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The cannulas/needles for anesthesia and analgesia enhanced for ultrasound visibility - Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter.

The Spectra Sonic Block Needles consist of a stainless steel needle and a clear standard female Luer locking hub. The needles are available in a range of needle tip configuration, gauges and lengths to match the end-user need. These needles have an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Sonic Block Needles will be marketed as sterile, non-pyrogenic, and single use devices.

The needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles / cannulas may be used during all anesthesia and analgesia procedures according to the physician's indication.

Needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are standard needles /cannulas equipped with dimpled echogenic tip in order to significantly enhance ultrasound visibility. This surface technology allows for a variety of sizes. The inner diameter is not effect by the echogenic treatment. This feature completely encircles the tip of the needles / cannulas so all sides appear bright under ultrasound. In order to enhance ultrasound visibility, the needles / cannulas are equipped with a special dimpled pattern named Sonic Block dimples to the needles / cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.

This document is a 510(k) premarket notification for a medical device, specifically anesthesia conduction needles (Spectra Sonic Block Tuohy, Quincke, Chiba, and Crawford needles). It aims to demonstrate substantial equivalence to a predicate device (Pajunk Medical Systems, K113207).

The information provided does not describe an AI medical device or a study involving AI assistance for human readers. Instead, it focuses on the physical and performance characteristics of a traditional medical device (needles) to prove its substantial equivalence to an already marketed device. Therefore, many of the requested items related to AI system acceptance criteria, MRMC studies, standalone algorithm performance, and ground truth establishment for AI training/test sets are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the studies performed to prove it meets those criteria, within the context of a traditional medical device submission.

Here's the breakdown of the available information:

Device: Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba, and Spectra Sonic Block Crawford Needles

Type of Device: Anesthesia Conduction Needles (Class II, Product Code: BSP)

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

The document doesn't present a formalized "acceptance criteria" table in the way one might typically see for an AI device (e.g., minimum sensitivity, PPV). Instead, it demonstrates performance by meeting established medical device standards and showing equivalence to a predicate device. The performance data effectively serve as proof of meeting implicit acceptance criteria related to safety and efficacy for this type of device.

• Standard ISO Luer hubs (in accordance with ISO 594)
• Needle bond strength (in accordance with ISO 7864)
• Stiffness and breakage (in accordance with ISO 9626) |
  | Material Compatibility & Safety | Cannula: 304 Stainless Steel (Same as predicate)
  Square Hub: Polycarbonate (Same as predicate)
  Protector: LDPE (Same as predicate)
  Adhesive: Epoxy (Same as predicate)
  Claims: Does not pose a chemical hazard, device does not contain a thermal source, device does not admit any form of radiation, device does not contain an electrical source. |
  | Dimensional Specifications | Tip Configurations: Tuohy, Beveled (Chiba & Facetted), Crawford, Quincke (Identical to predicate)
  Lengths: 20mm-180mm for all types (Identical to predicate)
  Diameters (Gauges): 16G-26G for all types (Identical to predicate)
  Needle Bevels: Tuohy (8°), Crawford (45°), Quincke (16°), Chiba (30°) (Identical to predicate) |
  | Intended Use | "Intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter." (Substantially similar to predicate). |
  | Echogenicity (Ultrasound Visibility) | Enhanced for ultrasound visibility using a "dimpled echogenic tip" named "Sonic Block dimples" designed to optimally reflect ultrasonic waves. (Different method from predicate's "CornerStone" but functionally similar/improved). |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes performance testing for a physical medical device (needles), not a machine learning model's test set. Therefore, "sample size" refers to the number of needles or materials tested according to various ISO and AAMI standards. The exact number of samples for each specific test (e.g., how many needles for bond strength, how many material samples for biocompatibility) is not detailed in this summary. It states that "The Spectra Medical Devices, Inc. Sonic Block Needles passed all tests."

• Data Provenance: Not applicable in the context of clinical data for an AI model. The tests are laboratory-based performance validations.

