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The Synthes Metallic Spiked Washers are indicated for ligament reattachment or fixation.

The Synthes Metallic Spiked Washers are washers of various sizes with metal spikes arrayed around a center hole.
The Synthes Spiked Washers are available in either implant quality 316L stainless steel or CP titanium. The washer for use with 2.7 mm screws has an inner diameter of 3.2 mm and an outer diameter of 9.0 mm. The washer for use with 3.5 mm and 4.0 mm screws has an inner diameter of 4.0 mm and an outer diameter of 13.5 mm. The washer for use with 4.5 mm and 6.5 mm screws has an inner diameter of 5.5 mm and an outer diameter of 13.5 mm. The smaller washer has six spikes while the two larger washers with an outer diameter of 13.5 mm both have eight spikes.

The provided document, K013806, is a 510(k) Premarket Notification for the Synthes Metallic Spiked Washers, dated February 8, 2002. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a new clinical trial with specific performance criteria.

Therefore, the document does not contain acceptance criteria or a study designed to prove the device meets such criteria.

Here's why and what information is provided:

• Substantial Equivalence: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
• No Specific Performance Study: The document explicitly states: "Documentation was provided which demonstrated the Synthes Metallic Spiked Washers to be substantially equivalent to other legally marketed devices." It does not describe a performance study with acceptance criteria as would be found in a PMA (Premarket Approval) submission or a device undergoing clinical trials to establish its efficacy and safety against predefined metrics.

Based on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not applicable for a 510(k) submission focused on substantial equivalence.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Information that is available in the document:

• Device Name: Synthes Metallic Spiked Washers
• Indications for Use: The Synthes Metallic Spiked Washers are indicated for ligament reattachment or fixation.
• Materials: Stainless Steel and Titanium (either implant quality 316L stainless steel meeting ASTM F138 or CP Titanium meeting ASTM F67).
• Device Description: Washers of various sizes with metal spikes arrayed around a center hole.
  • Washer for 2.7 mm screws: inner diameter 3.2 mm, outer diameter 9.0 mm, six spikes.
  • Washers for 3.5 mm and 4.0 mm screws / 4.5 mm and 6.5 mm screws: inner diameter 4.0 mm / 5.5 mm, outer diameter 13.5 mm, eight spikes.
• Predicate Devices: Synthes Spiked Washer (K971447) and Synthes Titanium Locked Spiked Washer (K972778), highlighting similar indications, modifications, features, and size ranges.
• Sterilization: Provided either sterile or non-sterile. Non-sterile devices must be sterilized before use (parameters in Attachment I(b)), with steam sterilization recommended for a Sterility Assurance Level (SAL) of 10^-6. Intended for single use only.

Essentially, a 510(k) submission largely relies on comparing the new device against existing, cleared devices rather than conducting new performance studies with detailed acceptance criteria and ground truth establishment.

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Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

The Spiked Washer is available in the following sizes: 8.0 mm OD / 3.2mm ID (6 spikes), 13.5 mm OD / 4.0 mm ID (8 spikes), and 13.5 mm OD / 6.0 mm ID (8 spikes). The spikes provide a link between the washer and the ligament, with flats at the base of each spike to limit penetration into the ligament and prevent excessive compression. The Spiked Washer is manufactured from a polyetheretherketone resin containing 6% barium sulfate.

The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the Synthes Spiked Washer. It primarily discusses the device description, intended use, material, classification, and substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data against a set of acceptance criteria.

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The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

The Acufex® Washer Systems are used in fixation of soft tissue to bone. The systems include various style polyacetal (with a titanium ring) or titanium washers and titanium screws. The screws are available with a diameter range from 4.5 to 9 mm and 18 to 70 mm in length. Various washers have spikes to engage to bone. Suture spiked washers are designed with spikes for engagement to bone and suture holes to secure suture tendon construct. Also, suture washers are used to secure suture tendon construct to bone.

The provided text is a 510(k) summary for a medical device called the Acufex® Washer System. It describes the device, its indications for use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.

However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. This type of information is typically found in the test reports and clinical data sections of a full 510(k) submission, which are not typically included in the publicly available summary.

Therefore, I cannot fulfill your request to create the table and answer the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

To answer your questions, I would need a different type of document, such as a detailed clinical study report or a design verification and validation report for the device.

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The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

The DePuy OrthoTech Spiked Washer is a circular device with eight inferior (fixative surface) spikes and a central hole for screw insertion. The DePuy OrthoTech Spiked Washer is manufactured from polyacetal polymer and is available in two outer diameters, 8mm and 13.5mm.

The provided text is a 510(k) premarket notification for a medical device called the DePuy OrthoTech Spiked Washer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable to the information contained in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the sense of predefined thresholds for performance metrics from a clinical study. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is a comparison of its design, material, and intended use with the predicate devices.

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

• Sample Size: Not applicable. This submission is not based on a clinical test set with human or animal subjects that would have a "sample size." It relies on a comparison of device characteristics.
• Data Provenance: Not applicable. The data primarily consists of design specifications and regulatory information for the proposed device and its predicates.

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

• Not applicable. There was no "test set" in the traditional sense of a dataset requiring expert interpretation. The ground truth is established by the design specifications and technical characteristics of the devices themselves.

4. Adjudication method for the test set

• Not applicable. No adjudication method was used as there was no test set requiring interpretation or consensus among 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

• Not applicable. This is not an AI-assisted device and 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.

7. The type of ground truth used

• The "ground truth" in this context is the design specifications, material composition, and stated intended use of the DePuy OrthoTech Spiked Washer and its identified predicate devices (Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer and Synthes® Spiked Washer). Substantial equivalence is established by comparing these fundamental attributes.

8. The sample size for the training set

• Not applicable. There is no training set in the context of this 510(k) submission.

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

• Not applicable. There is no training set for which ground truth would need to be established.

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The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.

Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.

I am sorry. This document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It only contains a 510(k) summary for a medical device called Acufex® Tibial Anchor Screw & Spiked Washer, which describes its features and compares it to similar devices already on the market.

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