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Synthes RIA System is intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis.

Synthes RIA System is a flexible intramedullary reaming and bone harvesting device with simultaneous irrigation and aspiration that consists of disposable tube assemblies, disposable reamer heads, disposable drive shaft seal, disposable locking clip, disposable graft filter and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation as well as the harvesting of bone and bone marrow, and as part of the treatment regimen for osteomyelitis.

The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the typical sense of a performance evaluation with metrics like sensitivity, specificity, etc. This document is a 510(k) summary for the Synthes RIA System, focused on establishing substantial equivalence to a predicate device and expanding its indications for use.

Instead of a traditional performance study, the substantial equivalence assertion is supported by a literature review demonstrating existing clinical practice and outcomes related to the expanded indications.

Therefore, many of the requested fields cannot be directly answered, as the nature of the submission is not a device performance study against predefined metrics.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly defined in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) revolve around demonstrating that the expanded indications for use (osteomyelitis treatment and adolescent use) are substantially equivalent to existing, legally marketed practices or devices.
• Reported Device Performance: No quantitative performance metrics are reported. The "performance" is implicitly demonstrated through the cited literature, which describes successful clinical application of intramedullary reaming and bone harvesting in the contexts of osteomyelitis and adolescent patients.

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

• Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the collection of patients from various retrospective studies and case studies cited in the literature review.
  • For osteomyelitis: 18 patients (Lidgren L, Torholm C), 25 patients (Ochsner PE, Gosele A, Buess P), 32 patients (Pape H-Ch, et. al.), 2 patients (Ilyas AM, Mudgal CS), 1 patient (Bellapianta J, et. al.), 11 patients (Zalavras CG, Sing A, Patzakis MJ), 1 patient (Cobbs KF) - with some overlap as Pape and Lidgren studies also reference adolescents.
  • For adolescent use: 5 patients (Mehlman CT, Bishai SK), and "several" patients in other cited articles (Gordon JE, et. al.; Jencikova-Celerin L, et. al.; Keeler KA, et. al.), plus the adolescent patients from the Pape and Lidgren osteomyelitis studies.
• Data Provenance: Predominantly retrospective analyses and case studies, as clearly stated in the descriptions of the cited literature. The countries of origin are not specified for most studies, but the authors' names suggest a mix of international research.

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

• Number of Experts: Not applicable. Ground truth was not established by a panel of experts for a novel test set in this context. The "ground truth" is implied by the clinical outcomes reported in the independent literature, which would have been assessed by the clinicians (e.g., surgeons, radiologists) involved in those studies.
• Qualifications of Experts: Not specified for the individuals who originally published the cited literature. Presumably, they are orthopedic surgeons or similar medical specialists based on the nature of the research.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no formal adjudication process for a "test set" in this submission. The clinical findings and conclusions of the referenced peer-reviewed articles serve as the evidence.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on demonstrating substantial equivalence through literature review, not on comparing the device's diagnostic or treatment effectiveness against a standard or human readers with AI assistance.
• Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no such study was performed or presented.

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

• Standalone Performance Study: Not applicable. The Synthes RIA System is a manual surgical instrument, not an AI algorithm or a device requiring standalone performance metrics in this sense. Its effectiveness is intrinsically linked to its use by a human surgeon.

7. The Type of Ground Truth Used

• Type of Ground Truth: Clinical outcomes and expert observations documented in published medical literature (retrospective analyses, case studies). This can be categorized as a form of "outcomes data" and "expert consensus" derived from independent clinical research. For osteomyelitis, the ground truth would be the diagnosis and successful treatment (e.g., infection eradication, bone healing) reported by the treating clinicians in the cited studies. For adolescent use, it refers to the successful application of intramedullary reaming in this age group as reported in the literature.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The submission relies on existing clinical literature to support its expanded indications, not on a data-driven model.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device submission.

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Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.

Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads, tube assemblies, drive shaft seals and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The RIA System is also designed to harvest bone and bone marrow. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA System is available in various lengths and diameters.

The provided text is a 510(k) summary for the Synthes (USA) Reamer Irrigator Aspirator (RIA) System and a letter from the FDA regarding its substantial equivalence. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in terms of diagnostic accuracy or effectiveness metrics.

The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed clinical performance study with specific acceptance criteria and performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information from the given input. The document confirms that the device is substantially equivalent to existing devices and outlines its intended use, but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.

Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA device is available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm.

Here's an analysis of the provided text regarding the Synthes Reamer Irrigator Aspirator (RIA) System, focusing on acceptance criteria and study information:

Analysis of Acceptance Criteria and Device Performance Study

The provided document is a 510(k) summary for the Synthes (USA) Reamer Irrigator Aspirator (RIA) System (K013527). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific performance metrics and acceptance criteria as might be seen for novel high-risk devices.

Therefore, the document does not contain explicit acceptance criteria or a study demonstrating the device meets those criteria in the way envisioned by the prompt's structured questions. Instead, the "study" is the comparison to the predicate device, K993335 (Synthes (USA) Reamer Irrigator Aspirator (RIA) System). The primary "acceptance criteria" in a 510(k) context for a device like this are that it is substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness information to the predicate device.

Given this, I will address the prompt's questions based on the information available and clarify what is not present in a standard 510(k) for a device of this type.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit, quantitative acceptance criteria with specific performance metrics are not typically found in a 510(k) summary for devices like the Synthes RIA System, which relies on substantial equivalence to a predicate. The "performance" demonstrated is that the modified device performs as intended and is substantially equivalent to its predecessor.

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

• Sample Size: Not applicable in the context of this 510(k) submission. There was no "test set" of patients or cases in a clinical study sense. The demonstration of substantial equivalence is based on device description, technical specifications, and comparison to the predicate.
• Data Provenance: Not applicable. No clinical data or patient data is mentioned or used for this 510(k) clearance.

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

• Not applicable. No "test set" or external experts were used to establish ground truth for a performance study. Clinical expertise during the FDA review process would be from FDA reviewers evaluating the submission.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. The Synthes RIA System is a mechanical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human improvement with AI assistance is entirely irrelevant to this device.

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

• Not applicable. As noted above, this device is a mechanical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable in the clinical study sense. The "ground truth" for a 510(k) in this context is the established safety and effectiveness of the predicate device, which the new device is compared against.

8. The Sample Size for the Training Set

• Not applicable. As a mechanical surgical instrument, there is no "training set" in the machine learning or AI context. Device design and engineering principles, along with manufacturing standards, guide its development.

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

• Not applicable. There is no training set for this type of device.

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Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.

The RIA System consists of two types of components; a series of disposable reamer assemblies and reusable drive shafts. The RIA is a device designed for expedited reaming of a medullary canal in preparation of internal fixation. The device includes a free rotating reamer head connected to the distal end of the manifold/tube assembly. The manifold allows both irrigation and aspiration during the reaming process. Irrigation is passed through the cannulation of the reamer and aspiration is drawn from the rear of the flutes in the reamer. The RIA coupled with the Drive Shaft serves as a flexible reaming device and is available in reaming diameters ranging from 9 mm to 24 mm and range in 200 mm to 550 mm in effective reaming lengths.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or how ground truth was established.

The document is a 510(k) summary for the "Synthes Reamer/Irrigator/Aspirator (RIA) System," which primarily focuses on regulatory approval, substantial equivalence to predicate devices, and intended use. It does not contain details about performance testing or clinical studies in the context of acceptance criteria.

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