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)

This is not applicable as the document describes a physical medical device (needles) and its performance against engineering and biocompatibility standards, not an AI model requiring expert ground truth for interpretation.

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

Not applicable. This is for assessing clinical performance in AI, not for physical device testing.

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 device is a needle, not an AI system. There is no human reader assistance component.

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, not an algorithm.

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

Not applicable to this type of device submission. The "ground truth" for this device's performance is established by compliance with recognized international standards (ISO, AAMI) for mechanical, biological, and sterility properties. For example, the "ground truth" for bond strength is the force required to meet the ISO 7864 standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no "training set."

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

Not applicable. Since there is no training set for an AI model, there's no ground truth for it.

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The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or an extension set.

The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle consists of a stainless steel needle and a clear or colored (translucent) standard female Luer lock square or round Hub locking connector for rapid (flashback) visualization. The stainless steel needles are available with and without an echogenic feature (i.e. mechanical dimpling treatment to the needle point surface), and with or without lubrication. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need (16 to 30 gauges).

The provided document is a 510(k) summary for a medical device (SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance in the context of AI/ML or diagnostic accuracy.

Therefore, many of the requested categories for AI/ML study details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific performance metrics (like sensitivity, specificity, AUC), are not applicable or available in this document. This document describes a traditional medical device, not an AI/ML system.

However, I can extract information related to the performance data presented to support the substantial equivalence claim.

Here's the information derived from the document:

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance, but rather lists the mechanical and biocompatibility tests performed and concludes that the device "exhibited comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable."

• ISO 594-1 (Luer Fittings)
• ISO 7864:11 (Sterile hypodermic needles)
• Luer compatibility
• Hub and Needle Strength
• Penetration Force | "Exhibited comparable mechanical and functional characteristics to the predicate device." The device's performance in these tests was deemed acceptable and comparable to the predicate device, supporting substantial equivalence. |
  | Biocompatibility Testing | - ISO 10993-5: Cytotoxicity Study Using the ISO Elution Method
• ISO 10993-4: In Vitro Hemolysis Study (Modified ASTM-Extraction Method)
• ISO 10993-11: USP and ISO Systemic Toxicity Study - Extracted
• ISO 10993-10: ISO Intracutaneous Study - Extract
• ISO 10993-10: ISO Maximization Sensitization Study - Extract | "Biocompatible acceptable." The product contact materials were "well characterized chemically and physically," and test results confirmed "compliance with ISO 10993 requirements." |
  | Sterility | "Supplied Packaged Sterile" | The device is supplied as sterile. (Sterilization method: EO (Ethylene Oxide)) |

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

• Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the following performance data was provided" without specifying the number of units tested for each mechanical or biocompatibility assessment.
• Data Provenance: Not specified. This is a submission to the FDA for a new device, so the testing would have been conducted by the manufacturer or their contracted labs. No information about country of origin of data (e.g., patient data) is relevant here as this is a physical device. The studies are prospective in the sense that they were conducted for this specific submission.

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

• This is not applicable for this type of medical device submission. Ground truth in the context of diagnostic accuracy or AI/ML is not relevant here. The "truth" for mechanical and biocompatibility tests is based on the results of validated laboratory methods and adherence to international standards (ISO, ASTM).

4. Adjudication method for the test set

• This is not applicable. No human interpretation or adjudication common in AI/ML validation studies is mentioned. The assessment is based on objective laboratory measurements against established standards.

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. The device is a physical anesthesia needle, 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

• This is not applicable. The device is a physical anesthesia needle, not an algorithm.

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

• The "ground truth" for the performance data in this context refers to established international standards and validated laboratory test methods (e.g., ISO 594-1, ISO 7864:11, ISO 10993 series). The device's characteristics were measured against these standards to demonstrate compliance and comparability to the predicate.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.

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

• This is not applicable. There is no "training set" or corresponding ground truth.

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Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.

