA Staff," provide recommendations for testing to demonstrate safety and effectiveness.
   • Predicate device performance: The performance of previously cleared, substantially equivalent devices serves as a benchmark.

7. The sample size for the training set:
   Not applicable. This device does not involve machine learning or AI, so there is no training set in that context.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

Summary of Non-Applicability:

It is crucial to understand that this 510(k) summary is for a physical medical implant (spinal plating system), not a diagnostic algorithm, AI-powered device, or a drug. The regulatory pathway for such a device primarily focuses on demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Biocompatibility: That the materials are safe for use in the human body (implicitly covered by "material composition is identical to numerous other Alphatec Spine products that have been cleared").
• Mechanical Performance: That the device can withstand the forces and stresses it will encounter in the body without failure, as demonstrated by nonclinical bench testing against established standards.

Therefore, many of the questions asked, which are highly relevant for AI/ML-based diagnostic devices or clinical effectiveness studies, do not apply to this specific 510(k) submission for a spinal implant.

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The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.

The provided text describes a special 510(k) for a modification to the Denver Pleurx Drainage Kit, focusing on changes to the vacuum bottle/drainage line assembly. The acceptance criteria and the study to prove the device meets these criteria are related to demonstrating substantial equivalence to the currently marketed product, specifically regarding flow rate and other design specifications, and applying risk management techniques.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned appear to be internal verification processes rather than clinical trials with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. The verification process seems to be based on engineering specifications and risk management, not expert consensus on patient outcomes or interpretations.

4. Adjudication method for the test set

The document does not describe any adjudication method, as there's no mention of a test set requiring adjudication by experts.

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

The document does not describe an MRMC comparative effectiveness study. The device is a medical drainage kit, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

The document does not describe a standalone algorithm performance study. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the engineering specifications and safety parameters of the device and its predicate. This is a technical ground truth related to mechanical performance and safety, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

The document does not mention a training set, as the described studies are not for machine learning or AI models.

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

Not applicable, as there is no training set mentioned.

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The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
• revision of a previously failed arthroplasty. .

The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.

The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.

The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.

This document does not contain information about acceptance criteria and a study proving a device meets these criteria. It is a 510(k) summary for a medical device (APR Metasul Acetabular Inserts) which describes the product, its intended use, and claims substantial equivalence to previously marketed devices.

There is no mention of specific performance measures, thresholds, or studies designed to assess the device against predefined acceptance criteria. Instead, the submission relies on demonstrating similarity in design, materials, sterilization, manufacturing methods, and intended use to existing cleared devices, as per the 510(k) pathway for medical device clearance in the US.

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TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain. The model 4900 series of Transcutaneous Electrical Nerve Stimulation (TENS) devices are user-interactive, microcontrolled-stimulators designed to provide lowfrequency, non-invasive electrical stimulating therapy to patients for the management of chronic, intractable pain. The model 4900 series design meets the latest electromedical standards and safety requirements, including the Performance Standard for Electrode Lead Wires and Patient Cables. The devices are microprocessor controlled and contain six preprogrammed therapy modes. The TENS devices (model 4900 series) firmware memory functions include: a nonvolatile read-only memory (ROM), last therapy recall, low battery notification and a self-check feature, which notifies the operator when a service condition exists. The ROM is designed to provide the therapy-mode accessibility, while providing the safety features, such as, zero amplitude at "startup" or when an "open channel condition is identified. The 4900 series of TENS devices are "user friendly" with a user interactive, softkey pad and a clearly visible, two-line, sixteen character, liquid crystal display (LCD) to show the operating parameters. The Model 4900S TENS device(s) are portable, personnel and designed to be easily handled with its light weight, trim (0.875" wide by 2.5" by 3.5") rectangular shaped, durable plastic shell. The device is fitted with a belt clip and can easily be worn without inhibiting the mobility of the patient. The device operates efficiently with a 9-volt battery power supply. The device delivers an output of 25 mAmp for 55 hours under a 500K Ohm load. The efficient power allocation (between the operation of the device and the electrical stimulation delivered to the patient) results from the interaction of a microcontroller; microprocessor; a crystal-controlled oscillator; RAM memory; circuit interface drivers; and a custom ROM. The crystal-controlled oscillator insures accurate timing of all pulse waveforms. The microprocessor-controller, in addition to operating the "house keeping functions", such as the LCD readouts, power on, open channel-control and the power off functions, maintains communications to the custom ROM and the variety of modalities available for the different models. The six available nreprogrammed modalities: Constant mode: SMP mode: Burst Mode: Rate Modulated Mode, Width Modulated Mode, and Multi-Modulated Mode. The physician or physical therapist may choose to use, depending on the specific model of TENS device, any one of six available modalities.