The Spectra Soft Tissue and Aspiration Biopsy Needles consist of a stainless steel needle and a translucent standard female Luer locking hub. A stylet rod assembly mates with the needle hub assembly. A depth stop is integral with each needle type to facilitate depth placement. The needle assembly is covered by a translucent removable needle guard. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Needles are available with an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Soft Tissue Biopsy Needles will be marketed as sterile, non-pyrogenic, and single use devices.

The provided document is a 510(k) Premarket Notification from the FDA for Spectra Soft Tissue Biopsy Needles. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria for device performance as would be expected for an AI/CADe device.

Therefore, the specific information requested, such as acceptance criteria table, sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not available in this document. The document describes performance testing for safety and basic functionality, not clinical performance for diagnostic accuracy.

Here's an analysis based on the information available in the document, framed against the requested items:

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

The document does not provide a table with specific acceptance criteria that relate to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a clinical study proving those criteria were met for diagnostic accuracy. Instead, it details performance tests related to material safety and mechanical functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The document describes testing of the physical biopsy needles themselves (biocompatibility, mechanical performance), not an AI/CADe system evaluated on a dataset of patient images or clinical outcomes.

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)

This information is not applicable and not provided. "Ground truth" in the diagnostic sense (e.g., presence or absence of disease in an image) is not relevant to the type of device and testing described here. The "ground truth" for the performance tests would be the established safety and mechanical standards.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for diagnostic devices to resolve discrepancies in expert interpretation, which is not the focus of this submission.

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 MRMC study was done. This device is a physical biopsy needle, not an AI/CADe system.

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

A standalone performance study, as understood for AI/CADe systems, was not conducted because this is a physical medical device. The "standalone" performance here refers to the physical and chemical characteristics of the needle itself.

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

For the biocompatibility tests, the "ground truth" is defined by the regulatory standards and recognized biological responses to materials (e.g., no cytotoxicity, no sensitization). For mechanical tests, the "ground truth" is adherence to established engineering standards (e.g., ISO 594 for Luer hubs, bond strength specifications). No patient-level diagnostic "ground truth" (pathology, expert consensus) is involved in this documentation.

8. The sample size for the training set

This information is not applicable and not provided. There is no AI algorithm being trained.

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

This information is not applicable and not provided because there is no AI algorithm being trained.

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The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.

Spectra Medical's Device, Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule.

This document is a 510(k) summary for a medical device: Spectra Medical's Sodium Chloride Injection, 0.9%, USP 5 mL, 10 mL Ampule.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

This document describes a pharmaceutical product (sterile saline solution for flushing), not an AI/ML powered medical device. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for low-risk medical devices in the US. This pathway typically involves comparing the new device's indications, technological characteristics, and performance data to a legally marketed predicate, rather than conducting new performance studies with specific acceptance criteria that would be relevant for an AI/ML system.

Therefore, I cannot populate the requested table and answer the study-related questions, as they are not applicable to the content of this 510(k) summary. The document explicitly states:

• "There has been no change to the performance characteristics of the device system." (Section 6)
• "There has been no change to the fundamental scientific technology." (Section 7)

These statements indicate that no new performance studies (of the kind expected for an AI/ML device) were conducted or are being presented in this submission. The device is claimed to be "identical to the predicate device" with only a difference in ampule size.

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The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.

Spectra Medical's, Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule

This document is a 510(k) summary for a medical device called "Sodium Chloride Injection, 0.9%, USP, 10 mL Ampule" by Spectra Medical. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance data from a specific study. Therefore, most of the requested information about acceptance criteria and a study proving their fulfillment is not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This document does not specify any acceptance criteria or report new performance data for Spectra Medical's device. The core argument for clearance is "substantial equivalence" to a predicate device (K023740 - Syrex Pre-filled Syringe with 0.9% Sodium Chloride).

The document explicitly states:

• "There has been no change to the performance characteristics of the device system."
• "There has been no change to the fundamental scientific technology."
• "Spectra Medical's Chloride Injection, 0.9%, USP, 10 mL Ampule is identical to the predicate device. The difference is that the Spectra medical product is in a 10 mL ampule whereas the predicate device is in a syringe."

Therefore, no acceptance criteria or new reported performance are provided for this specific submission as it relies on the predicate device's established performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No test set or new data is presented in this 510(k) summary. The submission relies on the existing data and performance characteristics of the predicate device.

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):

Not applicable. No new test set or ground truth establishment is described.

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

Not applicable. No new test set or adjudication process is 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:

Not applicable. This device is a Sodium Chloride Injection, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.

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

Not applicable. This device is a Sodium Chloride Injection, not an algorithm.

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

Not applicable. No new ground truth was established for this submission. The "truth" for this submission is that its formulation and intended use are identical to a legally marketed predicate device, with only a change in packaging (ampule vs. syringe).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

In summary:

This 510(k) submission is for a device that is considered "substantially equivalent" to a previously cleared predicate device. The basis for this equivalence is that the product (0.9% Sodium Chloride Injection) is identical to the predicate device in terms of its composition, performance characteristics, and fundamental scientific technology. The only difference highlighted is the packaging (10 mL ampule vs. syringe). Therefore, no new clinical studies, performance data, or detailed acceptance criteria are presented in this document for the Spectra Medical device itself, as it is deemed to meet the established safety and effectiveness of its predicate.

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The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.

Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewwire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.

The provided text describes the submission of a 510(k) premarket notification for the Spectra Guidewire Introducer Needle, arguing its substantial equivalence to predicate devices rather than claiming novel effectiveness. Therefore, the document does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating that the device is safe and effective for its intended use by meeting established standards and exhibiting similar technological characteristics to legally marketed predicate devices.

Here's a breakdown based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions that "The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices." However, the specific quantitative acceptance criteria (e.g., tensile strength, flow rates, sharp-ness specifications) and the precise reported performance values are not detailed in the provided text.

The acceptance criteria are generally framed around adherence to recognized standards for medical devices and comparison to predicate devices, rather than novel performance benchmarks.

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

The document states that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." However, the sample size used for the test set (i.e., how many devices were tested for performance, how many units of materials, etc.) is not specified.

Regarding data provenance, the testing would have been conducted by Spectra Medical Devices, Inc. or contractors they employed, likely in the US (given the company's address in Wilmington, Massachusetts). The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, not from a prospective clinical trial on human subjects. The type of data is primarily in vitro and bench testing data to demonstrate compliance with standards and equivalence.

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

This type of information is not applicable in this context. The "ground truth" for a medical device like an introducer needle in a 510(k) submission is established by engineering specifications, material standards, and comparisons to legally marketed predicate devices, not by expert consensus on clinical findings. Performance is measured against physical and chemical parameters, not against interpretations of medical images or patient outcomes by experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert assessment of data (e.g., radiology reads). In the context of a 510(k) for an introducer needle, "adjudication" is not a standard part of the device's technical performance testing. Device performance is determined by meeting pre-defined physical and material specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with AI assistance. The Spectra Guidewire Introducer Needle is a physical surgical instrument, not a diagnostic imaging device or an AI algorithm intended to assist human interpretation.

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

No, this is not applicable. The Spectra Guidewire Introducer Needle is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For this device, the "ground truth" for performance assessment is primarily based on:

• Established engineering specifications and material standards: These define what constitutes acceptable strength, biocompatibility, sterility, dimensions, etc. (e.g., ISO 11135, ISO 10993).
• Performance characteristics of predicate devices: The "ground truth" for equivalency is that the new device performs similarly to legally marketed devices that have already been deemed safe and effective. This is assessed via various physical and chemical bench tests (e.g., material compatibility, physical dimensions, functional tests implicitly covered by "design, materials, and method of use").

There is no "pathology" or "outcomes data" ground truth in the context of this 510(k) submission to demonstrate substantial equivalence of a guidewire introducer needle. Clinical outcomes would typically be part of a PMA (Premarket Approval) submission for a novel, high-risk device.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an algorithm or AI model. As established, this device is a physical medical instrument, not a software or AI product.