The provided document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria, sample sizes, and expert adjudications.

Therefore, the document does not contain the acceptance criteria or a study design that would typically be described for a new, innovative device proving its performance against pre-defined metrics. Instead, it relies on demonstrating that the new device (4900 Series TENS) is substantially equivalent to existing TENS devices already on the market (predicate devices).

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

• Acceptance Criteria & Reported Performance: The document describes the technical specifications and features of the 4900 series TENS devices (e.g., output current, battery life, operating modes, safety features) but does not present these as acceptance criteria for a study or report specific performance numbers against such criteria. The "Performance Standard for Electrode Lead Wires and Patient Cables" is mentioned, indicating compliance with general electromedical and safety standards, not a specific performance study.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: These elements are characteristic of a clinical investigation or a performance study where a device's efficacy or accuracy is being evaluated against a known truth. The 510(k) submission for this TENS device focuses on features, design, and comparison to predicate devices, not a clinical trial to establish new claims of effectiveness. The claim is for "symptomatic relief and management of chronic intractable pain," which is a well-established indication for TENS devices, generally supported by a body of evidence for the TENS modality itself, rather than requiring a de novo clinical study for each new model.

In summary, the provided 510(k) document is a regulatory submission for market clearance based on substantial equivalence, not a report of a study designed to prove device performance against specific acceptance criteria.

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The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).

Here's an analysis of the provided text regarding the SCIMED® Luge™ Guide Wire, focusing on the requested information.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study reports with detailed performance metrics against pre-defined acceptance criteria. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment for AI/ML models, and detailed adjudication methods, is not present in these documents. The device cleared is a guide wire, which is a medical device, not an AI/ML diagnostic tool, thus many of the AI/ML specific questions are not applicable.

Acceptance Criteria and Study for SCIMED® Luge™ Guide Wire

The SCIMED Luge Guide Wire's acceptance criteria and proven performance are based on its substantial equivalence to previously marketed SCIMED Guide Wires (ChoICE, Sceptor, and ChoICE PT Families). The study primarily involved non-clinical testing and comparison of design and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical trial demonstrating new performance metrics. The comparison is based on the design, materials, manufacturing processes, and non-clinical testing results against existing predicate devices.
• Data Provenance: The data provenance is from non-clinical testing of the Luge Guide Wire and comparison with the design specifications and known performance characteristics of the predicate SCIMED Guide Wires. This is retrospective in the sense that it relies on established data and designs of existing products. The country of origin for the data is implied to be within the US, where SCIMED Life Systems, Inc. is located.

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

• Not Applicable. This device clearance is based on substantial equivalence to predicate devices through non-clinical testing and design comparison, not on establishing a "ground truth" for diagnostic accuracy by a panel of experts.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no clinical "test set" requiring expert judgment for ground truth, no adjudication method is described. The review process is handled by the FDA based on the submitted non-clinical data and comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is not mentioned as part of this 510(k) submission. These studies are typically for AI/ML diagnostic devices where the performance of human readers with and without AI assistance is evaluated. This device is a guide wire, not a diagnostic AI/ML system.

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

• Not Applicable. This device is a physical medical instrument (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is the established safety and effectiveness profile of the predicate devices (ChoICE, Sceptor, and ChoICE PT Families of Guide Wires) in their intended use. The Luge Guide Wire's equivalence is demonstrated against this established standard through physical and engineering comparisons.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the conventional sense for model development. The design and manufacturing processes are likely informed by years of experience and testing with previous guide wire designs, but not in the format of a discrete "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, this question is not relevant.

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