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

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

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The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.

Spectra, GLASS LOR SYRINGE

This document is a 510(k) clearance letter from the FDA for a medical device called "Spectra, GLASS LOR SYRINGE". This type of letter generally does not include detailed study results, acceptance criteria, or performance data beyond stating that the device is substantially equivalent to a predicate. The letter confirms the device can be marketed based on its equivalence.

Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be available in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. This document is an FDA clearance letter based on substantial equivalence, not a detailed study report. It does not contain specific acceptance criteria or performance metrics beyond the general statement of substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The 510(k) letter does not include details about specific test set sample sizes or data provenance.

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)

• Cannot be provided. Information on expert involvement for ground truth establishment for a test set is not present in this regulatory clearance letter.

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

• Cannot be provided. Details on adjudication methods are not included in this document.

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

• Cannot be provided. This device is a "GLASS LOR SYRINGE" (Loss of Resistance Syringe), a physical medical device. It is not an AI algorithm, and therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or performed for this product.

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

• Cannot be provided. As a physical syringe, the concept of "standalone algorithm performance" is not relevant.

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

• Cannot be provided. This information is not part of an FDA clearance letter for a physical device. For a device like a syringe, performance is typically assessed through physical and mechanical testing against recognized standards or direct comparison to a predicate, rather than through complex ground truth establishment methods relevant to diagnostic algorithms.

8. The sample size for the training set

• Cannot be provided. As this is a physical device and not an AI algorithm, there would be no "training set" in the computational sense.

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

• Cannot be provided. This is not applicable to a physical device.

Summary based on the provided text:

The provided document is an FDA 510(k) clearance letter for the "Spectra, GLASS LOR SYRINGE." This letter indicates that the device has been deemed substantially equivalent to legally marketed predicate devices. The basis for this determination is typically a comparison of the device's technological characteristics and performance to those of the predicate.

While the letter confirms the device meets the regulatory requirements for market entry, it does not contain the detailed study data, acceptance criteria, or performance reports that would include information on sample sizes, expert involvement, ground truth establishment, or specific metrics like sensitivity, specificity, or effect sizes. Such detailed information would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.

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The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.

The provided text is a 510(k) summary for the SPECTRA-LOR, Loss of Resistance Syringe. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific acceptance criteria.

The document explicitly states: "The SPECTRA-LOR, Loss of Resistance Syringe is equivalent to the predicate device, AVID-NIT Loss of Resistance Syringe in materials of construction, intended use, capacity and bench testing." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device, rather than new studies proving pre-defined acceptance criteria for the SPECTRA-LOR syringe's performance.

Therefore, I cannot provide the requested information from the text.

If this were a typical AI device submission, the response would look like this (but based on the actual information provided, such details are absent):

1. Table of Acceptance Criteria and Reported Device Performance
(No specific acceptance criteria or performance metrics were provided in the document for the SPECTRA-LOR syringe. Its approval is based on substantial equivalence to a predicate device.)

2. Sample Size Used for the Test Set and Data Provenance
(Not applicable, as no dedicated study with a test set was described to prove specific performance metrics for the SPECTRA-LOR syringe.)

3. Number of Experts Used to Establish Ground Truth and Qualifications
(Not applicable, as no specific study involving expert-established ground truth was described.)

4. Adjudication Method for the Test Set
(Not applicable.)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
(Not applicable. This device is a physical syringe, not an AI-assisted diagnostic tool.)

6. Standalone (Algorithm Only) Performance Study
(Not applicable. This device is a physical syringe, not an algorithm.)

7. Type of Ground Truth Used
(Not applicable, as no ground truth was established for performance metrics in a study for this device.)

8. Sample Size for the Training Set
(Not applicable. This device is a physical syringe, not a machine learning model requiring a training set.)

9. How the Ground Truth for the Training Set Was Established
(Not applicable.)

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